Internal Auditing of Laboratory Quality Management Systems

PREAMBLE
This document provides information about the processes involved in Conducting Internal Quality System
Audits for Laboratories. A wide range of references were consulted in preparing this guide, therefore it
presents a global approach to the conduct of laboratory audits against the ISO/IEC 17025 Standard.
Laboratories are however advised that they need not restrict themselves or their staff only to what is
included in this guide.
This guidance manual is not to be used for commercial purposes.
The development of this manual on Internal Quality System Audits for Laboratories was supported by the
European Union through the 9th EDF Funded Caribbean Laboratory Accreditation Services Project (CLAS),
implemented by the CARICOM Regional Organisation for Standards and Quality (CROSQ).
For further information, please contact:
CARICOM Regional Organisation for Standards and Quality (CROSQ)

2nd Floor Nicholas House
29-30 Broad Street
Bridgetown
Barbados, W.I.
www.crosq.org
crosq.caricom@crosq.org
Authors
Giselle Guevara, BSc., MPhil, MBA
Project Coordinator
EDF Funded Caribbean Laboratory Accreditation Services Project
CROSQ
Barbados
Ing. Manfred Kindler

Accreditation Expert and Consultant
Kindler International Division
Berlin, Germany
manfred@manfredkindler.de
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Acknowledgements
The Authors are most grateful to the several persons who provided support, very useful input, feedback and
gave generously of their time in the development and production of this document. We especially wish to
thank those colleagues who reviewed the Manual and paused in their busy schedule to provide incisive
comments, helpful tips and stimulating input. Thank you for everyone who provided examples and ideas for
the content of this manual, sometimes without even knowing you were helping.
We are truly thankful and wish to recognise the contributions of Valerie Wilson and Wendy Kitson-Piggott as
Technical Editors, Michael Seepersaud, CROSQ-IDB Project Manager for assisting with the manual
publication. Thanks to Manfred Kindler who provided useful technical information, invaluable feedback and
assistance, in the production and compilation of this material.
We wish to thank CROSQ, the CARICOM Secretariat and the European Union funded CISP Project for their
contribution to the production of this guide. Preparation and Editing of this manual was a long and precise
task we therefore wish to extend our special gratitude to all who assisted and facilitated the process.
Produced and Printed with support from the European Union under the 9th EDF Fund
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INTERNAL AUDITING OF LABORATORY QUALITY MANAGEMENT SYSTEMS
Table of Contents
CHAPTER 1: QUALITY MANAGEMENT SYSTEMS FUNDAMENTALS .................................. 7

1.1 INTRODUCTION ............................................................................................................. 7
1.2 QUALITY TERMS AND DEFINITIONS............................................................................ 8
1.3 ACCREDITATION vs. CERTIFICATION ........................................................................10
CHAPTER 2: INTRODUCTION TO INTERNAL QMS AUDITING PROCESS ..........................12
2.1 INITIATING THE PROCESS...........................................................................................12
2.2 USING THE PDCA MODEL IN THE AUDIT PROCESS.................................................13
2.3 AUDITING ROLES AND RESPONSIBILITIES ...............................................................15
2.4 HORIZONTAL AND VERTICAL AUDITS .......................................................................15
CHAPTER 3: PLANNING FOR INTERNAL AUDITS .................................................................21
3.1 PREPARING THE AUDIT PLAN ....................................................................................21
3.2 DEVELOPING THE AUDIT SCHEDULE ........................................................................22
3.3 AUDITOR PREPARATION .............................................................................................23
3.4 AUDITOR COMPETENCIES ..........................................................................................26
CHAPTER 4: CONDUCTING THE INTERNAL AUDIT ..............................................................27
4.1 INITIATING THE AUDIT PROCESS ...............................................................................27
4.2 CONDUCTING THE AUDIT ............................................................................................28
CHAPTER 5: MANAGING AUDIT OUTCOMES ......................................................................30
5.1 NON-CONFORMITIES....................................................................................................30
5.2 RECORDING and REPORTING AUDIT FINDINGS .......................................................32
5.3 ROOT CAUSE INVESTIGATION ...................................................................................35
5.4 TAKING CORRECTIVE ACTION ...................................................................................36
5.5 MANAGEMENT REVIEW ...............................................................................................37
CHAPTER 6: AUDIT TOOLS ....................................................................................................38
6.1 AUDIT CHECKLIST ........................................................................................................38
6.2 AUDITOR PREPARATION .............................................................................................41
6.3 PROCEDURE FOR CONDUCTING INTERNAL AUDITS ..............................................43
6.4 CORRECTIVE ACTION RECORDING FORMAT ...........................................................46
CHAPTER 7: FAQs on LABORATORY QUALITY .............................................................47
APPENDICES ............................................................................................................................52
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LIST OF FIGURES
Figure 1 Summary of the Accreditation Application process ...................................................11

Figure 2 Overview of the Internal Audit Process ........................................................................13
Figure 3 Document Control Checklist .........................................................................................16
Figure 4 Example of a Vertical Audit checklist ...........................................................................18
Figure 5 Example of an Audit Schedule ......................................................................................22
Figure 6 Example Twenty Milestones Audit Checklist ...............................................................23
Figure 7 Competencies required for effective auditing .............................................................26
Figure 8 Example of Audit Elements ...........................................................................................28
Figure 9 Example of a Non Conformity report form ...................................................................30
Figure 10 Summary Audit report form.........................................................................................34
Figure 11 Example of a Root Cause Analysis Report ................................................................35
Figure 12 Example Audit checklist ..............................................................................................38
Figure 13 Example of a Corrective Action Form ........................................................................46
LIST OF APPENDICES
APPENDIX 1: SUMMARY OF CLAUSES IN ISO/IEC 17025 .........................................................52

APPENDIX 2: LIST OF POLICIES IN ISO/IEC 17025 ....................................................................54
APPENDIX 3: LIST OF PROCEDURES IN ISO/IEC 17025 ...........................................................55
APPENDIX 4: LIST OF SHALLS IN ISO/IEC 17025 ..................................................................57
APPENDIX 5: SAMPLE ACCREDITATION ACTION PLAN .........................................................62
APPENDIX 6: EXAMPLE OF A VERTICAL ASSESSMENT FORM (ISO/IEC 17025) ...................63
APPENDIX 7: EXAMPLE OF A FORM FOR THE WITNESSING OF TESTING ...........................63
APPENDIX 8 REFERENCE DOCUMENTS ....................................................................................64
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CHAPTER 1: QUALITY MANAGEMENT SYSTEMS FUNDAMENTALS
1.1 INTRODUCTION
The International Standards ISO/IEC 17025 - General Requirements for the Competence of
Testing and Calibration Laboratories and ISO 15189 Medical Laboratories Particular
Requirements for Quality and Competence both respectively state that a laboratory shall establish,
implement and maintain a quality system appropriate to the scope of its activities including the
type, range and volume of testing and/or calibration activities it undertakes.
Laboratory Accreditation is the formal recognition of a laboratorys technical competency to

perform specific tests, types of tests or calibrations. ISO/IEC 17025 and ISO 15189 1 accreditation
requirements are recognised internationally as defining and incorporating essential elements of a
quality management system for laboratories (ref: Appendix 1). The requirements for each stage of
the quality improvement process are described in the various clauses of the ISO/IEC 17025 and
ISO 151892. Achieving compliance with the ISO/IEC 17025 and/or ISO 15189 Standard can be
achieved in a stepwise manner that ensures efficient use of resources.
Essential components of these standards include the following:
A laboratory that operates within a Quality Management System (QMS) will have a
single QUALITY MANUAL hereafter referred to as the Manual, that contains the
documented policies for the laboratory and either includes or refers to the processes,
procedures and forms used by laboratory staff to implement the QMS throughout all
the disciplines in the laboratory
A laboratory shall periodically and in accordance with a predetermined schedule and

procedure, conduct internal audits of its activities to verify that its operations continue
to comply with the requirements of the quality system and the Standard (ISO
17025/15189 clause 4.14)
Laboratory standards mandate that the laboratorys internal audit programme must address ALL
aspects of the quality management system and ALL requirements of the agreed Standard. The
Standard also mandates that audits be coordinated by an authorised and competent person
specifically tasked with the responsibility for overseeing the laboratorys quality improvement
initiative. Evaluations of regional laboratories have identified the need for the strengthening of
auditing skills as the thrust towards accreditation becomes more widespread.
The complexity of the auditing process depends on the size, scope and organizational structure of
the laboratory. Audits can be scheduled and conducted in a manner that involves and motivates
staff. Many of the auditing strategies outlined in this publication can be implemented in a simplified
1
This document references the ISO/IEC 17025:2005 General Requirements for the competence of Testing
and Calibration Laboratories
2
Please note that wherever Clause is mentioned in this document, it refers to a Clause of the ISO/IEC
17025 or ISO 15189 Standard
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manner. This Manual is intended to serve as a guide and training manual for laboratory staff and
managers.
Note
Periodic audits facilitate early identification of quality gaps and allow timely corrective interventions to be taken that
reduce or prevent the occurrence of laboratory errors.
1.2 QUALITY TERMS AND DEFINITIONS
In order to master the process of auditing a laboratorys Quality Management System (QMS) some
key quality concepts, terms and definitions must be understood. It is important that laboratory staff
and management understand how important audits are to both the QMS development process and
the accreditation process. Key quality terms, concepts and definitions include the following:
a. Quality Management System

A program developed to support efficient, effective, high quality and appropriate laboratory services
(e.g. accurate and precise results, appropriate test selection, timely reporting, and correct
interpretation of results, clinical usefulness, and recommendations for further investigations).
The QMS facilitates a comprehensive and coordinated laboratory effort (policies, processes and
procedures), designed to meet quality objectives and to direct and control an organization with
regard to quality. The QMS is comprised of the Quality Manual (Quality Policy, General policies,
etc), Administrative Procedures, Technical Procedures and Technical and Quality Records.
b. Policy
A brief written statement describing the laboratorys intended action with respect to the specific
requirement of the Standard.
c. Process
A series of inter-related steps involved in an activity or examination that uses resources to
transform inputs into outputs. Processes may often be linked since the output of one process is
often the input to the next. Rarely is there a process that is not linked to some other.
d. Procedure
Written work instructions that specify the way to carry out a step in the process, an activity or an
examination. Procedures describe in detail exactly how one individual should perform an activity.
e. Record
Any information that provides evidence (e.g. requisitions, examination results and reports,
instrument printouts, laboratory workbooks and worksheets, accession records, calibration records,
quality control records, records of audits, complaints and action taken, external quality assessment
records, instrument maintenance records, incident/accident reports, staff training and competency
records, personnel records).
f. Document
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Any documented information that provides direction (e.g. instructions including policy statements,
textbooks, reference intervals and their origins, procedures, specifications, calibration tables,
charts, posters, notices, memoranda, plans, software, drawings, regulations and standards).
g. Document Control
A system to regulate the handling and management of documents (including archiving, storing and
destruction), containing information that communicates policies, processes and procedures and
records. Usually refers to documents that are part of the quality management system.
h. Audit
A systematic and independent examination to determine whether quality activities and related
results comply with an agreed standard. An audit can also determine whether the standard being
used is appropriate for achieving the organisations objectives and is being implemented effectively
Note: In this document the term Internal Audit is used to emphasize that the audit is done by the
organization itself
i. Audit scope
The extent and boundaries of an audit that are usually established before the audit process begins
j. Audit plan
A description of the activities and arrangements for the conduct of an audit
k. Management review
A formal evaluation by top management of the status and adequacy of the quality system in
relation to the organisations quality policy and objectives
l. Quality management
That aspect of the overall management function that determines and implements the quality policy
m. Quality manager
The staff member (by whatever title) who has responsibility for the laboratorys quality system and
its implementation and who, in this capacity, reports directly to top management
n. Quality auditor
Person qualified to perform quality audits
o. Observation
A statement of fact made during an audit, substantiated by objective evidence
p. Objective evidence
Qualitative or quantitative information, records or statements of actions related to the quality of a
quality system activity, element or service which is based on observation, measurement or test and
which can be verified
q. Audit findings
Documented audit evidence generated by evaluation of the QMS against specified audit criteria
r. Nonconformity
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The non-fulfillment of specified requirements of the standard
s. Corrective Action
An action taken to eliminate the causes of an existing nonconformity, defect or other undesirable
situation in order to prevent a recurrence
t. Preventive Action
An action taken to eliminate the cause of a potentially undesirable result
1.3 ACCREDITATION vs. CERTIFICATION
Laboratory accreditation requires the application of assessment criteria specifically developed to

determine technical competence. These criteria are based on the international standards
ISO/IEC 17025 and ISO 15189, for Testing/Calibration and Medical Laboratories respectively.
Accreditation bodies, through specialist technical assessors, aim to ensure that your laboratorys
test data are accurate and reliable and use these standards to conduct a thorough evaluation of all
factors relevant to the laboratorys competence.
The ISO 9001 standard is widely used in manufacturing and service organizations to evaluate and
certify their management systems for controlling the quality of their products or services. The ISO
9001, however, does NOT assess the technical competence of an organisations operations and
thus cannot be used for accrediting laboratories.
Note
While laboratories may be certified to ISO 9001, such certification does not make any statement about the technical
competence of a laboratory as this standard does not contain technical requirements for laboratory personnel and
operations3.
Why Is a Laboratorys Technical Competence Critical?

Because it is important for laboratories to:
Minimise Risk
In the world today, customers seek reassurance that the products, materials or services they
produce or purchase meet their expectations or conform to specific requirements. This often
means the product is sent to a laboratory to determine its characteristics against a standard or a
specification. For the manufacturer or supplier, choosing a competent laboratory minimizes the
risk of producing or supplying a faulty product.
Avoid Expensive Retesting

Testing of products and materials can be expensive and time consuming even when they are done
correctly the first time. If not done correctly, then the cost and time involved can be even higher if
the product has failed to meet specifications or expectations and re-testing is required. This can
negatively impact the reputation of a supplier or manufacturer. Additionally, the supplier can also
3
See ISO CASCO Communiqu on Accreditation vs. Certification and ILAC Publication on Laboratory
Accreditation or ISO 9001 Certification (www.ilac.org.tt)
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be held liable for any failure of the product, particularly if it involves public safety or financial loss to
a client. Choosing a competent laboratory thus minimises the chance of retesting being required,
increase in operational costs and or exposure to legal action.
How does a Laboratory Apply for Accreditation?
Figure 1 summarises the steps in the accreditation process from the pre-audit visit to the final
award of the accreditation certificate.
Figure 1 Summary of the Accreditation Application process
Accreditation Bodys Pre-Audit

Pre-Assessment visit: initial external audit by experts from
Accreditation Body
Corrective actions completed
Application to Accreditation Body

Complete application process for accreditation to
ISO/IEC 17025 or ISO 15189
Accreditation Body Document Review

On-site Visit
Review of documents forwarded by laboratory previously
On site assessment by assessor team follows
Laboratory Corrective Actions

Cause Analysis identify the source of non conformances and
confirm corrective actions
Accreditation
Accreditation Body -vote on accreditation decision
Laboratory - receipt of accreditation certificate
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CHAPTER 2: INTRODUCTION TO INTERNAL QMS AUDITING PROCESS
2.1 INITIATING THE PROCESS

On behalf of laboratory management, the Quality Manager is responsible for ensuring that all areas
of the laboratorys activities and responsibilities covered by ISO/IEC 17025 or ISO 15189 and the
Quality Manual are audited periodically.
Audits must be planned so that all aspects of the laboratory operational procedures, including the
performance of calibrations and tests, are covered within a specified period of time. Where a
laboratory is accredited for calibration, sampling or testing at satellite sites located away from its
permanent premises, these activities must be included in the audit program.
The Quality Manager may delegate the task of performing audits provided that the person used:
1) has technical or scientific training
2) is familiar with the laboratorys quality system and accreditation requirements
3) has been trained in the techniques of auditing.
4) is, where possible, independent of the activity (i.e. auditors cannot audit their own activities
or activities for which they have direct responsibility)
Audits carried out by parties such as customers or accreditation body assessors cannot be
considered to be a substitute for, or to override the laboratorys responsibility for conducting its own
internal audit.
Internal Audits must be planned to establish that:

1 management objectives, as defined in the quality system, are met in all respects
2 all personnel, at all levels, are satisfactorily carrying out their assigned duties and
responsibilities
3 The procedures detailed in the quality system are being followed
Audits should be designed to reveal the extent of compliance with requirements in all of the
elements examined and should serve to check on the competence of personnel at all levels
Note
Where a laboratory has accreditation for calibration, sampling or testing on sites away from its permanent premises,
these activities must be included in the audit program.
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2.2 USING THE PDCA MODEL IN THE AUDIT PROCESS
A simple approach to developing an audit system for the laboratory is to use the Plan-Do-Check-
Act (PDCA) model to elucidate the steps which must be taken to ensure a thorough process as in
Figure 2 below.
Figure 2 Overview of the Internal Audit Process
ESTABLISH THE AUDIT

PROGRAMME
Objectives and extent
Responsibilities
Resources
Procedures
PLAN
INITIATE THE AUDIT
Appoint the audit team leader
Define the audit objectives, scope and criteria
Determine the feasibility of the audit
Establish initial contact with the auditee
CONDUCT DOCUMENT REVIEW

Review relevant management system documents
and include records
Determine document adequacy with respect to audit criteria
DO
PREPARE FOR ON- SITE
ACTIVITIES
Prepare the audit plan
Assign work to the audit team
Prepare work documents
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CONDUCT ON SITE ACTIVITIES
Conduct opening meeting
Ensure effective communication during the audit
Define roles and responsibilities
Collect and verify information
Generate audit findings
Prepare audit conclusions
Conduct a closing meeting
CHECK
PREPARE, APPROVE AND DISTRIBUTE

AUDIT REPORT
Prepare the audit report
Approve and distribute the audit report
COMPLETE THE AUDIT

Identify needs for corrective and
preventive actions and implement
Identify opportunities for improvement
and implement
ACT
AUDIT FOLLOW UP
Monitor and review
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2.3 AUDITING ROLES AND RESPONSIBILITIES
ROLE OF THE QUALITY MANAGER IN AUDITING

At a minimum, the Quality Manager is responsible for the following:
a. To identify and select laboratory staff who have demonstrated the potential to be
effective auditors to be trained as auditors
b. To identify facilitators to conduct audit training and to provide appropriate briefing for
facilitators
c. To evaluate training outcomes to ensure that staff are competent and to update training
records
d. To plan, record and organize audits and ensure that deficiencies are corrected rapidly
and effectively. The Quality Manager should have sufficient authority in the organization
to command respect and secure any changes or actions that are necessary to maintain
a satisfactory quality system. The Quality Manager must have direct access to the
highest levels of management at which final decisions are taken on matters relating to
quality e.g., Head of the Laboratory or Managing Director,
e. Where, in exceptional circumstances, the laboratory appoints an external audit officer,
the Quality Manager is responsible for ensuring that the person selected is trained in
the techniques of auditing and is fully familiar with accreditation requirements, the
laboratorys quality manual, and all relevant procedures.
In a small laboratory, audits are usually carried out by the Quality Manager. In large
laboratories with a very wide range of testing activities, the Quality Manager may need to
appoint several audit officers or deputies to cover specific areas or activities. Staff should not
audit their own activities and should be independent of the specific activities being audited
and thus should be able to contribute fresh perspectives. Staff required to carry out auditing
must be trained in the techniques of auditing and for these activities must report to the Quality
Manager who must monitor and control their activities. One strategy for engaging staff in the
quality improvement process may be to involve them in the auditing of activities conducted in
departments other than their own.
ADDITIONAL KEY ROLES AND RESPONSIBILITIES
There are several additional responsibilities that must be undertaken or spearheaded by other
staff in collaboration with the Quality Manager. These include (ref: Section 6.2):
the training facilitators who develop training material and programmes and conduct
relevant training for staff
the human resource officer who schedules, plans and organizes the training events
2.4 HORIZONTAL AND VERTICAL AUDITS

There are two major auditing strategies generally used, both of which should be included in
your auditing programme and interchanged as necessary to cover all elements or requirements
in the QMS. These auditing strategies are referred to as the horizontal and the vertical
audit respectively.
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Horizontal Audits
Horizontal audits involve detailed checking of specifically selected items. For example, all
items of equipment that are required to be calibrated would be checked to ensure that:
a) they have been calibrated at the appropriate time and to the appropriate level of
uncertainty
b) they were labelled or otherwise coded to indicate their calibration status
c) the calibration certificates are up-to-date
d) records of calibration are up-to-date and all documentation is readily available at the
designated location.
Disadvantage: When the horizontal audit is only carried out over a specific section of the
laboratory, it may only reveal some of the weaknesses that may exist in the quality system.
Laboratories should therefore carry out horizontal audits across the entire laboratory as often
as is feasible. Supplementing an audit programme based on the horizontal auditing approach
with vertical audits will strengthen the programme.
Figure 3 illustrates a typical example of a checklist which can be used for a horizontal audit of
the document control requirements.
Figure 3 Document Control Checklist

Instructions - If the laboratory has implemented the action, process or procedure referred to, the auditor will
tick YES and state in the Proof/Comments column what was seen to verify or prove implementation. If not,
then tick NO and include any relevant and useful comments
Yes No Proof/Comments
1. Is there an up to date SOP for document control?
2. Is the document current and within review date?
3. Is there evidence that the document has been prepared, checked
and approved by a suitably qualified member of staff?
4. Does the document have the necessary information such as version
number, unique identification, title, review dates, etc.?
5. Is there evidence of cross referencing to other documents?
6. Is there evidence that documents are accessible and secure?
7. Is there evidence of appropriate document distribution?
8. Is there evidence that this is working?
9. Is there evidence of a process for document change?
10. Is there evidence of a backup procedure for the document control
system?
11. Is there evidence that previous versions of documents have been
archived?
12. Are previous versions of documents available for retrieval?
13. Is there evidence that staff adhere to the document control
procedure?
14. Is there evidence that out-of-date documents are being withdrawn
from circulation?
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15. Are out of date documents reviewed?
16. Are documents appropriately formatted etc?
17. Is there evidence of regular document review?
18. When was the last document review?
19. Is staff trained in document control?
20. Do they have documented evidence of the training?
21. Is there adequate back-up of documents?
22. Is staff informed when documents are updated and available?
Vertical Audits
In a vertical audit, a number of calibration or test items or samples are selected at random. Each
operation associated with these items or samples is checked including:
a) the competency and actual practices of relevant reception, calibration and/or testing staff
b) the adequacy of maintenance records for equipment used
c) the appropriateness of the calibration or test methods and procedures used
d) the appropriateness of the quality control methodologies in use
e) environmental conditions during calibration or testing
f) the reliability of results recording and reporting,
g) the adequacy of storage and disposal practices
If vertical audits are conducted more frequently than horizontal audits, it is important to vary the
point of entry into the system, e.g., by selecting items on different occasions through a random
selection of reports or certificates, item numbers, technician records or retained test/calibration
items.
Disadvantage: Vertical audits intervene at a specific point in time and do not check a specific
element across the entire laboratory operation. For example, a vertical audit will not include a
check on ALL calibrations or tests being performed in the laboratory but would be confined to
only the calibrations or tests associated with the particular report, certificate, item or record
randomly selected. Vertical audits should therefore be viewed as complementary to horizontal
audits and should not replace the full horizontal audit exercise.
Where it is not feasible to carry out a complete audit program covering all aspects of the quality
system in one session, laboratories must make sure that all areas, including the witnessing
(observation) of the performance of tests, are monitored over a 12 month period. A plan must
be prepared to ensure that horizontal and vertical audits are carried out at the appropriate
frequency. This plan can detail aspects of the laboratory operation to be addressed each
month so that complete coverage can be achieved over a period of 12 months.
It may be necessary for laboratories to carry out additional unscheduled audits whenever there
is reason to doubt the effectiveness of the quality system. For example, activities must be
audited promptly when a laboratory has received a complaint about its calibration/testing
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activities that raises some doubt about the laboratorys compliance with its stated policies,
procedures or standards. Management should ensure that someone is given the task of
auditing the Quality Managers activities to ensure that the quality function is carried out
satisfactorily.
Figure 4 Example of a Vertical Audit checklist
Lab Name
Report number Audit date
Department Title
Name of auditor Date and signature of auditor
Instructions
1. Select laboratory sample number(s) either from the computer record or from work sheets or logbook etc.
2. Audit from receipt of sample to issuing of report.
Audit area Records/methods checked and Observations Non Conformity

procedures witnessed (Yes/No)
Chain of Custody form
Is the chain of custody form
available for the sample?
Is there sufficient information to
allow unique identification of:
the client
the sample
Are details relating to the client and
sample available:
date and time of collection
type of sample
tests requested
date and time of receipt
environmental conditions
client information
Has transcription of the tests
requested been done accurately?
Check: - logbook or computer entry

with original chain of custody form.
Sample Reception
Are there procedures for sample
receipt and logging in?
Are there procedures for storage
and handling of samples?
Are there criteria for rejection of
samples?
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Are there procedures for ensuring
staff safety?
If the sample or sub sample was
referred to another laboratory, are
records in place of tests sent away?
Test methods/procedures
Are there documented standard
operating procedures readily
available and are they detailed
enough to allow a consistency of
application?
List those checked
Is there evidence of document
control procedures in place?
State last revision date.
Is there evidence of review of

procedures?
State date of last review.
Were procedures followed in
accordance with documented
method?
List technicians checked.
Is there evidence of raw data and
calculations performed?
Have calculations been checked for
accuracy?
Quality Control
Are there documented standard
operating procedures for conducting
the QC process?
Are records available for each stage
of the process?
Are they detailed enough to allow
determination of the result, batch
number, status of QC material?
Are QC results monitored for
accuracy and precision of testing
results?
Are records available for each stage
of the procedure such that there is a
complete audit trail of staff,
equipment, reagents and quality
control procedures involved?
List all records examined
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Reporting results
Is a copy of test report able to be
generated?
Are there any transcription errors
between workbooks and the test
report?
Does the report contain sufficient

information as required by ISO
17025
Laboratory name
Unique identifiers
Dates of sample receipt,
testing & reporting
Sample description etc.
Reference intervals and
interpretative comments as
appropriate
Pagination e.g. Page 1 of 1
included where appropriate
Check report
Is there evidence of the report being
delivered to the client?
Does the laboratory have
procedures for reporting of results?
Have results been authorized by

approved staff?
Is the turnaround time acceptable?
Does the laboratory monitor

turnaround time routinely?
Can the completed report be traced

back to the original sample
information?
Page 20 of 64
CHAPTER 3: PLANNING FOR INTERNAL AUDITS
3.1 PREPARING THE AUDIT PLAN
An audit plan including the audit scope, the audit criteria, the audit schedule, reference
documents (such as the organisations quality manual and audit procedure) and the names of
audit team members, should be developed and documented by the Quality Manager. An audit
timetable should be developed by each auditor in conjunction with the auditee (person being
audited) to ensure the smooth and systematic progress of the audit. It is a requirement of
ISO/IEC 17025 that audits be carried out in the context of a pre-determined programme such
that each aspect of the quality system is examined at least once per year. Where the
laboratory holds a separate accreditation for site calibration or testing, or for sampling, audit
programs must exist for those areas.
Each auditor should be assigned specific QMS elements or functional departments to audit.
These assignments should be made by the person designated as the Lead Auditor in
consultation with the full auditing team. It is expected that assigned auditors should have
some technical knowledge of the departments they are required to audit.
Depending on the size and scope of a laboratorys operation and in order to ensure that the
laboratorys operations are audited effectively, the frequency of audits may vary considerably
among laboratories. It is important to observe the requirement that each aspect of the
quality system is examined at least once per year.
To ensure that the laboratory complies with its auditing requirement, it is essential that:
(a) the laboratory has planned for audits in its quality system
(b) the laboratory has nominated a person, or persons, to be responsible for
conducting audits
(c) the procedures for auditing are documented
(d) the audits are actually carried out
(e) the audits are conducted in accordance with a pre-planned program
(f) the results of audits are recorded
(g) remedial action is initiated immediately by the laboratory to correct all non-
compliances identified in its quality system within a reasonable timescale and
(h) the remedial action is effective and completed promptly
Prior to the actual audit, a review of documents, manuals, previous audit reports and
records should be carried out to check for conformity with the quality management system
requirements and any previously recorded quality gaps as well as to develop a checklist of
key issues to be audited.
Key Documents for the Conduct of Audits

Working documents required to facilitate the auditor's investigations and to document and
report results may include:
a) criteria documents such as ISO/IEC 17025 and any supplementary laboratory manuals
and documents
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b) checklists used for evaluating quality management system elements (normally prepared by
the auditor assigned to audit that specific element)
c) forms for reporting audit observations, such as a non-conformance form or corrective
action request form. These permit the recording of the nature of the nonconformity, the
agreed corrective action, and the eventual confirmation that the action has been taken
effectively.
Examples of checklists and forms are included in Chapter 6 (Audit Tools).
Note
Audit cchecklists should include all requirements of the standard for specific elements of the laboratory operation.
Several generic checklists for the auditing of laboratory QMS systems exist.
3.2 DEVELOPING THE AUDIT SCHEDULE

To ensure proper planning for the Audit is conducted and all staff are aware of which sections of
the QMS are to be audited at what time, a detailed Audit schedule must be prepared in advance.
This audit schedule should outline which sections of the QMS and which departments will be
audited whether by vertical or horizontal audits. The audits also assist the trained auditors to
properly arrange their workload to accommodate the audits.
Figure 5 Example of an Audit Schedule

Clause Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Document control
Review of contracts
External services and supplies
Subcontracting
Resolution of complaints
Identification of non
conformations/ Corrective
Actions
Preventive actions
Test methods
Equipment
Measurement traceability
Sampling
Handling of test and calibration
methods
Reporting of results
Service to the customer
Personnel
Resolution of complaints
Accommodation and
environment
Management review
Improvement
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3.3 AUDITOR PREPARATION
Audits are conducted by observing activities taking place, asking questions, evaluating responses
and examining items such as records, equipment and reports. Auditors are unlikely to be effective
in these activities unless they have prepared a clear plan of exactly what they intend to look at
during the audit and while they are looking at those items, specifically what they will be looking for.
The written list of the items the auditor intends to look at and for during the audit is called the audit
checklist. To avoid omission of specific areas, this checklist can be designed to include detailed
headings for each of the aspects to be audited. Auditors should arrive for the audit with a very
clear understanding of what items they intend to look at and while they are looking at those items,
specifically what they intend to look for.
Checklists can be generated in two ways:

1) The Audit Manager generates the checklist for the auditor. Typically, the Audit Manager
maintains a master list containing a very large number of checklist items covering all
aspects of the QMS. This has the advantage of facilitating the Audit Managers
responsibility to ensure comprehensive audit coverage of the laboratorys activities.
2) The Auditors generate their own checklists for each audit they undertake. Typically the
auditors read those parts of the quality system documentation that relate to the activity to
be audited and decide what items to look at and for based on that reading. The Audit
Manager can advise the auditor on topics/activities/QMS elements that should be
covered.
Note
Unless the auditors have a clear idea of what they intend to look for, they cannot realistically estimate how long each
checklist item will require and hence whether or not the overall checklist (audit plan) is reasonable in the time allocated.
Figure 6 is a checklist developed using the 20 Milestone approach. This checklist can be used to
perform a quick overview of the Quality Management system when the laboratory staff are in the
process of developing and initiating the Internal Audit system. Once audits have been well
established and the QMS is up and running smoothly, the laboratory staff can then move to a more
complex checklist which includes details elements from the standard.
Figure 6 Example Twenty Milestones Audit Checklist

Standard Requirements Look for Look at Documents/Actions
MS 1: Quality Policy
Have the Objectives of the quality management system and the
laboratory's commitment to quality been defined in a quality
policy statement?
MS 2: Management
Is there an organizational plan for the laboratory?
MS 3: Scope
Has the laboratory documented its scope?
MS 4: Quality System
Does the laboratory have a written document control system?
Is there a Quality manual of policies and reference to procedures
readily available to all personnel?
Has Laboratory management established, documented,
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implemented, and maintained a quality management system?
Is there an updated document distribution master list?
Is there a plan for continuous quality improvement?
MS 5: Procedures
Is there a documented procedure describing methods for sample
collection and labelling, preservation, and conditions for
transportation, and storage before testing, consistent with good
laboratory practice?
Is there a complete procedure manual reflecting current
procedures?
Does the laboratory have a system documenting that all
personnel are knowledgeable about the contents of procedure
manuals (including changes) relative to their activities?
Are there guidelines for the release of results?
Is there a program for management and retention of records?
MS 6: Test Instructions
Is there documentation that all personnel performing sample
collection have been trained in the proper selection and use of
equipment/supplies, and collection techniques?
Are new procedures validated initially and periodically verified?
Are there instructions for use of Instruments available?
Are up to date procedures documented and available to staff as
necessary?
MS 7: Sampling
Is the sampling manual distributed to all sample collecting areas
within the lab AND to areas outside the main laboratory (such as
client sites or other laboratories)?
Are chain of custody forms completed with the required
information?
Are samples safely disposed of according to established policy?
Are QC values evaluated for suitability?
Are results verified (double checked) before release?
MS 8: Review contracts
Are requests properly reviewed before work is accepted?
MS 9: Equipment
Does the quality control program clearly define goals for
monitoring analytic performance, procedures, policies, tolerance
limits, corrective action and related information?
Are control samples tested in the same manner and by the same
personnel as client samples?
Is there evidence of active review of results of controls,
instrument maintenance and function, temperature, etc. for
routine procedures?
Is there documentation of corrective action taken when controls,
etc. fall outside of control limits?
Does the system provide for the timely correction of errors?
MS10: Validation and Quality Control
For quantitative tests, has a statistically valid acceptable range
been established for each lot of control material by repetitive
analysis in runs that include previously tested control materials?
MS 11: Work conditions
Does the laboratory have adequate conveniently located space
so that the quality of work, quality control procedures, safety of
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personnel, and clients are not compromised?
Is there a Safety manual of policies and procedures readily
available to all personnel?
MS 12: Literature
Have computer applications associated with testing and
laboratory information been validated and safe guarded?
Are there explicit documented policies that specify who may use
the computer system to enter or access data, change results, or
alter programs?
MS 13: Traceability (Calibration)
Are all reagents checked when received and labeled as to
content, date of receipt, date of opening and date of expiry?
Is there a documented schedule, procedure and active review for
regular maintenance of Equipment either by maintenance
contracts or documented in-house procedures?
MS 14: Uncertainty
Have uncertainty budgets been estimated and calculated for
each type of test area or method?
Have tolerence limits for testing properties been established?
MS 15: Training
Is there a functional continuing education program adequate to
meet the needs of the laboratory personnel?
Are personnel records maintained on all employees?
Has the competency of each person to perform his/her assigned
duties been assessed?
MS 16: Monitoring
Is the Proficiency testing program sufficient for the extent and
complexity of testing done in the laboratory?
Is there appropriate evidence of review of problems, and their
solutions, as identified by PT?
For areas where proficiency testing is not available, are other
procedures used to validate performance on a regular basis?
Does the quality improvement (QI) program follow a documented
operational plan?
Are key indicators of quality monitored and evaluated for
improvement opportunities?
MS 17: Internal Auditing
Are internal audits planned and conducted as scheduled?
MS 18: Complaints
Have the clients' and staff satisfaction with the laboratory service
been measured within the past 2 years?
MS 19: Review Documents
Are quality control records available at the workstation? Are
control data organized and presented so they can be evaluated
daily by the technical staff to detect problems, trends, etc?
Are manual and automated result entries verified before final
acceptance and reporting by the computer?
Is there a documented system to ensure that all revised reports
for previously reported incorrect (erroneous) results are identified
as revised, corrected, or amended on all forms of reports (paper,
video displays, etc.)?
MS20: Management review
Have review meetings been conducted?
Have corrective actions been addressed & recorded?
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3.4 AUDITOR COMPETENCIES
As stated above, auditors have to effectively observe and examine, ask pertinent questions,
evaluate responses, critically analyse the information they receive while comfortably interacting
with auditees, laboratory management and the Quality Manager. A successful auditor must
therefore exhibit a mix of the competencies detailed in Figure 7 below.
Figure 7 Competencies required for effective auditing

Competencies (based on ISO/IEC 19011:2002) Lead Auditor Technical
Auditor Auditor
An Auditor must:
Be open minded and mature
Be willing to consider alternative ideas or points of view
Possess sound judgment & analytical skills
Be ethical fair, truthful, sincere, honest, and discreet
Be observant actively aware of physical environment and activities
therein
Be decisive reach timely conclusions based on logical reasoning and
analysis
Be self reliant acts and functions independently while interacting
effectively with others
Be tenacious persistent, focused on achieving objectives
Obtain and assess objective evidence fairly
Remain true to the purpose of the assessment
Interact with personnel in such a way that will best yield the assessment
objective
Constantly evaluate the effect of assessment observations and personal
interactions during an assessment
Commit full attention and support to the assessment process
React effectively in stressful situations
Perform the assessment process without deviating due to distractions
Arrive at generally acceptable conclusions based on assessment
observations
ASSESSOR KNOWLEDGE AND SKILLS
Understand the criteria in the relevant accreditation standard (i.e.,
ISO/IEC 17025)
Understand the accreditation bodys policies applicable to the desired
scope of accreditation
Be able to accurately interpret and apply the criteria to the actual
assessment situation
Demonstrate a track record of appropriate knowledge and skills applied
in a laboratory environment
EDUCATION
At a minimum, post secondary education in a relevant
scientific/technological discipline
Attestation from technical peers to confirm the relevance of education
and knowledge credentials
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CHAPTER 4: CONDUCTING THE INTERNAL AUDIT
4.1 INITIATING THE AUDIT PROCESS
Taking the First Steps

Internal auditors who develop their own checklists usually do so after reading the available
documentation about the activities to be audited. Documentation will include relevant sections of
the quality manual as well as relevant procedures and test methods but may also include:
1) sampling plans
2) QC plans
3) contracts
4) standards and
5) other pertinent documentation.
During the review of documentation the auditor may find some items that appear to be non-
compliant. For example, what is stated in a specific procedure may not appear to correspond to the
related policy outlined in the Quality Manual or to the related client contract. A further example
may be that what is stated in a test method may appear not to be compatible with the requirements
of the standard. When auditors find such apparent discordances, they include them in their
checklists so that, on the day of the audit, the apparent non-compliance can be confirmed or
refuted.
Audits will address QMS elements such as document control, sample reception and identification,
equipment control, labelling of reagents, record keeping, etc. However, they should encompass, to
the extent permitted by the scope and the technical background of the auditors, the technical
correctness of the laboratorys activities. These more technical aspects will usually include staff
competencies, equipment, QC and method reliability, environmental appropriateness and sample
management.
Audits based on checklists are generally compliance and implementation focused. During the
preparatory stage the compliance of the documented system is assessed and on the day of the
audit the correlation between documentation and actual practice is determined. Since audits are
also intended to provide information on the effectiveness of the QMS, that is, the extent to which
the laboratorys quality objectives are being achieved, it is important to ensure that these quality
objectives are written in specific measurable terms.
Note
While a laboratorys documentation may be satisfactory, the auditor MUST confirm that the documented description
corresponds to the actual practice.
Page 27 of 64
Figure 8 Example of Audit Elements
Staff
qualifications, training, experience
basis for authorization to conduct tests/use equipment
ongoing proficiency checks
knowledge, understanding and performance of test methods
Equipment
initial verification for compliance with test methods
fitness for purpose
on-going maintenance, calibration, intermediate checks, etc.
status indication and limitations on use
availability of operating instructions, in house calibration
appropriate environment for use and storage
Methods
suitability/availability of documented methods, correctly followed appropriate interpretation (where
required)
preparation of reagents
current and updated methods
sampling
Environment
complies with requirements of test methods
recorded and monitored (to extent necessary)
appropriate housekeeping
Sample Handling
sampling techniques and sample ID
conditioning and preparation of samples
retention and disposal of samples
Quality Control
control of reference standards and materials
appropriate methodology
QC checks correctly analysed and interpreted
action taken on results when appropriate
4.2 CONDUCTING THE AUDIT
The time committed to the audit process is largely spent observing activities taking place, asking
questions, interviewing the technicians and other staff, listening to responses, formulating follow-up
questions, and seeking clarification. Thus conducting the audit at the location where the activity is
taking place is essential. It is important for internal auditors to have contacted the relevant
Manager prior to the audit to confirm the arrangements, including what they wish to witness and
who they would like to talk to. A brief meeting or other contact with the Manager just prior to the
audit to reconfirm the arrangements should be undertaken before initiating the audit process.
Page 28 of 64
Questioning Styles
The types of questions asked and the way in which questions are asked are critical to the
responses and information received. Different types of questioning styles exist and each can prove
to be effective in specific circumstances. These include:
a) Closed questions:
Closed questions invite Yes/No responses but may miss significant bits of information.
b) Open questions:
Open questions may be prefaced by the words how, what, why, where, and who and
are likely to obtain a richer body of information than closed questions. When the
response to an open question is not what the auditor is expecting it to be, or it is not
clear, rephrasing the question is usually worthwhile to obtain clarification or
confirmation.
c) Hypothetical questions:
Hypothetical or what if questions can be helpful but must be used with caution. If the
auditors consider a particular circumstance to have the potential to lead to quality
problems but can find no evidence to show that this has yet happened and are unable
to persuade the auditee of the potential for problems, they can hypothesize the
circumstance under which they think the problem will arise by asking what if
questions. The circumstances hypothesized must, of course, not be so improbable that
it is unreasonable to expect the QMS to be able to accommodate them. Questions
based on unstated assumptions should, similarly, only be used with care since they
can very easily lead to miscommunication.
The internal auditor may not have technical expertise in the actual test being conducted, but can
look at the control procedures and evaluate their implementation and effectiveness. If, having
looked at an item on the checklist, no problems are found, the auditor should move on to the next
item on the checklist.
From time to time the auditor may find what appears to be a non-conformance, or failure to
implement effectively or some other condition likely to adversely impact quality. When this
happens the auditor should investigate the problem to the depth necessary to confirm or disprove
its existence and to understand the nature and magnitude of the problem. At an early stage in this
process the auditor should explain to the auditee the circumstances they think they have found and
why it is considered to be a problem. This gives the auditee an early opportunity to correct any
misunderstandings or miscommunication and if it is a problem, the auditee can assist the auditor to
understand the circumstances in which it arose. When the auditor has clarified the circumstance,
all the information needed for presenting the report and explaining the problem to management
should be recorded. Auditees must be aware of what the auditor will be reporting before the
auditor proceeds to the next checklist item.
Note
Most problems that occur in labs arise from simple and preventable circumstances such as: misidentified and mixed up
samples, procedures not completely followed, results incorrectly recorded or transcribed. The QMS should have
control procedures established to minimize and/or prevent these and to identify them if they do occur.
Page 29 of 64
CHAPTER 5: MANAGING AUDIT OUTCOMES
5.1 NON-CONFORMITIES
A nonconformity is simply defined as nonfulfilment of a specified requirement. When auditors find

objective evidence of a nonconformity they are required to report this by writing a nonconformity
statement on a nonconformity report form (NCR), also called a corrective action request (CAR).
Often the objective evidence is physical, such as an unauthorized change to a controlled

document, a nonconforming product, or an uncalibrated gauge being used. What the auditee
states of others or claims happened elsewhere cannot be recorded as objective evidence.
Objective evidence is FACTUAL, not based on opinion, judgment, or prejudice but on validated
information.
Figure 9 Example of a Non Conformity report form

Lab Name Department
Audit Date
Number Description of Non Reference to ISO Section in Quality Auditor
conformity 17025 Manual/Procedure
1
2
3
4
5
6
7
When the auditor has objective evidence of failure to comply with a specified requirement they may
raise a nonconformity. In a laboratory, the primary source of specified requirements is the
laboratorys quality manual, procedures, test methods and the remainder of the quality system
documentation. What is stated in its quality system documentation must be done. If the laboratory
is accredited or is seeking accreditation then the relevant requirements of the accreditation body
are also specified requirements and there may, as well, be other regulatory requirements in
specific fields of testing.
Types of Non Conformities

Nonconformities fall into several groups. These include
a) failures of intent
b) implementation failures
c) effectiveness failures
Intent Nonconformities
Intent nonconformities arise when the QMS, as it is intended to be operated, is non-compliant with
external requirements. Examples of these are as follows:
a) a legal requirement may be that results of pesticide testing be retained for 15 years but the
laboratorys QMS permits disposal of quality records after 5 years
Page 30 of 64
b) a labelling requirement to which the laboratory is committed to comply requires that the
estimated uncertainty of measurement be included on all test certificates but the
laboratorys practice is to include this only if requested by the client
c) An accreditation body requires that work be sub-contracted only to laboratories that they
have accredited for that testing activity but the laboratorys QMS authorizes them to sub-
contract to any laboratory they deem competent.
In all of these examples, the system, operating the way it was planned and intended to operate, is
non-compliant with a specified requirement. Hence such nonconformities are often referred to as
system nonconformities or intent nonconformities or structural nonconformities.
Implementation Nonconformities
Failures of implementation occur when one or more of the requirements of the laboratorys QMS
are not complied with. Examples of this are as follows:
a) the laboratorys policy, as stated in the quality manual, is that raw data and original
observations are recorded in the technicians notebook and then transferred as
derived results onto the worksheets. The auditor found, however, that one technician
actually records the raw data on the rear of the worksheet not in the notebook
b) the laboratory procedure requires that environmental conditions be monitored every
day, but it is found that the technician actually records environmental conditions every
3 days.
While both of these findings are implementation nonconformities, the first is relatively minor since
raw data is not destroyed. The corrective action for this may simply be to change the QMS to
permit this practice. However in the second instance the nonconformity is more serious because of
the departure from the laboratorys QMS that requires the monitoring of environmental data which
may affect results.
Effectiveness Nonconformities
The auditors will find circumstances where the QMS is both compliant and being implemented as
intended, but nevertheless there is still a quality problem. Examples of this are as follows:
a) the auditor may find that a scale, purchased from The Equipment Co. and certified as
meeting the requirements OIML 123, did not in fact comply with those requirements.
b) a technician is authorized to perform a test or operate an item of equipment on the
basis of training received, but is then found not to be fully competent to do so.
The auditors establish that the laboratorys procedures for evaluating and approving suppliers are
fully compliant with external requirements and recommended good practices and had been
followed. Additionally the laboratorys follows its training procedures; however it does not verify the
effectiveness of the training. It is evident in both situations that those procedures were not effective
at least in this case.
Classifying Nonconformities by Importance (Potential Impact)

Most internal audit systems require auditors to classify the nonconformities they raise according to
their importance. The most commonly used classifications are Major or Minor nonconformities.
This often leads to differences of opinion between auditor and auditee, especially if the
classification criteria are not clear or the decisions are subjective.
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A major nonconformity is usually defined as the absence or complete failure of a required quality
system element and a minor nonconformity as an isolated failure to comply with a quality system
element. Thus intent nonconformities, because they will lead to ongoing non-compliance perhaps
throughout the laboratory, are more likely to be classed as major than will implementation or
effectiveness nonconformities.
Major Nonconformities
Major nonconformities can include for example when the auditor finds:
a) that the laboratorys QMS did not include a requirement for the monitoring and control
of amendments to documents or
b) that while the QMS does have a requirement for control of amendments there are 3
documented test methods with unauthorized amendments or
c) two cases of technicians working with old versions of SOPs and a worksheet that
carries no revision status indication or
d) that a test was incorrectly carried out because the documented procedure could not be
found and the technician relied on his memory
The combined effect of the above findings suggest that the laboratorys document control system is
not working effectively.
The consequences of the nonconformity also have a bearing on the classification. A

nonconformity which seriously jeopardises the validity of test results received by the client, or has
the potential to do so, would be a major nonconformity. Specific circumstances may thus dictate if
a nonconformity will be recorded as major or minor by the auditor. For example:
a) if a nonconformity would have been detected by the laboratorys control mechanisms prior
to release of results and the laboratory could recover the situation by retesting, most
auditors would classify this as minor
b) If retesting was not possible (perhaps a destructive test) or retesting would take too long to
meet the agreed date for results to be provided, this is more serious since the laboratory
has failed to meet its client agreement and depending on the circumstances this might be
classified as major
c) If the nonconformity would be unlikely, had the auditor not found it, to have been detected
by the laboratorys control mechanisms and thus invalid test results would probably have
been supplied to the client, this is even more serious. Most auditors would seriously
consider recording a major nonconformity in this situation
d) Finally, if the auditors found that this had in fact happened and that, over an extended
period, invalid results had been given to clients, this is almost as serious as it can get.
This would certainly be classified as a major nonconformity
5.2 RECORDING and REPORTING AUDIT FINDINGS
Recording Audit Findings

Laboratories are required to maintain detailed records of all audits, which are clear and readily
accessible. The audit records must indicate and document what activities the auditors observed
Page 32 of 64
(such as test methods, equipment, records, and documents), who was involved, and what was
found. This is necessary so that future audits of the same department can complement the audit,
not just repeat it, and can also achieve more comprehensive coverage.
If the auditors consider they have found nonconformity then it is very important to ensure that all
relevant details are recorded so it can be understood later, such as WHAT they found and WHY it
is a nonconformity. Depending on the circumstances it might also be necessary to record WHERE
and WHEN the events occurred and WHO was involved. Documented information on
nonconformities must also include the location of the specified requirement that has not been
complied with (e.g. 4.6.2 of Quality Manual, section 5 of test method ASTM 1234) and, why this is
an actual or potential quality problem.
Non-conformances must be fully recorded, with details of the corrective actions suggested by the
auditee, how and by whom they are to be implemented, and including an agreed timescale for their
achievement, which is based on the seriousness of the non-compliances and decided in
consultation with the Quality Manager.
Audit summary forms are useful in maintaining a record of the audit findings and corrective actions.
This summary will help to highlight areas of weakness and deterioration of the QMS but it may also
include positive statements about satisfactory performance. This should be signed by both the
Quality Manager and Head of Laboratory/Managing Director.
Reporting Audit Findings

Each audit report should include the following:
a. name of auditor
b. date of audit
c. areas (departments) audited
d. details of aspects examined including sample numbers, equipment identification
etc, where appropriate (even where no non-conformances were observed)
e. any non-conformances observed; (category e.g., major or minor; if necessary)
f. corrective action agreed, responsibility for and time period for completion,
confirmed date for completion
g. signature of the Quality Manager confirming that the corrective action process has
been completed.
Most systems require the auditor to produce a written report summarizing the audit findings. This
should outline what was audited and what was found. Both conformance and nonconformances
can be addressed in the report. Nonconformities need not be repeated but can simply be referred
to. A summary report form can be provided to minimize the auditors work.
Note
Where the audit reveals serious non-compliances, consideration should be given to auditing the relevant areas again in
the near future to check that the actions taken are still effective.
Page 33 of 64
Figure 10 Summary Audit report form
Instructions to Auditor: Prepare the narrative report by using and attaching separate sheets. The report
should summarise what was seen and the findings of the Audit. The total number of pages of the report
should also be identified on each page.
LABORATORY NAME:
QUALITY MANAGER: REPORT DATE:
AUDITORS (PRINTED NAME / SIGNATURE/DATE):
_________________________________/_______________________________/____________
_________________________________/_______________________________/____________
Names of Laboratory Staff Attending the Closing Meeting
__________________________ ___________________________ __________________________

The auditor(s) discussed the contents of this report and the nonconformity report with relevant laboratory
staff.
SIGNATURE OF LABORATORY OFFICIAL:____________________________ DATE:__________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Writing Nonconformity Statements

When auditors raise a nonconformity they are usually required to write statements of nonconformity
for anyone not involved in the audit to understand. Clear statements, for example, on what was
found and why they were considered to be nonconformities need to be documented. Thus the
Auditor, personnel with responsibility for proposing corrective action, persons with authority to
approve the proposed corrective action and those responsible for verifying that the corrective
action has been effective, will need to understand the nature of the problem. The statement of
nonconformity must provide that understanding and thus it is important that the statement is
factual, concise and complete.
Page 34 of 64
5.3 ROOT CAUSE INVESTIGATION
Identifying the Root Cause of Nonconformities

When a problem is identified, the labs corrective action procedures should ensure that action is
taken at three levels:
I. First: the problem has to be fixed e.g., retest, notify the client, repair
malfunctioning equipment, notify staff concerned, redraft worksheets, amend
procedures, etc.
II. Second: the scale and nature of the problem needs to be determined - Is it a one-
off occurrence or not? Has it happened before? Are similar things happening in
other sections?
III. Third: the underlying reason(s) or root cause for the problem need to be
determined and appropriate action taken such that the problem is unlikely to recur.
Auditors can maximize the benefit of the audit if they can steer the manager to what they consider
to be the root cause(s). This can be achieved in various ways. Examples are as follows:
a) By wording the nonconformity statement appropriately and identifying the clause
within the document/standard against which the nonconformity is assigned
b) By ensuring that the problem is clearly articulated to the auditee at the time of the
audit.
If the proposed corrective action appears to be superficial, fixing the problem but not the root
cause, the auditor can ask for more appropriate action. Usually this is best done indirectly by
asking what if questions. Avoid direct advice to facilitate ownership of the solution by the
auditee.
Root Cause Investigation

A Root Cause Analysis is a process for identifying the basic or causal factors that underlie
variation in performance such as, for example, the occurrence of an adverse event, a near miss, or
a non conformity. The focus is primarily on systems and processes and not individual
performance. Figure 11 outlines the types of questions that may be posed in a root cause analysis
process.
Figure 11 Example of a Root Cause Analysis Report

Level of Analysis Questions Findings Root Ask Take
Cause? Why? Action?
Yes/no Yes/no Yes/no
What Adverse Event/ What are the details of the event: (Brief
happened? Near Miss description)
When did the event occur? (Date, day
of the week, time)
What area was impacted?
Why did it happen? The process or Reference the affected process or SOP
activity in which the
event occurred
What steps were involved in
(contributed to) the event?
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Level of Analysis Questions Findings Root Ask Take
Cause? Why? Action?
Yes/no Yes/no Yes/no
To what degree is necessary
information available when needed? Is
it accurate, complete, and
unambiguous?
Equipment factors How did the equipment performance
possibly affect the outcome?
Environmental What factors may have directly affected

factors the outcome?
To what degree was the physical

environment (or changes) a factor in
the event and did it affect the
processes being carried out?
Other Are there other factors that may have
possibly influenced this outcome?
Were there any uncontrollable factors

involved in the event?
Why did this happen? Human Resource What was the role of staff that may
What systems underlie issues have contributed to the outcome?
those factors?
How can orientation and training be
improved?
5.4 TAKING CORRECTIVE ACTION
Acting on Audit Findings

It is important that the Quality Manager and the laboratorys internal auditors monitor progress on
non-compliance actions to ensure that agreed timescales are met. Corrective action request forms
(CARs), on which auditors report the non conformities found, are useful.
In certain situations the laboratory may have to stop calibration/testing in a specific area until
satisfactory remedial action has been implemented. It may also be necessary to take action with
regard to work already completed which may now be considered suspect.
Thus, whenever a non-conformity that may jeopardize the result of a calibration or test is
discovered, the corresponding activity should be halted until the appropriate corrective action has
been taken and has been shown to lead to satisfactory results. In addition, results that may have
been affected by the non-conformity should be investigated and customers informed if the validity
of corresponding calibration, test or inspection certificates/reports is in doubt.
Responsibilities
The corrective action procedure will need to be followed to reveal the root causes of some
problems and to implement effective corrective and preventive actions. The implementation of the
agreed corrective action is the responsibility of the auditee.
The auditor should check the effectiveness of corrective actions as soon as possible after the
agreed time frame has elapsed. The Quality manager should have the ultimate responsibility for
confirming the clearance of nonconformities and then closing them out.
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The laboratory must have procedures to ensure that appropriate corrective action is proposed,
authorized, completed and verified for all nonconformities raised by the auditors. Responsibility
and authority for each stage must be defined and documented.
Usually the authority to accept the proposed corrective action lies with the Lead Auditor, Quality
Manager (if different), or Lab Manager. The auditor may be asked to verify that the approved
corrective action has been taken and has been effective. For internal audits this is usually most
readily accomplished by returning to look at the evidence first hand. In other cases the evidence
may be sent by email.
5.5 MANAGEMENT REVIEW

The prime purpose of the internal audit system is to provide information that will enable laboratory
management to make an informed judgement as to the extent to which the overall QMS is
appropriate, compliant and effectively implemented. The entire cycle of audits which cover all
areas of the QMS is intended to verify continued compliance of processes. The mechanism in the
QMS for reviewing the effectiveness of the System and decision-making on the improvement
process is the Management Review, usually conducted annually. The Management Review
provides the opportunity for review and discussion of the combined audit findings, examination of
patterns and trends demonstrated by the audit data as well as providing the opportunity to highlight
particular areas of laboratory strength and weakness and to discuss strategies for quality systems
strengthening.
Page 37 of 64
CHAPTER 6: AUDIT TOOLS
6.1 AUDIT CHECKLIST
Instructions - If the laboratory has implemented the action, process or procedure referred to, the auditor will
tick YES and state in the Proof/Comments column what was seen to verify such. If not, then tick NO and
make any comment which might be necessary for follow up at a later date.
Figure 12 Example Audit checklist

4.1 ORGANIZATION AND MANAGEMENT
Does the laboratory have a documented description of the medical
laboratory that includes its current licensure and/or other legally
required recognition to function as a medical laboratory?
Does the laboratory have a documented description of the services it
provides for patient care?
Does the description include services it provides for patient care?
Does the description include services that address the needs of
clinical services?
Does the laboratory have a written policy that declares commitment
to the standard, regardless of the site or facility where work is
performed?
Does the laboratory have a written policy that addresses the
declaration of conflicts of interest that could influence the credibility of
laboratory activities?
4.15 MANAGEMENT REVIEW
Are there dated documents signed by the laboratory director
indicating review of the laboratory quality management system?
Do the reviews indicate the suitability and effectiveness of the
system?
Is there a currently dated and signed documented management plan
indicating quality goals, objectives, and action plans?
5.1 PERSONNEL
Are there documentation and records to show that the requirements
have been met?
Are the organizational chart and personnel records relating to
qualifications, continuing education and training, competency
evaluations, and job descriptions available?
Are the roles, responsibilities, and authority of the laboratory director
included either in the job description for the position or in a formal
letter of appointment?
Is there documentation on how the laboratory director fulfils the
responsibilities regarding the professional, scientific, consultative,
organizational, administrative, and educational matters?
Is there a process of appointing and monitoring delegates for
assigned responsibilities?
Is a process for monitoring of all work performed in place?
Are quality improvement strategies and activities documented?
Has a quality management system been implemented?
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Has the laboratory shown that the resources are adequate to meet
the demands of the volume and scope of services provided by the
laboratory?
Are there policies, processes, procedures and records dealing with
the competency assessment of staff and their task assignment,
training and continuing education?
Are appropriately qualified and experienced personnel making
relevant professional judgments on the examinations carried out?
Have policies been developed and implemented related to electronic
data entry, storage, security, access, modification, and retrieval?
5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS
Have safety precautions been implemented in the laboratory?
Do personnel have adequate bench space and/or room?
Are staff and patients protected from unwarranted hazards?
Do ambient temperature control, electrical supply, and water supply
meet the requirements of the in-vitro diagnostic systems and
computer systems?
Are the laboratory design and environment suitable for the volume
and scope of services provided?
Are environmental conditions monitored that could adversely affect
the quality of the measurements or other results?
Is there segregation of incompatible sections of the laboratory?
Is access to the laboratory or parts of it controlled?
Are processes and procedures in place to store samples, slides,
blocks, and documents, including records and results?
Are work areas clean and well maintained?
5.3 LABORATORY EQUIPMENT
Does the laboratory have processes, procedures, and results for the
verification of all instruments and analytical systems?
Have the laboratory results obtained from instrument systems been
validated prior to release?
Are there results of the routine monitoring of instruments, reagents,
and analytical systems?
Is the required calibration of instrument systems carried out and
documented?
Are there documented processes, procedures, and records of
preventive maintenance?
Are preventive maintenance records reviewed by management?
Is each piece of equipment uniquely identified?
Is there an effective inventory control system for reagents?
Is the detailed acquisition, use, maintenance, repair and replacement
information available for each piece of equipment?
Are hazardous materials correctly identified and stored?
Are the required hazardous material data sheets readily available to
all staff?
Is there evidence that personnel are trained and authorized to use
items of equipment, and are records available?
Are equipment manuals and/or instructions for use available at the
work site?
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Is equipment correctly installed and inspected?
Are personnel aware of the regulations, processes and procedures
for the safe disposal of chemical, radioactive and biological
materials?
Are documents available to show how defective equipment is
identified and decommissioned?
Is the medical significance of defective equipment performance
determined, and is there appropriate notification of the health care
professional?
Are safe practices followed for the servicing of defective equipment?
Is a record of instrument/equipment calibration available at the work
site?
Is calibration or verification carried out on equipment that has been
repaired or otherwise has been outside of direct control by the
laboratory?
Does the laboratory apply correction factors and, if so, are they
correctly developed and applied?
Have computer systems been shown to be suitable for intended use
in the laboratory?
Are electronic data secured?
5.4 PRE-EXAMINATION PROCEDURES
Does the request form seek information detailed in the standard?
Are there processes and procedures to seek information missing
from a request form?
Are monitoring and feedback available on completion of request
forms?
Is a primary sample collection manual available in paper or electronic
format?
Does the manual meet the requirements of the standard?
Are users aware of the manual, and do they follow its directions?
Are laboratory personnel familiar with the contents of the manual?
Does the primary sample collection manual document control meet
the requirements for such a document?
Is there active monitoring of sample transport?
Are there processes and procedures in place to monitor the integrity
of samples and conformity to safety regulations during transport?
Is traceability of the primary sample to an identifiable patient a
requirement for accepting a sample?
Are there procedures, processes, and facilities for accepting,
examining and reporting on urgent samples?
Is there evidence of traceability of secondary samples to the primary
one and to the requisition?
Are verbal requests for laboratory services accepted and, if so, is
there documentation and traceability of the request?
Are samples stored under appropriate conditions, at least until issue
of the final report?
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6.2 AUDITOR PREPARATION
Sample Procedure for Training Internal Auditors

Sample Procedure for training Internal Quality System Auditors Issue Date: 9th June 2009
Document No. Revision No. 1
ACME Practice Laboratory Ltd P010
Page 1 of 2
Revision date : 9th June 2010
Approved by Quality Manager Issued by General Manager
AMENDMENT SHEET
Version Page No. Description of Change Approved by Effective Date
PURPOSE
This procedure provides guidelines for the management of Internal Quality Auditor training for the Staff
within the Laboratory. It explains the steps by which Auditor training needs should be identified,
implemented, recorded, audited and reviewed.
SCOPE
This procedure applies to the theoretical and practical training of Laboratory staff as Internal Auditors for the
purpose of implementing the Internal Audit schedule and program.
DEFINITIONS
Quality Manual a document stating the Quality policy, quality Management system, and quality practices
of an organization.
Test Methods Technical Procedures for conducting testing of samples in the Laboratory
SOP Standard Operating Procedures
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PROCEDURE
START
Responsibilities Documents Generated
Identify persons to train as auditors List of Trainee Internal

Quality Manager Auditors
Quality Manager Identify facilitator and establish objectives Training Proposal
Training Manual
Trainer Develop training materials
Human Resources Training Schedule

Schedule and organize training
Attendance Register
Trainer Evaluation Forms
Conduct training
Quality Manager Conduct

Is the investigation
No
training
effective? & document
findings
Quality Manager YES
Update training records

Quality Manager
Plan and execute Audits Competency
Evaluation
END Investigation Report
RELATED DOCUMENTS
Training Matrix Personnel Records
Employee training files
REFERENCES Audit plan and

Quality Manual schedule
Human Resources Records
Page 42 of 64
6.3 PROCEDURE FOR CONDUCTING INTERNAL AUDITS
Example Procedure for Conducting Internal Audits

ACME PRACTICE LABORATORY Issue Date: Date Revised:
BARBADOS
Standard Operating Procedure Effective Date: Revision 1
LAB-SOP xyz Procedure for conducting Internal Quality Audits Page #
Prepared By: Date:

Reviewed By: Date:
Approved By: Date
Purpose
To verify that our Quality System is in compliance with ISO/IEC 17025 (ISO 15189) and that procedures are
in compliance with our documented Quality System.
To ensure the requirements of the ISO Standard are met and that all employees are following procedures of
the Quality System.
Scope
Audits to the Quality System are completed once a year (more if necessary) in order to ensure the system is
working and also to implement corrective or preventative actions if there are any problems
Definitions and Acronyms
Quality System: Organizational structure, procedures, processes and resources needed to implement
and maintain quality management.
Auditor: An employee who has the qualifications to perform quality audits.
Lead Auditor: An auditor designated to manage a quality audit.
Observation: A statement of fact made during an audit and substantiated by objective evidence.
Objective Evidence: Records or statements of fact, which can be verified.
Nonconformance: The non-fulfillment of specified requirements.
Responsibilities
The Internal Audit Team is responsible for conducting all Internal Audits for the Quality System.
Management will review all findings and actions related to Internal Audits.
Procedure
Quality System functions are audited once a year and more frequently as required based on status and
importance. The schedule of audits will be completed by the Quality Manager and kept in the Quality
System records. Audits are conducted by individuals who have the following qualifications:
General knowledge of company operations
Prior audit experience
Formal ISO training and/or on-the-job training
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Internal audits have a lead auditor to document the entire audit and the audit team to assist in the process.
Internal Audits will be done in accordance with the written procedures and checklists which are found in the
Quality System database. Audits should be led by an individual not directly related to the function being
audited. Auditors will review revisions to the ISO Standard to assure the Quality Manual and related
procedures have been updated to comply with the change. The following documents are used in the audit
process:
Previous audit findings
A copy of the procedure (s)
Internal Assessment checklist
Previous Corrective Actions (Reports from past audits)
Audit Preparation
An experienced auditor is designated as the Lead Auditor. The Lead Auditor has final decisions regarding
the conduct of the audit and any observations. The Lead Auditor is responsible for:
a) Preparing and maintaining the Audit Schedule, auditee notification at least one week prior to an audit,
b) Preparing the Audit Plan, conducting opening and closing meetings,
c) Selecting the Audit Team, ensuring that Auditors are independent of the activity they have been assigned
to audit,
d) Briefing the Auditors, defining the requirements of each audit assignment and assisting in the preparation
of audit checklists as needed,
e) Assisting Auditors in preparing the Audit Reports,
f) Reporting on Audit Results at Management Review Meetings.
Opening Meeting Objectives

a) Introduce the members of the audit team to the auditees and establish communication links with
activities being audited.
b) Review the scope and objectives of the audit and provide a short summary of the methods and
procedures to be used to conduct the audit.
c) Clarify the details of the audit plan and confirm the time and date for the closing meeting and any
interim meetings.
Conducting the Audit

All areas of the QMS will be audited at least once per year. In addition to annually scheduled audits, the
Lead Auditor may select certain activities for follow-up for more frequent auditing as their status and past
compliance history changes.
General Housekeeping, work environment, knowledge of the Quality System and Policy, traceability,
document and data control and control of quality records are observed in all audits. If not reviewed, the
reason must be noted in the on the Audit Report.
The Auditors will collect evidence through interviews, examination of documents and quality records, and
observation of activities and conditions in areas of concern.
Information gathered through interviews should be tested or investigated by acquiring the same information
from other independent sources, such as physical observation, measurements and records.
All audit observations are documented, even if not originally covered on the checklist. Area management
will be constantly informed of findings, there are to be no surprises at the closing meeting.
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During the audit, the Lead Auditor may make changes to the Auditors work assignments or the audit plan, if
necessary to achieve the audit objectives.
Closing Meeting Objectives

a) Present audit observations to auditees management, taking into account their perceived
significance.
b) Present the audit teams conclusions regarding the effectiveness of the quality system in the form
of audit reports and quality issue forms.
c) Findings of nonconformance will be resolved through the Quality Issue process, keeping in mind
that corrective actions need to be to a degree appropriate to the magnitude of the problem and
commensurate with the risks encountered.
NOTE: For internal audit quality issues, the Lead Auditor is authorized to accept or reject corrective actions
unless problem solving is required.
Follow-Up Audit Activities

Necessary follow-up activities are determined by the Lead Auditor as corrective actions are submitted for
approval.
The Lead Auditor will note required follow-up on the audit schedule and determine an appropriate length of
time needed to implement the corrective action and judge its effectiveness.
Follow-up activities may be assigned to an auditor or performed by the Lead Auditor. Findings are noted on
the original Quality Issue and, if satisfactory, the issue is approved by the Lead Auditor and closed.
Internal Audits are reviewed in the annual Management Review Meeting. The corrective actions and the
report (summary) are reviewed.
Documents Generated
Audit checklists
Audit reports
Opening and closing meeting attendance list
Related Documents
Corrective and Preventive Actions Procedure
Auditor Training Procedure
Audit Schedule
Audit Plan Form
Audit Report Form
References
ISO 17025 General Requirements for Quality and Competence in Testing and Calibration Laboratories
END OF PROCEDURE
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6.4 CORRECTIVE ACTION RECORDING FORMAT
Figure 13 Example of a Corrective Action Form

Level of Analysis Corrective action Who is Responsible Measures of Effectiveness
For any findings identified as needing Action Item #1 Measure:

an action, indicate the planned
action, implementation date, and
Action Item #2 Measure:
measure of effectiveness (how can
the action be verified for
effectiveness).
Cite any references that were considered in developing this analysis and action plan:
Page 46 of 64
CHAPTER 7: FAQs on LABORATORY QUALITY
What is calibration?
Calibration is the process of comparing a measuring instrument against an appropriate standard to establish
the relationship between the values indicated by the instrument and those of the standard (the standard
provides a known and widely accepted reference point). Calibrating an instrument is intended to eliminate or
reduce bias when the instrument is used to measure.
Do all measuring instruments need to be calibrated?

All measuring devices usually need to be calibrated - whether they are simple devices or state-of-the art
systems - because certain instrument characteristics change with time. There are some situations where an
instrument need not be calibrated, for example where its readings are for information only and their
accuracy has little or no impact on the test, product or service being provided.
How often should an instrument be calibrated?

Calibration frequency can be established using the manufacturers recommendations. In some cases,
commercial calibration laboratories can suggest intervals for particular instruments. There are two main
considerations when determining the calibration frequency. Firstly, the instruments reproducibility should be
taken into account. New devices should be calibrated frequently in order to establish their reproducibility.
Secondly, the required uncertainty of measurement should be assessed. If the instruments reproducibility
is shown by successive calibrations to be substantially better than the potential uncertainty then the interval
between calibrations can be extended. At the other extreme, where the instruments reproducibility
approaches the limits of uncertainty, the calibration intervals should be much shorter.
In order to be confident that our calibrations are accurate we must be able to trace or link these results back
to a calibration standard, held by a national measurement institute, through an unbroken chain of
comparisons and where each link in the chain has stated measurement uncertainties. This is referred to as
traceability. In addition, it is important to ensure that appropriate equipment and procedures are used in the
calibration process by trained and authorized personnel.
Why perform calibrations?

To improve the measurement accuracy and reliability of the instrument
To reduce the number of end-products rejected because they are outside acceptable tolerances
To provide products with reduced and more competitive tolerances, better reliability, and access to
quality-conscious markets
To minimize unnecessary rework and delays, resulting in customer dissatisfaction
To eliminate or minimise health and safety, legal and regulatory issues
What is traceability?
Traceability is the ability of a measured result to be linked or related or traced to appropriate measurement
standards - generally international or national standards - through an unbroken chain of comparisons
(traceability chain) in which all uncertainties are indicated. It should be noted that the instrument itself is not
traceable, but the result produced by the instrument is! Traceability applies to both physical and chemical
measurements. The standard referred to can be a material measure, measuring instrument, reference
material or measuring system that defines, realizes, conserves or reproduces a unit or one or more values
of a quantity that serves as a reference.
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What is the meaning of traceability to international standards?
Representatives of seventeen nations signed the Metre Convention Treaty which provided the foundation
for the establishment of the International System (SI) Units. Since then, national standards laboratories have
cooperated in the development of measurement standards that are traceable to the SI.
Units of measurement with the highest accuracy are realized by international measurement standards. The
value of the international standard is usually determined by comparison of national standards of the highest
quality or in the case of the kilogram by the mass of the International Prototype. National measurement
standards, maintained in a national metrology institute (NMI) are compared with these international
standards before they are used as a reference for calibration of standards of lower precision. Therefore it is
possible to demonstrate an unbroken chain of comparisons that ends at a national standards body.
What is the traceability chain?

It is a series of comparisons between the devices under test to a reference standard. The final comparison
in the chain is made using the International System (SI) units as the reference. Each comparison is a link in
the chain and the uncertainty of each comparison (link) must be known and documented. NMIs provide the
ultimate measurement references for their countries. The intent of all NMIs is to match the SI units as
closely as possible so that traceability to the SI can be established by comparing to an NMI that in turn
compares its reference standards to the SI.
SI UNITS
Primary National
Standard
NMI
Secondary
Standards
NMI
Working
Standards
NMI or other
Calibration
ofinstrument
What are the benefits of traceability?

Allows you to be competitive and operate in the global environment thus reducing technical barriers
to trade
It provides another way of guaranteeing a measurements accuracy.
It is an essential element of a quality control system
It links people, organizations, documents, techniques and measurements within a large and
diverse measurement community
What is measurement uncertainty?

Test or calibration measurements are subjected to imperfections in each step of a process from sampling
to final measurement. Measurement uncertainty (also referred to as uncertainty of a measurement) is the
term used to describe this imperfection, and is defined as the parameter associated with the result of a
Page 48 of 64
measurement that defines the range of the values that could reasonably be attributed to the measured
quantity. This indicates the interval within which the true value of the quantity being measured is expected to
lie with a stated level of confidence.
How is measurement uncertainty evaluated?

Measurement uncertainty is evaluated by quantifying and combining a number of uncertainty components,
which can be:
Random Effects e.g., fluctuations in temperature, humidity, air-pressure, variability in
performance of the measurement, sampling.
Systemic Effects e.g., offset of measuring instruments, drift in its characteristics between
calibrations, personal bias in reading an analogue scale or uncertainty of the value of a reference
standard.
The components are quantified either by evaluation of the results of several repeated measurements, or by
estimation based on data from records, previous measurements, knowledge of the equipment and
experience of the measurement. The evaluation from repeated measurements is done by applying a
mathematical formula derived from statistical theory. The parameter determined is the standard uncertainty
expressed as a standard deviation. Measurement uncertainty is usually written as an expanded
uncertainty and provides an interval within which the value of the measurand (measured substance) is
believed to lie with a higher level of confidence. It is obtained by multiplying the combined standard
uncertainty by a coverage factor (k); where k is based on the level of confidence desired. For a level of
confidence of 95%, k is 2.
Why is measurement uncertainty important?

It provides laboratories and customers with valuable information about the accuracy and reliability of test or
calibration data.
It tells how well the results represent the value of the quantity being measured.
It helps to maintain confidence in the comparability of results (which helps to reduce barriers to trade).
It shows whether a result is within the acceptable limits or outside of it.
It is a requirement of ISO 17025:2005 (clause 5.4.6) and ISO 15189 (clause 5.6)
What is laboratory quality control (QC)?

Quality control (QC) is an integral part of a laboratorys operation. It is designed to monitor, detect, reduce,
and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results and
improve the quality of the results reported by the laboratory. Quality control is a measure of precision or how
well the measurement system reproduces the same result over time and under varying operating conditions.
The control can be a substance, sample or procedure intended to verify the performance characteristics of a
test system. QC should not be confused with quality assurance (QA), which encompasses everything a
laboratory does to assure high quality services to its customers.
Why establish a QC program?

Your QC program should be a monitoring system that provides immediate information about the
acceptability of results, as well as a method for evaluating data over time. Most control material is
accompanied by the manufacturers approximate target values for the mean and standard deviations (S.D.).
These stated values should only be used as a guide since the laboratory must always establish its own
mean and standard deviation for each analytic procedure using a statistically significant number of control
determinations (repetitions of 20 or more runs). Control charts, developed using the laboratorys calculated
mean and S.D, are used to plot QC control results and to determine acceptability of a test run. Westgard
rules may be used to analyze the QC data. Additionally, policies and procedures for remedial action for QC
failures should be documented and applied as needed to maintain accuracy and reliability.
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What do we look for on QC charts?
1. Excessive scatter points are widely scattered above and below the mean. This is evidence of
poor reproducibility of results. Common cause is operator variability in pipetting or failure to strictly
observe all steps in the procedure.
2. Bias majority of points fall either above or below the mean. The two most common causes are an
error in calibration or an error in reconstituting a control material.
3. Drift or trend QC results move away from the mean in a particular direction over an extended
period of time. Causes are outdated reagents, deterioration in reagents or instrument is losing its
calibration.
4. Shift control values suddenly change from the normal distribution above and below the mean to
results that remain either above the mean or below the mean. Common causes are recent
recalibration interventions, change in a reagent lot, sudden deterioration of reagents (e.g. possibly
not refrigerated overnight), new technician or a major change in instrument performance.
What are the benefits of conducting QC?

Monitors the stability of test methods or systems.
Assesses the accuracy and precision of test results and test methods.
Alerts the analyst if there is a problem with the reagent, test method, or instrument.
Demonstrates competency of laboratory personnel
Allows the laboratory to track the overall performance of a test procedure over time.
Detects random and systemic errors.
What is method validation?

Method validation is defined as the confirmation, through the provision of objective evidence, that the
requirements for a specific test method or application have been fulfilled. The aim is to establish the
operational limits and performance characteristics of a new, modified or otherwise inadequately
characterised test method.
When is method validation performed?

Test methods should be validated when:
a new test method is being developed
an established test method is modified
QC indicates that an established method is changing with time
demonstrating the equivalence between two methods, e.g. a new method and a standard method.
How is method validation performed?

The studies used to determine method performance characteristics should be conducted with equipment
that is within specification, working correctly and adequately calibrated. The technician conducting the study
must be competent and capable of making appropriate decisions from the data produced during the study.
The following are common characteristics tested during method validation studies:
Specificity/selectivity ability to accurately measure the analyte in the presence of interferences.
Linearity - ability of an analytical method to produce test results that vary in a manner that is
directly proportional to the changes in concentration of analyte in a sample - within a given
concentration range.
Accuracy closeness of the measured value to the true value for the sample.
Range the concentration interval over which acceptable accuracy, linearity and precision are
obtained.
Precision (Repeatability & Reproducibility) the amount of scatter in the results obtained from
multiple analyses of a homogeneous sample.
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Detection Limit lowest concentration of the analyte that can be confidently detected by the
method.
Quantization Limit strictly the lowest concentration that can be determined with an acceptable
level of repeatability, precision and trueness.
Robustness ability of the test method to remain unaffected by small but deliberate changes, e.g.
temperature.
Recovery assesses the efficiency of the method in detecting all of the analyte present.
Why is method validation necessary?

To provide objective evidence that the results are accurate and reliable
To demonstrate that a test method is fit for implementation
Validation data can be used to design QC programmes
What is verification?
Test method verification is a simplified validation process employed to check or verify a test methods
performance characteristics. It typically includes a subset of the parameters evaluated when a complete
validation is performed, and asks the question Does this new test method perform to its specification in my
laboratory?
When is verification conducted?

It should be done before a new externally validated test method is employed by the laboratory to report
results.
How is verification conducted?

The laboratory should:
Develop a clear, detailed verification procedure that defines the parameters to be evaluated.
Define and approve the acceptance criteria (e.g., manufacturers package insert) to be used in
analyzing the results.
Compare evaluation study results to the previously established performance characteristics.
Based on the results, accept or reject the test method.
Summarize the data collected from the verification study in a final report.
The following is a listing of the most common subset of characteristics used in verification studies:
Characteristics Analyzed Types of Studies Performed

Accuracy Comparison of methods to estimate inaccuracy or bias
Precision Replication experiment to estimate imprecision
Reportable range of test results for the test Linearity type experiment to estimate imprecision and to
method determine reportable range
Manufacturers reference intervals (medical Collecting reference values to verify the established reference
laboratories) range
Why is verification necessary?

To provide objective evidence that your laboratory has the ability to achieve acceptable results for
a given test method.
To prove that an externally validated test method is acceptable for its intended use in your
laboratory.
END OF DOCUMENT
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APPENDICES
APPENDIX 1: SUMMARY OF CLAUSES IN ISO/IEC 17025
MANAGEMENT REQUIREMENTS
4.1 Organization
Laboratory management shall have responsibility for the design, implementation, maintenance and
improvement of the quality management system.
4.2 Management system (QMS)

The QMS shall have all its procedures documented. It shall include internal quality control and participation
in interlaboratory comparisons. A quality policy statement and a documented quality manual are needed.
4.3 Document control

Define, document and maintain procedures to control all documents and information. Define retention
periods and archive documents for later reference.
4.4 Review of request, tenders and contracts

Ensure that all parties understand and abide by the provisions made in contracts. Keep records of all
reviews, including significant changes and maintain these records.
4.5 Subcontracting of tests and calibrations

Have procedures for evaluation and selection of subcontracted laboratories and consultants. Maintain a
register of all subcontractors used.
4.6 Purchasing external services and supplies

Ensure that external services, equipment and consumable supplies consistently meet the laboratorys
standards. Have an inventory control system and quality records of external commodities purchased.
4.7 Service to the client

Clients shall be afforded consideration to verify that their samples are appropriately handled and analysed.
Confidentiality shall be maintained.
4.8 Complaints
Keep records of any complaints or feedback and of investigations or corrective action taken by the
laboratory.
4.9 Identification and control of non-conformities

When a non-conformity is detected: a) Personnel must be designated for problem resolution;
b) Corrective action must be defined and taken immediately; c) The deviation must be documented, and
reviewed by staff.
4.10 Improvement
Review all procedures at regular intervals to identify any potential source of non-conformance. Action plans
must be developed, documented and implemented as appropriate.
4.11 Corrective Action

Carry out investigations to determine the root causes of problems. Document and implement any changes
made to procedure. Review all procedures regularly and take action to improve the system.
4.12 Preventive Action
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Identify any necessary improvements and areas of non-conformities, either technical or concerning the
management system. Develop action plans and procedures to reduce the likelihood of potential non-
conformities.
4.13 Control of records

Establish procedures for Identification, Collecting, indexing, access, Maintenance, Safe disposal of quality
and technical records
4.14 Internal Audits

Formally and periodically carry out internal audits to ensure that the QMS is maintained.
4.15 Management review

Laboratory management must periodically review the QMS to maintain and improve the system. Findings
must be recorded and any corrective action needed must be taken immediately.
TECHNICAL REQUIREMENTS
5.1 General
5.2 Personnel
Define qualifications and duties for all personnel. Implement the Quality Management System (QMS) and
procedures.
5.3 Accommodation and environmental conditions

Ensure the facilities for examination allow for correct performance of tests and reliability of results.
5.4 Test and calibration methods and method validation

Use only relevant, validated, documented procedures which meet the needs of the users of the laboratorys
services. Record any deviations or changes in procedure.
5.5 Equipment
Provide the laboratory with relevant, functioning and calibrated equipment. Ensure authorized personnel
operate equipment in a safe working environment.
5.6 Measurement traceability

The laboratory must have documented evidence that measurements made by the laboratory can be traced
to the International System of Units (SI).
5.7 Sampling
The laboratory must be sure that there is a good understanding and agreement between the customer and
the laboratory with respect to the sampling process to be carried out.
5.8 Handling of test and calibration items

Authorized personnel must review results and determine reliability before releasing results. Disposal of
samples must be in accordance with local standards.
5.9 Assuring the quality of test and calibration results

Establish quality control methods to verify attainment of quality results. Document, record and retain
records of results. Take action if results are suspected to be incorrect.
5.10 Reporting results

Results must be reported legibly, unambiguously and in an identifiable manner. Use an audit log if the
present reporting system cannot capture changes or alterations
Page 53 of 64
APPENDIX 2: LIST OF POLICIES IN ISO/IEC 17025
ISO 17025 Section in Quality NOT

Policy Name (Description) Clause Number Manual DONE DONE
For ensuring the protection of confidential information 4.1.5c
For avoiding involvement in activities that would diminish 4.1.5 d
confidence in the laboratorys competence, impartiality,
judgement or operational integrity
Quality Policy Statement 4.2.2
For conducting a review of requests, tenders and contracts 4.4.1
For the selection and purchasing of external services and 4.6.1
supplies, equipment and consumable supplies that affect
the quality of tests and calibrations
For the resolution of complaints 4.8
To identify and control nonconformities when they occur 4.9.1
To designate appropriate authorities for implementing 4.11.1

corrective actions
For identifying training needs and providing personnel 5.2.2
training
Page 54 of 64
APPENDIX 3: LIST OF PROCEDURES IN ISO/IEC 17025
ISO
17025 Section in
Clause Quality/Procedure NOT
Procedure Name (Description) Number Manual DONE DONE
For ensuring the protection of confidential information 4.1.5c
For avoiding involvement in any activities that would diminish 4.1.5d
confidence in its competence, impartiality, judgement, or operational
integrity
To control all documents 4.3.1
For approval and issue of documents 4.3.2.2
For hand amendments of documents pending re-issue (if allowed) 4.3.3.3
To describe how changes in documents maintained in the 4.3.3.4
computerised systems are made and controlled
For review of requests, tenders and contracts 4.4.1
For the selection and purchasing of external services and supplies 4.6.1
that affect the quality of tests and calibrations
For the resolution of complaints 4.8
To identify and control nonconformities when they arise 4.9.1
To designate appropriate authorities for implementing corrective 4.11.1
actions
To identify, document and eliminate the root cause(s) of 4.11.2
nonconformities
For initiating and monitoring preventive actions 4.12.2
For identification, collection, indexing, access, storage, maintenance 4.13.1.1
and safe disposal of records
To protect and back up records stored electronically 4.13.1.4
For internal audits which include the types of audit, frequencies, 4.14.1
methodologies and required documentation
For conducting management reviews 4.15.1
For checking that the environment does not adversely affect the 5.2.2
performance of specimen collection and equipment
To ensure good housekeeping 5.3.5
To describe test and calibrations methods 5.4.1
To describe validation methods 5.4.5.2
5.4.6.1
For estimating uncertainty of measurement for calibration labs
For estimating uncertainty of measurement for testing Labs performing 5.4.6.2
calibrations
For protecting the integrity of (electronic/computer) data at all times 5.4.7.2b
To provide up-to-date instructions on the use and maintenance of 5.5.3
equipment
Page 55 of 64
ISO
17025 Section in
Clause Quality/Procedure NOT
Procedure Name (Description) Number Manual DONE DONE
For safe handling, transport, storage and use of equipment 5.5.6
For performing intermediate checks to maintain confidence in the 5.5.10
calibration status of equipment
For ensuring correction factors are correctly updated 5.5.11
For calibration of equipment 5.6.1
For calibration of reference standards 5.6.3.1
For intermediate checks to maintain confidence in the calibration 5.6.3.3
status of reference, primary, transfer or working standards and
reference materials
For safe handling, transport, storage and use of reference standards 5.6.3.4
For sampling performed by the laboratory 5.7.1
For recording relevant data and operations relating to sampling 5.7.3
For transportation, receipt, handling, protection, storage, retention 5.8.1
and/or disposal of test/calibration items
For avoiding deterioration, loss or damage to the test or calibration 5.8.4
item during storage, handling and preparation.
For quality control procedures that monitor the validity of tests and 5.9.1
calibrations undertaken
Page 56 of 64
APPENDIX 4: LIST OF SHALLS IN ISO/IEC 17025
Requirement Met Not Met N/A Clause

The laboratory shall be an entity that can be held legally responsible. 4.1.1
The laboratory management system shall cover all work carried out in
4.1.3
permanent and mobile facilities
If personnel do perform activities other than testing, e.g. consulting, the

4.1.4
organisation shall be defined in order to identify conflicts of interest
The laboratory shall have personnel and resources needed to carry out its
4.1.5.a
duties according to its scope of accreditation
The laboratory shall have arrangements to avoid their personnel being

influenced by internal or external pressure that could influence the quality of 4.1.5.b
their work, e.g. paid by the number of tests performed
The laboratory shall have policy and procedures to avoid involvement in

4.1.5.d
anything that could diminish its confidence
The laboratory shall define its organisation and management structure and the
4.1.5.e
relationships in the organisation, e.g. by using an organisation chart.
The laboratory shall specify the responsibility, authority and interrelations of

4.1.5.f
personnel that could influence the test results.
The laboratory shall provide supervision of testing staff, including trainees, by

4.1.5.g
competent personnel.
The laboratory shall have technical management with the competence and
4.1.5.h
resources needed for the overall responsibility for quality.
The laboratory shall appoint a Quality Manager. 4.1.5.i

The laboratory shall appoint deputies for key personnel. 4.1.5.j
The laboratory shall establish, implement and maintain an appropriate quality
4.2.1
system for its activities.
The laboratorys quality system and policies shall be defined in a named

4.2.2
Quality Manual.
The quality policy statement shall be signed by the management. 4.2.2.a-e
The Quality Manual shall make references to supporting document systems
4.2.3
and outline the structure of the system.
The roles and responsibilities of the Technical Management and Quality

4.2.4
Manager shall be defined.
Page 57 of 64
The laboratory shall include or make reference to external and internal
4.3.1
documents in the quality system.
All documents issued as part of the quality system shall be reviewed and
approved. A master list (or equivalent) shall outline the documented quality 4.3.2.1
system and be used to control the documents.
The procedures adopted shall ensure that:
- Authorised documents are available where needed
- Documents are periodically reviewed and if necessary 4.3.2.2
Replaced
- Invalid/obsolete documents are removed and marked as such
Quality system documents generated by the lab shall have an ID, page
4.3.2.3
numbering, information pertaining to their validity and be authorised.
Changes to documents shall be reviewed and approved by the same

4.3.3.1
functionary that approved the original.
Altered text in documents shall, if possible, be identified in the revised
4.3.3.2
document.
If the laboratory allows for changes in documents to be made by hand, that

4.3.3.3
procedure must be documented.
If changes to electronic documents are allowed, that procedure must be

4.3.3.4
documented.
The laboratory shall have procedures for the review of requests, tenders and
4.4
contracts.
Records of reviews (including subcontractors) shall be maintained. 4.4.2 / 4.4.3
When the laboratory is going to use a subcontractor, it shall use a competent
4.5.1
one.
The laboratory shall inform the client if the laboratory uses subcontractors 4.5.2
The laboratory shall maintain a register with its approved subcontractors and
4.5.4
their competence.
The laboratory shall have a policy and procedure for the selection of
purchasing of services and supplies and a procedure for the approval of 4.6.1 / 4.6.2
bought goods.
The laboratory shall offer its clients a service. 4.7

The laboratory shall have a policy and procedure for complaints and a list of
4.8
received complaints.
Page 58 of 64
The laboratory shall have a policy and procedure to control non conforming
4.9.1
work.
The laboratory shall monitor the effect of any corrective action. 4.10.4
When there is a doubt that the laboratory does not follow its own procedures,
4.10.5
the laboratory shall perform an internal audit:
If there is the need or opportunity to perform a preventive action the laboratory

4.11
shall do that.
The laboratory shall have a system for archiving of its documents. 4.12
Each observation etc. shall be documented in a way that makes it possible to

4.12.2.1
identify the responsible person, and if of importance, the time.
Mistakes shall not be tippexed or erased, the wrong note shall be over-lined,
4.12.2.3
dated and signed together with the correct result.
The laboratory shall have a procedure and a predetermined schedule for

4.13
internal audits covering the whole quality system.
The management shall periodically, according to a schedule, perform

4.14
management reviews.
The laboratory shall ensure the competence of its personnel. That competence
5.2.1
shall be documented.
The laboratory shall have a policy about training and competence and a
5.2.2
procedure to detect the need for training.
The laboratory shall have up-dated documented job descriptions. 5.2.4
The laboratory shall have documented authorisations for personnel to perform
5.2.5
specific tasks, e.g. signing of test reports.
The laboratory must have facilities and an environment that does not affect the
5.3.1
test result.
The laboratory shall, if necessary, monitor, control and record environmental

5.3.2
conditions.
The laboratory shall use appropriate test methods and laboratory specific
5.4.1
SOPs where needed.
The laboratory shall inform the client of the appropriate method to meet the
clients needs. The lab shall choose international, regional or national methods
5.4.2
or methods published in reputable organizational or technical journals or
methods proposed by the manufacturer of the equipment used.
Non standard methods shall be validated before use. 5.4.4 / 5.4.5.2
When calibrating, the uncertainty shall be estimated. 5.4.6.1
Page 59 of 64
Testing laboratories shall have procedures to estimate its uncertainty. 5.4.6.2
Calculations and data transfers shall be checked periodically. 5.4.7.1
The laboratory shall validate its own developed software and have procedures
5.4.7.2
to protect data stored electronically, e.g. log in / user name and back ups.
The laboratory shall have the equipment needed to perform the tests. 5.5.1
Used equipment shall have the quality needed and shall be appropriately
5.5.2
calibrated.
The equipment shall be operated by competent staff; instructions shall be

5.5.3
available where needed.
Each item of equipment shall be identified and properly documented. 5.5.4 / 5.5.5
Equipment suspected to function incorrectly shall be prevented from being

5.5.7
used
When intermediate checks (verifications) are needed to guarantee the function

of a piece of equipment, those checks shall be performed according to a 5.5.10
defined plan and procedure.
The laboratory shall have a programme for calibration of its equipment. 5.6.1
When necessary the testing laboratory shall have traceability to SI units for the
5.6.2.2
physical factors in question.
The laboratory shall have a programme and procedures for the calibration of
5.6.3.1
its reference standards.
Reference material shall be traceable to SI units or to certified reference
5.6.3.2
material where possible.
The laboratory shall have procedures to ensure the calibration status of its
5.6.3.3
standards and reference material.
The laboratory shall have procedures for the handling of its standards and
5.6.3.4
reference materials.
If the laboratory carries out sampling, it shall have a plan and procedure for
5.7
that.
The laboratory shall have procedures for receipt, transport, pre-treatment
5.8.1 / 5.8.2
labelling and identification etc. of test items.
If any abnormality is detected upon receipt of a test item, this shall be recorded 5.8.3 / 5.10.3.1.a /
and noted in the test report. 5.10.3.2.e
Page 60 of 64
The laboratory shall have plans and procedures for monitoring the validity of its
results. Systems shall be used in order to detect trends, e.g. the use of 5.9
statistical evaluations.
The result shall be presented in a calibration certificate or test report fulfilling
5.10
the requirements in ISO 17025.
If opinions and interpretations are included in the report, the basis of that must
5.10.5
be explained and clearly separated from the result.
If subcontractors have been used that must be clear from the report. 5.10.6
In the case of electronic transmission of results, this must be agreed (in

5.10.7
writing) with the client and the requirements in ISO 17025 must be met.
Additions or corrections to a test report can only be made by a new document

5.10.9
with an explanation.
Page 61 of 64
APPENDIX 5: SAMPLE ACCREDITATION ACTION PLAN
ACTION PLAN FOR THE PERIOD: JANUARY 2011 TO DECEMBER 2011
GOAL:
ORGANISATION NAME:
Objectives:
1)
2)
3)
Date prepared:
Prepared by:
Activities Responsible Indicator of Deadline Schedule (weeks or months)

success
Area of Improvement
Organisation and Management

Clause 4.1
e.g. Outcome 1 Quality manager and Approved 15-1- 2011
Revision of the Quality Manual Lab management available copies
and the quality policy statement of the quality
and have them approved by the manual and the
lab director quality policy
statement
1.1
1.2
1.3
Outcome 2
2.1
2.2
2.3
Outcome 3
3.1
3.2
3.3
Outcome 4
4.1
4.2
4.3
4.4
Add more rows as necessary
Page 62 of 64
APPENDIX 6 EXAMPLE OF A FORM FOR THE WITNESSING OF TESTING
Name of Laboratory:
Department Name:
Auditor name: Date of Audit:
(PLEASE COMPLETE ONE FORM PER TEST WITNESS)

1. Type of sample
2. Name of method, calibration process or operation being evaluated and brief description.
3. Name of person
observed
4. Qualifications/
Experience
5. Detailed comments, observations and/or reference. Indicate what was demonstrated and/or talked through as
applicable. (Use reverse if necessary)
Additional / General Comments This space may also be used to expand on comments in specific sections
5.1 Validation data for method / technique / procedure
6. Non conformities / conclusions
6.1 Overall impression of conduct of method / technique / procedure
Signature
Assessor/Auditor
Signature of person
Date
observed
Page 63 of 64
APPENDIX 7 REFERENCE DOCUMENTS
Preparing For Accreditation: Guidance on Implementation of Quality Management Systems (QMS) For Medical
Laboratories. A QMS How To Guide. Edition 1 December 2006 Strengthening Of Medical Laboratory Services In The
Caribbean. A CARIFORUM Project Funded by the European Union (CAREC EU Project)
Estimation of uncertainty of measurement in Medical Laboratories, 12th September 2006. European Diagnostic
Manufacturers Association Position paper. www.edma-ivd.be
M3003 The Expression of Uncertainty and Confidence in Measurement, Edition 2 August 2006 United Kingdom
Accreditation Service www.ukas.com
Uncertainty of Measurement in Clinical Microbiology. Fuentes-Arderiu X, eJIFCC vol 13 no. 4.

www.ifcc.org/ejifcc/vol13no4/130401006
International Laboratory Accreditation Cooperation (ILAC) Documents www.ilac.org

ILAC G2 Traceability of Measurement
ILAC G9 Guidelines for the Selection and Use of Certified Reference Materials
ILAC G13 Guidelines for the requirements for the Competence of Providers of Proficiency Testing Schemes
Quality Management Standards

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17043 Conformity Assessment General Requirements for Proficiency testing
ISO/IEC Guide 2:2004 Standardisation and related activities General Vocabulary
ISO/IEC 17000 Conformity Assessment - General Vocabulary
ISO 19011:2002 Guidelines for quality and/or environmental management system auditing
ISO/TR 10013:2001 Guidelines for Quality Management System documentation
ISO 10002: 2004 Quality Management Customer Satisfaction Guidelines for complaints handling in
organisations
ISO 9000 Quality Management Systems Fundamentals and vocabulary
ISO 9001 Quality Management Systems Requirements
Page 64 of 64

Internal Auditing of Laboratory Quality Management Systems

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Internal Auditing of Laboratory Quality Management Systems

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PREAMBLE

This guidance manual is not to be used for commercial purposes.

For further information, please contact:

CARICOM Regional Organisation for Standards and Quality (CROSQ)

Ing. Manfred Kindler

CHAPTER 1: QUALITY MANAGEMENT SYSTEMS FUNDAMENTALS .................................. 7

Figure 1 Summary of the Accreditation Application process ...................................................11

APPENDIX 1: SUMMARY OF CLAUSES IN ISO/IEC 17025 .........................................................52

Laboratory Accreditation is the formal recognition of a laboratorys technical competency to

Essential components of these standards include the following:

A laboratory shall periodically and in accordance with a predetermined schedule and

1.2 QUALITY TERMS AND DEFINITIONS

a. Quality Management System

1.3 ACCREDITATION vs. CERTIFICATION

Laboratory accreditation requires the application of assessment criteria specifically developed to

Why Is a Laboratorys Technical Competence Critical?

Avoid Expensive Retesting

Figure 1 Summary of the Accreditation Application process

Accreditation Bodys Pre-Audit

Corrective actions completed

Application to Accreditation Body

Accreditation Body Document Review

On site assessment by assessor team follows

Laboratory Corrective Actions

2.1 INITIATING THE PROCESS

Internal Audits must be planned to establish that:

ESTABLISH THE AUDIT

CONDUCT DOCUMENT REVIEW

PREPARE, APPROVE AND DISTRIBUTE

COMPLETE THE AUDIT

ROLE OF THE QUALITY MANAGER IN AUDITING

ADDITIONAL KEY ROLES AND RESPONSIBILITIES

2.4 HORIZONTAL AND VERTICAL AUDITS

Figure 3 Document Control Checklist

Figure 4 Example of a Vertical Audit checklist

Report number Audit date

Name of auditor Date and signature of auditor

Audit area Records/methods checked and Observations Non Conformity

Check: - logbook or computer entry

Is there evidence of review of

Does the report contain sufficient

Have results been authorized by

Is the turnaround time acceptable?

Does the laboratory monitor

Can the completed report be traced

Key Documents for the Conduct of Audits

Examples of checklists and forms are included in Chapter 6 (Audit Tools).

3.2 DEVELOPING THE AUDIT SCHEDULE

Figure 5 Example of an Audit Schedule

Checklists can be generated in two ways:

Figure 6 Example Twenty Milestones Audit Checklist

Figure 7 Competencies required for effective auditing

4.1 INITIATING THE AUDIT PROCESS

Taking the First Steps

4.2 CONDUCTING THE AUDIT

A nonconformity is simply defined as nonfulfilment of a specified requirement. When auditors find

Often the objective evidence is physical, such as an unauthorized change to a controlled

Figure 9 Example of a Non Conformity report form

Types of Non Conformities

Classifying Nonconformities by Importance (Potential Impact)

The consequences of the nonconformity also have a bearing on the classification. A

5.2 RECORDING and REPORTING AUDIT FINDINGS

Recording Audit Findings

Reporting Audit Findings

____________ _ ______________