Internal Audit For ISO 9001:2008: Presented By: Robere & Associates (Thailand) LTD

INTERNAL AUDIT
for ISO 9001:2008
Presented by : Robere & Associates (Thailand) Ltd.
© Robere & Associates

(Thailand) Ltd. 90-IQA-E-DN 1 of 126
Version 2.01
AGENDA
Day 1 Day 2
 Introduction to the audit  Review of day 1
 Roles & responsibilities  ISO 9001 conformance
 Auditor skills audit (continue)
 Conflict handling  Developing checklist
 Audit cycle  Performing mock audit
 ISO 9001 conformance  Presentation of the mock
audit audit result
 Question & Answer

Version 2.01
Audit Principle
ISO 9001 Standard

Auditing
Customer&
Regulation Quality Management System
Requirement
Auditing
Actual Practice

Version 2.01
Internal Audit Objective
 To ensure that the QMS complies with
ISO9001 requirements
 To ensure that the organization complies
with the defined QMS and meets the
objective
 To make sure that the QMS is effective in
meeting the objectives

Version 2.01
Internal Audit Objective
 To identify non-conformity and areas of
improvement for the QMS
 To provide management information about
the state of the business
 To improve quality awareness and
involvement of employees

Version 2.01
What is an Audit
 A systematic independent and
documented examination
 A determination of whether quality
activities and related results :

comply with planned arrangements

are implemented effectively

Version 2.01
Relevant terminology
 Auditor
 Auditee
 Audit Team
 Audit program
 Audit criteria

Version 2.01
Definition
 Audit finding
 Audit conclusion
 Objective evidence
 Non-conformity (NC)
 Corrective action
 Preventive action

Version 2.01
Types of Audit

First Party Audit
carried out within an organization by its own
personnel with a primary focus on QMS

Second Party Audit
performed by or on behalf of a customer with a
primary focus on contract

Third Party Audit
performed by a Certification Body with a primary
focus on ISO
Version 2.01
Version 2.01
Audit Party
Auditor Team
Observers (Lead Auditor &
Team members)
Internal
auditing
Company’s Member of top
Auditees management
(Client) (QMR)
Version 2.01
Auditor Responsibilities

maintain the integrity of the audit function

communicate audit requirements

plan and conduct the assigned audit

document the observations

report results

verify corrective action effectiveness

maintain confidentiality

support the team leader and other team members
Version 2.01
Lead Auditor Responsibilities

same as other auditor in the team

manage the team

assist in team selection

quality control over the team's work

interfacing with auditee management

preparation/submission of audit report

Version 2.01
Auditor Roles

audit conformity of actual practices against the
define QMS against ISO9001

obtain and audit objective evidence fairly

treat concerned personnel in a way that will best
achieve the audit purpose

remain true to the purpose of the audit without fear
or favor

react effectively in stressful situations

perform the audit process without deviating due to
©
distractions
Robere & Associates
Version 2.01
Auditor Roles

commit full attention and support to the audit
process

arrive at generally acceptable conclusions based on
audit evidences

identify opportunity for improvement

Version 2.01
Auditor Personal Attributes

has the qualifications to perform a quality audit

is assigned and authorized to perform any or all
portions of a QMS audit

be mature and open minded

use facts and documented evidence, not hearsay

has strong communication and analytical skills

is independent of the work being audited

Version 2.01
Auditee Responsibilities

inform employees

co-operate with auditors

provide logistical resources

corrective action

Version 2.01
Auditor Skill Ladder
Technology Knowledge
ISO Standards Understand situation
Audit Principles Audit skills Analyse evidence
Identify NC
Schedule
Checklist Preparation
Auditor
Meetings meeting
NC Report Audit meeting
Audit Report Reporting
Communications Depth
Interpersonal Sampling Width
Decision making
Time management General Skill
Conflict management
Version 2.01
Version 2.01
Where Conflicts Can Occur
 Conflict is not always avoidable. The five mo
st common types of conflict an auditor might
encounter include:

Conflict between audit team members.

Conflict between auditor and auditee.

Conflict between auditor and auditee’s manag
ement.

Conflict between auditor and auditor’s manage
ment.

Conflict between auditee and auditee’s manag
ement
Version 2.01
Exercise (20 minutes)

During the audit process, you are facing
conflict (as given in the attachment). You are
required to analyze what type the conflict is
and as an auditor how you will handle it.

Version 2.01
Audit Cycle
5. Corrective Action &
Follow-up
1. Audit 4. Report the

Planing Audit
2. Audit 3. Conduct the

Preparation Audit
Version 2.01
1. Audit Planning
1.1) Determine the Audit Scope
 consider :

Reason for the audit

Activities or processes in the audit scope

Concerned product and requirements

Auditees and areas will be audited

Version 2.01
1. Audit Planning
1.2) Team sizing & Selection
 consider :

Auditor personal attributes

Auditor’s skills

Required knowledge

Independence

Assign lead auditor and auditors

Version 2.01
2. Audit Preparation
2.1) Audit schedule
 should include :

Date and time of the audit

Name of auditors

Processes, activities, locations and areas to
be audited

Related documents, e.g. quality manual, pro
cedure, work instruction

Related requirements

Name of Auditee or area responsibilities

Approval of the audit schedule
Version 2.01

Sample
Internal Audit Schedule ABC (Thailand) Ltd.
Date Time Auditor Process/ Reference ISO9001
Responsibility Document Requirement
1/1/2001 9:00-12:00 Sakda Management / QM, QP560, 5.1,5.2,5.3,5.4,5.5,
Thanit MD,QMR QP850, QP423 5.6,6.1,8.4,8.5,
QP424 4.2.2,4.2.3,4.2.4
1/1/2001 13:00-16:00 Srinuan Sales / QP720, QP622 7.2,5.3,5.4.1,
Yupa Sales Mgr. QP850 5.5.1,5.5.3,6.2.2,
QP423 8.2.1,8.2.3,8.4,8.5,
QP424 4.2.2,4.2.4
Approved by QMR Nithisit
Version 2.01
2.1 Audit schedule
 Suggestion in preparing the audit schedule is

analysing relationship between the defined
process and requirements or documents

utilizing Audit Planning Matrix.

Version 2.01
Sample of an audit planning matrix - requirements
Process / Department
Element
MGT
PUR
W/H
M/A
Sale
QC
4.1 General Requirement
4.2 Documentation Requirement X X X X X X
5.1 Management commitment X
5.2 Customer focus X
5.3 Quality policy X X X X X X
5.4 Planning X X X X X X
5.5 Responsibility, Authority and Communication X X X X X X
5.6 Management review X
6.1 Provision of resource X
6.2 Human resources X X X X X
6.3 Infrastructure X X X X X
6.4 Work environment X X X X X
7.1 Planning of realization processes X X X
7.2 Customer related-processes X
7.3
7.4 Purchasing X X
7.5 Production and service provision X X X
7.6 Control of measuring and monitoring devices X
8.1 Planning X
8.2 Measurement and monitoring X X
8.3 Control of nonconformity X X
8.4 Analysis of data X X X X X X
8.5 Improvement X X X X X X
Version 2.01
Sample of an audit planning matrix - documents
Process/ Department
Management
Purchasing
System
W/H
M/A
QC
Document (QM, Procedure,WI)
QM- 001 X
QP 423 X X X X X X
QP 424 X X X X X X
QP 560 X
QP 622, WI 630, WI 640 X X X X X
QP 720 X
WI 743 X
QP 824 X
WI 840, WI 851 X X X X X X
QP 710 X
WI 741 X
(Thailand) Ltd. QP 760 X
90-IQA-E-DN 29 of 126
Version 2.01

Factor to be considered
 Time & activities, required by the audit team

Preparation

Meeting
 The audit criteria / requirements
 Complexity of the audit
 Number & competency of the audit team mem
bers
 Limit of available time
 Availability of auditees
Version 2.01
“When the audit schedule is changed, the

concerned parties shall make known as soon as
possible”

Version 2.01
Group Activity (20 minutes)
Each group is assigned to plan to conduct
an internal audit in your organization.
1. Define scope of the audit
2. Prepare Audit Planning Matrix
3. Prepare Audit Schedule
Then, present your audit plan to the class.

Version 2.01
2.2 Team Meeting and Assignment.
 Assure every auditor has the same
understanding.
 Assign the role of lead auditor and auditors.
 Confirm responsibility of the team member.
 Discuss the audit requirements and
documentation.
 Review relevant documents.
 Prepare checklist.
Version 2.01
2.2 Review of QMS documentation such as
 Quality Manual
 Quality Policy and Objective
 Procedure and Work Instruction
 Other working documents
 Customer specific documents
 Forms and Record
 Regulatory Requirement
Version 2.01
2.2 Preparing audit checklist
Benefit
 Ensure sample is balanced
 Assure coverage of the audit subject
 Assists in sequencing the process audit
 Provides a record of the audit for future
reference
Version 2.01
2.2 Types of checklist
 Criteria checklist
 Bullet-point checklist
 specific question checklist
 standard question checklist

Version 2.01
Criteria checklist
 Be structured in accordance with QMS
standard
 Example :
Item Yes No Comment
- The internal audit has been conducted at
planned intervals
- The audit has been planned in consideration
of the status and importance of the processes
and area to be audited, as well as the results
of previous audits
Version 2.01
Bullet-point checklist
 Only title or brief suggest point
 Example :
Item Yes No Comment
- Vender selection and evaluation method
- Selection and evaluation criteria
- Evaluation record

Version 2.01
Specific question checklist
 Be structured around a discrete process,
department, or procedure
 Example :
Item Yes No Comment
- Has the calibration plan been prepared?
- Is there a list of equipments required
calibration?
- Have the equipments been calibrated twice
a year?
Version 2.01
Standard question checklist
 Could the form of either of previous
checklist
 Be uniform practice within organization
 Example :
Item Yes No Comment
- What method does each department use
in purchasing?

Version 2.01
Group activity (30 minutes)
Product a checklist for the audit of assigned
process

Version 2.01
3. Conduct the Audit
3.1) Opening Meeting

introduction of auditors

inform audit scope

explain audit method

explain audit criteria

Version 2.01
3.2) Audit Trail A P
C D

Detail of activities within processes.

Control activities and interface of these
processes.

Follows the Plan / Do / Check / Act cycle
Version 2.01
3.2) Conducting process audit
 Begin at Quality policy and objectives
Quality  understand the organizational
Policy quality polity
 ensure the departmental
Goal Goal Goal
objectives are real,
measurable, and monitored for
Objectives
Objectives
Objectives
Objectives
Objectives
Objectives
effectiveness
Objectives
Objectives
Objectives
Objectives
Objectives
Objectives
 objectives are the key to
Objectives
Objectives
Objectives
Objectives
Objectives
Objectives
continuous improvement
Version 2.01
Example Support processes Impro
g ve ment
ni n
lP an Related Process
Ana
lysi
Purchasing process
s of
Communication
dat
Purchasing Order
a
requisition placement
ing
itor ss
monProce
Planning Inventory control
Auth
ority
assig& resp Receipt of purchased product r c e nt
nme onsib u
esoageme
nt ility R
Control of M an
documents & Records
Version 2.01
3.3) Collecting Evidence
 Interviews
 Examination of documents
 Observation of activities Procedure
You are looking for facts not mistakes

Version 2.01

Interviewing
 Talk to the right person
 Ask proper question
 Listen carefully to the answer
 Remain on the purpose
 Analyze and control situations
Be aware that Auditor should be a good listener, while
©
having Auditee explains his processes
Robere & Associates
Version 2.01

Questioning Technique
 Open ended questions - to allow explanation
 Close-ended questions - to limit scope of answer
 Leading questions - to lead the subject
 Clarify questions - to summarize the point

Version 2.01
Version 2.01
3.2) Conducting process audit
Consider :

The purpose, input, output, control and
resources applicable to each process

Links between process and quality objectives

The steps in the process and responsibilities

Process measurement

Evidence of continual improvement

Need of internal and external customers
Version 2.01
Exercise 15 minutes

In group, establish 2 questions of each type of
question ( total 8 ) which is suitable for an audit
...?

Version 2.01
3.4) Identify & record the audit evidences
 Documents

Quality Policy & Objectives

Quality Manual

Procedure &Work Instruction

Version 2.01
3.4) Identify & record the audit evidences
 Observation of implementation

Records of activities

Actual practice

Understanding & Awareness
 Result of effectiveness

Minute of management review

Result of data analysis

Record of corrective and Preventive action

Version 2.01
4. Report the Audit

Auditor judges the level of NC

Reasonable & realistic, supported with
objective evidence.

Not bias by auditor’s personal opinion.

Auditor reports the NC to the management of a
udited area

Team auditor reports the result of the audit to t
he top management
Version 2.01
4. Report the Audit

Grading Non-Conformity
 Major Non-Conformity

significant failure to conform with requirements

jeopardize certification
 Minor Non-Conformity

isolated non-fulfillment of specific requirement

negligible effect on quality
 Observation

for improvement
Version 2.01
4. Report the Audit
Example of Non-Conformity
 Procedure for control of document are not documented
 There are no evidence of authorized approval for
the delivered products which had not been inspected
as planned
 A purchased item has been purchased from a supplier
who is not listed in the approved vendor list
 There are uncontrolled drawings; 2 at the Assembly De
partment, 5 at Production Department and 2 at Engine
ering Department
Version 2.01
4. Report the Audit

Non-Conformity report
 detail of NC
 audit evidences & reference documents
 name of auditors and auditees
 others as necessary
 be clear and understandable
Be remind that
“You are auditing the system, not the person”
Version 2.01
4. Report the Audit
Example of NC report writing
 There is no evidence of follow-up activities
within suitable timeframe for many corrective
actions, e.g. the record no. 201, 208, 231,
245 and 263 (NC to clause 8.2.2)
 At sales department, the quality objectives
have been established but there is no action
plan to ensure that the objectives will be
achieved. (NC to clause 5.4.2)
Version 2.01
4. Report the Audit
Example of NC & Corrective Action Request From
CORRECTIVE ACTION REQUEST (CAR) CAR No.________
To: _____________________ Result of Internal Audit

From: __________________ Result of Management Review
Audit Date : ______________ Other__________________________
Problem/NC :
NC founder
Date :
Root cause
Corrective/Preventive action
Due date : Responsible person: Approved by (QMR) :
Follow-up activity: Result of action

Satisfied
Not satisfied,
issued new CAR no. _________
Follow-up by: QMR :

Version 2.01
4. Report the Audit
 Reporting the audit activity
 State the non-conformity supported
with the audit evidences
 Point-out the good
 Provide a complete, concise and
clear record of the audit
Be ensure that the report is easy to understand by
readers who might not involved in the audit
Version 2.01
4. Report the Audit

Suggested content in an audit report
 The audit objective
 The audit scope, time period and place
 Audit team members and auditees
 The audit criteria
 The audit finding
(NC, observation and recommendation)
 The audit conclusions
 The distribution list of the audit report
Version 2.01
5. Corrective Action & Follow-up
Corrective Action Process 1
Approve the
Identify the problem proposed action
Investigate the
root cause Implement the corrective action
Propose corrective action Follow-up result of action
1 Summarize status of the problem
Version 2.01
5. Corrective Action & Follow-up
 Auditee takes action on the nonconformity
 Auditor follows up corrective action

effective on the agreed timebound.

supported with evidence showing:
 the cause of problem is eliminated.
 Prevention of re-occurance.

Version 2.01
( Part 2 )
Auditing
the Quality Management System
ISO 9001:2008 Requirement

Version 2.01
1. Scope
1.2 Application
 Application and exclusion is based on the nature of a
n organization and its product.
 Exclusion shall not affect the organization’s ability, or r
esponsibility, to provide product that meet customer an
d applicable regulatory requirements
 Exclusion are limited to requirements within clause 7

Version 2.01
4.1 General Requirement
 Document, implement and maintain the QMS
 Define necessary processes, their application,
criteria and methods
 Define sequence and interaction of these processes
 Provide information and resources
 Monitor, measure, analyze and take action to
ensure achievement of planned results
 Continual improve the process and QMS
 Define and control outsource processes
Version 2.01
4.2 Documentation Requirement
4.2.1 General
 QMS documentation include;

a quality policy and quality objectives

A Quality Manual

Documented procedures as required by ISO 9001

Documents required by an organization to ensure;
 Effective planning/operation
 Control of its processes

Records required by ISO 9001
Version 2.01
4.2.2 Quality Manual
 shall be established and maintained which
includes;

The scope of the QMS
 Including details and justification of any
exclusions

Documented procedures or reference

Description of sequence & interaction of
processes included in the QMS.
Version 2.01
4.2.3 Control of documents
 QMS documents shall be controlled
 A documented procedure shall be established to;

approve prior to use

review, update as necessary and re-approve

identify changes and the current revision status

Ensure available at points of use

Ensure legible and readily identifiable

identify and control distribution of external documents
©

Prevent unintended use of obsolete documents
Robere & Associates
Version 2.01
Version 2.01
4.2.4 Control of Quality Records
 established and maintained records
 records shall be legible, readily identifiable,
retrievable
 A documented procedure shall define;

Identification, legibility, storage, protection,
retrieval, retention period, disposition.

Version 2.01
5. Management Responsibility

Version 2.01
5.1 Management commitment
 Top management shall provide evidence of
commitment by;

Communicating the importance of meeting
customer, statutory, regulatory requirements

Establishing the quality policy

Ensuring quality objectives are established

Conducting management reviews

Ensuring the availability of resources

Version 2.01
5.2 Customer focus
 Top management shall ensure

customer requirements are determined and
are met

thereby, enhancing customer satisfaction

Version 2.01
5.3 Quality Policy
 Ensure that the quality policy;

is appropriate to the purpose of the organization

includes a commitment to comply with
requirements and continual improve the
effectiveness of the QMS

provides a framework for establishing and
reviewing quality objectives

is communicated and understood

is reviewed for suitability
Version 2.01
5.4 Planning
5.4.1 Quality Objectives
 Ensure objectives are established at relevant
functions and levels
 These objectives shall be;

Measurable

Consistent with the Quality Policy

Version 2.01
5.4 Planning
 Planning of the QMS to meets requirements
of 4.1 and the Quality Objectives.
 The integrity is maintained when the QMS is
changes.

Version 2.01
5.5 Responsibility, Authority &
Communication
5.5.1 Responsibility & Authority
 Defined and communicated;

Responsibilities

Authorities

Interrelation

Version 2.01
5.5 Responsibility, Authority &
Communication
5.5.2 Management Representative
 Top Management shall appoint a QMR from the
member of management team
 QMR is responsible for;

Ensuring the processes of the QMS are
established, implemented and maintained

Reporting to top management on the performance
of the QMS, including needs for improvement

Promoting awareness of customer requirements
©
throughout the organization
Robere & Associates
Version 2.01
5.5 Responsibility & Authority &
Communication
5.5.3 Internal Communication
 Ensure appropriate, regarding the
effectiveness of the QMS

Version 2.01
5.6 Management Review
5.6.1 General
 Top Management shall review the QMS
at planned intervals to ensure suitability,
adequacy and effectiveness.
 Records of management reviews shall be
maintained

Version 2.01
5.6.2 Review Input
 shall include;

Results of audits

Customer feedback

Process performance and product conformity

Status of preventive and corrective action

Follow up actions from previous management
reviews

Planned changes that could effect the QMS

Recommendations for improvement
Version 2.01
5.6.3 Review Output
 shall include decisions and actions related to;

Improvement of the effectiveness of the QMS
and its processes

Improvement of product, related to customer
requirements

Resource needs

Version 2.01
6. Resource Management

Version 2.01
6.1 Provision of resources
 Determine and provide resources

Version 2.01
6.2 Human Resources
6.2.1General
 Personnel shall be competent on the basis of;

Appropriate education

Training

Skills

Experience

Version 2.01
6.2 Human Resources
6.2.2 Competence, awareness and training
 Determine the necessary competence
 Provide training or take other actions to
satisfy these needs
 Evaluate the effectiveness of the actions taken
 Ensure personnel are aware of their own
impact on quality
 Maintain records of education/training,
skills and experience
Version 2.01
6.3 Infrastructure
 Determine, provide, maintain infrastructure;

Buildings, workspace and associated utilities

Process equipment, both hardware & software

Supporting services such as transport or
communication

Version 2.01
6.4 Work Environment
 Determine and manage the conditions of
the work environment needed to achieve
conformity to product requirements

Version 2.01
7. Product realization

Version 2.01
7.1 Planning and product realization
 Plan and develop the processes
 Determine the following (as appropriate)

Quality objectives & requirements for the product

The need to establish processes, documents,
and provide product specific resources
 Required verification, validation, monitoring,
inspection and test activities specific to the
product and the criteria for product acceptance
 Records
Version 2.01
7.2 Customer Related Processes
7.2.1 Determination of requirements related
to the product
 Requirements specified by customer
 Requirements not stated by the customer
but necessary for use
 Statutory and regulatory requirements
related to the product
 Additional requirements determined by
the organization
Version 2.01
7.2.2 Review of requirements related to
the product

Review to ensure;

Product requirements are defined

The difference are resolved

The ability to meet the defined requirements

Maintain records of the results of the review
and required actions.

Where product requirements are changed;

Documents are amended

Relevance are made aware of the changes
Version 2.01
7.2.3 Customer Communication
 Determine and implement effective
arrangements for customer communication
in relation to;

Product information

Enquiries, contracts or order handling,
including amendments

Customer feedback, including customer
complaints

Version 2.01
7.3 Design and Development
7.3.1 Design & Development planning
 Plan, control and determine;

Design and development stages

The review, verification and validation that
are appropriate to each stage

Responsibilities and authorities

Manage all interfaces
 Planning output shall be updated

Version 2.01
7.3.2 Design & Development Inputs
 Determined & reviewed Inputs relating to
product requirements
 Maintain records

Version 2.01
7.3.3 Design & Development Outputs
 Provided in a suitable form
 Meet the input requirements
 Provide appropriate information for purchasing,
production and for service provision
 Contain product acceptance criteria
 Specify the product characteristics
 Approved prior to release
Version 2.01
7.3.4 Design & Development review
 Perform systematic reviews at planned
appropriate stages
 Maintain records of both the results of the
reviews and actions

Version 2.01
7.3.5 Design & Development Verification
 Verify to ensure that outputs have satisfied the
input
 Maintain records of the results of the
verification and necessary actions

Version 2.01
7.3.6 Design & Development validation
 Validate to ensure that the product is capable
of fulfilling the requirements for the specified
or known intended use or application
 Performed as planned, and completed prior to
delivery or implementation of the product
 Maintain records of the results of validation
and necessary actions

Version 2.01
7.3.7 Control of changes
 Identify and control design and development
changes
 Evaluate effect of the changes on constituent
parts and delivered product
 Reviewed, verified and validated (as appropriate)
and approved prior to implementation
 Maintain records of the result of the review of
changes and necessary actions
Version 2.01
7.4 Purchasing
7.4.1 Purchasing process
 Control to ensure that purchased product
conforms to specified purchase requirements
 Evaluate and select suppliers based on their
ability
 Establish criteria for selection, evaluation and
re-evaluation
 Maintain records of the results of evaluations
and necessary actions
Version 2.01
7.4 Purchasing
7.4.2 Purchasing Information
 Ensure the adequacy of specified purchase
requirements prior to their communication to
the supplier
 Purchasing information includes:

Detail of purchased product

Requirements for approval of product , QMS,
etc.(if required)

Version 2.01
7.4 Purchasing
7.4.3 Verification of purchased product
 Establish and implement the inspection to
ensure that purchased product conforms to
specified requirements
 State the verification arrangements and
method of product release in the purchasing
information, Where the verification at the
suppliers premises is a requirement

Version 2.01
7.5 Production and Service Provision
7.5.1 Control of production & service provision
 Plan and carry out under controlled conditions:

availability of product characteristics information

availability of work instructions

use of suitable equipment

availability and use of monitoring and measuring
devices

implementation of monitoring and measurement
activities

implementation of release, delivery and post delivery
activities
Version 2.01
7.5.2 Validation of processes for product and
service provision
 Validate processes to demonstrate the ability to
achieve planned results
 Establish arrangements include:(as applicable)

Defined criteria for review and approval of
processes

Approval of equipment and qualification of
personnel

Use of specific methods and procedures

Requirements for records

Re-validation
Version 2.01
7.5.3 Identification & Traceability
 Identify the product by suitable means
 Identify monitoring and measuring status
 Control and record the unique identification of
the product, where traceability is a specified
requirement

Version 2.01
7.5.4 Customer property
 Exercise care with customer property
 Identify, verify, protect and safeguard
 Report and maintain records of any lost,
damaged or the found unsuitability for use

Version 2.01
7.5.5 Preservation of product
 Identify, handle, pack, store and protect to
preserve the conformity of product and
constituent parts

Version 2.01
7.6 Control of Monitoring and
measuring devices
 Determine the monitoring and measurement to be
taken, and needed devices/software
 Measuring equipment shall be:

calibrated or verified at specified intervals or prior
to use, against national or international standards
 record the basis, where no such standards exist

adjusted or re-adjusted as necessary

identified calibration status

safeguarded from adjustments

protected form damage and deterioration
Version 2.01
7.6 Control of Monitoring and
measuring devices….cont…
 Assess and record the validity of previous
measuring results, when equipment is found not
to conform to specified requirements
 Take appropriate action on the equipment and
any product affected
 Maintain records of the results

Version 2.01
8. Measurement, Analysis
and Improvement

Version 2.01
8.1 General
 Plan and implement needed monitoring,
measurement, analysis and improvement
processes
 Determine applicable methods, statistical
techniques and the extent of their use

Version 2.01
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
 Monitor information relating to customer
perception as to whether the organization has
fulfilled customer requirements
 Determine methods for obtaining and using
this information

Version 2.01
8.2.2 Internal Audit
 Plan and conduct internal audits at planned
intervals
 Establish and implement the documented procedure
 Define audit criteria, scope, frequency and methods
 Select and assign auditors
 Take action eliminate cause of non-conformities
without undue delay
 Verify the actions taken and report the results

Version 2.01
8.2.3 Monitoring & Measurement of processes
 Apply suitable methods for monitoring and
measurement of the QMS processes
 Take correction and corrective action, when
planned results are not achieved

Version 2.01
8.2.4 Monitoring & measurement of product
 Monitor and measure the characteristics of the
product at appropriate stages, in accordance
with planned arrangements
 Maintain evidence of conformance with the
acceptance criteria and the authorize person(s)
for product release
 Product release and service delivery without
completion of all the planned arrangements
shall be approved by relevant authority or
©
customer
Robere & Associates
Version 2.01
8.3 Control of Nonconforming
product
 Identify and control to prevent unintended use or delivery
in accordance with documented procedure
 Dispose by:(one or more)

By taking action to eliminate the detected nonconformity,
then re-verification

By authorizing its use, release or acceptance under
concession

By taking action to preclude its original intended use or
application
 Maintain records of the nature of non-conformities and
any subsequent actions taken
 Take appropriate action, when nonconforming product is
detected after delivery or use
Version 2.01
8.4 Analysis of data
 Determine, collect and analyze appropriate
data relating with:

Customer satisfaction

Conformance to product requirements

Characteristics and trends of processes
and products including opportunities for
preventive action

Suppliers

Version 2.01
8.5 Improvement
8.5.1 Continual Improvement
 continually improve the effectiveness of the
QMS through the use of the;

Quality Policy

Quality objectives

Audit results

Analysis of data

Corrective and preventive action

Management review

Version 2.01
8.5 Improvement
8.5.2 Corrective Action
 Establish and implement a documented
procedure for:

Reviewing non-conformities and customer
complaints

Determining the causes

Evaluating the need for action to ensure that they
do not recur

Determining and implementing the actions needed

Recording of results of action taken

Verification of corrective action taken
Version 2.01
8.5 Improvement
8.5.3 Preventive action
 Establish and implement a documented
procedure for;

Determining potential non-conformities

Evaluating the need for action to prevent
occurrence

Determining and implementing action needed

Records of results of action taken

Verification of the preventive action taken
Version 2.01
Activity

Each team will be assigned to audit a
process:
 Prepare an audit checklist using the audit
matrices as guideline (45 minutes)
 Conduct a mock audit using the prepared
checklist, record the result and NC in the
provided from (60 minutes)
 Make a presentation of the result of activities
(5 minutes/team)
Version 2.01
Closing Activities

Summary
 Audit Objectives
 Auditor responsibility
 Audit process

Plan, prepare, conduct, report, corrective
action & follow-up

Version 2.01
Question?

Version 2.01

Internal Audit For ISO 9001:2008: Presented By: Robere & Associates (Thailand) LTD

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Internal Audit For ISO 9001:2008: Presented By: Robere & Associates (Thailand) LTD

Uploaded by

Copyright:

Available Formats

INTERNAL AUDIT

for ISO 9001:2008

Presented by : Robere & Associates (Thailand) Ltd.

© Robere & Associates

© Robere & Associates

ISO 9001 Standard

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

1. Audit 4. Report the

2. Audit 3. Conduct the

© Robere & Associates

© Robere & Associates

© Robere & Associates

“When the audit schedule is changed, the

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

You are looking for facts not mistakes

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

To: _____________________ Result of Internal Audit

Due date : Responsible person: Approved by (QMR) :

Follow-up activity: Result of action

© Robere & Associates

© Robere & Associates

ISO 9001:2008 Requirement

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates

© Robere & Associates