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TECHNICAL REQUIREMENTS
of
ISO/IEC 17025:2005
Organisations
SANAS No/s.
Date/s of
evaluation
Assessor/s &
Observers
Laboratory
Area / field of
operation
Laboratory
Representative
This report covers the following:
Document Review only
Implementation on
Site Visit only
Document Review
Other
and Site Visit
Compliance = C, Non-compliance = NC, Not applicable = NA C
C l a u s e REQUIREMENTS & COMMENTS.
NC
NB1: Comment below on adequacy of how requirements have been addressed, documented and/or
NA
implemented. References to ISO/IEC 17025: 2005 are in italics & indicated as Std. The order of assessment
need not follow the order of the checklist. Assessors are expected to know & have the standard, this
worksheet is designed as guidance to prompt detailed recording of the process.
NB2: Where a clause is marked as NA, reason must be provided as to why its not applicable.
REFER TO ISO/IEC 17025: 2005 FOR DETAIL AND FOR CLARIFICATION NOTES.
TECHNICAL REQUIREMENTS
Personnel: How are the following addressed/implemented?
Competence of all who operate specific equipment, perform tests/calibrations, evaluate results,
Note Std sign reports/ certificates. Qualified on basis of appropriate education, training, experience and/or
demonstrated skills. Appropriate supervision of trainees.
5.2.2
Goals education, training, skills. ID training needs, provide training. Evaluate effectiveness of
training. Programme relevant to tasks.
5.2.3
Employed by/under contract. Supervised, competent, work in accordance with labs management
system.
5.2.4
Current job descriptions for managerial, technical, key support personnel involved in
Note Std tests/calibrations
5.2.5
Authorize specific personnel to: perform particular types of sampling, test, calibration; issue reports
certificates; give opinions, interpretations; operate particular types of equipment.
Records of authorisation(s), competence, educational, professional qualifications, training, skills,
experience of all technical personnel, including contracted personnel. Dated, readily available.
4.3.2.1 Are personnel who review and approve documents issued as part of the management system
&
authorized to do so?
ILAC
Do the personnel who undertake development and modification of methods have the necessary
G18
technical understanding and knowledge of the technology used?
5
5.2
5.2.1
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5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
Test & Calibration Methods & Method Validation: How are the following addressed/implemented?
General. Appropriate for scope. Include sampling, handling, transport, storage, preparation,
Note Std use/operation of equipment. Estimation of measurement uncertainty & statistic techniques for
& See 4.3
analysis of data, where their absence could jeopardize results. Up-to-date and readily available.
Deviations documented, technically justified, authorized, accepted by customer
Selection of methods: How are the following addressed/implemented?
5.4.2
Meet needs of customer, appropriate for tests/calibrations. Prefer international, regional, national
stds. Latest valid edition. Supplements to ensure consistency. By reputable technical
organisations/in relevant scientific texts/journals or specified by the manufacturer of the equipment
Laboratory developed method/s appropriate for intended use and validated.
Customer informed as to the method chosen.
Confirm that it can properly operate standard methods before introducing the tests/calibrations.
Confirmation repeated if standard method changes.
Customer informed when method proposed by customer is considered to be inappropriate or out
of date.
5.4
5.4.1
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5.4.3
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5.5
5.5.1
5.5.2
See 5.6
5.5.3
5.5.4
5.5.5
a)
b)
c)
d)
e)
f)
g)
h)
5.5.6
Note Std
5.5.7
see 4.9
5.5.8
5.5.9
5.5.10
5.5.11
5.5.12
Procedures for safe handling, transport, storage, use and planned maintenance of measuring
equipment to ensure proper functioning and in order to prevent contamination or deterioration.
Defective Equipment, prevented from use until shown by calibration or test to perform correctly.
Examine effect of defect on previous tests/calibrations, Control non-conforming work procedure.
When practicable identified to indicate calibration status, date last calibrated, re-calibration due.
Outside direct control, ensure function & calibration checked, satisfactory before returned to use.
Intermediate checks to maintain confidence in calibration status carried out to defined procedure.
Calibrations' correction factors, procedures to ensure copies (eg in software) are correctly updated
Equipment, hardware and software, safeguarded from adjustments, which would invalidate results.
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5.6
5.6.1
Note Std
5.6.2
5.6.2.1
5.6.2.1.1
Notes in
Std
See also
5.10.4.2
5.6.2.1.2
5.6.2.2
5.6.2.2.1
Note Std
5.6.2.2.2
Reference standards and reference materials: How are the following addressed/implemented?
Reference standards. Programme & procedure for calibration, traceable. Used for calibration only
unless not invalidated. Calibrated before and after any adjustment
5.6.3.2 Reference materials. Traceable to SI units/to certified reference materials. Internal checked
5.6.3.3 Intermediate cheeks. Checks to maintain confidence in calibration status of reference, primary,
transfer/working standards, reference materials according to defined procedures and schedules
5.6.3.4 Transport and storage. Procedures for safe handling, transport, storage and use in order to
Note Std prevent contamination or deterioration and to protect their integrity
5.6.3
5.6.3.1
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Handling of Test and Calibration Items: How are the following addressed/implemented?
Transport, receipt, handling, protection, storage, retention, disposal, protect integrity/ interests
Identify, for life of item, not confuse, accommodate sub-division and transfer of items.
Departures recorded on receipt. Where doubt consult customer before proceeding and record
Avoid deterioration, loss/damage storage, handling, preparation. Follow instruction. Environmental
Notes Std conditions maintained, monitored, recorded. Storage secure, protect condition and integrity.
5.8
5.8.1
5.8.2
5.8.3
5.8.4
5.9
5.9.1
Assuring the Quality of Test & Calibration Results: How are the following addressed/implemented?
QC procedures to monitor validity of results, data recorded, trends, statistics. Planned & reviewed:
Note Std
a)
b)
c)
d)
e)
5.9.2
Signed :
Lead/Technical
Assessor
2015-11-17
Date
SANAS
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