vertical assessment iso/iec 17025:2005 laboratories - Sanas

VERTICAL ASSESSMENT
ISO/IEC 17025:2005 LABORATORIES
F 44-07
Organisation’s
SANAS No/s.
Date/s of
evaluation
Assessor/s &
Observers
Laboratory
Area / field of
operation
Laboratory
Representative
Certificate or Report (Select one or more final Report /Certificate. Record at least the number, date and the accredited
parameters, as on the Accreditation Schedule, measured. Include details of calibrations/tests performed, name of
analyst/metrologist and technical signatory)
Clause REQUIREMENTS AND COMMENTS Compliance = C, Non-compliance = NC, Not applicable = NA
NB: Indicate WHAT has been checked and HOW requirements have been implemented. The order
of assessment need not follow the order of the checklist. Assessors are expected to know & have
the standard, this checklist is designed as guidance to prompt detailed recording of the process.
REFER TO ISO/IEC 17025:2005 FOR DETAIL AND FOR CLARIFICATION NOTES.
4.13.2 / 5.4.7 Technical Records (state which data and calculations were checked)
4.13.2.1
4.13.2.1
4.13.2.3
5.4.7.1
5.4.7.1
Raw data/original observations, calculations, derivations
Traceability to the person performing the test / calibration
Records permanent, corrections legible and authorised
Appropriate calculation checks. Randomly re-calculate,.)
Randomly check correctness of data transfers. Laboratory's control checks appropriate/effective
C
NC
NA
5.2 Training Check training records of identified operator(s) for accredited work from selected Results
5.2.5 Operator/s identified as competent for the work and is proof of competence available
5.2.5 Proven competent at the time that the work was performed
5.2.2 Appropriate method of determination of competence
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Additional Assessor Notes (This may be used for rough notes as well)
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5.4.1-6 Performance capability of selected methods
5.4.2
5.4.3
5.4.4
5.4.5.2
Proof of confirmation of proper operation of -standard methods,
-laboratory developed methods
-non-standard methods
Methods validated and availability of performance capability
5.4.5.3 Capability appropriate for use. Statistical application appropriate – (e.g. where relevant significant
figure or rounding off policy for final results)
5.4.6.2 Testing laboratories - Method uncertainty or specification tolerances
5.4.6.1 Calibration laboratories - Results within MC and availability of supporting calculations
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5.9 Assurance of validity of results
eg a)-e) Indicate how the laboratory monitors results
Appropriate and effective for ensuring the controlled performance of the accredited work
Monitoring data suitably recorded (e.g. control charts), evaluated reviewed.
Effective control limits or tolerances been established
Evidence of actions implemented when breaches have occurred.
5.9
Proficiency testing/Interlaboratory comparisons / Calibration measurement audit sample
(refer to F176 for detailed evaluation)
Appropriateness for the work performed
Evaluate results - action on anomalies or outliers.
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Additional Assessor Notes (This may be used for rough notes as well)
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5.5 / 5.6 Calibration of equipment and/or standards used (Indicate which equipment/standards)
5.5.2 Appropriateness of calibration and verification programmes, cover operating range
5.5.8 Calibration status
5.5.5 f) Records of calibration and verification complete, tolerances appropriate
5.5.10 In-house verification techniques sufficient to ensure validity of calibration
5.5.11 Suitable application of correction factors
5.6.2.1
5.6.2.2
5.6.2.1.1
5.6.3.1
5.6.3.2
5.6.3.3
Traceability to national standards
Traceability to appropriate measurement standards
External calibration services used - demonstrated competence, measurement capability and
traceability, certificates contain measurement results, measurement uncertainty
Reference standards traceable calibration, not invalidate performance when used
Reference materials -traceable, SI, CRMs. Internal reference materials - checked
Intermediated checks - reference, primary, transfer and working standards
5.5 / 5.6 Equipment maintenance and operation
5.5.3 Instructions on use and maintenance
5.5.5 a-h Records complete
5.5.6 Handling/transport/storage/use to prevent contamination/deterioration of - equipment and
5.6.3.4 - std/reference materials
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Additional Assessor Notes (This may be used for rough notes as well)
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5.3 Accommodation and environmental conditions
5.3.1 Critical areas of accommodation/environmental control which would affect the performance of the
accredited work. (eg. Special room, Dust filtration, Positive pressure, Lighting, Static, Electric
screening, Air lock entrance, Cleanliness, Vibration level, EMI, Dedicated Earth, etc.)
5.3.2 Monitored, controlled and actioned when required
5.3.3 Effective segregation of tests / equipment / standards and consumables
5.8.4 Adequate storage areas
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4.6 Purchasing of supplies (eg. Reference materials, critical consumables, etc.)
4.6.2 Supplies verified prior to use to meet the quality criteria as required for the methods accredited
4.6 System ensure supplies for the uninterrupted performance of work documented and effective -
e.g. stock control, requisitioning, ordering and storage
5.8 Handling of calibration or test items
5.8.2 Uniquely identified, ensure that there can be no confusion regarding the identify at any time
5.8.3 Condition of the item noted, where applicable
5.8.4 System avoid deterioration/damage during storage, handling, preparation, and calibration or test
5.10
Reporting of the results (See detailed requirements in 5.10 of ISO/IEC 17025:2005 or SANAS
F49)
If not full report, written agreement and all data available in laboratory
Signed:
Technical Assessor
Signed :
Lead Assessor
Date
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