Guidance on Technical Aspects of ISOIEC 17025 from
- Slides: 13
Guidance on Technical Aspects of ISO/IEC 17025 from CITAC- NCSLI Joint Workshop Pittcon 2002, New Orleans Regina Robertson, Technical Manager NATA, Australia National Association of Testing Authorities, Australia - Laboratory LA. 1
Presentation Summary l History of Revision of the Guide l Comparison of Technical Content of ISO/IEC 17025 and the Contents of the Guide l Some Features of the Guide – Specification of the analytical requirement – Sampling, Sample Handling and Preparation – Reagents/Traceability/MU/Method Validation – Calibration l Conclusions National Association of Testing Authorities, Australia - Laboratory LA. 2
History of Revision of the Guide l Guide 1 was revised to: – reflect changes in good measurement practice in chemistry – accommodate ISO/IEC 17025 l Draft 2 (20 October 2001) l Draft 3 (8 March 2002) l Comment by 31 March 2002 for finalisation by mid-April 2002 and publication National Association of Testing Authorities, Australia - Laboratory LA. 3
CITAC/Eurachem Guide to Quality in Analytical Chemistry-An Aid to Accreditation Members of working group: Bernard King / Alan Squirrell Maire Walsh / David Holcombe Aims in revision: Explain the “how” in QA in chemistry National Association of Testing Authorities, Australia - Laboratory LA. 4
CITAC/Eurachem Guide to Quality in Analytical Chemistry-An Aid to Accreditation Provides laboratories with guidance on: l best practice for their analytical operations l implementing QA – concentrates on technical issues – some guidance on “compliance” for accreditation, certification etc National Association of Testing Authorities, Australia - Laboratory LA. 5
Technical Aspects of ISO/IEC 17025 (Section 5) l 5. 1 General l 5. 2 Personnel l 5. 3 Accommodation and environmental conditions l 5. 4 Test and calibration methods and method validation l 5. 5 Equipment l 5. 6 Measurement traceability l 5. 7 Sampling l 5. 8 Handling of test and calibration items l 5. 9 Assuring the quality of tests results l 5. 10 Reporting the results National Association of Testing Authorities, Australia - Laboratory LA. 6
A Potted Guide to the “Guide” l Scope/Laboratory audit and review l Environment/Equipment/ Reagents l The analytical task l Traceability/MU l Specification of the analytical requirement l Method validation l Analytical strategy/Nonroutine analysis l Sampling, sample handling, and preparation l Calibration/Reference materials/QC and PT l Computers and computer controlled systems l References / Appendices National Association of Testing Authorities, Australia - Laboratory LA. 7
Some Features of the Guide 7. Specification of the analytical requirement (4. 1. 2, 4. 4. 1, 4. 7, 4. 9. 1 etc) – analytical service must be appropriate to meeting the needs of the customer – the customer’s functional requirement must be translated into the laboratory’s analytical requirement – a clear and adequate specification of the requirement is “key” National Association of Testing Authorities, Australia - Laboratory LA. 8
Some Features of the Guide 11. Sampling, Sample Handling and Preparation (5. 7, 5. 8) – sampling strategy depends on the nature of the problem – why is the analysis required and how will it be carried out – define terms used in sampling plan clearly – properties of analytes of interest need to be considered – lab sample test portion – size and stability of sample (type of analysis, need for further tests, effect on MU etc) – be aware of the importance of sampling/statistical basis National Association of Testing Authorities, Australia - Laboratory LA. 9
Some Features of the Guide 14. Reagents – verify quality of new batch before use against outgoing batch 15. Traceability (5. 6) – matter of choice what traceability is to – not feasible to trace to the mole if the measurand is defined in functional terms measurand is defined by the method and traceability is to stated references eg reference material – links traceability and MU National Association of Testing Authorities, Australia - Laboratory LA. 10
Some Features of the Guide 16. Measurement Uncertainty (5. 4. 6) – provides mini tutorial on subject – repeatability/reproducibility are not full statement of MU as sytematic errors aren’t considered 18. Method Validation (5. 4. 5) – systematic laboratory studies method is fit for purpose – information and data from validation can be used in MU – define terminology and state parameters in the method to assist user – don’t assume your “standard” method is adequately validated National Association of Testing Authorities, Australia - Laboratory LA. 11
Some Features of the Guide 19. Calibration (5. 5) – defines types of calibrations according to type of analysis – possibility of calibrating whole analytical processes by use of reference material – day-to-day calibration requirements will be identified in method validation – level and frequency based on experience- (not less than recommended by manufacturer) – volumetric glassware National Association of Testing Authorities, Australia - Laboratory LA. 12
Conclusions l The Guide should be a useful aid to laboratories and accreditation and other compliance monitoring bodies l It is a practical distillation of matters that may appear obvious, as well as additional current information on hot topics National Association of Testing Authorities, Australia - Laboratory LA. 13
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