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Guidance on Technical Aspects of ISO/IEC 17025 from CITAC

Guidance on Technical Aspects of ISO/IEC 17025 from CITAC. CITAC- NCSLI Joint Workshop Pittcon 2002, New Orleans Regina Robertson, Technical Manager NATA, Australia. Presentation Summary. History of Revision of the Guide

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Guidance on Technical Aspects of ISO/IEC 17025 from CITAC

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  1. Guidance on Technical Aspects of ISO/IEC 17025 from CITAC CITAC- NCSLI Joint Workshop Pittcon 2002, New Orleans Regina Robertson, Technical Manager NATA, Australia

  2. Presentation Summary • History of Revision of the Guide • Comparison of Technical Content of ISO/IEC 17025 and the Contents of the Guide • Some Features of the Guide • Specification of the analytical requirement • Sampling, Sample Handling and Preparation • Reagents/Traceability/MU/Method Validation • Calibration • Conclusions

  3. History of Revision of the Guide • Guide 1 was revised to: • reflect changes in good measurement practice in chemistry • accommodate ISO/IEC 17025 • Draft 2 (20 October 2001) • Draft 3 (8 March 2002) • Comment by 31 March 2002 for finalisation by mid-April 2002 and publication

  4. 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

  5. CITAC/Eurachem Guide to Quality in Analytical Chemistry-An Aid to Accreditation Provides laboratories with guidance on: • best practice for their analytical operations • implementing QA • concentrates on technical issues • some guidance on “compliance” for accreditation, certification etc

  6. 5.1 General 5.2 Personnel 5.3 Accommodation and environmental conditions 5.4 Test and calibration methods and method validation 5.5 Equipment 5.6 Measurement traceability 5.7 Sampling 5.8 Handling of test and calibration items 5.9 Assuring the quality of tests results 5.10 Reporting the results Technical Aspects of ISO/IEC 17025(Section 5)

  7. Scope/Laboratory audit and review The analytical task Specification of the analytical requirement Analytical strategy/Non-routine analysis Sampling, sample handling, and preparation Environment/Equipment/Reagents Traceability/MU Method validation Calibration/Reference materials/QC and PT Computers and computer controlled systems References / Appendices A Potted Guide to the “Guide”

  8. 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”

  9. 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

  10. 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

  11. 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

  12. Some Features of the Guide 19. Calibration (5.5) • defines types of calibrations according to type of analysis • possibility of calibratingwholeanalytical 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

  13. Conclusions • The Guide should be a useful aid to laboratories and accreditation and other compliance monitoring bodies • It is a practical distillation of matters that may appear obvious, as well as additional current information on hot topics

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