Guidance on Technical Aspects of ISO/IEC 17025 from CITAC

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



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 National Association of Testing Authorities, Australia - Laboratory LA. 2

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 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:



best practice for their analytical operations



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)

  

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 National Association of Testing Authorities, Australia - Laboratory LA. 6

A Potted Guide to the “Guide”



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 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



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 National Association of Testing Authorities, Australia - Laboratory LA. 13