1. ISO/IEC 17025 A review of the new standard for laboratory accreditation

2. Background 1 ISO Guide 25 - 1978 ISO TC/176 established
ISO/IEC Guide 25
- 1982
- 1990
ISO 9000 Series
- 1987
ISO/IEC 17025
- 2000
ISO TC/176
established
- 1994 1

3. Structure 1. Scope 2. Normative references 3. Terms and definitions
4. Management requirements
5. Technical requirements
Annexes

4. Technical Requirements of ISO/IEC17025
General
Personnel
Accommodation and environmental conditions
Test and calibration methods and method validation
Equipment

5. Technical Requirements of ISO/IEC17025 (cont)
Measurement traceability
Sampling
Handling of test and calibration items
Assuring the quality of test and calibration results
Reporting the results

6. Technical Requirements of ISO/IEC 17025 (cont)
Technical requirements described in greater detail but ideas are not really new for accredited laboratories
Reference to “needs” of client
Requirement for sampling plan if doing sampling

7. Technical Requirements of ISO/IEC 17025 (cont)
Greater emphasis/detailed requirements on:
Method validation
Estimation of measurement uncertainty/ traceability for TESTING laboratories
Provision for inclusion of interpretations and opinions on test reports

8. Management Requirements
4.1 Organization and management
4.2 Quality system
4.3 Document control
4.4 Review of requests,tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the client

9. Management Requirements (cont)
4.8 Complaints
4.9 Control of non-conforming testing and/or calibration work
4.10 Corrective action
4.11 Preventive action
4.12 Control of records
4.13 Internal audits
4.14 Management reviews

10. 4.1 Organisation New aspect
identification of potential conflicts of interest

11. 4.2 Quality System New aspect
more detailed requirements for quality policy statement

12. 4.3 Document Control
specific requirements for control, review and approval, issue and amendment of documents
incorporates ISO 9000 requirements

13. 4.4 Requests, Tenders, Contracts
identification of customer needs
ensure capability to meet needs
dealing with changes and deviations
incorporates ISO 9001 requirements

14. 4.5 Sub-contracting
aspects cover permanent sub-contracting, agency or franchising arrangements

15. 4.6 Purchasing
incorporates ISO 9001 requirements in simplified form

16. 4.7 Service to Clients cooperation with clients
notes cover various aspects of laboratory-client relationship
closest equivalent in ISO 9001 is clause 4.19 Servicing

17. 4.8 Complaints
Same general coverage as Guide 25 Section 16 in simplified form

18. 4.9 Non-conforming Work
specific procedures for dealing with non-conforming testing or calibration work/results
points to need for corrective action
consistent with ISO 9001 requirements

19. 4.10 Corrective Action
specific procedures for cause analysis, selection and implementation of corrective action,subsequent monitoring and follow-up audits
incorporates ISO 9001 requirements

20. 4.11 Preventive Action dealing with potential problems
quality improvement process
incorporates ISO 9001 requirements

21. 4.12 Records covers quality system and technical records
consistent with ISO 9001 requirements

22. 4.13 Internal Audits
Same general coverage as Guide 25 - paras 5.3 and 5.5

23. 4.14 Management Reviews specific guidance on matters to be considered
to be conducted periodically