Roderick Chappel, Sandy Walker and Elizabeth M. Dax nrl.au

1. Quality Management Systems (QMS)for LaboratoriesPreparation and ImplementationRequirements of ISO/IEC 17025 and ISO 9000Elizabeth M. DaxNational Serology Reference Laboratory, Australiawww.nrl.gov.au

2. From the National Serology Reference Laboratory, Australia41 Victoria Parade, Fitzroy, Vic Australia 3065WHO Collaborating Centre on HIV/AIDS since 1985 Roderick Chappel, Sandy Walker and Elizabeth M. Dax www.nrl.gov.au

3. Aims of the QMS Section • To clarify the requirements of a Quality Management System (QMS)

4. Objectives of the QMS Section (1) • Define aims, costs and benefits of a QMS • Share NRL’s experience in preparing for and implementing a QMS • Define requirements of ISO/IEC 17025 and the overlap with ISO 9001

5. Objectives of the QMS Section (2) • To train in the more ‘difficult’ elements of ISO/IEC 17025 and ISO 9001, including • Requirements of a documented quality system • Document control • Internal audits • Corrective action • Equipment • Management review

6. Aims in Achieving Quality • To ensure that outputs and outcomes are • consistent • reproducible • traceable • efficacious • To ensure no harm

7. The Value of Standards • Help us do things better • Necessary compliance • Learning from others' experiences • Encourage continuous improvement

8. Effect of Quality Management on Costs • Initial costs • internal costs of failure • e.g. testing errors, reworking • external costs of failure • e.g. complaints, losing customers

9. Effect of Quality Management on Costs • Implementation costs • Ongoing costs • prevention • appraisal • failure costs (reduced)

10. Implementation Costs Cost $ Internal costs Prevention Appraisal Ongoing Costs Internal costs External Costs External Costs Time Effect of Quality Management on Costs

11. The Benefits  Independent endorsement of competence  Improved service to stakeholders Increased awareness of quality Organisational stability

12. Accreditation and Certification • Laboratory Accreditation • NATA/RCPA Medical Testing • NATA - ISO/IEC Guide 25:1990 • NATA - ISO 17025:2000

13. Accreditation and Certification • Quality Certification • ISO 9001, ISO 9002:1994 • ISO 9001:2000

14. Requirements Simplified

15. Quality Assurance SystemsWhy Both NATA & ISO 9000? ISO 9000 Management NATA Technical

16. Implementing the Guidelines  Design a system  Implement the system Verify the system meets the guidelines (audits, review)  Finalise implementation QUALITY SYSTEM

17. Developing a Quality System In a Quality System, work activities are described in written procedures and carried out in a planned way. The structure of a Quality System conforms to the relevant standards. Mission Statement Quality Policy How policy implemented. Quality Strategy QP + QS + description of quality system, how standards are applied. Quality Manual Describe how processes which affect quality are carried out. Procedures Additional detail on how specific jobs are carried out. Work Instructions

18. Implementing a QMS 1. Management • Management and staff commitment • “Management & leadership is for everyone” • Appoint Quality Manager to establish, implement and maintain the quality system

19. Implementing a QMS 2. Quality System Planning • Training of appropriate personnel • Visit other organisations

20. Implementing a QMS 3. Quality System Design • Identify core processes • Create an organisation process map • Structure documentation around the processes • “Allow standard to fit organisation”

21. Implementing a QMS 4. Format of Documents • Determine format of quality system documents • Document this in a procedure

22. Implementing a QMS cont. 5. Successful implementation requires: • planning, management, • belief in system • understanding the “spirit” of the standard • understanding organisation’s aims • having staff involved at all levels • look for real process improvements • setting realistic time frames

23. Implementing a QMS 5. Implementation • Set out the program for Implementation in stages: Gantt chart format is most appropriate

24. Implementation at NRL 1996 1997 Mar May Jul Sep Nov Jan Mar May Jul Sep Nov ID Task Name 1 NRL CERTIFICATION 2 Quality system planning 3 Training - P & WI preparation 4 Produce Ps & WIs 5 Implementation 6 Prepare Quality Manual 7 Schedule audits 8 NATA assessment 9 Produce Ps & WIs 10 Implementation 11 Update Quality Manual 12 Schedule audits 13 ISO assessment

25. ISO Guide 25/ISO Guide 17025

26. ISO Guide 25 now ISO Guide 17025 • ISO/IEC 17025 draws on ISO 9000:1994 • Accreditation and certification • different histories • on convergent paths • With ISO/IEC Guide 25, close to ISO 9001

27. Management versus Laboratory Standards • A large overlap between • ISO 9000 • and • ISO Guide 25 - ISO/IEC 17025 • Much of what follows applies directly to ISO 9000

28. Management versus Laboratory Standards • ISO/IEC 17025 includes: • almost all of ISO 9000 management requirements • technical requirements

29. ISO/IEC 17025 & ISO/IEC Guide 25 • Basically similar - structural change • More prescriptive in parts • More emphasis on: • Method validation

30. Using Structure of ISO/IEC 17025 • Limited differences • Newer • Better structure • Guide 25 versus NATA requirements

31. ISO/IEC 17025 4. Management requirements 5. Technical requirements

32. ISO/IEC 17025 - Technical 5.1 General 5.2 Personnel 5.3 Accommodation and environment 5.4 Selecting & validating test methods 5.5 Equipment