1. National Institute of Public Health and the Environment RIVM Bilthoven

2. A Quality System for laboratories: Introduction  Margryt Oldenhof

3. Quality is everywhere

4.  Question: What is quality?  Participant discussion Intermezzo

5. Quality is:  The degree to which an item or process meets or exceeds the customers requirements and expectations  The degree to which a set of inherent (existing) characteristics fulfils requirements  A satisfied customer  Act as agreed  Flexibility

6. Laboratory processes: Black box or transparancy?  client ->input-> laboratory ->output ->client Report

7. Good Quality System  Starting were is matters most: Laboratory

9. The Laboratory Process Laboratory Report Sample

10. ISO/IEC 17025:2005 scope  General requirements for the competence of testing and calibration laboratories  Accreditation: formal confirmation: 1 - working conform ISO 17025 2 – competence of laboratory

11. ISO 17025 structure 1. Management requirements -> working processes 2. Technical requirements -> competence

12. Accreditation versus certification Accreditation (ISO 17025) 1. Conformity 2. Compentence Certification (i.e.ISO 9001) 1. Conformity

13. Focus ISO 9001  Satisfied customer  Continous improvement

14. ISO17025:2005 compared to ISO 9001  ISO 17025: 2005 includes the principles of ISO 9001 but follows not exactly all the requirements of ISO 9001

15. Deming-circle DO PLAN ACT CHECK

16. Plan–Do-Check-Act cycle  Planning phase: define targets, quality policy and procedures  Do: implementation phase  Check: control phase  Act: Action, adaptation and correction phase based on findings and decide to make changes to a process, policy etc.

17. Documentation of activities  Act as described  Describe the way you act  Documentate procedures  Follow the procedures and record relevant* information and non-conformities relevant* for the management and/or technical requirements

18. Quality triangle Q-policy Q-managementsystem HRMICTFinancial services Technical services Admini- stration Primary proces

19. Q-Policy statement Q-manual Instructions and forms Procedures ( SOPS) Documentation system