Peter Askolin, M. Sc. ( Chemistry ) Lead assessor at Division of Chemistry

1. Peter Askolin, M. Sc. (Chemistry)Lead assessor at Division of Chemistry Swedish Board of Accreditation and Conformity Assessment SWEDAC

2. Issues • Short introduction of SWEDAC • Accreditation procedure • Accreditation requirements according to EN ISO/IEC 17025 • (Flexible scope (or not)) • Statistics about medical laboratories accredited by SWEDAC and DANAK Peter Askolin, SWEDAC

3. SWEDACBoard of Accreditation and Conformity Assessment Placed under the Foreign Department • Handles all Technical Control in Sweden • Divided in 3 divisions that are handling accreditation of laboratories. • General technology • Chemistry • Medical Technology and Electrotechnics Peter Askolin, SWEDAC

4. EN ISO/IEC 17025First edition 1999-12-15 General requirements for the competence of testing and calibration laboratories

5. EN ISO/IEC 17025 • Replaces EN 45001 • International ISO standard • A general standard not only for accreditation use • Divided into 2 parts • Management requirements (4§) • Technical requirements (5§) Peter Askolin, SWEDAC

6. §4 Management requirements • Incorporates ISO 9001 and 2 requirements • Big efforts is made to guarantee the independency of the laboratory. • Potential conflicts in interests shall be identified (e.g. the laboratory is placed directly under production) • Personnel and management shall be free from financial, commercial and other pressures (external) Peter Askolin, SWEDAC

7. §4 Management requirements • Technical management • Quality system • Contracting reviews • Subcontracting tests to other laboratories • Internal audit and Management review • Corrective actions and preventive actions • Control of records Peter Askolin, SWEDAC

8. Technical management • Technical leader shall be pointed out and deputie(s) for him. • Has the overall responsibility of laboratory operations. • Leads the laboratory work so that the required quality is reached. • Technical competence Peter Askolin, SWEDAC

9. Contract reviews • Confirmation that both the laboratory and its customer have understood the commissioned work in the same manner • Confirmation that the laboratory has necessary competence and resources for the commissioned work • Shall include work that is subcontracted to other laboratories. Peter Askolin, SWEDAC

10. Subcontracting • Accreditation can only be granted for work that the laboratory usually performs itself. • Shall be reported and approved by the customer • Shall clearly be marked out. • The laboratory shall make sure that the subcontractor works according to the std. • The laboratory have overall responsibility Peter Askolin, SWEDAC

11. Internal audits • Shall be performed regularly • Shall include all activities and elements • Shall be carried out by trained and qualified personnel • Independent from the activity being audited Peter Askolin, SWEDAC

12. Management review • Shall be done periodically by the laboratory management • To ensure quality improvements, suitability and introduce necessary changes. • Shall be documented Peter Askolin, SWEDAC

13. Corrective actions • Shall include cause analysis • Selection and implementation of corrective action • Shall be monitored • Additional audits Peter Askolin, SWEDAC

14. Preventive actions • Routines to identify needs to improvement • Identify potential sources of non-conformances Peter Askolin, SWEDAC

15. Personnel Choosing methods Standard Modified standards, sector approved methods Own methods Example of an accreditation scope Validation of non standard methods Sampling Opinions and interpretations Measurement uncertainty Traceability Reference materials Control of data Technical requirements Peter Askolin, SWEDAC

16. Choosing methods • Standard methods • Only verification needed • Modified standard methods • Verification • Validation of modification needed • Methods developed by the laboratory • Full validation needed for all matrices • Documentation Peter Askolin, SWEDAC

17. Validation of methods • Required • Does not need to be preformed by the laboratory that uses the method • All documentation shall be found at the laboratory • The laboratory has to verify the competence and recourses that developed the method. • SWEDAC has a document (informative) that helps chemical laboratories in validation. Peter Askolin, SWEDAC

18. Uncertainty • Laboratory has to • Identify potential components in uncertainty • Make an estimation of the uncertainty • Ensure that the result doesn’t give wrong impression • Based on knowledge, validation, experience Peter Askolin, SWEDAC

19. Personnel • Can be employed or contracted • Supervision in introduction • Basic competency for accredited activities • Job descriptions shall be maintained for all personnel (e.g responsibly for validation) Peter Askolin, SWEDAC

20. Opinions and interpretations • Shall be based on the results • It must be clearly identified • Procedures • Technical competence • The big responsibility for opinions and interpretations • Not to be mixed with specifications Peter Askolin, SWEDAC

21. Sampling • Can be accredited separately • The laboratory cant automatically exclude sampling • Will be assessed if the laboratory performs such activities even if not accredited Peter Askolin, SWEDAC

22. Control of data • Control of datasets (e.g. Excel datasheets) • Regularly controlled and when changed • Documented (traceability) • Validation of software developed by the laboratory. • Electronic signatures (traceablility) Assessed by computer experts if necessary Peter Askolin, SWEDAC

23. Accreditation Procedure • Application from the laboratory • The lead assessor from AB chooses the assessment team according to the scope • Documentation will be assessed • Visit to confirm compliance • Laboratory fixes non-compliances • Decision made by the AB Peter Askolin, SWEDAC

24. Flexible scope • What is a flexible scope? • Requirements on the laboratory • Restrictions • Example of a flexible scope accredited by SWEDAC Peter Askolin, SWEDAC

25. What's this? • The laboratory can change the scope without asking permission from AB • The changes will be audited on the yearly audit visit at the laboratory • Freedom with great responsibility • Certain limitations Peter Askolin, SWEDAC

26. Requirements • Experience • Great technical competence • Personnel pointed out to do validations and development of methods Peter Askolin, SWEDAC

27. Restrictions • Restricted to methods that are already used in the laboratory. • Laboratory has to have experience in the method used and its limitations • New methods cant be added to the scope • New methodology cant be introduced Peter Askolin, SWEDAC

28. SWEDAC 70 Clinical laboratories 32 Transfusion medicine 34 Clinical microbiology 8 Clinical pharmacology 5 Clinical physiology 5 Clinical pathology 1 Hospital physics DANAK Total of 17 accreditation's in laboratory medicine 8 of them at Statens Serum institute 2 Clinical biochemistry 1 Private in Clinical biochemistry and physiology 3 Veterinary laboratories 1 Forensic genetics Accredited laboratories Peter Askolin, SWEDAC

29. Thank you Peter Askolin, SWEDAC