Accreditation or Certification for Laboratories?

1. Accreditation or Certification for Laboratories? Kyriacos C. Tsimillis

2. In Today’s Society… • some trends are of importance • free movement of goods • elimination of technical barriers to trade • broadening of quality concept

3. Quality Issues are… • nowadays considered to be of highest importance as a result of increasing awareness of existing needs. • This is illustrated in • legislative requirements and • high competition on quality aspects

4. Specific Needs… • exist in some sectors • food • health care services • environmental studies • New Approach Directives • dangerous substances

5. There is a Need to… • create an international technical language to ensure common understanding!

6. As a Result… • efficient tools and mechanisms are required. • Emphasis is given on their worldwide implementation in a harmonised way

7. Tools and Mechanisms • Standardization • Laboratory infrastructure • Quality management • Metrology • Accreditation • GLP

8. Tools and Mechanisms (cont.) • Technical Notification • Environmental management • Modules/Notified Bodies • Harmonised Standards • Ecolabeling • Occupational health and safety

9. The Infrastructure Required… • consists of • Laboratories • Standardization bodies • Certification bodies • Inspection bodies • Accreditation bodies

10. How can We be Sure that… • products and services meet the specifications? • By “conformity assessment”, i.e. checking that products and services meet the relevant standard´s specifications.

11. Demands Accreditation Certification Body Inspection Body Laboratory Demands Market Product/ Service Consumer Legislation Supplier Requirements Conformity Assessment

12. ISO/IEC Guide 2 and EN 45020 • refer to definitions and terminology of standardization and related activities.

13. Following the Definitions… • Accreditation refers to competence to carry out specific tasks • Certification refers to assurance of conformity to specified requirements

14. Testing is Carried out… by laboratories • in the private sector • in – house • second party • third party • in the public sector • competent authorities

15. We need to Measure! • If you cannot measure something • it doesn't exist! • Therefore we need • methodology • equipment • personnel

16. The Role of Laboratories • drafting of standards • development of new methods • implementation of standards, technical regulations and the legislation • provision of services (testing, calibration, consultancy)

17. Accreditation Body Legislation Calibration Laboratories Laboratories LABORATORY • Suppliers • Equipment • Reagents, CRM’s Certification Body Clients The Laboratory Environment

18. Laboratories Need… • to demonstrate their technical competence and reliability • to this end they need also to have policies how to estimate the uncertainty of their measurements

19. Laboratories’ Operationis Based on… • Quality System • methodology • equipment (suitability, calibration, • maintenance, conditions) • personnel (competence) • determination of uncertainty

20. Basic Documents for Laboratories • ISO 17025 • EA Guidelines • ISO 9000 • ISO 14000 (if applicable) • GLP (if applicable) • Legislation

21. To Avoid any Hidden Barriers… • to the free movement of goods, services and personnel, conformity assessment activities should be homogeneous and be implemented according to relevant Guides of ISO/IEC and EA Guidelines

22. Sources of Information • www.european-accreditation.org • www.eurachem.ul.pt • www.eurolab.org • www.ilac.org • www.irmm.jrc.be

23. Accreditation and Certification present both • similarities related to the audit-based nature of the procedures and • differences with regard to the tasks and the resulting procedure

24. They are Both Related to… • quality assurance policies • considered of high importance tools • in today’s society with regard to the free movement of goods

25. However… This is not enough and does not fit the purpose!

26. We Need Something More! • We need tools for the assessment of the technical competence of laboratories to carry out specified tasks

27. Is there any Confusion… • on the use of these two procedures, their significance and their role within conformity assessment activities? • If so, why does this happen?

28. Can Both Activities… • be used by laboratories to document their competence and the reliability of their results? • Do these two procedures represent equivalent criteria?

29. Main Differences Refer to… • the objective and content • the documentation • assessors’ competence • procedure of assessment • the use of the logo • how wide the scope is

30. Differences in the Procedure refer to the following issues • validation of test methods • expression of uncertainty • calibration of equipment • competence of personnel

31. What about Uncertainty? • How educated is the client to consider properly and make correct use of the expressed uncertainty of measurement?

32. The Meaning of Uncertainty • is not well understood by the clients. • They may not choose a laboratory which produces results that are “uncertain” to some extent!

33. Technical Competence of Personnel Means… • Suitable academic qualifications • Adequate experience/training • Awareness and familiarisation with particular methods and techniques

34. Quality Means… • meeting the customers’ needs. • How clear are these needs for the customers and how are they expressed in the communication with the laboratories?

35. Who are the Customers? • competent authorities • industrial units • purchasers • individuals • other laboratories

36. ISO 9000 Provides… • for suppliers and sub-contractors to be included in the approved list. • Relevant requirements are specified in the Quality System.

37. The Most Usual Requirement… • is ISO 9000 certification • this refers also to laboratories that are listed as approved suppliers/ subcontractors

38. A Survey was Carried out… by ILAC in 1996 to evaluate the competence of the laboratories, the needs of their customers and market trends.

39. According to the Survey… • a small percentage of laboratories are certified • big laboratories use accreditation for ISO 9000 compliance • accreditation is preferred to certification to demonstrate technical competence

40. Suggestions were Made … • for the revision of ISO/IEC Guide 25 and EN 45001 and harmonization with ISO 9000 on management issues • this would facilitate the promotion of mutual recognition of this part of the system.

41. The Standard ISO 17025 • has replaced the former European standard EN 45001 to ensure a worldwide acceptance of a unique document for the assessment of laboratories under accreditation

42. 1999 Edition of the Standard • provides for a clarification of the situation • it classifies the main requirements in two main categories, • the Management Issues and • the Technical Competence Issues.

43. The Structure of the Standard… • enables a direct correlation with ISO 9000:1994. • ISO 17025 specifies management requirements and technical requirements in separate chapters. • The former corresponds to ISO 9000 requirements

44. Therefore the Two Standards… • can easily be correlated and provide the basis for comparison of the two procedures they refer to

45. The Standard ISO 9000:2000 • is a new version of the previously existing ISO 9000 series. • This fact doesn’t alter the findings of the correlation made above

46. It is Expected that… • in this way an agreement for mutual recognition could be established thus enabling laboratories to avoid duplication in work and additional costs.

47. To Achieve Reliability… • a Laboratory needs to take some basic steps, starting with the preparation and implementation ofa Quality System.

48. Accreditation Establishing Reliability… • Reliability • Competence of personnel • Suitability of equipment • Calibration of equipment • Interlaboratory comparisons • Method validation Quality System

49. When Taking the First Step… • the Laboratory should prepare and implement a Quality System as described by either ISO 9000 or ISO 17025. • This step does not impose the need for certification

50. Further to a Quality System…. We need to ensure factors contributing to the reliability of the Laboratory • Technical competence of personnel • Adequacy of infrastructure • Fitness of methodology