1. A LOOK AT AMENDMENTS TO ISO/IEC 17025 (1999) Presented at NCSLI Conference Washington DC August 11, 2005 by Roxanne Robinson

2. Topics to be covered A look at the changes The impact on the laboratory Future of ISO/IEC 17025

3. A look at the changes Global changes –Quality or laboratory management system  Management system Note: management system means quality, administrative and technical systems that govern the operations of the lab –Client  Customer –Nonconformances  Nonconformities

4. A look at the changes 17025 was considered to meet the process orientation presentation of 9K2K without any changes. –Part 5 of 17025 is presented by section in the way a test sample or unit under test would be processed through the laboratory.

5. A look at the changes References revised: –eliminated ISO 9001(1994) and ISO 9002 (1994) –inserted ISO 9001:2000

6. A look at the changes Always clearly stated that conformance to ISO 9001 does not demonstrate competence to produce technically valid results; but Introduction was revised to also indicate that 17025 compliance does not imply that the lab’s quality management system meets all of the quality system requirements of 9K2K

7. A look at the changes Section 1.6 revised to indicated that labs complying with 17025 also meet the principles of 9K2K

8. A look at the changes Section 4.1.5: –a) implementation, maintenance and improvement of the management system was added to the responsibilities of management and technical personnel REVISE ROLES AND RESPONSIBILITIES IN QUALITY MANUAL

9. A look at the changes Section 4.1.5: –new requirement: “k) The lab shall ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system” MAKE PERSONNEL AWARE

10. A look at the changes New Section 4.1.6: –“Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.” MAKE PERSONNEL AWARE

11. A look at the changes Section 4.2.2 has been revised so that the laboratory’s quality policy statement no longer needs to include the overall objectives –however, the objectives must be established and reviewed during the management review –and the quality policy statement must include the purpose of the management system rather that the objectives REVISE THE QUALITY POLICY AND MANAGEMENT REVIEW AGENDA

12. A look at the changes Section 4.2.2 (e) has been further revised so that the laboratory’s quality policy statement relating to the laboratory management’s commitment to compliance with 17025 must include the continual improvement of the management system related to quality REVISE THE QUALITY POLICY

13. A look at the changes Three new clauses have been inserted, first: “4.2.3: Top management shall provide evidence of commitment to the continual improvement of the management system” EVIDENCE OF COMMITMENT THROUGH ACTIVE PARTICIPATION IN REVISION TO QUALITY DOCUMENTS, MONITORING AND MEASURING NON COMFORMING WORK, CORRECTIVE ACTIONS, COMPLAINTS, USE OF PREVENTIVE AND CORRECTIVE ACTIONS, ETC.

14. A look at the changes The second new clause is: –“4.2.4: Top management shall communicate to the organization the importance of meeting the customer as well as statutory and regulatory requirements” MAKE PERSONNEL AWARE AND ENSURE THAT CONTRACT REVIEW PROCEDURE AND PROCESSES ARE APPROPRIATE

15. A look at the changes The third new clause is: –“4.2.7: Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented” WHEN MAKING CHANGES, INCLUDE AFFECTED PARTIES, AND MAKE SURE THE CHANGES AGREE WITH OBJECTIVES AND GOALS AND CONTINUE TO MEET THE ISO/IEC 17025 REQUIREMENTS

16. A look at the changes 4.7 Service to the Customer, new section: –“ 4.7.2: The laboratory shall seek feedback, both positive and negative, from its customers. The feedback should be used and analyzed to improve the management system, testing and calibration activities and customer service.” Note gives examples of types of feedback including surveys and review of reports with the customer RECORDS OF SOLICITATIONS AND THE FEEDBACK AND THE MANNER IN WHICH THE FEEDBACK IS USED

17. A look at the changes New Clause: –“4.10 Improvement: The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analyses of data, corrective and preventive action and management review.” ADDRESSED THROUGH COMPLIANCE WITH THESE OTHER CLAUSES OF THE STANDARD

18. A look at the changes Section 4.12 Preventive Action was revised to require action plans when improvement opportunities or preventive action is required THE LAB HAS TO BE AWARE OF IMPROVEMENT OPPORTUNITIES AND USE THE PREVENTIVE ACTION PROCESS ALREADY IN PLACE

19. A look at the changes 4.15 Management Reviews was revised to add recommendations for improvement to the laundry list of items to take account of when performing a management review CONSIDER FOR THE MANAGEMENT REVIEW AGENDA(S) The top management rather than the executive management shall conduct the review

20. A look at the changes And though they said they would not touch Part 5, the follow changes were made: –Section 5.2.2 Personnel was revised to included the requirement that the evaluation of the effectiveness of the training actions taken be done. RECORDS OF THE EVALUATION OF EFFECTIVENESS THROUGH PT, AUDIT RESULTS, NON CONFORMING WORK OR OTHER MEANS IS NEEDED

21. A look at the changes 5.9 Assuring the quality of test and calibration results: –“ 5.9.1(f) regular checking of equipment for stability and integrity” was added. CHANGE TO CALIBRATION OR MAINTENANCE PROCEDURES –“5.9.2 Quality control data shall be analyzed and where it is found to be outside pre-defined criteria, planned actions shall be taken to correct the problem and to prevent incorrect results from being reported” was added. ESTABLISH PRE DEFINED CRITERIA AND KEEP RECORD OF ACTIONS TAKEN

22. A look at the changes Annex A was changed to compare 17025 to 9K2K rather than 17025 to 9001 (1994) and 9002 (1994) Bibliography was updated

23. Impact on the laboratory Equivalence with 9000 was diluted; marketing edge is lessened More responsibilities for top management Emphasis on continual improvement and personnel awareness of quality efforts and changes Customer feedback use and analysis required Evaluation of effectiveness of training required Analysis of QC data required

24. Future of ISO/IEC 17025 The new ISO/IEC 17025 has a May 2005 date. So work on the next expected revision would begin in 2009, unless significant reason given for earlier change. Next version of 17025 would be published in 2012 to allow synchronization with the 9000 revisions

25. Future of ISO/IEC 17025 The accredited laboratories’ demonstration of compliance with the new 17025 will begin two years after the publication of the document, so we are looking at Summer 2007.

26. Thank you for your Attention! Any questions? Roxanne Robinson rrobinson@a2la.org 301 644 3208