National Cooperation for Laboratory Accreditation Annual General Meeting International versus National Recognition: A Comparison

Transcription

1 National Cooperation for Laboratory Accreditation Annual General Meeting International versus National Recognition: A Comparison August

2 Purpose of International Recognition Simply put, the purpose of international recognition is to support international trade through the removal of technical barriers. 2

3 Components of International Recognition ISO/IEC 17011: 2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies. ISO/IEC : General requirements for the competence of testing and calibration laboratories. Peer evaluation by other accreditation bodies. Signatory to a Mutual Recognition Arrangement (MRA). 3

4 Mutual Recognition Arrangements (MRA) Accreditation bodies around the world, which have been evaluated by peers as competent, have signed an arrangement that enhances the acceptance of products and services across national borders. The purpose of these arrangements are to create an international framework to support international trade through the removal of technical trade barriers. International Laboratory Accreditation Cooperation (ILAC) Asian Pacific Laboratory Accreditation Cooperation (APLAC) InterAmerican Accreditation Cooperation (IAAC) European cooperation for Accreditation (EA) 4

5 Maintaining / Purpose of MRAs In order to maintain the value and integrity of the MRA, signatories agree to notify the cooperation of any significant changes including: Status or operation of the accreditation body Changes in name or legal corporate status The establishment, revision, suspension or termination of any agreements Changes in key senior staff or the organizational structure The MRA process promotes trust and builds confidence among accreditation bodies in their ability to determine a laboratory s competence to carry out testing or calibration. 5

6 Purpose of National Recognition To provide coordination and focus for laboratory accreditation in the United States of America by: Developing recognition procedures and requirements that are in accordance with international standards and guidelines and that are accepted by all NACLA members and stakeholders. Reducing redundant AB evaluations through the acceptance of NACLA and/or International Laboratory Accreditation Cooperation (ILAC) recognition. Promoting the acceptance of NACLA and ILAC recognition. 6

7 Purpose of National Recognition (Con t) To provide coordination and focus for laboratory accreditation in the United States of America by: Administering NACLA recognition procedures with impartiality and integrity. Recognizing accreditation bodies (ABs) for compliance with the NACLA requirements. Working with industry specifiers and government/regulatory agencies in the United States to coordinate the development of Sector Specific technical requirements beyond those included in international guidelines used for AB recognition and laboratory accreditation. 7

8 Components of National Recognition ISO/IEC 17011: 2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies. ISO/IEC : General requirements for the competence of testing and calibration laboratories. NACLA Requirements/Sector Specific Technical Requirements NACLA Evaluation and Recognition Process 8

9 Maintaining NACLA Recognition In order to maintain NACLA recognition, accreditation bodies agree to notify the cooperation of any significant changes including: Status or operation of the accreditation body Changes in name or legal corporate status The establishment, revision, suspension or termination of any agreements with other accreditation bodies or other parties Changes in key senior staff or the organizational structure Changes to the scope of accreditations granted by the accreditation body Any new programs conducted for regulatory agencies 9

10 Conclusion International and national recognition minimum requirements are based on: ISO/IEC 17011: 2004 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies. ISO/IEC : General requirements for the competence of testing and calibration laboratories. Both use similar evaluation and maintenance processes. National recognition provides a means for industry specifiers and government/regulatory agencies a means to have recognized programs that meet their sector specific requirements beyond international recognition. Both work to remove technical barriers to trade either nationally or internationally. 10

11 Questions Thank you! Steve Doty NSWC Corona Division