Procedures and General Requirements - NIST

1 NIST Handbook 150. 2020 Edition National Voluntary Laboratory Accreditation Program (NVLAP). Procedures and General Requirements Dana S. Leaman Bethany Hackett This publication is available free of charge from: NIST Handbook 150. 2020 Edition National Voluntary Laboratory Accreditation Program (NVLAP). Procedures and General Requirements Dana S. Leaman Bethany Hackett National Voluntary Laboratory Accreditation Program Standards Coordination Office Laboratory Programs This publication is available free of charge from: August 2020. Department of Commerce Wilbur L. Ross Jr., Secretary National Institute of Standards and Technology Walter Copan, NIST Director and Undersecretary of Commerce for Standards and Technology NVLAP AND THE NVLAP LOGO.

2 The term NVLAP and the NVLAP logo are registered marks of the Federal Government, which retains exclusive rights to control the use thereof. Permission to use the term and symbol (NVLAP logo with approved caption) is granted to NVLAP-accredited laboratories for the limited purpose of announcing their accredited status, and for use on reports that describe only testing and calibration within the scope of accreditation. NVLAP reserves the right to control the quality of the use of the NVLAP term, logo, and symbol National Institute of Standards and Technology Handbook 150 2020 Edition Natl. Inst. Stand. Technol. Handb. 150 2020 Ed., 44 pages (August 2020). This publication is available free of charge from: Contents Foreword.

3 Iii Introduction .. iv 1 General information .. 1. Purpose and scope .. 1. This publication is available free of charge from: Organization of handbook .. 1. Program description .. 1. References .. 2. Terms and definitions .. 3. NVLAP information .. 8. 9. Impartiality .. 9. Referencing NVLAP accreditation .. 10. Mutual recognition .. 10. Accreditation of laboratories located outside of the United States .. 10. Complaints .. 10. 2 LAP establishment, development and implementation .. 11. Bases for establishment .. 11. Development of technical Requirements .. 12. Announcing the establishment of a LAP .. 12. Adding to or modifying a LAP .. 12. Termination of a LAP.

4 13. 3 Accreditation process .. 13. Application for accreditation .. 13. Management system review .. 14. On-site assessment .. 15. Proficiency testing .. 17. Accreditation decision .. 18. Granting accreditation .. 18. Renewal of accreditation .. 19. Monitoring visit .. 20. Changes to scope of accreditation .. 20. Suspension of accreditation .. 20. NIST Handbook 150:2020 i Revocation of accreditation .. 21. Voluntary termination of accreditation .. 21. Appeals .. 21. 4 Criteria for 22. General .. 22. NVLAP program-specific Requirements .. 22. This publication is available free of charge from: Annex A (normative) Referencing NVLAP accreditation .. 23. Annex B (normative) Implementation of traceability policy in accredited laboratories.

5 29. Annex C (normative) Conditions for 33. Annex D (normative) Accreditation of laboratories located outside of the United States .. 35. Annex E (normative) Use of the Accredited Laboratory Combined ILAC MRA Mark .. 36. NIST Handbook 150:2020 ii Foreword The NIST Handbook 150 publication series sets forth the Procedures , Requirements , and guidance for the accreditation of testing and calibration laboratories by the National Voluntary Laboratory Accreditation Program (NVLAP). The series is comprised of the following publications: NIST Handbook 150, NVLAP Procedures and General Requirements , which contains the General Procedures and Requirements under which NVLAP operates as an unbiased third-party This publication is available free of charge from: accreditation body.

6 NIST Handbook 150-xx program-specific handbooks, which supplement NIST Handbook 150 by providing additional Requirements , guidance, and interpretive information applicable to specific NVLAP laboratory accreditation programs (LAPs). The 2020 edition of NIST Handbook 150 supersedes and replaces the 2016 edition. In addition to a number of editorial revisions, the following main changes have been made with respect to the previous edition of the handbook: incorporation of previously issued NVLAP Policy Guides and updated definitions and references;. update to the references to the Requirements of ISO/IEC 17025; and incorporation of a requirement for applicant laboratories to have an official copy of ISO/IEC.

7 17025 in order to proceed with the accreditation process (see clause 4 for additional information). Annexes A through E form a normative part of this handbook, meaning they contain provisions that laboratories must meet in order to conform to the Requirements for accreditation. This handbook is available on the NVLAP website ( ) and on request from NVLAP. Questions or comments concerning this handbook should be submitted to NVLAP, National Institute of Standards and Technology, 100 Bureau Drive, Stop 2140, Gaithersburg, MD, 20899-2140; phone: 301-975-4016; fax: 301-926-2884; e-mail: NIST Handbook 150:2020 iii Introduction As set forth in Part 285 of Title 15 of the Code of Federal Regulations, the National Voluntary Laboratory Accreditation Program (NVLAP) accredits testing and calibration laboratories that are found competent to perform specific tests or calibrations, or types of tests or calibrations.

8 NIST Handbook 150. presents the basic Procedures under which NVLAP operates, and incorporates by reference the accreditation Requirements of ISO/IEC 17025, General Requirements for the competence of testing and calibration laboratories. ISO/IEC 17025 and this handbook contain the General Requirements that testing This publication is available free of charge from: and calibration laboratories must meet if they wish to demonstrate that they operate an appropriate management system, are technically competent, and are able to generate technically valid results. NVLAP operates an accreditation system that conforms to ISO/IEC 17011, Conformity assessment . General Requirements for accreditation bodies accrediting conformity assessment bodies, which requires that the competence of applicant laboratories be assessed by the accreditation body against the Requirements of ISO/IEC 17025.

9 Growth in the use of management systems generally has increased the need to ensure that laboratories that form part of larger organizations or offer other services can operate to a quality management system that is seen as compliant with ISO 9001, as well as with ISO/IEC 17025. Care was taken by the ISO. Committee on Conformity Assessment (CASCO) to incorporate all those Requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory's management system. Testing and calibration laboratories that comply with the Requirements of this handbook will, therefore, also operate in accordance with the principles of ISO 9001, as stated in the introduction of ISO/IEC 17025.

10 NVLAP has entered into mutual recognition arrangements (MRAs) with equivalent accreditation bodies that comply with ISO/IEC 17011 and applicable MRA documents. The use of this handbook will promote cooperation among laboratories and other bodies, and assist in the exchange of information and experience and in the harmonization of standards and Procedures . This should, in turn, facilitate the acceptance of testing and calibration results among economies worldwide. NIST Handbook 150:2020 iv 1 General information Purpose and scope NIST Handbook 150 sets forth the Procedures and General Requirements under which the National Voluntary Laboratory Accreditation Program (NVLAP) operates as an unbiased third party to accredit both testing and calibration laboratories.