Transcription
NIST Quality Manual forMeasurement ServicesQM-IVersionVersioninitiation dateAuthorApproval608/01/2010MSAGMSAG1 of 43NIST-QM-I-V6-NonControlled.docNon Controlled CopyPagesFilename
Table of Contents1. Introduction .41.1 Institutional Commitment to Quality.41.2 Scope.41.3 Format of NIST Quality Manual for Measurement Services.52. References .52.1 Informative References.63. Definitions.74. Management Requirements .124.1 The National Institute of Standards and Technology .124.1.1 Description .124.1.2 Physical Locations .144.1.3 Organizational Structure for Scientific and Technical Research and Services;Responsibilities and Authorities .144.1.3.1 Organization Charts.144.1.3.2 Responsibilities, Authorities, and Delegations.174.2 NIST Quality Management System for Measurement Services .184.2.1 NIST Quality Policy .184.2.2 NIST Quality Objectives .194.2.3 Organizational Structure of the NIST QMS: Responsibilities and Authorities .204.2.3.1 NIST QMS Organization Chart.204.2.3.2 Responsibilities, Authorities, and Delegations.214.3 Control of Documents and Records.214.3.1 Scope.214.3.2 Document Approval and Issue .224.3.3 Document Changes .224.4 Administrative Requirements for Providing Measurement Services.224.4.1 Review and Approval of Requests, Tenders and Contracts for Procurement ofMeasurement Services .224.4.2 Procuring Products and Services, External Sources .234.4.3 Interaction with NIST Supporting Divisions .244.4.4 Subcontracting of Tests, Calibrations and Reference Material Certifications .244.4.5 Reference Materials Production Planning and Control .244.5 Corrective and Preventive Actions .244.5.1 Non-conformity and Corrective Actions.244.5.2 Customer Feedback and Concerns .254.5.3 Preventive Actions .254.6 Internal Assessments and Management Reviews .254.6.1 Assessments .254.6.2 Management Reviews .264.7 Service to the client.275. Technical Requirements .275.1 Introduction.275.2 Personnel.275.2.1 Competence .27VersionVersioninitiation dateAuthorApproval608/01/2010MSAGMSAG2 of 43NIST-QM-I-V6-NonControlled.docNon Controlled CopyPagesFilename
5.2.2 Education and Training Goals .285.2.3 Job Descriptions .285.2.4 Collaborators .285.3 Accommodations and Environmental Conditions .285.4 Test and Calibration Procedures and Procedure Validation .295.4.1 Calibrations and Special Tests .295.4.2 Reference Materials .295.4.3 Estimation of Uncertainty .295.4.4 Evaluation and Control of Data .295.5 Equipment.305.6 Measurement Traceability .305.6.1 NIST Traceability Policy .305.7 Sampling, Preparation, Homogeneity, and Stability.315.7.1 Calibration of Individual Instruments .315.7.2 Certification of Reference Materials.315.8 Handling of Test and Calibration Items.315.9 Quality Assurance Practices .315.10 Reporting Results.325.10.1 Reports of Calibrations and Special Test .325.10.2 Certificates for Reference Materials .335.10.3 Signatory Authority .33Appendix A. Sample Customer Concerns Form .34Appendix B. Assessment Process for SP 250 Calibration and SP 260 StandardReference Material Services.35Appendix C. Statements of Uncertainty Associated with Measurement Results .40VersionVersioninitiation dateAuthorApproval608/01/2010MSAGMSAG3 of 43NIST-QM-I-V6-NonControlled.docNon Controlled CopyPagesFilename
1. Introduction1.1 Institutional Commitment to QualityThe provision of measurement services, which include calibrations and certified reference materialrelated services, is an essential element of the work of the National Institute of Standards andTechnology (NIST) in fulfillment of its mission. In the conduct of this vital work, as in all its efforts,NIST is committed to performance excellence characteristic of a global leader in measurements andstandards. Our goal is to provide measurement services that meet the needs of our customers and,through continuous improvement, to seek to anticipate their needs, exceed their expectations, anddeliver outstanding value to the Nation.Achievement of this goal has been a hallmark of NIST (known as the National Bureau of Standardsprior to 1988) for over a century. It has always resulted from, and continues to rely on, the excellenceand commitment of NIST staff at every level of the Institute. The NIST Quality Management System(NIST QMS) comprises policies and procedures that NIST follows in the pursuit of performanceexcellence. They are documented in the NIST Quality Manual (NIST QM). All staff members whoseactivities affect the quality of our measurement services are to be familiar with the NIST QMSdescribed herein, and to implement it in their work. NIST commits that its QMS be, to the extentallowed by statute and regulation, in conformity with the international standard ISO/IEC 17025 and therelevant requirements of ISO Guide 34 as they apply to the Standard Reference Materials (SRMs )and related services that NIST delivers.Dr. Patrick D. Gallagher,DirectorNational Institute of Standards and Technology1.2 ScopeThe quality management system described in this manual covers measurement (calibration andreference material) services provided to customers both internal and external to NIST. These servicesare essential to achieving NIST’s goal to deliver high levels of satisfaction and value to its customers inacademia, other government organizations, and established and emerging industries where NIST’smeasurements and standards can increase productivity, lower market transaction costs, raise productand process quality, and reduce technical barriers to trade.In general, the scope of the NIST quality management system for measurement services encompassesall services listed in the NIST Special Publication (SP) 250, NIST Calibration Services Users Guideand the NIST Special Publication (SP) 260, Standard Reference Materials Catalog. In particular,specific services covered by the NIST QMS are those that are declared in conformity by the NISTMeasurement Services Advisory Group (MSAG). For the purposes of this document, the term“reference material” refers to the entire category of NIST SRM services such as Standard ReferenceVersionVersioninitiation dateAuthorApproval608/01/2010MSAGMSAG4 of 43NIST-QM-I-V6-NonControlled.docNon Controlled CopyPagesFilename
Materials, Reference Materials, etc. See Definitions, Section 3 of this document for a listing of termsshown in bold italics and their respective official NIST designations.By implication, the scope of the NIST QMS for Measurement Services includes the Calibration andMeasurement Capabilities (CMCs) listed in Appendix C of the Comité International des Poids etMeasures Mutual Recognition Arrangement (CIPM MRA)[http://www1.bipm.org/en/convention/mra/].1.3 Format of NIST Quality Manual for Measurement ServicesThe NIST QM for Measurement Services is organized in multiple levels: The first level, this document (NIST-QM-I), contains NIST-wide policies and proceduresstemming (primarily) from the executive leadership of NIST (i.e., the NIST Director andLaboratory Directors). Many of these policies and procedures govern all activities at NISTand thereby are controlling in so far as these activities are part of providing measurementservices. The subsequent levels also known as sub-level quality documentation (including theNIST-QM-xx series) contain policies and procedures established and maintained by eachDivision (or Technical Operating Unit) to meet its technical needs. The sub-level qualitymanagement systems and quality manuals vary in detail among the NIST Divisions thatprovide measurement services within the scope of the NIST QMS. The NIST-QM-xxseries explicitly references NIST-QM-I and contains the quality-specific policies andprocedures for activities such as acceptance of requests for measurement services;acquisition of materials and supporting services; technical procedures for calibrations;reference material certification measurements; staff qualifications, responsibilities, andtraining; handling and storage of calibration and reference material items; qualityassurance procedures; creation, storage, and control of technical records of all types; anddocument development, approval, and control relevant to the Division quality managementsystem. For reference materials, the NIST-QM-xx series contains, in addition to the aboveitems, procedures for candidate material selection, identification, preparation, storage, andcharacterization. Included in characterization are homogeneity, stability, value assignment,and uncertainty of certified values.2. ReferencesNIST is a non-regulatory federal agency within the U.S. Department of Commerce. All aspects ofNIST’s activities are compliant with Federal statutes and regulations, Executive Orders, andDepartmental Administrative Orders. The policies and procedures derived from these controllingdocuments, as we
ISO Guide 30:1992 Terms and definitions used in connection with reference materials Amd 1:2008 Revision of definitions for reference material and certified reference material . ISO Guide 31:2000 Reference materials – Contents of certificates and labels . ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
