NIST Quality System
Table of Contents Introduction
The NIST Quality System for Measurement Services is based on the
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) and the relevant requirements of
ISO/IEC Guide 34 (General requirements for the competence of reference material producers). The scope of the NIST Quality System includes the delivery of
Calibration Services and the development and certification of
Standard Reference Materials . The Measurement Services Advisory Group (MSAG) serves as the corporate quality manager; they are assisted by staff from the
National Voluntary Laboratory Accreditation Program for the implementation of the quality system. The NIST quality system for measurement services satisfies the requirements of the
International Committee for Weights and Measures (CIPM) Mutual Recognition Arrangement (MRA) for recognition of national measurement standards; and as such, has been recognized as conformant to the ISO/IEC 17025 and ISO Guide 34 by the
Inter-American Metrology System (SIM) Quality System Task Force and the
Joint Committee of the Regional Metrology Organizations and the BIPM (JCRB) . The BIPM is the
International Bureau of Weights and Measures .
Scope
Calibration Services (SP 250 Users Guide)
Standard Reference Material Services (Some examples)
- Hardness
- Optical properties
- Gases
- Biological fluids and materials
- Food
- Fuels
- Inorganic solutions
- Organic solutions
- Sediments, soils, ores
- Water
- Charpy
- Ionizing radiation
- Ceramics
- Polymers
- Cement
Quality system is structured into tiered sections:
- NIST level, QM-I
- Division level, QM-II
- Service level, QM-III
Quality documentation at the NIST level (QM-I) points to policies and procedures already in place.
- Institutional Commitment to Quality
- Scope
- Format of NIST Quality Manual for Measurement Services
Section 4: Management Requirements
- NIST, locations, and organizational structure
- Quality system, quality policy and objectives
- Quality documents and records
- Administrative requirements, review and approval of requests, tenders, contacts for performing services
- Corrective and preventative actions
- Internal assessments and management reviews
- Customer service
Section 5: Technical Requirements
- Personnel, training, collaborators
- Accommodation and environment
- Procedures and validations
- Estimates of uncertainty
- Control of data
- Equipment
- Measurement traceability
- Sampling, preparation, homogeneity, and stability
- Handling of test items
- Quality assurance practices
- Reporting results
Implementation of the NIST Quality System
- MSAG serves as the corporate NIST Quality Manager for Measurement Services
- NIST adopts multi-tiered approach to quality with a modular NIST quality manual
- NIST adopts ISO/IEC 17025 and ISO/IEC 34 as the basis for the NIST Quality System for measurement services: calibrations and SRMs
- NIST self-declares conformity to the NIST Quality System based on a specific assessment process
- Internal to NIST
- The same for all Labs, Divisions, and Services
- As independent and objective as possible
- Focused on quality management as opposed to technical competence, which presumed
Timetable for Implementation
- SP-250 Calibration Services
- December 31, 2003: Complete documentation assessments
- December 31, 2004: Complete full assessments
- SP-260 Standard Reference Materials
- March 31, 2005: Complete documentation assessments*
- March 31, 2006: Complete full assessments**
* Quality systems for
calibration and measurement capabilities (CMCs) listed in the CIPM MRA Database will need to be assessed during CY 2004 to meet the requirements established by the JCRB under the MRA.
** All NIST reference materials for which the value-assignment process is initiated [WCF labor costs logged] on or after the MSAG's formal declaration of conformity will have been produced under the NIST Quality System for Measurement Services. Reference materials that are in stock or in progress prior to the MSAG's formal declaration will not have been produced under the NIST Quality System.
Benefits of having a formal Quality System
- Enables us to meet our obligations under the CIPM MRA in the universally accepted way
- Responds directly to the issues raised by the National Research Council (Board on Assessment of NIST Programs) cross-cut issue: Measurement Services
- Use the same standard as our customers
- Make the operation of our services more transparent to our customers
- Help others implement Quality Systems: Lead by example
CIPM MRA
- The JCRB has set a deadline for MRA signatories to have their quality systems reviewed and approved in order to support the claimed CMCs
- All leading NMIs including NIST have adopted the ISO/IEC 17025 and the ISO/IEC 34 as the basis for their quality systems
In October 1999, the directors of the national metrology institutes (NMIs) of 38 Member States of the Metre Convention signed a MRA for national measurement standards and for calibration and measurement certificates issued by national metrology institutes. The purposes of the MRA are:
- To establish the degree of equivalence of national measurement standards maintained by NMIs;
- To provide for the mutual recognition of calibration and measurement certificates issued by NMIs;
- thereby to provide governments and other parties with a secure technical foundation for wider agreements related to international trade, commerce, and regulatory affairs, thus assuring that measurements traceable to different NMIs can be accepted across borders
Technical basis and confidence in measurements
- International comparisons of measurements, known as key comparisons ;
- Supplementary international comparisons of measurements;
- Quality systems; and
- Demonstrations of competence by NMIs.
Outcome should be statements of the measurement capabilities of each NMI in a database publicly available on the web. (See the
Calibration and Measurement Capabilities of National Metrology Institutes .)
