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Laboratory Quality Systems | |
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Laboratories conforming to ISO/IEC Guide 25 " General Requirements for the Competence of Calibration and Testing Laboratories" and ANSI/NCSL Z540-1, "Calibration Laboratories and Measuring and Test Equipment - General Requirements," must have a documented quality system. These standards provide specific guidance for establishing a quality system for calibration and testing laboratories. A major requirement of these standards is documentation of the laboratory quality system through a quality manual, laboratory procedures, and administrative procedures. The Z 540-1-1994 standard was adopted in NIST Handbook 143, Program Handbook in 1996 and includes additional OWM comments and requirements. (The system is currently being updated to ISO 17025.) State laboratories are encouraged to use the following materials (files available below) to enable compliance to NIST Handbook 143, 1997: • NIST IR 5802 Quality Manual Template NIST IR 5802 Quality Manual Template The NISTIR 5802 "Quality Manual Template" is a sample quality manual that was specifically developed to assist the State metrology laboratories in conforming to ISO/IEC Guide 25 and ISO 9001 and may also be a useful tool for other calibration and/or testing laboratories. It is available below for downloading. Draft Standard Administrative Procedures The NISTIR 5802 "Quality Manual Template" is a sample quality manual that was specifically developed to assist the State metrology laboratories in conforming to ISO/IEC Guide 25 and ISO 9001 and may also be a useful tool for other calibration and/or testing laboratories. It is available below for downloading. Draft Standard Administrative Procedures Standard Administrative Procedures were also developed for State metrology laboratories to provide generic administrative procedures specified in the NIST IR 5802 that may be fairly common among the State laboratories. The draft version of the Standard Administrative Procedures is available for downloading below. Members from NIST Office of Weights and Measures along with representatives from States in the State Laboratory Program have been working on evaluating the new ISO 17025 and comparing it to the current documented system to identify gaps and concerns. Training is being provided on ISO 17025 during 2000 for all State laboratories at the Regional Measurement Assurance Program (RMAP) meetings. A modified version of the Template Quality Manual is available below. Also, an Access database can also be downloaded. The database is the result of the working group meeting in December 1999 and cross-references the new ISO 17025 with Handbook 143, the Quality Manual, Draft Standard Administrative Procedures, and Laboratory Procedures. It identifies a number of gaps and areas which will require new/updated policies and procedures. Training materials (Powerpoint) will be made available as they are completed. The following files are in WordPerfect 6.1 format and may be downloaded using WordPerfect 6.0, 6.1, or 7.0. You may also download these documents using Microsoft Word, just be aware that there may be extensive formatting necessary after the conversion. The Access database is based on Office 97, SR-2. Note: If this file format is not accessible, one paper copy of this document will be mailed if a request is sent to owm@nist.gov. • Quality Manual Template Participants in the 17025 Working Group • Michael Dynia, State of Connecticut | |
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For technical questions concerning the Metrology Resources for State and Commercial Laboratories, contact us:
Weights and Measures Division, NIST, 100 Bureau Drive, Stop 2600, Gaithersburg, MD 20899-2600 Date created: November 30, 2000 Privacy Policy / Security Notice / Accessibility Statement | Disclaimer | FOIA |
