| 3. General Information and Operational Requirements 3.1 Purpose The NIST Enabling Act (31 Stat. 1449, 15 USC 271, Chapter 6 Weights and Measures) as modified by "authorities and functions pursuant to the Omnibus Trade and Competitiveness Act of 1988," provides the legislative authority to recognize qualifying State weights and measures (legal metrology) laboratories. Authorization includes "the provision of means and methods for making measurements consistent with those of the national standards." Compliance with the criteria contained in this Handbook is the most effective means for ensuring accurate measurements consistent with national standards. 3.2 Description, Quality Policy, and Objectives In 1965, Congress funded NIST to establish the State Standards Program to provide new standards of mass, volume, and length to the States, the District of Columbia, Puerto Rico, and the Virgin Islands to update their weights and measures laboratories and increase their measurement capabilities. The program also provided the laboratory equipment necessary for the States to use the standards in their measurement services. As part of the States' responsibilities in the distribution of standards and equipment, each jurisdiction was required to provide an acceptable laboratory facility meeting specifications established under the State Standards Program and maintain acceptable staffing. The laboratory metrologist was required to complete training at NIST in the use of the standards and equipment. State Laboratory Program Quality Policy It is the policy of the State Laboratory Program to help all State laboratories achieve and maintain recognition and to enable State legal metrology laboratories to provide their customers accurate and traceable measurement services in an environment of continuous quality improvement. As part of its continuing support to the States, NIST manages the State Laboratory Program. This is a program of the NIST Office of Weights and Measures designated to provide guidance, technical support, and assistance to State legal metrology laboratories to ensure accurate and traceable measurements from NIST to the local jurisdictions. The program operates through continued partnership with the State laboratories to manage numerous activities within the program. OWM objectives are to: - Support the basic level of measurement services required for legal metrology enforcement/oversight activities;
- Provide technical support for the accuracy and traceability of State legal Metrology laboratories to the national standards through development, training, publication of, and use of standard procedures, protocols, and measurement assurance programs;
- Provide and maintain the recognition program for State legal metrology laboratories evidence of continuing measurement traceability to include auditing the use and care of the physical standards of mass, length, and volume; and
- Assist the States to upgrade and expand the measurement services of State legal metrology laboratories to satisfy the changing needs of their clients.
3.3 Scope of Recognition 3.3.1 Voluntary and noncontractual The recognition function for State legal metrology laboratories is a voluntary, nonregulated program of support to the States. It provides a cost-effective means for providing evidence of measurement accuracy and traceability. (See sections 3.9.8 and 3.9.9.) 3.3.2 Legal compliance requirements While there are currently no Federal requirements for recognition, some States have weights and measures laws that require continued formal accreditation, certification, or other form of recognition by NIST as evidence for maintaining traceability for primary standards used in the enforcement of weights and measures laws. 3.3.3 Limitations The OWM recognition program is limited in scope. It is provided for government legal metrology laboratories only. The NIST National Voluntary Laboratory Accreditation Program (NVLAP) offers accreditation services to all laboratories and is not limited in the scope of whom they may accredit. 3.3.4 Liability NIST recognition does not certify individual measurements made by a State, but formally recognizes that the State laboratory has traceable standards, the capability to perform reliable measurements and that the metrologist has been trained in the proper procedures to provide these measurements. Recognition also indicates that the metrologist has submitted data, records, and documentation as specifically requested by NIST. NIST assumes no liability for the accuracy and traceability of individual measurement results provided by a recognized laboratory. 3.4 Technical Support and Assistance OWM offers consultative and technical support to all State legal metrology laboratories regardless of their recognition status through informal and formal means. Informal assistance may be in the form of telephone, facsimile, e-mail, or written requests and assistance. Formal support and assistance are available through the training program and the Regional Measurement Assurance Program (RMAP) of the State Laboratory Program. See Appendix A for types of technical assistance available. 3.5 Confidentiality To the extent permitted by applicable laws, OWM will seek to ensure confidentiality of all information obtained relating to the application, on-site assessment, evaluation, and recognition of laboratories. Exception: see section 3.9.9. Results of proficiency tests are generally discussed openly at annual RMAP meetings in the spirit of continuous improvement and teamwork. Proficiency testing may be held confidential if any participating State laboratory requests confidentiality of the results in writing to OWM prior to the beginning of each interlaboratory comparison. 3.6 Development of Requirements 3.6.1 Use of national and international standards wherever available When national or international standards are available in the area of accreditation requirements for calibration laboratories, OWM will adopt such standards as program criteria after suitable review. Adoption of national or international standards, rather than independent development of standards is required by Federal law wherever feasible and appropriate. 3.6.2 Laboratory review, solicitation of comment by those affected The technical requirements associated with the current version of Handbook 143 were developed in conjunction with an ISO 9000 Task Force of the National Conference on Weights and Measures. The technical requirements for mass and volume have been incorporated into the draft of NIST Handbook 150-2, Calibration Laboratories Technical Guide. Draft laboratory publications are reviewed by affected laboratories prior to publication. 3.7 Documentation General and technical requirements of recognition for State laboratories are maintained and published by the NIST Office of Weights and Measures. Additional documents and records to support the program are maintained by the NIST Office of Weights and Measures. In addition to this publication, which includes the general and technical requirements for State laboratory recognition, other publications are available: - NIST Special Publication (SP) 791, State Weights and Measures Laboratories: State Standards Program Description and Directory
This document contains a general program description and laboratory directory and is updated periodically. - NIST Handbook 145 Handbook for the Quality Assurance of Metrological Measurements
This handbook contains laboratory procedures that are used in NIST/OWM Training Program and are recommended for use in State laboratories. Adequate data must be provided by the laboratory to justify deviation from documented procedures. This handbook includes Good Laboratory Practices, Good Measurement Practices, and Standard Operating Procedures. - NIST IR 5672, Advanced Mass Measurements and Measurement Assurance Program for State Calibration Laboratories
This publication documents guidelines for facilities, equipment, standards, and training recommended for precision mass calibration and measurement control programs. It is consistent with the technical criteria for mass calibration. - NIST IR 5802, Quality Manual Template
This publication is a quality manual template developed as a model for State weights and Measures laboratories. It conforms to ISO/IEC Guide 25, ANSI/NCSL Z540-1-1994, and NVLAP documentation requirements. 3.8 Records Records related to recognition or accuracy and traceability of measurements and standards for each State are maintained in the NIST Office of Weights and Measures. Procedures regarding record retention are maintained in the Office of Weights and Measures. These documents include but are not limited to the following: - Traceability records for primary standards
- Measurement Control/Assurance Data (control charts and surveillance tests) - latest year
- Training
- Quality Manuals (latest version)
- Proficiency Testing (round robin reports of the RMAPs)
- Internal Audits (including management review)
- On-site Assessment Reports
Letters verifying status of a laboratory’s recognition level, traceability, and accompanying records will be provided to a State when Certificates of Traceability are issued, and may be sent on behalf of the State to customers, when formally requested in writing on official letterhead. Facsimile requests are not acceptable. 3.9 Rights, Duties, Responsibilities of the Recognized Laboratory 3.9.1 Display of Certificates of Measurement Traceability The laboratory is encouraged to post its Certificate of Measurement Traceability in the laboratory and may copy it for customer/client use as evidence of traceability. The copy of the certificate must include the Scope of Recognition (if not incorporated into the certificate). 3.9.2 Use of recognition or traceability status on calibration reports The laboratory may reference its recognition status or traceability status on reports only if the laboratory is recognized in that particular measurement parameter and scope at the level specified on the calibration report. The laboratory must make no statements regarding recognition for measurement parameters or levels of uncertainty which are not covered by the Certificate of Measurement Traceability and Scope. 3.9.3 Reference to recognition status A laboratory may reference its Certificate of Measurement Traceability in promotional literature provided that it is consistent with NIST legal policy (15 CFR Ch. 11, 200.113) on the use of the NIST name (and NVLAP name and logo if applicable). This policy has been circulated to all State laboratories, is available in the Office of Weights and Measures as well as most local libraries. A general condition on the use of the NIST name is that it may not be used for endorsement purposes, but may be used to make factual statements regarding recognition or traceability. 3.9.4 Notification of change The laboratory must advise the NIST OWM of any changes that affect the quality of measurement services provided by the laboratory. This includes, but is not limited to: changes in staff, damage to or loss of environmental controls in its facility, damage or change of laboratory equipment used to provide measurement services, and damage, replacement, or recalibration of primary standards used to provide measurement services (including improvements as well as adverse changes). Any change that may adversely affect the quality of measurement results is particularly important and must be reported. 3.9.5 Provide timely submissions OWM solicits information from all laboratories each year as a reminder of the recognition requirements. The laboratory must submit a report between October 1 and November 15 of each year. This submission must include those items specifically requested, but is not limited to the items listed in the recognition process. Requests for technical assistance may be made at the same time. Routine failure of a laboratory to provide requested material in a timely manner will result in limited recognition. 3.9.6 Reciprocity with other OWM-recognized laboratories Recognized State laboratories may have reciprocity with other recognized or accredited State laboratories as a part of the voluntary registration program for service agents. Reciprocal acceptance of calibration reports should be limited to laboratories that have maintained recognition with OWM or formal accreditation. Calibration reports from laboratories that have failed to maintain recognition or formal accreditation should be refused. Information on recognition status will be made available to States through Special Publication 791, Laboratory Directory and through individual status requests. 3.9.7 Subcontracting Little or no subcontracting is conducted by State legal metrology laboratories. In the event that a laboratory determines that it is in its best interest to subcontract calibrations, it should only subcontract to other recognized or accredited laboratories. 3.9.8 Failure to maintain recognition Any laboratory that fails to maintain recognition will be encouraged to correct deficiencies and be given an opportunity to submit evidence of corrective action for whatever deficiency exists. A laboratory that has lost recognition status may subsequently comply with the recognition criteria. Laboratories are encouraged to work closely with the NIST Office of Weights and Measures to re-establish recognition as soon as possible. OWM will assist each laboratory as much as possible based on need and resources available. 3.9.9 Notification of status The NIST Office of Weights and Measures reserves the right to notify State and Federal agencies as well as any indigenous industry of a State regarding recognition or accreditation status. This is generally accomplished through the periodic publication of a laboratory directory. 3.9.10 Response to deficiencies and corrective action requests A laboratory will have a specified amount of time to respond to deficiencies addressed through annual review, internal management review, NIST OWM review, or through an on-site assessment conducted by NIST staff or its designated technical experts (TEs). At the end of the specified time period, the laboratory may be given a "conditional recognition" detailed later in this publication. In the event that the laboratory fails to respond, or fails to respond adequately, it will not be recognized in the particular area under question until such time as it responds or corrects deficiencies. The laboratory has the right to appeal OWM decisions as described later in this publication. | 