For reasons set forth in the preamble, Title 15 of the Code of Federal Regulations part 280 is amended as follows:
PART 280 - Fastener Quality
1. The authority for part 280 continues to read as follows:
Authority: Section 13 of the Fastener Quality Act (Pub.L. 101-592, as amended by Pub.L. 104-113).
2. Section 280.1 is amended by adding paragraph (d) to read as follows:
Sec. 280.1 Purpose/description of rule.
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(d) Delegations of authority. The Secretary of Commerce has delegated authority to the Director, National Institute of Standards and Technology to promulgate regulations in this part under sections 5 through 8 of the Fastener Quality Act (15 U.S.C. 5404 - 5407). In addition, the Secretary of Commerce has delegated concurrent authority to the Under Secretary for Export Administration to amend the regulations issued under sections 5 through 7 of the Act, regarding enforcement. The Secretary of Commerce has also delegated concurrent authority to amend the regulations issued under section 8 of the Act, regarding recordal of insignias, to the Assistant Secretary and Commissioner of Patents and Trademarks.
3. Section 280.2 is amended by revising the definitions for accreditation, consensus standards organization, and original laboratory testing report, and adding the remaining definitions as set forth below:
Sec. 280.2 Definitions.
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Accreditation for purposes of the Act and this part means accreditation of a testing laboratory or the registration of a fastener manufacturing facility employing a quality assurance system (a Facility).
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Accredited registrar means a registrar, as defined in this part, that is accredited by a recognized accreditor and appears on the Registrars List described in section 280.810(b).
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Accreditor means a Registrar accreditation body that meets the requirements of Subpart K of this part.
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Authorized representative means an employee of an organization who is authorized by that organization to speak on its behalf for purposes of the Act and this part.
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Certified Copy [of a laboratory testing report] means a complete and accurate copy of the original laboratory testing report, which contains a statement describing it as an accurate and complete copy of the original and which is signed by an authorized representative of the accredited laboratory issuing the report or, in the case of metal chemistry testing reports, an authorized representative of the metal manufacturer.
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Consensus standards organization means the American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI), American Society of Mechanical Engineers (ASME), Society of Automotive Engineers (SAE), or any other consensus standards setting organization (domestic or foreign) publicly identified by NIST as having comparable knowledge, expertise, and concern for the health and safety in the field for which such organization purports to set standards.
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Facility means a fastener manufacturing facility, or a facility performing subcontracted processes for a fastener manufacturing facility, implementing a fastener quality assurance system as defined in this part.
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Fastener Quality Assurance System (QAS). (1) Fastener Quality Assurance System (QAS) means a fastener manufacturing system that has as a stated goal the prevention of defects through continuous improvement, and which seeks to attain that goal by incorporating:
(i) advanced quality planning;
(ii) monitoring and control of the manufacturing process;
(iii) process inspection embodied in a comprehensive and written control plan for product/process characteristics, process controls (including statistical process control), tests, and measurement systems that will occur during mass production; and
(iv) the creation, maintenance, and retention of electronic, photographic, or paper records, available for inspection during the periods required by section 10 of the Act and section 280.7 of this part, regarding the inspections, tests, and measurements required by or performed pursuant to the control plan.
(2) A Fastener Quality Assurance System contains the following elements at a minimum:
(i) a documented quality management system that satisfies the requirements of ISO-9001
(ii) a requirement that raw material certification supplied to the fastener manufacturer shall be traceable to that of a mill heat of material that has been tested by a laboratory on the Accredited Laboratory List;
(iii) a requirement that subcontracted processes, including plating and heat treating, are controlled by the manufacturer, to avoid product lot contamination, and that finished lots of fasteners shall be traceable to subcontracted processes performed by a registered Facility on the Facilities List described in section 280.810 or tested by a Laboratory on the Laboratories List described in section 280.101;
(iv) a requirement that the fastener manufacturer fully document fastener sampling and inspection points and an in-process control plan that emphasizes defect prevention, relates frequency of inspection, corrective action for nonconforming characteristics, and sampling frequency and sample size; a requirement that the control plan be made available to the customer upon request and shall identify those standards and specifications upon which the plan is based; and
(v) a requirement that the in-process control plan include those characteristics specified by the QAS standard, characteristics specifically indicated by applicable fastener standards and or specifications, and those characteristics as designated by the end user for evaluating product functionality.
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Original laboratory testing report means: (1) In general, a laboratory testing report which is originally signed by an approved signatory or is a copy thereof, certified by the laboratory that conducted the test; or
(2) For purposes of the alternative procedures for chemical characteristics described in section 5(d) of the Act and section 280.15 of this part only, a laboratory testing report which is originally signed by an approved signatory or is a copy thereof, certified by the laboratory that conducted the test or by the metal manufacturer.
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Recognized accreditor means an accreditor, as defined in this part, that is recognized by NIST and appears on the Accreditors List described in section 280.810(a).
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Registered facility means a facility, as defined in this part, that is registered by an accredited registrar and appears on the Facilities List described in section 280.810(c).
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Registrar means a quality systems Registrar that meets the requirements of Subpart L of this part.
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Registration means evaluation and certification of a manufacturing facility as competent to carry out and conforming to the applicable requirements of a Fastener Quality Assurance System when such evaluation and certification is performed by a Registrar as defined in this part.
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Significantly alter means to alter or take any other action which could weaken or otherwise materially affect the performance or capabilities of the fastener as it was originally manufactured, grade or property class marked, tested, or represented. The term does not include the application of adhesives or sealants, locking elements, provisions for lock wires, coatings and platings of parts having a minimum specified Rockwell C hardness of less than 32, or cutting off of fasteners. The cutting of finished threaded rods, bars or studs to produce individual smaller length threaded studs for resale is not a significant alteration. However, cut threaded studs, rods, and bars offered for sale shall be individually marked with the grade or property class identification marking appearing on or accompanying the original threaded studs, rods, and bars from which the fasteners were cut.
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4. Section 280.6 is revised to read as follows:
Sec. 280.6 Laboratory Test Reports
(a) When performing tests for which they are accredited under this part, each laboratory accredited under Subparts C, D, or E of this part and currently listed in the Accredited Laboratory List shall issue test reports of its work which accurately, clearly, and unambiguously present the test conditions, test set-up, test results, and all information required by this section. All reports must be in English or be translated
into English, must be signed by an approved signatory, must be
protected by a tamper resistant system, and contain the following
information:
(1) Name and address of the laboratory;
(2) Unique identification of the test report including date of issue and serial number, or other appropriate means;
(3) Name and address of client;
(4) Fastener Description, including:
(i) Manufacturer (name and address);
(ii) Product family (screw, nut, bolt, washer, or stud), drive and/or head configurations as applicable;
(iii) Date of manufacture;
(iv) Head markings (describe or draw manufacturer's recorded insignia and grade identification or property class symbols);
(v) Nominal dimensions (diameter; length of bolt, screw or stud; thickness of load indicating washer); thread form and class of fit;
(vi) Product standards and specifications related to the laboratory in writing by the manufacturer, importer or distributor;
(vii) Lot number;
(viii) Specification and grade of material;
(ix) Coating material and standard and specification as applicable;
(5) Sampling information
(i) Standards and specifications or reference for sampling scheme;
(ii) Final manufacturing lot size;
(6) Test Results
(i) Test results for each sample;
(ii) All deviations from the test method;
(iii) All other items required on test reports according to the test method;
(iv) Where the report contains results of tests performed by sub-contractors, these results shall be clearly identified along with the name of the laboratory and accreditation information listed in paragraph (a)(10) of this section.
(v) A statement that the samples tested either conform or do not conform to the fastener standards and specifications and identification of any nonconformance, except as provided for in section 280.13 and 280.14;
(7) A statement that the report must not be reproduced except in full;
(8) A statement to the effect that the test report relates only to the item(s) tested;
(9) Name, title and signature of approved signatory accepting technical responsibility for the tests and test report;
(10) The name of the body which accredited the laboratory for the specific tests performed which are the subject of the report, and code number assigned to the laboratory by the accreditation body, and the expiration of accreditation.
(b) When performing tests for which they are registered under this part, each facility registered under Subpart I or J of this Part and currently listed in the Facilities List shall issue test reports of its work which accurately, clearly, and unambiguously present test results, and all information required by this section. In addition, the facilities shall attach reports of chemical characteristics and any report of the tests conducted in a laboratory under the accredited laboratories list. All reports must be in English or be translated into English, must be signed by an approved signatory, must be protected by a tamper resistant system, and contain the following information:
(1) Name and address of the facility;
(2) Unique identification of the test report, including date of issue and serial number, or other appropriate means including references to control plan identification;
(3) Name and address of client, if applicable;
(4) Fastener Description, including:
(i) Manufacturer (name and address);
(ii) Product family (screw, nut, bolt, washer, or stud), drive and/or head configurations as applicable;
(iii)Date of manufacture;
(iv) Head markings (describe or draw manufacturer's recorded insignia and grade identification or property class symbols);
(v) Nominal dimensions (diameter; length of bolt, screw or stud; thickness of load bearing washer); thread form and class of fit;
(vi) Product standards and specifications related to the facility in writing by the manufacturer, importer or distributor;
(vii)Lot number;
(viii)Specification and grade of material;
(ix) Coating material and standard and specification as applicable;
(5) Sampling information:
(i) Standards and specifications or reference for sampling scheme;
(ii) Final manufacturing lot size;
(iii) Identification of control plan governing production of the lot to which the test report is applicable;
(6) Test Results:
(i) Test results of actual tests required by applicable fastener standards and specifications, and characteristics designated by the end user;
(ii) All deviations from the test method;
(iii) All other items required on test reports according to the applicable fastener standards and specifications, and characteristics designated by the end user;
(iv) Where the report contains results of tests performed by sub-contractors, these results shall be clearly identified along with the name of the laboratory/facility and accreditation/registration information listed in paragraph (b)(9) of this section.
(v) Where all processes under the applicable QAS were found to be in accordance with the inspections, tests and measurements required by the standards and specifications and the QAS and characteristics designated by the end user, a statement that the samples tested conform to the applicable fastener standards and specifications;
(vi) Where any process under the applicable QAS was found not to be in accordance with the inspections, tests, or measurements required by such QAS, a statement that the samples tested do not conform to the applicable fastener standards and specifications and identification of any nonconformance;
(7) A statement that the report must not be reproduced except in full;
(8) Name, title and signature of approved signatory accepting technical responsibility for the tests and test report;
(9) The name of the registrar which registered the facility, and code number assigned to the facility by the registrar, and the expiration of registration.
(c) For alternative chemical tests carried out under section 280.15 of this part, each laboratory accredited under Subparts C, D, or E of this part and currently listed in the Accredited Laboratory List shall provide to the fastener manufacturer, either directly or through the metal manufacturer, a written inspection and testing report containing all required information. All reports must be in English or be translated
into English, must be signed by an approved signatory, must be
protected by a tamper resistant system, and contain the following
information:
(1) Name and address of the laboratory;
(2) Unique identification of the test report including date of issue and serial number or other appropriate means.
(3) Name and address of client;
(4) Coil or heat number of metal being tested;
(5) Test Results
(i) Actual tests required by the standards and specifications;
(ii) Test results for such coil or heat number chemical characteristics;
(iii) All deviations from the test method;
(iv) All other items required on test reports according to the test method;
(v) Where the report contains results of tests performed by sub-contractors, these results shall be clearly identified along with the name of the laboratory and accreditation information listed in paragraph (c)(9) of this section.
(vi) A statement that the samples tested either conform or do not conform to the metal standards and specifications and identification of any nonconformance;
(6) A statement that the report must not be reproduced except in full;
(7) A statement to the effect that the test report relates only to the item(s) tested;
(8) Name, title and signature of approved signatory accepting technical responsibility for the tests and test report;
(9) The name of the body which accredited the laboratory for the specific tests performed which are the subject of the report, and code number assigned to the laboratory by the accreditation body, and the expiration of accreditation.
(d) The laboratory shall issue corrections or additions to a test report only by a further document suitably marked, e.g.,
ASupplement to test report serial number .....@ This document must specify which test result is in question, the content of the result, the explanation of the result, and the reason for acceptance of the result.(e) For tests carried out by a Facility registered pursuant to Subpart I or J of this Part, the Facility shall maintain laboratory test reports in the forms of electronic, photographic, or paper records, available for inspection during the periods required by section 10 of the Act and section 280.7 of this part, regarding the inspections, tests, and measurements required or performed pursuant to the QAS control plan.
5. Section 280.7 is amended by revising paragraph (a) to read as follows:
Sec. 280.7 Recordkeeping Requirements.
(a) Each laboratory accredited under Subparts C, D, or E or section 280.104 of this part shall retain for 5 years after the performance of a test all records pertaining to that test concerning the inspection and testing, and certification, of fasteners under the Act and this part. The final test report or the test records maintained by the laboratory shall contain sufficient information to permit the test to be repeated at a later time if a retest is necessary. The laboratory shall maintain the test report and a record of all original observations, calculations, and derived data. The records shall include the identity of personnel performing the testing. Procedures for storage and retrieval of records must be documented and maintained in the laboratory
=s quality manual.* * * * *
6. Section 280.10 is revised to read as follows:
Sec. 280.10 Sampling.
(a) For tests conducted either in a laboratory on the Accredited Laboratory List or in a Registered Facility, if a manufacturer represents that the fasteners in a particular sample have been manufactured to a standard or specification which provides for the size, selection or integrity of the sample to be inspected and tested, the sample shall be determined in accordance with that standard or specification.
(b) For tests conducted in a laboratory on the Accredited Laboratory List, if a manufacturer represents that the fasteners in a particular sample have been manufactured to a standard or specification which does not provide for the size, selection or integrity of the sample to be inspected and tested, the sample shall be determined in accordance with the sampling plan provided by ASME/ANSI B18.18.2M, Inspection and Quality Assurance For High-Volume Machine Assembly Fasteners; ASME/ANSI B18.18.3M, Inspection and Quality Assurance for Special Purpose Fasteners; or ASME/ANSI B18.18.4M, Inspection and Quality Assurance for Highly Specialized Engineering Applications--Fasteners.
(c) For tests conducted in a Registered Facility, and not in a laboratory on the Accredited Laboratory List, if a manufacturer represents that the fasteners in a particular sample have been manufactured to a standard or specification which does not provide for the size, selection or integrity of the sample to be inspected and tested, the sample for inspections and tests by the Facility shall be determined by the sampling plan provided by its Fastener Quality Assurance System or by standards and specifications intended for use with a Fastener Quality Assurance System, as appropriate. Or, a manufacturer operating a Registered Facility may elect to conduct inspections and tests upon all of the fasteners within a specified lot, provided that this election is documented in the control plan of its Fastener Quality Assurance System.
7. Section 280.11 is amended by revising paragraph (b) to read as follows:
Sec. 280.11 Significant Alterations of Fasteners.
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(b) If the significant alteration is only electroplating of fasteners having a minimum specified Rockwell C hardness of 32 or above, the requirements set forth in paragraphs (a)(2) and (a)(3) of this section shall not apply, but the alterer shall assign a new lot number as set forth in paragraph (a)(1) of this section and shall test the electroplated fasteners as required by the plating standards and specifications.
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8. Section 280.12 is revised to read as follows:
Sec. 280.12 Applicability.
(a) The requirements of the Fastener Quality Act and this part shall be applicable only to fasteners manufactured on or after July 26, 1998.
(b) Metal manufactured prior to July 26, 1998 may not be used to manufacture fasteners subject to the Act and this part unless the metal has been tested for chemistry pursuant to section 280.15 of this part by a laboratory accredited under the Act and this part and the chemical characteristics of the metal conform to those required by the standards and specifications.
(c) Nothing in the Act and this part prohibits selling finished fasteners manufactured prior to July 26, 1998 or representing that such fasteners meet standards and specifications of a consensus standards organization or a government agency.
(d) Fasteners manufactured on or after [30 days after date of publication] may be represented, sold, or offered for sale as complying with the Act and these regulations if they are tested and certified by a laboratory appearing on the Accredited Laboratory List described in section 280.101, and meet all other requirements of the Act and this part.
(e) Fasteners manufactured on or after [30 days after date of publication] by a Facility listed on the Facilities List may be represented, sold, or offered for sale as complying with the Act and these regulations upon NIST
=s acknowledgment of receipt of the items required in section 280.810(c)(3).9. Section 280.104 is added to Subpart B to read as follows:
Sec. 280.104 Accreditation of Certain Manufacturing Facilities as Laboratories
(a) Subject to the limitations contained in paragraphs (b), (c), and (d) of this section, registration of a fastener manufacturing facility employing a fastener quality assurance system shall be deemed to meet the requirements of accreditation of a laboratory for purposes of the Act and this part. The independent third-party Registrar registering such facility under this section shall comply with all procedures set forth in Subparts I through L of this part. Records documenting the inspection and testing of a lot of fasteners performed by such an accredited laboratory shall be maintained by the facility in accordance with the requirements of sections 280.6, 280.808, and 280.809 of this part.
(b) In any instance where a Facility accomplishes any in-process inspection and testing by performing laboratory tests on a sample of fasteners at any stage in the manufacturing process, those tests must be conducted by a laboratory on the Accredited Laboratory List. Such a laboratory may be located on the same premises as a fastener manufacturing facility if the laboratory is separately accredited pursuant to a provision of this part other than section 280.104(a).
(c) Any laboratory tests performed outside the Facility
=s in-process inspection and testing must be conducted by a laboratory on the Accredited Laboratory List.(d) Chemical and raw material testing must be performed by a laboratory on the Accredited Laboratory List.
10. Section 280.602 is amended by revising paragraphs (e)(2), (h), and (j) and adding paragraphs (k), (l), (m), (n), and (o) to read as follows:
Sec. 280.602 Violations.
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(e) Misrepresentation and concealment of facts
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(2) In connection with the preparation, submission, use, or maintenance of a laboratory test report, certificate of conformance as described in sections 280.5 and 280.6 of this part, or any quality assurance system document required by this part or;
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(h) Falsification of Documents Relating to Accreditation of Laboratories or Registrars or Approval or Recognition of Accreditors or Accreditation Bodies. No person shall falsify or make any false or misleading statement on or in connection with any document relating to laboratory accreditation or approval or recognition of accreditation bodies, Accreditors or Registrars as required by section 6(a) or 6(b) of the Act or this part.
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(j) Falsification of Laboratory Accreditation, Accreditation Body or Accreditor. No person shall falsely claim to be an accredited laboratory or approved or recognized accreditation body or Accreditor as described in section 6 of the Act or Subparts B, C, D, E, I and J of this part.
(k) Sale of fasteners manufactured prior to the implementation date as compliant with the Act. No person shall represent, sell, or offer for sale fasteners manufactured prior to July 26, 1998 as being in conformance with the Act or this part except as provided for in section 280.12(d) or (e) of this part.
(l) Failure to Assign lot number traceable to Manufacturer
=s single, unique lot number. No importer, distributor, or significant alterer shall assign a lot number unless the assigned lot number is traceable to a manufacturer=s single, unique lot number.(m) Falsification of Documents relating to the registration of Fastener Manufacturing Facilities as accredited laboratories, accreditation of Registrars or recognition of Accreditors. No person shall falsify or make any false or misleading statement on or in connection with any document relating to the registration of Fastener Manufacturing Facilities as accredited laboratories, accreditation of Registrars or recognition of Accreditors as required by Subparts I, J, K, and L of this part.
(n) False claim of registration of Fastener Manufacturing Facilities as accredited laboratories, accreditation of Registrars, and recognition of Accreditors. No person shall falsely claim to be a registered Fastener Manufacturing Facility, an accredited Registrar, or a recognized Accreditor as described by Subparts I, J, K, and L of this part.
(o) Falsification of Documents relating to the Certification of FQA Compliance required for provisional listing on the Facilities List. No person shall falsify or make any false or misleading statement on or in connection with any document relating to the certification of FQA compliance required for provisional listing on the Facilities List pursuant to section 280.810(c)(3).
11. Subparts I through L are added to read as follows:
Subpart I - Special Rule for the Accreditation of
Certain Fastener Manufacturing Facilities, Whose Implemented Fastener Quality Assurance Systems Meet Defined Requirements, as Laboratories
Sec.
280.800 Introduction.
280.801 Application.
280.802 Review and decision process.
280.803 Criteria for recognition.
280.804 Maintaining recognized status.
280.805 Voluntary termination of recognition.
280.806 Involuntary termination of recognition by NIST.
280.807 Subcontracting.
280.808 Reports.
280.809 Record keeping.
280.810 Listing of recognized accreditors, accredited Registrars, and registered facilities.
280.811 Removal from a list.
280.812 Appeal.
Subpart I - Special Rule for the Accreditation of Certain Fastener Manufacturing Facilities, Whose Implemented Fastener Quality Assurance Systems Meet Defined Requirements, as Laboratories
Sec. 280.800 Introduction.
(a) This special rule applies to those fastener manufacturers, employing a fastener quality assurance system (QAS) as defined in this part, who wish to seek accreditation of the particular manufacturing facility employing the QAS as a laboratory within the meaning of the Act. This rule consists of this Subpart, and Subparts J, K and L. The rule adopts the view that a fastener manufacturing facility is deemed to be an accredited laboratory for purposes of the Act and this part if such facility employs a fastener quality assurance system (QAS) that has been formally registered by a NIST-recognized quality systems Registrar. The rule applies only to facilities manufacturing fasteners; raw materials for fastener manufacture must be tested and certified by a laboratory listed on the Accredited Laboratory List. This Subpart sets out the full process that NIST requires for the accreditation of a fastener manufacturing facility employing a QAS in the United States: a fastener manufacturing facility employing a QAS (a
AFacility@) will be deemed to be an accredited laboratory if it is registered by a Quality Systems Registrar (a "Registrar") that in turn has been accredited by a Registrar Accreditation Body (an "Accreditor") that has been recognized by NIST. Subpart J provides for foreign Accreditors to be recognized and to recognize Registrars under the same procedures.(b) A chain is thus established to assure the proper regulation of Facilities: NIST recognizes Accreditors that meet the requirements of Subpart K of this Part, which is based upon ISO Guide 61; the NIST-recognized Accreditors may in turn accredit Registrars that meet the requirements of Subpart L of this Part, which is based upon ISO Guide 62. The Registrars, in turn, may register Facilities that satisfy the elements of a fastener quality assurance system (QAS), as defined in this part.
(c) Within this Subpart, sections 280.801 through 280.809 contain the procedures that NIST uses to process requests from Accreditors for recognition by NIST. Section 280.810 establishes three lists that NIST will maintain: section 280.810(a) provides for a list of Accreditors that have been recognized by NIST; section 280.810(b) provides for a list of Registrars that have been accredited by Accreditors listed according to section 280.810(a); and section 280.810(c) provides for a list of Facilities that have been registered by Registrars listed according to section 280.810(b). The remainder of this Subpart, sections 280.811 and 280.812, contain procedural provisions related to the lists established by section 280.810.
Sec. 280.801 Application.
(a) Application must be made by Accreditors to NIST for recognition to accredit Registrars under the Act. Upon request, NIST will provide application forms and instructions. The applicant shall complete the application in English and may provide whatever additional enclosures, attachments or exhibits the applicant deems appropriate.
(b) Application packages may be obtained from: Manager, FQA Accreditation Body Evaluation Program, NIST, Bldg. 820, Room 282, Gaithersburg, Maryland, 20899. Requests may be made by mail or by FAX to: (301) 963-2871.
(c) The applicant shall reimburse NIST for all costs incurred in the evaluation of its accreditation program and subsequent costs incurred in ensuring the continued compliance of its program. Reimbursement shall be in accordance with the fee schedule established by NIST for this purpose.
(d) An application may be revised by an applicant at any time prior to the final decision by NIST. An application may be withdrawn by an applicant, without prejudice, at any time prior to the final decision by NIST.
Sec. 280.802 Review and decision process.
(a) Applications submitted by Accreditors will be accepted by NIST and their receipt acknowledged in writing. The applications will be reviewed by NIST against the criteria specified in this Subpart and in Subpart K of this part. NIST may request additional information as needed from the applicant.
(b) NIST shall conduct on-site assessments of the facilities of the applicant including all of the applicant's organizational units and locations covered by the application.
(c) If the applicant's program is deemed by NIST to have met the requirements for recognition, the applicant shall be notified by NIST in writing. The recognition notice shall include the date when the recognition begins and the scope of the recognition. The recognition period shall be for as long as the Accreditor continues to satisfy the requirements of section 280.803. As part of maintaining its approved status, each Accreditor shall agree to be reassessed by NIST every two years following its initial notice of recognition. NIST will maintain and make available to the public a list of recognized Accreditors.
(d) If the applicant does not meet the requirements for recognition, the applicant shall be notified in writing, listing the specific requirements from this Subpart and Subpart K of this part which the applicant's program has not met. After receipt of such a notification, and within the response period provided by NIST, the applicant may:
(1) Submit additional information for further review. Reviewing the new submission may involve additional on-site visits by NIST personnel. Additional fees may be required. Or,
(2) Submit a request that the original application be reconsidered, including a statement of reasons why the applicant should have been recognized.
Sec. 280.803 Criteria for recognition.
An applicant for NIST recognition must demonstrate the ability to operate a registrar accreditation program consistent with the requirements of this Subpart and Subparts A and K of this part, and accredit registrars of Facilities to requirements set out in Subpart L of this part.
Sec. 280.804 Maintaining recognized status.
(a) Accreditors shall continue to satisfy all the requirements of recognition during the recognition period.
(b) Upon request, recognized Accreditors shall make available to NIST and/or BXA all records and materials pertaining to the program.
(c) NIST has the right to participate as an observer during any on-site visit to a Registrar being audited by a NIST-recognized Accreditor, or a Facility being audited by an accredited Registrar, or it may perform its own surveillance visit of such bodies at its discretion.
(d) Neither the Accreditor, nor any Registrar it accredits, nor any Facility registered under the Act and this part shall take any action which states or implies the approval, or endorsement by NIST or any other agency of the U.S. Federal Government of any product or report pertaining to a product associated with any activities carried out under the recognition. None of these entities may take any action which states or implies that they are recognized or authorized by NIST to act or perform in any area(s) beyond that which was specified in their recognition under this part.
Sec. 280.805 Voluntary termination of recognition.
An Accreditor may voluntarily terminate its recognition by giving written notice to NIST and to all Registrars accredited by that body under its accreditation program. The written notice shall state the date on which the termination will take effect.
Sec. 280.806 Involuntary termination of recognition by NIST.
(a) NIST may terminate or suspend its recognition of an Accreditor if such an action is deemed to be in the public interest.
(b) Before terminating the recognition of an Accreditor, NIST will notify the Accreditor in writing, giving it the opportunity to rebut or correct the stated reasons for the proposed termination. If the problems are not corrected or reconciled within 30 days, or such longer time as NIST in its sole discretion may grant, the termination shall become effective.
(c) An Accreditor may appeal a termination to the Director by submitting a statement of reasons why the recognition should not be terminated. NIST may, at its discretion, hold in abeyance the termination action pending a final decision by the Director. Within 60 days following receipt of the appeal, the Director shall inform the Accreditor in writing of his or her decision.
(d) Registrars and registered organizations which have been listed by NIST in accordance with this Subpart, based on their accreditation by an Accreditor whose recognition has been terminated, shall be removed from the list, unless an exception is granted by NIST.
Sec. 280.807 Subcontracting.
If a recognized Accreditor, an accredited Registrar, or a registered Facility subcontracts any of its functions to another entity it must place the work with another recognized Accreditor, accredited Registrar, or registered Facility; inform the client, before the fact, that subcontracting will be necessary, and clearly indicate in all appropriate records, and reports to the client, specifically what functions were subcontracted.
Sec. 280.808 Reports.
Reports and records shall be maintained in such a manner to preserve original data, and be collected as required into a final form, sufficient to satisfy customer and legal requirements. Such reports shall be provided upon request to the Bureau of Export Administration, to the National Institute of Standards and Technology, or to any other agency of the federal government authorized to obtain such records under this part.
Sec. 280.809 Record keeping.
Each recognized Accreditor, accredited Registrar, or fastener manufacturer whose Facility has been registered shall retain all applicable records required under the Act and this part for 5 years. All records are subject to the requirements in section 280.7 of this part.
Sec. 280.810 Listing of recognized accreditors, accredited registrars, and registered facilities.
(a) List of Accreditors. NIST shall prepare and maintain a list of Accreditors recognized under this Subpart and Subpart J of this Part.
(b) List of Registrars. NIST shall prepare and maintain a list of Registrars accredited by Accreditors listed in accordance with section 280.810(a).
(1) Names and information regarding accredited Registrars may only be included on the list from information submitted to NIST by an Accreditor listed in accordance with section 280.810(a) that submits the listing fee established by NIST and the following information, in English:
(i) the name of the Accreditor which granted the accreditation;
(ii) the name and address of the Registrar affected by the accreditation action;
(iii) the nature of the accreditation action (e.g., initial accreditation, renewal of accreditation, etc.);
(iv) a copy of the Registrar
(v) the name and telephone number of the accredited Registrar
=s authorized representative(s), and information concerning the physical locations of all organizational units involved in the accreditation activities.(2) All Accreditors listed by NIST in accordance with section 280.810(a) shall promptly notify NIST of each accreditation action taken. Accreditation actions include initial accreditations, denials of accreditation, renewals, suspensions, terminations, and changes in scope. Notifications shall be filed with: Fastener Quality Act Program Manager, Office of Standards Services, National Institute of Standards and Technology, Gaithersburg, Maryland 20899.
(c) List of facilities. NIST shall prepare and maintain a list of Facilities registered by Registrars listed in accordance with section 280.810(b).
(1) Names and information regarding registered Facilities may only be included on the list from information submitted to NIST by accredited Registrars listed in accordance with section 280.810(b) that submit the listing fee established by NIST, through their Accreditors, and the following information:
(i) the name of the fastener manufacturer and the address of the registered Facility;
(ii) the name of the authorized representative of the fastener manufacturer whose Facility is registered;
(iii) the scope of registration, stating the quality system standard(s) to which the Facility has been registered; and
(iv) the effective dates of the registration.
(2) All Registrars listed by NIST in accordance with section 280.810(b) shall promptly notify NIST of each registration action. Registration actions include initial registrations, denials of registration, renewals, suspensions, terminations, and changes in scope. Notifications shall be filed with: Fastener Quality Act Program Manager, Office of Standards Services, National Institute of Standards and Technology, Gaithersburg, Maryland 20899.
(3)(i) If a Facility intends to be listed in accordance with section 280.810(c)(1) but the registration process will not be completed by July 26, 1998, the Facility may be provisionally listed on the Facilities List by providing the following to NIST on or before September 30, 1998:
(A) certification that:
(1) the Facility is registered to QS-9000 or an equivalent by a quality systems registrar;
(2) the Facility conforms to all other requirements of the Act and these regulations at the time of certification;
(3) if the Facility ceases to be registered to QS-9000 or an equivalent by an accredited Registrar and/or ceases to conform to any other requirement of the Act and these regulations at any time during the provisional listing period, it will notify NIST of that fact within three working days; and
(4) if the Facility fails to apply to an accredited Registrar for registration under the FQA within 30 days of the time the Registrar is accredited by a NIST-approved Accreditor, an authorized representative of the Facility will immediately notify NIST. (If the Facility
(B) a list of fasteners produced or processed by the Facility, identified by either a part number or a specification number;
(C) a list of standards included in the Facility
(D) a copy of the Facility
=s registration certificate; and(E) the listing fee established by NIST.
(ii) The Facility must meet all the requirements of the Act and these regulations by May 25, 1999. If the Facility fails to receive FQA registration by May 25, 1999, it will be removed from the Facilities List.
(d) These lists will be readily accessible to the public. Only entities listed by NIST are authorized to offer services which comply with the Act and this part. NIST shall revise as appropriate all listings when notified of applicable actions and shall take appropriate steps to make changes promptly available to the public.
Sec. 280.811 Removal from a list.
NIST may remove from a list any listed entity if NIST deems such action to be in the public interest. An entity may appeal the removal or proposed removal from a list to the Director by submitting a statement of reasons why it should remain on the list. NIST may, at its discretion, hold in abeyance a removal action pending a final decision by the Director. The Director shall inform the entity in writing of the decision within sixty days following receipt of the appeal.
Sec. 280.812 Appeal.
An applicant Accreditor, Registrar, or fastener manufacturer whose Facility has been registered may appeal the removal or proposed removal from the Accreditors list, the Registrars list, or the Facilities list, to the Director.