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280.100 Introduction. 280.101 Accredited laboratory list. 280.102 Procedures for inclusion in the ac
credited laboratory list. 280.103 Removal from the accredited labora
tory list. 280.104 Accreditation of certain manufac
turing facilities as laboratories.
Subpart C-NIST Fastener Laboratory
280.200 Introduction. 280.201 Applicability of part 285, title 15,
Code of Federal Regulations. 280.202 Establishment of the Program. 280.203 Adding to or modifying the Pro
gram. 280.204 NVLAP Program Handbook. 280.205 Applying for accreditation. 280.206 Assessing and evaluating a labora
tory. 280.207 Granting and renewing accredita
tion. 280.208 Denying, suspending, and revoking
accreditation. 280.209 Voluntary termination of accredita
tion. 280.210 Change in status of laboratory. 280.211 Authorized representative. 280.212 Approved signatory. 280.213 Application of accreditation condi
tions and criteria.
forcement proceedings. 280.606 Representation. 280.607 Filing and service of papers other
than charging letter. 280.608 Answer and demand for hearing. 280.609 Default. 280.610 Summary decision. 280.611 Discovery. 280.612 Subpoenas. 280.613 Matter protected against disclosure. 280.614 Prehearing conference. 280.615 Hearings. 280.616 Interlocutory review of rulings. 280.617 Proceeding without a hearing. 280.618 Procedural stipulations; extension of
POST-RECORDAL MAINTENANCE 280.720 Maintenance of the certificate of
recordal. 280.721 Notification of changes of address. 280.722 Transfer or amendment of the cer
tificate of recordal. 280.723 Transfer or assignment of the trade
mark registration or recorded insignia. 280.724 Change in status of trademark reg
istration or amendment of the trade
mark. 280.725 Cumulative listing of recordal infor
mation. 280.726 Records and files of the Patent and
280.1100 Introduction. 280.1101 Scope.
Subpart Special Rule for the Accredita
tion of Certain Fastener Manufacturing Facilities, Whose Implemented Fastener Quality Assurance Systems Meet
Defined Requirements, as Laboratories 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 recogni
tion. 280.806 Involuntary termination of recogni
tion by NIST. 280.807 Subcontracting. 280.808 Reports. 280.809 Recordkeeping. 280.810 Listing of recognized accreditors, ac
credited registrars, and registered facili
ties. 280.811 Removal from a list. 280.812 Appeal.
REQUIREMENTS FOR REGISTRARS 280.1110 Registrars 280.1111 Registrar personnel. 280.1112 Changes in the registration require
ments. 280.1113 Appeals, complaints and disputes.
REQUIREMENTS FOR REGISTRATION 280.1120 Application for registration. 280.1121 Preparation for assessment. 280.1122 Assessment. 280.1123 Assessment report. 280.1124 Decision on registration. 280.1125 Surveillance and reassessment pro
cedures. 280.1126 Use of certificates and logos. 280.1127 Access to records of complaints to
fastener manufacturers. AUTHORITY: 15 U.S.C. 5401 et seq.; Pub. L. 105–234, 112 Stat. 1536.
SOURCE: 61 FR 50558, Sept. 26, 1996, unless otherwise noted.
Subpart J-Recognition of Foreign Registrar
280.900 Introduction. 280.901 Recognition of foreign entities.
8 280.1 Purpose/description of rule.
The Fastener Quality Act (the Act) (Pub.L. 101-592, as amended by Pub. L. 104–113) is intended to protect the public safety, to deter the introduction of nonconforming fasteners into commerce, to improve the ability to trace fasteners covered by the Act, and generate greater assurance that fasteners meet stated specifications. The Act:
(a) Requires that certain fasteners which are sold in commerce conform to
Subpart K-Requirements for Registrar
Accreditation Bodies (Accreditors)
GENERAL 280.1000 Introduction.
the specifications to which they are represented to be manufactured,
(b) Provides for accreditation of laboratories engaged in fastener testing; and
(c) Requires inspection, testing and certification, in accordance with standardized methods, of fasteners covered by the Act.
(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. [61 FR 50558, Sept. 26, 1996, as amended at 63 FR 18271, Apr. 14, 1998] $280.2 Definitions.
Unless the context requires otherwise or unless specifically stated the terms in this part have the meanings prescribed in the statute. In addition the following definitions apply.
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).
Accreditation body refers to the National Voluntary Laboratory Accreditation Program and those private entities currently approved by NIST under subpart D of this part and those foreign governments organizations currently recognized by NIST under subpart E of this part.
Accreditation criteria means a set of requirements used by an accreditation body which a laboratory must meet to be accredited.
Accredited registrar means a registrar, as defined in this part, that is accredited by a recognized accreditor and ap
pears on the Registrars List described in section 280.810(b).
Accreditor means a Registrar accreditation body that meets the requirements of subpart K of this part.
The Act means the Fastener Quality Act (Pub.L. 101-592, as amended by Pub.L. 104-113).
Alter means to alter by through hardening; by electroplating of fasteners; or by machining.
Alteror means a person who owns a fastener and causes it to be altered.
Approved signatory is an individual employed by a laboratory accredited under the Act and these regulations who is recognized by an accreditation body as competent to sign accredited laboratory test reports.
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.
Bureau of Export Administration or (BXA) means the Bureau of Export Administration of the United States Department of Commerce, including the Office of Export Enforcement.
Certificate of accreditation is a document issued by an accreditation body to a laboratory that has met the criteria and conditions of accreditation. The certificate, together with the assigned code number, and scope of accreditation issued by the accreditation body may be used as proof of accredited status.
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.
Commingling means the mixing of fasteners from different lots in the same container.
Commissioner means the Commissioner of Patents and Trademarks.
Consensus standards organization means the American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI),
American Society of Mechanical Engi- Fastener Quality Assurance System neers (ASME), Society of Automotive (QAS)–(1Fastener Quality Assurance Engineers (SAE), or any other con- System (QAS) means a fastener manusensus standards setting organization facturing system that has as a stated (domestic or foreign) publicly identi- goal the prevention of defects through fied by NIST as having comparable continuous improvement, and which knowledge, expertise, and concern for seeks to attain that goal by incorthe health and safety in the field for porating: which such organization purports to
(i) Advanced quality planning; set standards.
(ii) Monitoring and control of the Container means any package of fas
manufacturing process; teners traded in commerce.
(iii) Process inspection embodied in a Date of manufacture means that date
comprehensive and written control upon which the initial conversion of
plan for product/process characterismaterial into a fastener takes place.
tics, process controls (including statisDirector means the Director of the
tical process control), tests, and measNational Institute of Standards and
urement systems that will occur durTechnology (NIST).
ing mass production; and Facility means a fastener manufac
(iv) The creation, maintenance, and turing facility, or a facility performing
retention of electronic, photographic, subcontracted processes for a fastener
or paper records, available for inspecmanufacturing facility, implementing
tion during the periods required by seca fastener quality assurance system as
tion 10 of the Act and $280.7 of this defined in this part.
part, regarding the inspections, tests,
and measurements required by or perFastener means any screw, nut, bolt
formed pursuant to the control plan. or stud, washer or other item included within the definition for fastener con
(2) A Fastener Quality Assurance
System contains the following eletained in section 3(5) of the Fastener
ments at a minimum: Quality Act. The term "fastener” does
(i) A documented quality managenot include a screw, nut, bolt, or stud:
ment system that satisfies the require(1) That is produced and marked as
ments of ISO-9001 “Quality Systems ASTM A307 Grade A;
Model for quality assurance in design, (2) That is produced in accordance
development, production, installation with ASTM F432; or
and servicing,” ISO-9002 “Quality Sys(3) That is held out as being produced tems-Model for quality assurance in to other than the provisions of stand
production, installation and servards and specifications published by a icing,” or other quality system standconsensus standards organization, or a ards that incorporate ISO-9001 or ISO government agency.
9002 (e.g. QS-9000, AS-9000, etc.); A screw, nut, bolt, stud or washer (ii) A requirement that raw material held out as being produced according to certification supplied to the fastener requirements of a document other than manufacturer shall be traceable to that a document published by a consensus of a mill heat of material that has been standards organization is a fastener tested by a laboratory on the Accredwithin the meaning of the Act and this ited Laboratory List; part if that document incorporates or (iii) A requirement that subconreferences (directly indirectly) tracted processes, including plating standards and specifications published and heat treating, are controlled by by a consensus standards organization the manufacturer, to avoid product lot or government agency for purposes of contamination, and that finished lots delineating performance or materials of fasteners shall be traceable to subcharacteristics of the fastener.
contracted processes performed by a Fastener insignia register means the registered Facility on the Facilities register established at the U.S. Patent List described in $280.810 or tested by a and Trademark Office for the recordal Laboratory on the Laboratories List of fastener insignia to identify the described in 8280.101; manufacturer or private label dis- (iv) A requirement that the fastener tributor.
manufacturer fully document fastener