Subpart J - Recognition of Foreign Registrar
Accreditation Bodies
Sec.
280.900 Introduction.
280.901 Recognition of foreign entities.
Subpart J - Recognition of Foreign Registrar Accreditation Bodies
Sec. 280.900 Introduction.
In accordance with section 6(a)(1)(C) of the Act, this Subpart sets forth the conditions under which the recognition of foreign entities by their governments, by organizations acting on behalf of their governments, or by organizations recognized by the Director shall be deemed to meet the requirements of the Act.
Sec 280.901 Recognition of foreign entities.
Foreign Accreditors wishing to be recognized to accredit Registrars must submit an application for evaluation to NIST according to Subpart I of this Part. NIST recognition is limited to bodies that accredit Registrars which register Facilities producing fasteners covered by the Act. To be recognized by NIST, Accreditors must meet conditions set out in Subparts I and K of this Part and accredit Registrars of Facilities to conditions set out in Subpart L of this Part.
Subpart K - Requirements for Registrar Accreditation Bodies (Accreditors)
General
280.1000 Introduction.
280.1001 Scope.
Requirements for Accreditors
280.1010 Accreditors.
280.1011 Accreditor personnel.
280.1012 Decision on accreditation.
280.1013 References to accredited status.
280.1014 Change in the accreditation.
280.1015 Appeals, complaints and disputes.
280.1016 Access to records of appeals, complaints and disputes.
Requirements for Assessment
280.1020 Application for accreditation.
280.1021 Preparation for assessment.
280.1022 Assessment.
280.1023 Assessment report.
280.1024 Surveillance and reassessment procedures.
Subpart K - Requirements for Registrar Accreditation Bodies (Accreditors)
General
Sec. 280.1000 Introduction.
This Subpart sets out organizational, operational and other requirements that must be met by all Accreditors recognized by NIST under Subpart I or J of this part. This Subpart also sets out the requirements against which an Accreditor assesses the competence of an applicant Registrar.
Sec. 280.1001 Scope.
These are general requirements for an Accreditor to follow if it is to be recognized as competent and reliable in assessing and subsequently accrediting Registrars.
Requirements for Accreditors
Sec. 280.1010 Accreditors.
(a) General provisions. (1) The policies and procedures under which the Accreditor operates shall be non-discriminatory, and they shall be administered in a non-discriminatory manner. Procedures shall not be used to impede or inhibit access by applicant bodies other than as specified in this part.
(2) The Accreditor shall make its services accessible to all applicants whose activities fall within its declared field of operation. There shall not be undue financial or other conditions. Access shall not be conditional upon the size of the applicant body or membership of any association or group, nor shall accreditation be conditional upon the number of bodies already accredited.
(3) The accreditation criteria against which the competence of a Registrar is assessed shall be those outlined in Subpart L of this part. If an explanation is required as to the application of these documents to a specific accreditation program, it shall be formulated by relevant and impartial committees or persons possessing the necessary technical competence, and published by the Accreditor.
(4) The Accreditor shall confine its requirements, assessment and decisions on accreditation to those matters specifically related to the scope of the accreditation being considered.
(b) Organization of a recognized Accreditor. The structure of the Accreditor shall be such as to give confidence in its accreditations. In particular, the Accreditor shall:
(1) Be impartial;
(2) Be responsible for its decisions relating to the granting, maintaining, extending, reducing, suspending and withdrawing of accreditation;
(3) Identify the management (committee, group or person) which will have overall responsibility for all of the following:
(i) Performance of assessment and accreditation as defined in this part;
(ii) Formulation of policy matters relating to the operation of the Accreditor;
(iii) Decisions on accreditation;
(iv) Supervision of the implementation of its policies;
(v) Supervision of the finance of the Accreditor; and
(vi) Delegation of authority to committees or individuals, as required, to undertake defined activities on its behalf.
(4) Have documents which demonstrate that it is a legal entity;
(5) Have a documented structure which safeguards impartiality, including provisions to assure the impartiality of the operations of the Accreditor,; this structure shall enable the participation of all parties significantly concerned in the development of policies and principles regarding the content and functioning of the accreditation system;
(6) Ensure that each decision on accreditation is taken by a person or persons different from those who carried out the assessment;
(7) Have rights and responsibilities relevant to its accreditation activities;
(8) Have adequate arrangements to cover liabilities arising from its operations and/or activities;
(9) Have financial stability and resources required for the operation of an accreditation system;
(10) Employ a sufficient number of personnel having the necessary education, training, technical knowledge and experience for performing accreditation functions relating to the type, range and volume of work performed, under a responsible senior executive;
(11) Have a quality system, as outlined in paragraph (d) of this section, giving confidence in its ability to operate an accreditation system for registration bodies;
(12) Have policies and procedures that distinguish between accreditation and any other activities in which the Accreditor is engaged;
(13) Together with its senior executive and staff, be free from any commercial, financial and other pressures which might influence the results of the accreditation process;
(14) Have formal rules and structure for the appointment and operation of any committees which are involved in the accreditation process; such committees shall be free from any commercial, financial and other pressures that might influence decisions;
(15) Ensure that activities of related bodies do not affect the confidentiality, objectivity or impartiality of its accreditations and shall not offer or provide, directly or indirectly, those services that accredit others to perform, consulting services to obtain or maintain accreditation, or services to design, implement or maintain a certification scheme;
(16) Have policies and procedures for the resolution of complaints, appeals and disputes received from bodies or other parties about the handling of accreditation of any related matters;
(17) Have a structure where members are chosen to provide a balance of interest, where no single interest predominates; and
(18) Assure that other products, processes or services that may be offered, directly or indirectly, do not compromise confidentiality or the objectivity or impartiality of its accreditation process and decisions.
(c) Subcontracting. (1) When an Accreditor decides to subcontract work related to accreditation (e.g. audits) to an external body or person, a properly documented agreement covering the arrangements, including confidentiality and conflict of interest, shall be drawn up. The Accreditor shall:
(i) Take full responsibility for such subcontracted work and maintain its responsibility for granting, maintaining, extending, reducing, suspending or withdrawing accreditation;
(ii) Ensure that the subcontracted body or person is competent and complies with the applicable provisions of this part, including section 280.807, and is not involved, either directly or through its employer, with the design, implementation or maintenance of a registration scheme in such a way that impartiality could be compromised; and
(iii) obtain the consent of the applicant or accredited body.
(2) Requirements in paragraphs (c)(1)(i) and (ii) of this section are also relevant, by extension, when an Accreditor uses, for granting its own accreditation, work provided by another Accreditor with which it has signed an agreement.
(d) Quality system. (1) The management of the Accreditor with executive responsibility for quality shall define and document its policy for quality, including objectives for quality and its commitment to quality. The management shall ensure that this policy is understood, implemented and maintained at all levels of the organization.
(2) The Accreditor shall operate a quality system in accordance with the relevant elements of this part and appropriate to the type, range and volume of work performed. This quality system shall be documented, and the documentation shall be available for use by the staff of the Accreditor.
(3) The Accreditor shall ensure effective implementation of the documented quality system procedures and instructions.
(4) The Accreditor shall designate a person with direct access to its highest executive level who, irrespective of other responsibilities, shall have defined authority to ensure that a quality system is established, implemented and maintained in accordance with this part, and report on the performance of the quality system to the management of the Accreditor for review and as a basis for improvement of the quality system.
(5) The quality system shall be documented in a quality manual and associated quality procedures, and the quality manual shall contain or refer to at least the following:
(i) A quality policy statement;
(ii) A brief description of the legal status of the Accreditor, including the names of its owners, if applicable, and, if different, the names of the persons who control it;
(iii) The names, qualifications, experience and terms of reference of the senior executive and other accreditation personnel influencing the quality of the accreditation function;
(iv) An organization chart showing lines of authority, responsibility and allocation of functions stemming from the senior executive and, in particular, the relationship between those responsible for the assessment and those making decisions regarding accreditation;
(v) A description of the organization of the Accreditor, including details of the management (committee, group or person), its constitution, terms of reference and rules of procedure;
(vi) The policy and procedures for conducting management reviews;
(vii) Administrative procedures including document control;
(viii) The operational and functional duties and service pertaining to quality, so that the extent and limits of each person
(ix) The policy and procedures for the recruitment and training of Accreditor personnel (including auditors) and monitoring their performance;
(x) A list of its subcontractors and details of the procedures for assessing, recording and monitoring their competence;
(xi) Its procedures for handling nonconformities and for assuring the effectiveness of any corrective actions taken;
(xii) The policy and procedures for implementing the accreditation process, including:
(A) The conditions for issue, retention and withdrawal of accreditation documents;
(B) Checks of the use and application of documents used in the accreditation;
(C) The procedures for assessing and accrediting applicants; and
(D) The procedures for surveillance and reassessment of accredited bodies.
(xiii) The policy and procedures for dealing with appeals, complaints and disputes; and
(xiv) The procedures for conducting internal audits based on appropriate international documentation.
(e) Conditions for granting, maintaining, extending, reducing, suspending and withdrawing accreditation. (1) The Accreditor shall specify the conditions for granting, maintaining, extending and reducing accreditation, and the conditions under which accreditation may be suspended or withdrawn, partially or in total, for all or part of the accredited body
=s scope of accreditation. In particular, the Accreditor shall require the accredited body to notify it promptly of any intended changes to the quality system or other changes which may affect conformity.(2) The Accreditor shall have procedures to grant, maintain, withdraw and suspend accreditation; to extend or reduce the scope of accreditation; and to conduct reassessment in the event of changes significantly affecting the activity and operation of the accredited body (such as change of ownership, changes in personnel or equipment), or if analysis of a complaint or any other information indicates that the accredited body no longer complies with the requirements of the Accreditor.
(f) Internal audits and management reviews. (1) The Accreditor shall conduct periodic internal audits covering all procedures in a planned and systematic manner, to verify that the quality system is being implemented and is effective. The Accreditor shall ensure that personnel responsible for the area audited are informed of the outcome of the audit; corrective action is taken in a timely and appropriate manner; and the results of the audit are documented.
(2) The top management of the Accreditor shall review its quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this part and the stated quality policy and objectives. Records of such reviews shall be maintained.
(g) Documentation. (1) The Accreditor shall document, update at regular intervals, and make available (through publications, electronic media or other means), on request:
(i) Information about the authority under which the Accreditor operates;
(ii) A documented statement of its accreditation system, including its rules and procedures for granting, maintaining, extending, reducing, suspending and withdrawing accreditation;
(iii) Information about the assessment and accreditation process;
(iv) A description of the means by which the Accreditor obtains financial support, and general information on the fees charged to applicants and accredited bodies;
(v) A description of the rights and duties of applicants and accredited bodies, as specified, including requirements, restrictions or limitations on the use of the Accreditor
(vi) Information on procedures for handling complaints, describing the scope of accreditation granted to each.
(2) The Accreditor shall establish and maintain procedures to control all documents and data that relate to its accreditation functions. These documents shall be reviewed and approved for adequacy by appropriately authorized and competent personnel prior to issuing any documents following initial development or any subsequent amendment or change being made. A listing of all appropriate documents with the respective issue and/or amendment status identified shall be maintained. The distribution of all such documents shall be controlled to ensure that the appropriate documentation is made available to personnel of the Accreditor, or applicants and accredited bodies, when required to perform any function relating to the activities of applicants and accredited bodies.
(h) Records. (1) The Accreditor shall maintain a record system to suit its particular circumstances and to comply with this part. The records shall demonstrate that accreditation procedures have been effectively fulfilled, particularly with respect to application forms, assessment reports, and other documents relating to granting, maintaining, extending, reducing, suspending or withdrawing accreditation. The records shall be identified, managed and disposed of in such a way as to ensure the integrity of the process and confidentiality of the information. The records shall be kept for a period of five years.
(2) The Accreditor shall have a policy and procedures for retaining records for a period of five years. The Accreditor shall have a policy and procedures concerning access to these records consistent with paragraph (h)(1) of this section.
(i) Confidentiality. (1) The Accreditor shall have adequate arrangements, consistent with applicable laws, to safeguard confidentiality of the information obtained in the course of its accreditation activities at all levels of its organization, including committees and external bodies or individuals acting on its behalf.
(2) Except as required in this part, information about a particular body shall not be disclosed to a third party without the written consent of the body.
Sec. 280.1011 Accreditor personnel.
(a) General provisions. (1) The personnel of the Accreditor involved in accreditation shall be competent for the functions they perform.
(2) Information on the relevant qualifications, training and experience of each member of the personnel involved in the accreditation process shall be maintained by the Accreditor. Records of training and experience shall be kept up to date.
(3) Clearly documented instructions shall be available to the personnel describing their duties and responsibilities. These instructions shall be maintained up to date.
(b) Qualification criteria for auditors and technical experts. (1) In order to ensure that assessments are carried out effectively and uniformly, the minimum relevant criteria for competence shall be defined by the Accreditor.
(2) Auditors shall meet the requirements of the appropriate international documentation.
(3) Technical experts are not required to comply with the requirements for auditors, and guidance on their personal attributes may be obtained from appropriate international documentation.
(c) Selection procedure. (1) The Accreditor shall have a procedure for selecting auditors and, if applicable, technical experts on the basis of their competence, training, qualifications and experience, and for initially assessing the conduct of auditors and technical experts during assessments, and subsequently monitoring the performance of auditors and technical experts.
(2) When selecting the audit team to be appointed for a specific assessment, the Accreditor shall ensure that the skills brought to each assignment are appropriate. The team shall:
(i) Be familiar with the Act and this part, accreditation procedures and accreditation requirements;
(ii) Have a thorough knowledge of the relevant assessment method and assessment documents;
(iii) Have appropriate technical knowledge of the fastener technology for which accreditation is sought and, where relevant with associated procedures and their potential for failure (technical experts who are not auditors may fulfil this function);
(iv) Have a degree of understanding sufficient to make a reliable assessment of the competence of the accredited body to operate within its scope;
(v) Be able to communicate effectively, both in writing and orally, in the required languages;
(vi) Be free from any interest that might cause team members to act in other than an impartial or non-discriminatory manner, for example,
(A) Audit team members or their organization shall not have provided consulting services to the applicant or accredited body which compromise the accreditation process and decision; and
(B) In accordance with the directives of the Accreditor, the audit team members shall inform the Accreditor, prior to the assessment, about any existing, former or envisaged link between themselves or their organization and the body to be assessed.
(d) Contracting of assessment personnel. The Accreditor shall require the personnel involved in the assessment to sign a contract or other document by which they commit themselves to comply with the rules defined by the Accreditor, including those relating to confidentiality and those relating to independence from commercial and other interest, and any prior and/or present link with the bodies to be assessed. The Accreditor shall ensure that, and document how, any subcontracted assessment personnel satisfy all the requirements for personnel outlined in this Subpart.
(e) Assessment personnel records. (1) The Accreditor shall possess and maintain up-to-date records on personnel conducting assessments, consisting of:
(i) Name and address;
(ii) Affiliation and position held in the organization;
(iii) Educational qualifications and professional status;
(iv) Experience and training in each field of competence of the Accreditor;
(v) Date of most recent updating of record; and
(vi) Performance appraisal.
(2) The Accreditor shall ensure, and verify, that any subcontracted body maintains records, which satisfy the requirements of this part, of assessment personnel who are subcontracted to the Accreditor.
(f) Procedures for assessment teams. Assessment teams shall be provided with up-to-date assessment instructions and all relevant information on accreditation arrangements and procedures.
Sec. 280.1012 Decision on accreditation.
(a) The decision whether or not to accredit a body shall be made on the basis of the information gathered during the accreditation process and any other relevant information. Those who make the accreditation decision shall not have participated in the audit.
(b) The Accreditor shall not delegate authority for granting, maintaining, extending, reducing, suspending or withdrawing accreditation to an outside person or body.
(c) The Accreditor shall provide to each of its accredited bodies accreditation documents such as a letter outlining the scope of accreditation and a certificate signed by an officer who has been assigned such responsibility. These accreditation documents shall identify, for the body and each of its sites covered by the accreditation:
(1) The name and address;
(2) The scope of the accreditation granted, including as appropriate:
(i) The type of registration scheme;
(ii) The standards and/or other normative documents and regulatory requirements against which products, services or systems are registered; and
(iii) Fasteners covered by the Act.
(3) The effective date of accreditation and, as applicable, the term for which the accreditation is valid.
(d) In response to an application for an amendment to the scope of an accreditation already granted, the Accreditor shall decide what, if any, assessment procedure is appropriate to determine whether or not the amendment should be granted and shall act accordingly.
Sec. 280.1013 References to accredited status.
(a) An Accreditor which is proprietor or licensee of a symbol or logo, intended for use under its accreditation program, shall have a policy governing its use. It shall normally allow an accredited body to refer to its accreditation in certificates, reports, and stationery and publicity material relating to accredited activities.
(b) The Accreditor shall not allow use of its mark or logo in any way which implies that the Accreditor itself approved a product, service or system registered by an accredited body. Where a Facility is registered only with respect to its quality assurance system, the symbol or logo shall not be used on a product or in any other way that may be interpreted as denoting product conformance, as required by section 280.804(d).
(c) The Accreditor shall take suitable action to deal with incorrect reference to the accreditation system, or misleading use of accreditation logos found in advertisements, catalogues, etc. Such action could include corrective action, withdrawal of certificate, publication of the transgression and, if necessary, other legal action.
Sec. 280.1014 Change in the accreditation.
The Accreditor shall give due notice of any changes it intends to make in its requirements for accreditation. It shall take account of views expressed by interested parties before deciding on the precise form and effective date of the changes. Following a decision on, and publication of, the changed requirements, it shall verify that each accredited Registrar carries out any necessary adjustments to its procedures within such time as, in the opinion of the Accreditor, is reasonable.
Sec. 280.1015 Appeals, complaints and disputes.
The Accreditor shall keep a record of all appeals, complaints and disputes, and remedial actions relative to accreditation; take appropriate corrective and preventive action; and document the actions taken and assess their effectiveness.
Sec. 280.1016 Access to records of appeals, complaints and disputes.
The Accreditor shall require each applicant and accredited Registrar to make available to it, when requested, the records of all complaints, appeals and disputes, and subsequent actions.
Requirements for Assessment
Sec. 280.1020 Application for accreditation.
(a) (1) As specified in section 280.1010(g)(1) of this part, the Accreditor shall maintain up-to-date detailed descriptions of the assessment and accreditation procedure, the documents containing the requirements for accreditation, and documents describing the rights and duties of accredited Registrars, and shall provide them to applicants and accredited Registrars. The Accreditor shall require that an accredited Registrar:
(i) Always complies with the relevant provisions of this part;
(ii) Makes all necessary arrangements for the conduct of the assessment, including provision for examining documentation and the access to all areas, records (including internal audit reports) and personnel for the purposes of assessment, surveillance, reassessment and resolution of complaints;
(iii) Only claims that it is accredited with respect to those activities for which it has been granted accreditation;
(iv) Does not use its accreditation in such a manner as to bring the Accreditor into disrepute, and does not make any statement regarding its accreditation which the Accreditor may consider misleading or unauthorized;
(v) Upon suspension or withdrawal of its accreditation, discontinues use of all advertising matter that contains any reference thereto and returns any accreditation documents as required by the Accreditor;
(vi) Does not allow the fact of its accreditation to be used to imply that a product, process, system, or person is approved by the Accreditor, as required by section 280.804(d);
(vii) Ensures that no accreditation document, mark or report, or any part thereof, is used in a misleading manner; and
(viii) In making reference to its accreditation status in communication media such as documents, brochures or advertising, complies with the requirements of the Accreditor.
(2) When the desired scope of accreditation is related to a specific program any necessary explanation shall be provided to the applicant. If requested, additional application information shall be provided to the body.
(b) The Accreditor shall require an official application form, duly completed and signed by a duly authorized representative of the applicant, in which or attached to which:
(1) The scope of the desired accreditation is defined; and
(2) The applicant agrees to comply with the requirements for accreditation and to supply any information needed for its evaluation.
(c) At least the following shall be provided by the applicant prior to the on-site assessment:
(1) The general features of the applicant body, such as corporate entity, name, address, legal status and, where relevant, human and technical resources;
(2) General information concerning the body covered by the application, such as its functions, and its relationship in a larger corporate entity, and its physical locations;
(3) A description of the systems or products it registers and the standards or other normative documents applicable to each; and
(4) A copy of its quality manual and, where required, the associated documentation.
Sec. 280.1021 Preparation for assessment.
(a) Before proceeding with the assessment, the Accreditor shall conduct, and maintain records of, a review of the request for accreditation to ensure that:
(1) The requirements for accreditation are clearly defined and documented;
(2) Any difference in understanding between the Accreditor and the applicant is resolved; and
(3) The Accreditor has the capability to perform the accreditation service with respect to the scope of the accreditation sought, the location of the applicant
(b) The Accreditor shall prepare a plan for its assessment activities to allow for the necessary arrangements to be made.
(c) The Accreditor shall nominate a qualified audit team to evaluate all material collected from the applicant and to conduct the audit on its behalf. Experts in the areas to be assessed may be attached to the Accreditor
=s team as advisers.(d) The applicant shall be informed of the names of the members of the audit team who will carry out the assessment, with sufficient notice to appeal against the appointment of any particular auditors or experts.
(e) The audit team shall be formally appointed and provided with the appropriate working documents. The plan for and the date of the audit shall be agreed upon with the applicant. The mandate given to the audit team shall be clearly defined and made known to the applicant, and shall require the audit team to examine the structure, policies and procedures of the applicant, and confirm that these meet all the requirements relevant to the scope of accreditation, and that the procedures are implemented and are such as to give confidence in the registrations of the applicant.
Sec. 280.1022 Assessment.
(a) The audit team shall assess all services of the applicant covered by the defined scope against all applicable accreditation requirements.
(b) The Accreditor shall witness fully the on-site activities of one or more assessments or audits conducted by an applicant before an initial accreditation is granted for any function requiring on-site activity by the applicant
Sec. 280.1023 Assessment report.
(a) The Accreditor may adopt reporting procedures that suit its needs but, as a minimum, these procedures shall ensure that:
(1) A meeting takes place between the audit team and the applicant
(2) The audit team provides the Accreditor with a report of its findings as to the applicant
=s conformity to all of the accreditation requirements;(3) A report on the outcome of the assessment is promptly brought to the applicant
=s attention by the Accreditor, identifying any nonconformity to be discharged in order to comply with all of the accreditation requirements;(4) The Accreditor shall invite the applicant to comment on the report and to describe the specific actions taken, or planned to be taken within a defined time, to remedy any nonconformity with the accreditation requirements identified during the assessment, and shall inform the applicant of the need for full or partial reassessment or whether a written declaration to be confirmed during surveillance will be considered adequate;
(5) The report shall contain as a minimum:
(i) The date(s) of the audit(s);
(ii) The name(s) of the person(s) responsible for the report;
(iii) The names and addresses of all sites audited;
(iv) The assessed scope of accreditation or reference thereto;
(v) Comments on the conformity of the applicant with the accreditation requirements and, where applicable, any useful comparisons with the results of previous assessment of the applicant; and
(vi) An explanation of any differences from the information presented to the applicant at the closing meeting.
(b) If the final report authorized by the Accreditor differs from the report referred to in paragraphs (b)(3) and (5) of this section, it shall be submitted to the applicant with an explanation of any differences from the previous report. The report shall take into consideration:
(1) The qualification, experience and authority of the staff encountered;
(2) The adequacy of the internal organization and procedures adopted by the applicant to give confidence in the quality of its services; and
(3) The actions taken to correct identified nonconformities including, where applicable, those identified at previous assessments.
Sec. 280.1024 Surveillance and reassessment procedures.
(a) The Accreditor shall have an established documented program, consistent with the accreditation granted, for carrying out periodic surveillance and reassessment at sufficiently close intervals to verify that its accredited Registrar continues to comply with the accreditation requirements.
(b) Surveillance and reassessment procedures shall be consistent with those concerning the assessment of the applicant as described in this part.
(c)(1) The Accreditor shall have arrangements to ensure that an accredited Registrar informs it without delay of changes in any aspects of its status or operation that affect its:
(i) Legal, commercial or organizational status;
(ii) Organization and management, for example key managerial staff;
(iii) Policies or procedures, where appropriate;
(iv) Premises; and
(v) Personnel, equipment, facilities, working environment or other resources, where significant.
(2) The accredited Registrar shall also inform the Accreditor of other such matters that may affect activities, or conformance with the requirements, or any other relevant criteria of competence specified by the Accreditor.