Subpart L - Requirements for Registrars
General
Requirements for Registrars
280.1110 Registrars.
280.1111 Registrar personnel.
280.1112 Changes in the registration requirements.
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 procedures.
280.1126 Use of certificates and logos.
280.1127 Access to records of complaints to fastener manufacturers.
Subpart L - Requirements for Registrars
General
Sec. 280.1100 Introduction.
This Subpart sets out organizational, operational and other requirements that must be met by all Registrars accredited under Subparts I or J of this part.
Sec. 280.1101 Scope.
These are general requirements that must be met by a third-party body registering Facilities. Note: In some countries, the bodies which verify conformity of quality systems to specified standards are called
Acertification bodies,@ in others Aregistration bodies,@ in others Aassessment and registration bodies@ or Acertification/registration bodies,@ and in still others Aregistrars.@ Reference to such bodies as ARegistrars@ should not be understood to be limiting.Requirements for Registrars
Sec. 280.1110 Registrars.
(a) General provisions. (1) The policies and procedures under which the Registrar 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 applicants other than as specified in this part.
(2) The Registrar shall make its services accessible to all applicants. 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 registration be conditional upon the number of Facilities already registered.
(3) The criteria against which the quality assurance system of an applicant is assessed shall be those outlined in the quality system standards or other normative documents relevant to the function performed. If an explanation is required as to the application of these documents to a specific registration program, it shall be formulated by relevant and impartial committees or persons possessing the necessary technical competence, and published by the Registrar.
(4) The Registrar shall confine its requirements, assessment, and decision on registration to those matters specifically related to the scope of the registration being considered.
(b) Organization of a registrar. The structure of the Registrar shall be such as to give confidence in its registrations. In particular, the Registrar shall:
(1) Be impartial;
(2) Be responsible for its decisions relating to the granting, maintaining, extending, reducing, suspending and withdrawing of registration;
(3) Identify the management (committee, group, or person) which will have overall responsibility for each of the following:
(i) Performance of assessment and registration as defined in this part;
(ii) Formulation of policy matters relating to the operation of the Registrar,
(iii) Decisions on registration;
(iv) Supervision of the implementation of its policies;
(v) Supervision of the finances of the Registrar; 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 Registrar, 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 registration system;
(6) Ensure that each decision on registration is taken by a person or persons different from those who carried out the assessment;
(7) Have rights and responsibilities relevant to its registration activities;
(8) Have adequate arrangements to cover liabilities arising from its operations and/or activities;
(9) Have the financial stability and resources required for the operation of a registration system;
(10) Employ a sufficient number of personnel having the necessary education, training, technical knowledge, and experience for performing registration 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 a registration system for Facilities;
(12) Have policies and procedures that distinguish between registration and any other activities in which the Registrar 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 registration process;
(14) Have formal rules and structures for the appointment and operation of any committees which are involved in the registration process; such committees shall be free from any commercial, financial, and other pressure that might influence decisions;
(15) Ensure that activities of related bodies do not affect the confidentiality, objectivity, or impartiality of its registrations and shall not offer or provide, directly or indirectly, those services that it registers others to perform, consulting services to obtain or maintain registration, or services to design, implement, or maintain quality systems;
(16) Have policies and procedures for the resolution of complaints, appeals, and disputes received from fastener manufacturers or other parties about the handling of registration or any other related matters;
(17) Have a structure where members are chosen to provide a balance of interests, 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 registration process and decisions.
(c) Subcontracting. (1) When a Registrar decides to subcontract work related to registration (e.g. audits) to an external body or person, a properly documented agreement covering the arrangements, including confidentiality and conflicts of interest, shall be drawn up. The Registrar shall:
(i) Take full responsibility for such subcontracted work and maintain its responsibility for granting, maintaining, extending, reducing, suspending, or withdrawing registration;
(ii) Ensure that the subcontracted body or person is competent and complies with the applicable provisions of this part, including section 280.7, and is not involved, either directly or through its employer, with the design, implementation, or maintenance of a quality system in such a way that impartiality could be compromised; and
(iii) Obtain the consent of the applicant or fastener manufacturer whose Facility is registered.
(2) Requirements in paragraphs (c)(1) and (2) of this section are also relevant, by extension, when a Registrar uses, for granting its own registration, work provided by another Registrar with which it has signed an agreement.
(d) Quality system. (1) The management of the Registrar 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 Registrar 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 Registrar.
(3) The Registrar shall ensure effective implementation of the documented quality system procedures and instructions.
(4) The Registrar 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 Registrar 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 Registrar, including the names of its owners, if applicable, and, if different, the names of the persons who control it;
(iii) The names and qualifications, experience, and terms of reference of the senior executive and other certification/registration personnel, affecting the quality of the certification/registration 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 taking decisions regarding registration;
(v) A description of the organization of the registration body, 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 services pertaining to quality, so that the extent and limits of each person
(ix) The policy and procedures for the recruitment and training of registration body personnel (including auditors) and monitoring their performance;
(x) A list of its subcontractors and details of the procedure 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 registration process, including:
(A) The conditions for issue, retention, and withdrawal of registration documents;
(B) Checks of the use and application of documents used in the registration of quality systems;
(C) The procedures for assessing and registering fastener manufacturers
(D) The procedures for surveillance and reassessment of registered Facilities.
(xiii) The policy and procedures for dealing with appeals, complaints, and disputes; and
(xiv) The procedures for conducting internal audits based on the provisions described in appropriate international documentation.
(e) Conditions for granting, maintaining, extending, reducing, suspending, and withdrawing registration. (1) The Registrar shall specify the conditions for granting, maintaining, reducing, and extending registration and the conditions under which registration may be suspended or withdrawn, partially or in total, for all or part of the Facility
=s scope of registration. In particular, the Registrar shall require the fastener manufacturer to notify it promptly of any intended changes to the quality assurance system or other changes which may affect conformity.(2) The Registrar shall require the fastener manufacturer to have a documented quality system which conforms to applicable quality system standards or other normative documents.
(3) The Registrar shall have procedures to grant, maintain, withdraw and, if applicable, suspend registration; to extend or reduce the scope of registration; and to conduct reassessment in the event of changes significantly affecting the activity and operation of the Facility (such as change of ownership, changes in personnel or equipment), or if analysis of a complaint or any other information indicates that the registered fastener Facility no longer complies with the requirements of the Registrar.
(4) The Registrar shall have documented procedures which shall be made available on request for:
(i) Initial assessment and for the surveillance and reassessment of a fastener manufacturer
(ii) Continuing conformity with relevant requirements; and for verifying and recording that a fastener manufacturer takes corrective action on a timely basis to correct all nonconformities; and
(iii) Identifying and recording nonconformities and the need for corrective action by fastener manufacturers on a timely basis for such items as incorrect references to the registration or misleading use of registration information.
(f) Internal audits and management reviews. (1) The Registrar shall conduct periodic internal audits covering all procedures in a planned and systematic manner, to verify that the quality assurance system is implemented and is effective. The Registrar 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 recorded.
(2) The top management of the Registrar 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 Registrar 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 Registrar operates;
(ii) A documented statement of its registration system including its rules and procedures for granting, maintaining, extending, reducing, suspending, and withdrawing registration;
(iii) Information about the assessment and registration process;
(iv) A description of the means by which the Registrar obtains financial support, and general information on the fees charged to applicants and fastener manufacturers whose Facilities have been registered;
(v) A description of the rights and duties of applicants and fastener manufacturers whose Facilities have been registered, including requirements, restrictions, or limitations on the use of the Registrar
(vi) Information on procedures for handling complaints, appeals and disputes; and
(vii) A directory of registered Facilities, including their locations, describing the scope of registration granted to each.
(2) The Registrar shall establish and maintain procedures to control all documents and data that relate to its registration 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 Registrar or of the fastener manufacturer whose Facility is registered, when required to perform any function relating to the activities of an applicant or registered Facility.
(h) Records. (1) The Registrar shall maintain a record system to suit its particular circumstances and to comply with this part. The records shall demonstrate that the registration 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 registration. 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 Registrar shall have a policy and procedures for retaining records for a period of five years. The Registrar shall have a policy and procedures concerning access to these records consistent with paragraph (h)(1) of this section.
(i) Confidentiality. (1) The Registrar shall have adequate arrangements, consistent with applicable laws to safeguard confidentiality of the information obtained in the course of its registration 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 product, quality assurance system, Facility, or fastener manufacturer shall not be disclosed to a third party without the written consent of the fastener manufacturer.
Sec. 280.1111 Registrar personnel.
(a) General provisions.
(1) The personnel of the Registrar involved in registration 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 registration process shall be maintained by the Registrar. 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 Registrar.
(2) Auditors shall meet the requirements of the appropriate international documentation. For the assessment of a quality system, the relevant guidelines for auditing and the criteria for auditors are those defined in 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 the appropriate international documentation.
(c) Selection procedure. (1) The Registrar 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 assessment and subsequently monitoring the performance of auditors and technical experts.
(2) When selecting the audit team to be appointed for a specific assessment, the Registrar shall ensure that the skills brought to each assignment are appropriate. The team shall:
(i) Be familiar with the Act and this part, registration procedures and registration 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 registration 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 Facility to provide products, processes or services in its registered 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 fastener manufacturer whose Facility is registered which compromise the registration process and decision; and
(B) In accordance with the directives of the Registrar, the audit team members shall inform the Registrar, prior to the assessment, about any existing, former or envisaged link between themselves or their organization and the fastener manufacturer whose Facility is to be assessed.
(d) Contracting of assessment personnel. The Registrar 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 Registrar, including those relating to confidentiality and those relating to independence from commercial and other interests, and any prior and/or present link with the fastener manufacturers whose Facilities are to be assessed. The Registrar shall ensure that, and document how, any subcontracted assessment personnel satisfy all the requirements for assessment personnel outlined in this Subpart.
(e) Assessment personnel records. (1) The Registrar shall possess and maintain up-to-date records on assessment personnel, 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 Registrar;
(v) Date of most recent updating of records; and
(vi) Performance appraisal.
(2) The Registrar 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 Registrar.
(f) Procedures for audit teams. Audit teams shall be provided with up-to-date assessment instructions and all relevant information on registration arrangements and procedures.
Sec. 280.1112 Changes in the registration requirements.
The Registrar shall give due notice of any changes it intends to make in its requirements for registration. It shall take account of views expressed by the 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 fastener manufacturer whose Facility is registered carries out any necessary adjustments to its procedures within such time as, in the opinion of the Registrar, is reasonable.
Sec. 280.1113 Appeals, complaints and disputes.
Appeals, complaints and disputes brought before the Registrar by fastener manufacturers or other parties shall be subject to the procedures of the Registrar. The Registrar shall keep a record of all appeals, complaints and disputes, and remedial actions relative to registration; take appropriate corrective and preventive action; and document the actions taken and assess their effectiveness.
Requirements for Registration
Sec. 280.1120 Application for registration.
(a) (1) As specified in subsection 280.1110(g)(1) of this part, the Registrar shall maintain up-to-date a detailed description of the assessment and registration procedure, the documents containing the requirements for registration and documents describing the rights and duties of fastener manufacturers whose Facilities are registered, and shall provide them to applicants and those fastener manufacturers. The Registrar shall require that a fastener manufacturer whose Facility is registered:
(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 its Facility is registered with respect to those activities for which it has been granted registration;
(iv) Does not use the registration in such a manner as to bring the Registrar into disrepute, and does not make any statement regarding its registration which the Registrar may consider misleading or unauthorized;
(v) Upon suspension or withdrawal of the registration (however determined), discontinues use of all advertising matter that contains any reference thereto and returns any registration documents as required by the Registrar;
(vi) Uses registration only to indicate that the quality assurance system as employed in its Facility is in conformity with specified standards or other normative documents, and does not use the registration to imply that a product or service is approved by the Registrar, as required by section 280.804;
(vii) Ensures that no registration document, mark or report, or any part thereof, is used in a misleading manner; and
(viii) In making reference to the registration in communication media such as documents, brochures, or advertising, complies with the requirements of the Registrar.
(2) When the desired scope of registration is related to a specific program, any necessary explanation shall be provided to the fastener manufacturer. If requested, additional application information shall be provided to the fastener manufacturer.
(b) The Registrar shall require an official application form, duly completed and signed by a duly authorized representative of the applicant fastener manufacturer in which or attached to which:
(1) The scope of the desired registration is defined; and
(2) The applicant agrees to comply with the requirements for registration and to supply any information needed for its evaluation.
(c) (1) At least the following information shall be provided by the applicant prior to the on-site assessment:
(i) The general features of the applicant, such as corporate entity, name, addresses, legal status and, where relevant, human and technical resources;
(ii) General information concerning the quality system and the activities it covers;
(iii) A description of the systems to be registered and the standards or other normative documents applicable to each; and
(iv) A copy of its quality manual and, where required, the associated documentation.
(2) The information gathered from the application documentation and the quality manual review may be used for the preparation of the on-site assessment and shall be treated with appropriate confidentiality.
Sec. 280.1121 Preparation for assessment.
(a) Before proceeding with the assessment the Registrar shall conduct, and maintain records of, a review of the request for registration to ensure that:
(1) The requirements for registration are clearly defined, documented, and understood;
(2) Any difference in understanding between the Registrar and the applicant is resolved; and
(3) The Registrar has the capability to perform the registration service with respect to the scope of the registration sought, the location of the applicant's operations, and any special requirements such as the language used by the applicant.
(b) The Registrar shall prepare a plan for its assessment activities to allow for the necessary arrangements to be made.
(c) The Registrar 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 Registrar
=s team as advisers.(d) The fastener manufacturer 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 to by the fastener manufacturer. The mandate given to the audit team shall be clearly defined and made known to the fastener manufacturer, and shall require the audit team to examine the structure, policies, and procedures of the Facility and the quality assurance system it employs, and confirm that these meet all the requirements relevant to the scope of registration, and that the procedures are implemented and are such as to give confidence in the products, processes, or services of the Facility being evaluated.
Sec. 280.1122 Assessment.
The audit team shall assesses the quality assurance system, employed in the Facility being evaluated, covered by the defined scope against all applicable registration requirements.
Sec. 280.1123 Assessment report.
(a) The Registrar 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 fastener manufacturer
(2) The audit team provides the Registrar with a report of its findings as to the conformity of the quality assurance system, as employed in the particular Facility, with all of the registration requirements;
(3) A report on the outcome of the assessment is promptly brought to the fastener manufacturer
=s attention by the Registrar, identifying any nonconformity to be discharged in order to comply with all of the registration requirements;(4) The Registrar shall invite the fastener manufacturer 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 registration requirements identified during the assessment of its quality assurance system, as employed in the particular Facility, and shall inform the fastener manufacturer of the need for full or partial reassessment of its quality assurance system 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 the Facility audited;
(iv) The assessed scope of registration or reference thereto, including reference to the standard(s) applied;
(v) Comments on the conformity of the quality assurance system, as employed in the particular Facility, with the registration requirements, with a clear statement of nonconformity and, where applicable, any useful comparison with the results of previous assessments of the quality assurance system, as employed in that particular Facility; and
(vi) An explanation of any differences from the information presented to the body at the closing meeting.
(b) If the final report authorized by the Registrar differs from the report referred to in paragraphs (a)(3) and (5) of this section, it shall be submitted to the fastener manufacturer 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 body to give confidence in the quality assurance system, as employed in the particular Facility; and
(3) The actions taken to correct identified nonconformities including, where applicable, those identified at previous assessments.
Sec. 280.1124 Decision on registration.
(a) The decision whether or not to register a fastener Facility shall be taken by the Registrar on the basis of the information gathered during the registration process and any other relevant information. Those who make the registration decision shall not have participated in the audit.
(b) The Registrar shall not delegate authority for granting, maintaining, extending, reducing, suspending, or withdrawing registration to an outside person or body.
(c) The Registrar shall provide to each fastener manufacturer whose Facility is registered, registration documents such as a letter or a certificate signed by an officer who has been assigned such responsibility. These documents shall identify, for the fastener manufacturer and the particular Facility covered by the registration:
(1) The name and addresses;
(2) The scope of registration granted, including as appropriate:
(i) The quality system standards and/or other normative documents to which quality systems are registered;
(ii) The product, process, or service categories; and, if appropriate,
(iii) Regulatory requirements, product standards, or other normative documents against which products are supplied.
(3) The effective date of registration and the term for which the registration is valid.
(d) Any application for amendment to the scope of a previously granted registration shall be processed by the Registrar. The Registrar shall decide what, if any, assessment procedure is appropriate to determine whether or not the amendment should be granted and shall act accordingly.
Sec. 280.1125 Surveillance and reassessment procedures.
(a) The Registrar shall carry out periodic surveillance and reassessment at sufficiently close intervals to verify that its registered Facilities continue to comply with the registration requirements. The period involved cannot be greater than one year.
(b) Surveillance and reassessment procedures shall be consistent with those concerning the assessment of the Facility as described in this part.
Sec. 280.1126 Use of certificates and logos.
(a) The Registrar shall exercise proper control over ownership, use and display of its quality system registration mark and logos.
(b) If the Registrar confers the right to use a symbol or logo to indicate registration of a Facility, the fastener manufacturer may use the specified symbol or logo only as authorized in writing by the Registrar. This symbol or logo shall not be used on a product or in a way that may be interpreted as denoting product conformity.
(c) The Registrar shall take suitable action to deal with incorrect references to the registration system or misleading use of certificates and logos found in advertisements, catalogs, etc. Such action could include corrective action, withdrawal of certificate, publication of the transgression and, if necessary, other legal action.
Sec. 280.1127 Access to records of complaints to fastener manufacturers.
The Registrar shall require each fastener manufacturer whose Facility is registered to make available to the Registrar, when requested, the records of all complaints and corrective action taken in accordance with the requirements of the quality system standards or other normative documents.