§ 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 the 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 § 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's responsibility are known to all concerned;

(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’ quality systems as employed in particular Facilities; and

(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's quality assurance system as employed in a particular Facility;

(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's logo and on the ways of referring to the registration granted;

(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.