§ 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 functions;

(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's responsibility are known to all concerned;

(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's logo and on the ways of referring to the accreditation granted, in conformance with § 280.804(d); and

(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.