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PRO-FR-105-ISO/IEC 17065: Checklist for Accreditation Requirements: ISO/IEC 17065 PRO-PL-102: Manual of Operations for Accreditation of Product Certification Bodies PRO-PR-145: Assessor Manual ISO/IEC 17011:2017, Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies
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1 | Objective | 1.1 | The objective of this notice is to establish the requirement for a document review to be conducted as part of the initial, surveillance, reassessment and follow-up assessments for all applicants and accredited certification bodies. This notice also provides guidance to ANSI assessors in reference to the minimum guidelines for developing and preparing the document review. | 2 | Definitions | | None. | 3 | Effective Date | | June 8, 2012. | 4 | Notice | 4.1 | Document Review | | The assessment team – lead assessor and technical assessor – shall conduct the document review related to the certification programs that the CB applicant or accredited for the Initial, Surveillance, Reassessment, and Follow-up (if needed) assessment activities. | 4.2 | Document Review Requirements | | The document review includes, but is not limited to, an evaluation of the following documents: | a) | Articles of Association (or equivalent); Letters of Incorporation | b) | PRO-FR-105:17065 Checklist | c) | Quality manual; | d) | Technical procedures, checklists, and/or forms for the product certification scheme; and | e) | Certification Scheme. | 4.3 | Document Review Report | | The document review shall be provided as a written report that includes, but is not limited to, the following elements: | a) | Name of Certification Body; | b) | Address of Certification Body; | c) | Date of Document Review; | d) | List of locations and associated activities;
| e) | Document organization structure and delegation of authority; | f) | Scope of accreditation to be assessed; | g) | Document potential findings/nonconformities to ISO/IEC 17065, ANSI Policy and Criteria, the Certification Body's Program requirements, and any related scheme requirements; | h) | Identification of any additional critical elements associated with the Certification Program; and | i) | Information gaps, as appropriate. |
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