Requirements for Completing the Document Review

PUBLIC NOTICE PRO-NT-113 Issued: 2016-4-20, Revision: 2

References 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
1.1The 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.
3Effective Date
June 8, 2012.
4.1Document 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.
4.2Document 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.
4.3Document 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.