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Policy and Criteria for Accreditation of Product Certification Programs

PUBLIC POLICY PRO-PL-101 Issued: 2010-1-15, Revision: 0

References ANSI-PL-100: ANSI AS Management System Policy Manual
PRO-PL-102: Manual of Operations for Accreditation of Product Certification Programs
PRO-PL-103: Operating Procedures of the Accreditation Committee
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
ISO/IEC 17000:2004, Conformity assessment - Vocabulary and general principles
ISO/IEC 17011:2004, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC 17065:2012, Conformity assessment - Requirements for bodies certifying products, processes and services
1.1This document serves as the overarching policy for accreditation of product certification programs under ISO/IEC 17065.
For the purpose of this document, the terms and definitions are provided in ISO/IEC 17000.
The policies, criteria and other requirements in this document govern ANSI accreditation of product certification bodies and their operation of certification programs (“certification program” is the term used in North America for certification systems or schemes). ANSI has established this accreditation program to support the market need for product certification and to provide an experienced source for accreditation in the United States. ANSI has established these policies and criteria to govern the accreditation of certification bodies of products, processes, and services. The criteria are compatible with the existing international standards and practices. To facilitate harmonization of certification activities among different countries, these criteria embody the requirements of ISO/IEC 17065:2012.
Programs are accredited by ANSI upon approval by the ANSI Accreditation Committee. The Committee, under ANSI Bylaws, is responsible for the accreditation policies and the operational aspects of national and international accreditation programs for certification of products, processes, services and related activities of the Institute. Its operational responsibilities include overseeing the processing by ANSI staff of applications for accreditation, rendering decisions on accreditation, and overseeing the monitoring by ANSI staff of Accreditation Programs as governed by this document and the Manual of Operations for Accreditation of Product Certification Programs (PRO-PL-102). The Committee functions under the ANSI Operating Procedures of the Accreditation Committee (PRO-PL-103).
The structure of this document mirrors ISO/IEC 17011 as an aid to demonstrate this ANSI accreditation program’s fulfillment of it.
4Accreditation Body
4.1Legal responsibility
ANSI is a Type B, not-for-profit corporation organized and existing under the New York Notfor-Profit Corporation Law (“NPCL”). The provisions of the NPCL are binding on ANSI, and ANSI shall at all times act in conformity with its Constitution, Bylaws, and Articles of Incorporation. The American National Standards Institute, incorporated in the state of New York, is a private, not-for-profit membership organization serving the standards and conformity assessment needs of its diverse constituencies.
4.2.1The legal structure of ANSI, as described in 4.1 above and documents PRO-PL- 101, PRO-PL-102, PRO-PL-103, and ANSI-PL-100, are intended to give confidence in ANSI accreditation.
4.2.2Decisions on accreditation are made by the ANSI Accreditation Committee (see PRO-PL-103).
4.2.3See 4.1 for a description of ANSI’s legal status.
4.2.4ANSI’s Vice President for Accreditation Services is responsible for the Accreditation Program (see ANSI-PL-100).
4.2.5ANSI top management has the overall authority and responsibility for supervision of implementation of policies, finance, contractual arrangements, and delegation of authority to committees or individuals, as described in ANSI-PL-100. The ANSI Accreditation Committee is responsible for development and approval of policies and decisions on accreditation, and, as may be required, to undertake defined activities (see PRO-PL-103).
4.2.6ANSI, as an accreditation body for product certification programs, obtains the necessary expertise on matters related to accreditation through the ANSI Accreditation Committee. For long-term strategies in accreditation and conformity assessment, ANSI obtains advice from its Conformity Assessment Policy Committee.
4.2.7PRO-PL-103 defines formal rules for appointment, terms of reference, and operation of the ANSI Accreditation Committee and identifies the parties.
4.2.8The entire structure in which the lines of authority and responsibility are displayed shall be found in ANSI-PL-100.
4.3.1ANSI is organized as described in 4.2.1 to safeguard its objectivity and impartiality. ANSI operates the Accreditation Program in accordance with PRO-PL-102 to safeguard its objectivity and impartiality.
4.3.2The ANSI Accreditation Committee is the mechanism for effective participation by interested parties in the ANSI Accreditation Program (see PRO-PL-103).
4.3.3Accreditation Program services are accessible to all applicants whose certification program meets the following criteria:
a)be operated by a certification body that can demonstrate independent third-party status as a certifier of products, processes or services;
b)be operational with participants (licensees) under contract; may be waived in situations where attaining participants (licensees) is dependent on achieving ANSI accreditation;
c)meet the requirements of the current ISO/IEC 17065; and
d)have a system in place for determining the continuing compliance by licensees with program standards and policies.
Access is neither conditional on the size of the applicant body nor membership in any association or group, nor is accreditation conditional upon the number of bodies already accredited.
4.3.4ANSI has policies and procedures (ANSI-PL-100, ANSI-TP-001 and ANSI-PR-030) to ensure the objectivity of all personnel and committees.
4.3.5The ANSI Accreditation Committee makes the decision on accreditation. Its members are competent to make that decision. ANSI contract assessors are not eligible for membership on the ANSI Accreditation Committee (see PRO-PL-103).
4.3.6The Accreditation Program will not offer or provide any service that affects its impartiality such as:
a)performing conformity assessments that certification bodies perform; or
b)acting as a consultant to certification bodies.
ANSI activities shall not be presented as linked with consultancy. Nothing shall be said or implied that would suggest that accreditation would be simpler, easier, faster or less expensive, if any specified person(s) or consultant(s) were used.
4.3.7The ANSI program director of Accreditation Services maintains a list of related bodies that includes evidence that those bodies do not compromise the confidentiality, objectivity, and impartiality of its accreditations. The ANSI Vice President for Accreditation Services with the participation of the ANSI Accreditation Committee will review the ANSI relationship with related bodies to ensure that there is no potential for conflict of interest. with the ANSI Accreditation Committee, ANSI accreditation services staff is responsible for identifying, analyzing, and documenting the relationships with related bodies to determine the potential for conflict of interest, whether they arise from within ANSI or from the activities of the related bodies. Where conflicts are identified, appropriate actions shall be taken.
4.3.8ANSI shall remain responsible for the content of the assessment report, including nonconformities, even if the lead assessor is not a permanent staff member of the Accreditation Body.
The ANSI Accreditation Program safeguards confidentiality of all information obtained in the course of accreditation activities at all levels of the organization, including those of committees and external bodies or individuals acting on its behalf (see ANSI-TP-001 and ANSI-PR-030).
4.5Liability and financing
ANSI has adequate financial and liability resources. The ANSI Vice President for Finance, Administration, and Human Resources is responsible for ANSI’s financial resources, as referenced in ANSI-PL-100. The ANSI Vice President and General Counsel has responsibility for liability insurance.
4.6Accreditation Activity
4.6.1ANSI describes its accreditation program in PRO-PL-101, PRO-PL-102, and PRO-PL-103. These documents have references to relevant international standards/guides and other normative documents.
4.6.2The ANSI Accreditation Committee develops/adopts guidance documents for e.g., ISO/IEC 17011 and ISO/IEC 17065 (see PRO-PL-103).
4.6.3The ANSI Accreditation Committee receives recommendations from the Evaluation Task Group, and makes decisions regarding the extension of the Accreditation Program (see PRO-PL-103), i.e., new accreditation programs and/or scope expansions.
5.1.1The Accreditation Program has established, implemented, and maintained a management system, and continually improves its effectiveness in accordance with the requirements of this document and ISO/IEC 17011 (see ANSI-PL-100).
5.1.2ANSI documents are maintained in accordance with ANSI-PR-001.
5.2Management System
5.2.1The Accreditation Program management system, which defines management's quality policy, quality objectives, and its commitment to quality, is documented in the ANSI Accreditation Program Management System - Policy Manual (ANSI-PL-100). Internal audits based on ANSI management system documents are used to ensure that the quality system is effectively implemented and maintained at all levels within the Accreditation Program.
5.2.2ANSI operates a management system, as documented in ANSI-PL-100.
5.2.3The ANSI Vice President for Accreditation Services is responsible for development, implementation, and maintenance of the management system (see ANSI-PL-100).
5.3Document control
5.3.1The ANSI staff controls all documents and data that relate to its accreditation functions. The review and approval of such documents are provided for in the ANSI Accreditation Program Management System - Policy Manual (ANSI-PL-100). A listing of appropriate documents with an identification of the respective issue and/or amendment status is maintained. The appropriate documentation will be made available to personnel of the Accreditation Program or to applicants and accredited bodies, when needed.
5.4.1The Accreditation Program maintains a record system, as described in ANSI-PL-100.
5.4.2ANSI has established procedures for retaining records in accordance with ANSI-PL-100.
5.5Non-Conformities and corrective actions
5.5.1ANSI has established procedures for identification and management of non-conformities of its own operations, as described in ANSI-PL-100.
5.6Preventive actions
5.6.1The Accreditation Program has established procedures to identify opportunities for improvement and to take preventive actions to eliminate the causes of potential nonconformities, as described in ANSI-PL-100.
5.7Internal audit
5.7.1Internal audits of the Accreditation Program shall be carried out periodically in accordance with ANSI-PL-100.
5.8Management review
5.8.1The ANSI Vice President for Accreditation Services shall conduct management review committee meetings in accordance with ANSI-PL-100.
ANSI has established procedures for handling complaints in accordance with ANSI-PL-100.
6Human resources
6.1Personnel associated with the accreditation body
6.1.1ANSI personnel (internal, external, temporary or permanent, full time or part time) involved in accreditation shall meet the requirements for competency for the functions that they perform in accordance with ANSI-PL-100.
6.1.2The ANSI program director is responsible for ensuring a sufficient number of assessors (including lead assessors) and experts for the Accreditation Program.
6.1.3ANSI has made clear to each person concerned the extent and the limits of his/her duties, responsibilities, and authorities through job descriptions for staff, PRO-PL-103 for ANSI Accreditation Committee members, and PRO-PR-145 for contract assessors.
6.1.4Contract assessors commit themselves to comply with the rules defined by ANSI in the assessor letter agreement. ANSI staff commits to comply with rules defined by ANSI in the employment letter. ACC members commit to comply with rules defined by ANSI in the signed Statement of Confidentiality and Conflict of Interest.
6.2Personnel involved in the accreditation process
6.2.1ANSI maintains up-to-date information on the relevant requirements, qualifications, initial and ongoing training, experience, and competence of the personnel involved in the accreditation process in accordance with ANSI-PL-100.
6.2.2ANSI maintains qualification criteria for assessors and experts in accordance with ANSI-PL-100.
6.2.3Selection Procedure
The specific scopes in which each assessor or expert has demonstrated competence is documented in accordance with ANSI-PL-100.
6.2.4Assessors and experts fulfill qualification requirements in accordance with ANSI-PL-100.
6.3.1The ANSI Accreditation Program ensures the satisfactory performance of the:
a)accreditation decision-making process in accordance with PRO-PL-103; and
b)assessment by establishing procedures to monitor the performance and competence of the assessors.
In particular, ANSI shall review the performance and competence of its personnel in order to identify training needs.
6.3.2ANSI shall monitor/evaluate each assessor’s performance and recommend appropriate follow-up actions to improve performance in accordance with ANSI-PL-100.
6.4Personnel records
6.4.1The ANSI accreditation program director maintains records of relevant qualifications, training, experience, and competence of each person involved in the accreditation process. Records of training, experience, and monitoring shall be kept up to date.
6.4.2ANSI possesses and maintains up-to-date records on assessment personnel in accordance with ANSI-PL-100.
6.4.3ANSI shall ensure and verify that any subcontracted body maintains records which satisfy the requirements of this document, including records on assessment personnel subcontracted to ANSI.
7Accreditation process
The ANSI accreditation process is described in PRO-PL-102.
8Responsibilities of the accreditation body and the certification body
8.1Obligations of the certification body
The obligations of the accredited certification body are documented in the American National Standards Institute Agreement of Accreditation and Monitoring of Product Certification Programs.
8.2Obligations of the accreditation body
8.2.1The ANSI Accreditation Program provides a directory of accredited certification bodies on the ANSI internet site. This information shall be updated regularly.
8.2.2Due notice of any changes to accreditation requirements shall be made to accredited certification bodies through procedures outlined in ANSI-PL-100.
8.3Reference to accreditation and use of symbols
8.3.1The procedure for use of accreditation symbols shall be found in PRO-PR-127.

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