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ANSI Accreditation Services Management System Policy Manual

PUBLIC POLICY ANSI-PL-100 Issued: 2018-5-22, Revision: 6

Attachments  BoD412-ANSIcaRole (5 Feb .pdf
 ANSI AS Impartiality Risk.docx
References ANSI-PR-030: Confidentiality and Conflict of Interest
ANSI-TP-001: Statement of Conflict of Interest, Confidentiality and Compliance with ANSI Accreditation Policies and Procedures
ANSI-TP-001 Electronic Version: Statement of Conflict of Interest, Confidentiality and Compliance with ANSI Accreditation Policies and Procedures
21 CRR Parts 1, 11 and 16 - Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications Final Rule
ANSI Constitution and By-Laws
ANSI/ASTM E2659-09, Standard Practice for Certificate Programs
ANSI/MSE 50028-2012, Superior Energy Performance - Requirements for verification bodies for use in accreditation or other forms of recognition
BoD 412/ExCo 329: ANSI's Role in Conformity Assessment
Conference for Food Protection - Standards for Accreditation of Food Protection Manager Certification Programs
IAF ID12:2015 Principles on Remote Assessment
IAF MD 20:2016, Generic Competence for AB Assessors: Application to ISO/IEC 17011
IAF MD12:2016, Accreditation Assessment of Conformity Assessment Bodies with Activities in Multiple Countries
IAF MD14:2014, Application of ISO/IEC 17011 in Greenhouse Gas Validation and Verification (ISO 14065:2013)
IAF MD6:2014, Application of ISO 14065:2013
IAF MD7:2010, Harmonisation of Sanctions to be applied to Conformity Assessment Bodies
IAF ML 2: 2016 General Principles on the Use of the IAF MLA Mark
IAF ML1:2016, Guidance for the Exchange of Documentation among MLA Signatories for the Assessment of Conformity Assessment Bodies
IAF ML3:2012, Guidance for responding to Inquiries on Multilateral Recognition Arrangement (MLA) Signatory Equivalence and on the acceptance of certification documents
IAF PL1:2009, Code of Conduct for Members of the IAF
IAF PL6:2016, IAF Memorandum of Understanding
IAF/ILAC-A5:22/2013, IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Application of ISO/IEC 17011:2004
ISO 14065:2013, Greenhouse gases - requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition
ISO 9000:2015, Quality management systems - Fundamentals and vocabulary
ISO/IEC 17000:2004, Conformity assessment - Vocabulary and general principles
ISO/IEC 17011: 2017 Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC 17024:2012, Conformity assessment - General requirements for bodies operating certification of persons
ISO/IEC 17065:2012, Conformity assessment - Requirements for bodies certifying products, processes and services
PAC-MLA-001, PAC Multilateral Recognition Agreement (MLA)
PAC-MLA-002, PAC Policies and Procedures for a MLA Among Accreditation Bodies
Contents
1Objective
1.1The objective of this Policy Manual is to describe the Management System and functions of the ANSI Accreditation Services Department and its accreditation programs based on ISO/IEC 17011. This document covers all aspects of the ANSI Accreditation Services Management System to ensure that the System meets the requirements of ISO/IEC 17011, thus allowing the ANSI Accreditation Services to achieve international recognition for accreditation of conformity assessment bodies (CABs).
2Definitions
2.1As a general rule, definitions of ISO/IEC 17000 and ISO 9000 are applicable.
2.2ACCREDITATION: Third-party attestation related to a CAB conveying formal demonstration of its competence to carry out specific certification tasks.
2.3ACCREDITATION BODY LOGO: Logo used by an accreditation body to identify itself.
2.4ACCREDITATION CERTIFICATE: Formal document or a set of documents stating that accreditation has been granted for the defined scope.
2.5ACCREDITATION SYMBOL: Symbol issued by an accreditation body to be used by accredited CABs to indicate their accredited status
2.6APPEAL: Request by a CAB for reconsideration of any decision made by the accreditation body related to its accreditation status.
2.7ASSESSMENT: Process undertaken by an accreditation body to assess the competence of a CAB, based on particular standard(s) and/or other normative documents and for a defined scope of accreditation.
2.8ASSESSOR: Person assigned by an accreditation body to perform, along or as part of an assessment team, an assessment of a CAB.
2.9CERTIFICATION: Procedure by which a third party gives a statement of conformity to specific requirements for a product, process or service.
2.10CERTIFICATION SYSTEM: Set of procedures and resources for carrying out the certification process as per certification scheme and leading to the issuance of a certificate of competence including maintenance.
2.11COMPLAINT: Expression of dissatisfaction, other than appeal, by any person or organization, to a CAB or an accreditation body, relating to the activities of that accreditation body or an accredited CAB, where a response is expected.
2.12CONFORMITY ASSESSMENT: Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled.
2.13CONFORMITY ASSESSMENT BODY (CAB): Body which performs conformity assessment services. In the context of this manual this can be a product or personnel certification body, verification/validation body or a certificate program.
2.14EDUCATION/TRAINING CERTIFICATE PROGRAM: A non-degree-granting education or training program consisting of a learning event or series of events designed to educate or train individuals to achieve specified learning outcomes within a defined scope and a system designed to ensure individuals receive a certificate only after verification of successful completion of all program requisites and an evaluation of learner attainment of intended learning outcomes.
2.15LEAD ASSESSOR: An ANSI qualified assessor who has been further listed by ANSI as fulfilling ANSI Lead Assessor requirements for an accreditation program.
2.16MANAGEMENT SYSTEM: System to establish policy and objectives and to achieve those objectives. (Note: A management system of an organization may include different management systems, such as a quality management system, a financial management system, or an environmental management system.)
2.17QUALITY MANAGEMENT SYSTEM: Management System to direct and control an organization with regard to quality.
2.18SYSTEM: Set of interrelated or interacting elements.
2.19TECHNICAL ASSESSOR: An assessor who is generally accepted by ANSI as being competent in a specific subject area(s).
2.20VERIFICATION / VALIDATION BODY (V/VB): Body that performs validations or verifications of GHG assertions in accordance with ISO 14065. NOTE: A validation or verification body may be an individual.
2.21PSYCHOMETRICIAN: Assessor with doctoral degree in educational measurement or other measurement related fields.
3American National Standards Institute (ANSI)
3.1INTRODUCTION
3.1.1ANSI’s Mission is to “enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems and safeguarding their integrity.”
3.1.2ANSI is a federation serving the standards and accreditation needs of its diverse constituencies. ANSI promotes the use of U.S. standards internationally, advocates U.S. policy and technical positions in international and regional standards organizations and encourages the adoption of international standards as national standards where these meet the needs of the user community. ANSI is the sole U.S. representative and dues-paying member of the two major non-treaty international standards organizations, the International Organization for Standardization (ISO), and, via the U.S. National Committee (USNC), the International Electrotechnical Commission (IEC).
3.2LEGAL BASIS
3.2.1The purposes and general description of ANSI is given in the ANSI Constitution and By-Laws.
3.2.2The American National Standards Institute (ANSI) is a 501(c)(3) not-for-profit corporation organized in accordance with New York Not-for-Profit Corporation Law (“NPCL”) and its own Constitution and By-laws. Since ANSI is a not-for-profit federation with members, the owners of the legal entity are the members.
3.3GOVERNANCE
3.3.1ANSI has a Board of Directors that is elected from its members. Among other duties the Board is responsible for appointing its respective officers. The duties and obligations of the Board members are outlined in the ANSI Constitution and By-Laws.
3.3.2The Board of Directors appoints the President and Chief Executive officer (CEO) who in turn is responsible for hiring and managing Vice Presidents (Senior Staff) and the rest of ANSI staff.
3.4CONFORMITY ASSESSMENT POLICY COMMITTEE (CAPC)
3.4.1CAPC is responsible for broad-based policy and position decisions on national, regional and international conformity assessment issues except as otherwise delegated by the Board of Directors of ANSI. “ANSI’s Role in Conformity Assessment” is further defined in Board of Directors Policy Document BoD 412/ExCo 329.
3.5INTERNATIONAL CONFORMITY ASSESSMENT COMMITTEE (ICAC)
3.5.1ICAC is responsible for the U.S. participation in the International Organization for Standardization (ISO) Council Committee on Conformity Assessment (CASCO).
3.5.2The purposes of ISO/CASCO are to:
a)study means of assessing the conformity of products, processes, services and quality systems to appropriate standards or other technical specifications;
b)prepare international guides and international standards relating to the practice of testing, inspection and certification of products, processes and services and to the assessment of management systems, testing laboratories, inspection bodies, certification bodies, accreditation bodies and their operation and acceptance;
c)promote mutual recognition and acceptance of national and regional conformity assessment systems, and the appropriate use of international standards for testing, inspection, certification, assessment and related purposes.
3.6ANSI FINANCE COMMITTEE
3.6.1The Finance Committee is composed of members of the ANSI Board of Directors appointed by the Chairman of this Board with the approval of the ANSI Board of Directors. The Finance Committee maintains a continuing review of the financial affairs of the Institute and makes appropriate recommendations to the ANSI Board of Directors and shall report at each meeting of this Board. The responsibilities of the Finance Committee include, but are not limited to, the following:
a)reviewing and providing a recommendation to the Board for the annual budget and the business plan proposed by the President;
b)authorizing investment policy;
c)authorizing acceptable accounting and disbursement procedures for all funds under jurisdiction by the Institute;
d)requiring an annual audit by a certified public accountant;
e)arranging at Institute’s expense for the bonding of appropriate personnel of the Institute.
3.7ANSI FINANCE DEPARTMENT
3.7.1The responsibilities of the Finance Department, under the auspices of the Chief Financial Officer, Vice President, Finance, Administration and Human Resources include, but are not limited to the following:
a)assuming overall responsibility for the financial management of the Institute
b)assistance to managers / directors in attainment of budgets;
c)ensuring the annual audit of the Institute in accordance with the Board decisions;
d)ensuring the timely and adequate reporting of financial matters to the ANSI Board;
e)ensuring that proper bookkeeping procedures are followed;
f)monitoring financial results and comparison to budgets and forecasts;
g)monitoring and reporting financial results related to the Accreditation Services.
3.8INFORMATION TECHNOLOGY (IT) DEPARTMENT
3.8.1The IT Department supports and provides the organization with technical expertise in the planning, selection and implementation of its computer, telecommunications, and office systems.
4ANSI Accreditation Services Department
4.1INTRODUCTION
4.1.1ANSI accreditation activities are referenced in Section 1.02 (7) (Purpose) and Section 6.09, 6.12 and 6.14 (Institute Program Oversight Committees) of the ANSI By-Laws. The By-Laws state as one of the purposes of the Institute “to establish, promulgate, and administer procedures and criteria for accreditation of conformity assessment programs and to encourage organizations to prepare and submit such programs for accreditation by the Institute.”
4.1.2ANSI Accreditation Services Department supervises the execution of policies, strategies and programs related to accreditation services activities. It is also responsible for promoting an effective public / private sector partnership involving voluntary accreditation, coordinating ANSI’s activities with federal and state government agencies and private sector organizations, and achieving ANSI’s accreditation services goals. The functions of the Department are to:
a)accredit CABs;
b)communicate with / educate stakeholders regarding the benefits and value of accreditation;
c)provide input to ISO/CASCO regarding new or revised Conformity Assessment Documents and to the International Accreditation Forum (IAF) and regional accreditation cooperation (IAAC and PAC) regarding accreditation documents;
d)participate in international conferences / meetings to learn new information, exchange information and continually move toward harmonization with other accrediting bodies.
4.2STRUCTURE AND AUTHORITY
4.2.1ANSI Accreditation Services Department is structured in accordance with the ANSI By-Laws and is headed by Vice President, Accreditation Services who is identified as "top management" in the context of ISO/IEC 17011 requirements for structural authority. The Vice President reports to the ANSI President and CEO.
4.2.2This organizational structure is intended to safeguard the objectivity and impartiality of activities, to enable the participation of all concerned parties and to give confidence in ANSI accreditations. The responsibilities for each staff member are described in their job descriptions.
4.2.3The Vice President is responsible for supervision of the Department’s staff, finances, contractual arrangements and the implementation of the established policies and procedures. The Director of Accreditation Services is responsible for operations management and continuous improvement of processes, policies and procedures and for ensuring that the management system is implemented in accordance with these policies and procedures. The Program Directors are responsible for managing and growing individual accreditation programs and for ensuring that the documented and implemented system is in compliance with national and international requirements. It is also the responsibility of each ANSI Accreditation Services staff member to ensure that the policies and procedures contained within the documented management system are adhered to at all times.
4.2.4An organizational chart of the ANSI Accreditation Services roles and relationships can be found in Annex A of this document.
4.3ACCREDITATION PROGRAMS
4.3.1ANSI’s Accreditation Programs are voluntary and open to any organization regardless of size of the applicant organization, its membership or the number of organizations already accredited by ANSI. They are established to provide the marketplace (including consumers, government and industry) with confidence in the competence of third party product / personnel certification programs, validation / verification bodies and certificate programs.
4.3.2ANSI’s Accreditation Programs are designed to:
a)be independent and objective;
b)provide systematic, standardized and consistent accreditation services for CABs;
c)meet user/consumer needs for accreditation with emphasis on public protection;
d)harmonize domestic and international accreditation activities;
e)be a tool that facilitates continual improvement
4.3.3Figure 1 below lists the currently offered Accreditation Programs along with the specific accreditation committees supporting them.
AcronymAccreditation ProgramAccreditation Committee
PROAccreditation Program for Product Certification Bodies in accordance with ISO/IEC 17065 and sector program requirementsANSI Accreditation Committee (ACC)
PCACAccreditation Program for Personnel Certification Bodies in accordance with ISO/IEC 17024Personnel Certification Accreditation Committee (PCAC)
CFPAccreditation Program for Personnel Certification Bodies in accordance with ANSI-CFP standard implemented in partnership with the Conference for Food Protection (CFP)ANSI-CFP Personnel Certification Accreditation Committee (ACAC)
GHGAccreditation Program for Validation / Verification Bodies for Greenhouse Gases in accordance with ISO 14065 and IAF MD 6Greenhouse Gas Validation / Verification Accreditation Committee (GVAC)
CAPAccreditation Program for Certificate Programs in accordance with ASTM E2659-2015, an American National StandardCertificate Accreditation Program Accreditation Committee (CAPAC)
4.3.4Accreditation committees consist of volunteers representing various parties affected by accreditation. Each accreditation committee is governed by a program-specific operating procedures document. Committee members as well as committee operating procedures are approved by CAPC.
4.3.5Accreditation committees assist the ANSI Staff in the development of policies and strategies, participate in review of complains and appeals per appropriate procedures and provide the independent objective decisions on CABs’ accreditation status including decisions on granting, maintaining, extending, reducing, suspending, placing on probation and withdrawing of accreditation. Accreditation committees also represent one of the important sources of expertise for ANSI on matters related to accreditation activity.
4.3.6The ANSI Vice President of Accreditation Services is responsible for ensuring that all committees have the necessary expertise and impartiality.
4.4FINANCIAL RESOURCES
4.4.1ANSI Accreditation Services are supported by the fees charged for services provided in the process of accreditation of CABs, as well as sponsorships and attendance fees generated by conferences and workshops.
4.4.2Fees are recommended and are subject to reevaluation by the appropriate program accreditation committee in collaboration with the Director of Accreditation Services, Program Directors and approved by the Vice President, Accreditation Services.
4.4.3Appropriate ANSI staff is responsible for ensuring that all applicants and accredited organizations are charged according to the documented fee structure and invoices are paid on a timely basis.
4.4.4Failure by CABs to pay fees will result in an accreditation action and may be the basis for accreditation being withdrawn.
4.4.5Costs associated with participation in recognition agreements are paid by ANSI.
4.4.6The financial stability of ANSI to maintain the accreditation programs can be demonstrated by the results of the Annual Audited Financial Report and the activities defined in the current ANSI Budget
4.5LIABILITY
4.5.1ANSI does not accept liability for mistakes made by CABs or any mistakes that may possibly occur on the certificate or report issued by ANSI accredited bodies. ANSI agreements contain a disclaimer that indemnifies the liability of ANSI. All applicants are required to sign such an agreement as a requirement for accreditation.
4.5.2ANSI maintains valid liability insurance policy for the purpose of conducting accreditation. The original insurance policy is administered by the ANSI General Counsel and a copy is kept by the Accreditation Services Department.
4.5.3No member of the ANSI Board, any accreditation committee or any employee of ANSI, acting in good faith shall be personally liable for any results of ANSI decisions or actions.
4.6CONFIDENTIALITY AND CONFLICT OF INTEREST
4.6.1ANSI Accreditation Services maintains high level of confidentiality in its operations. Client files, including contracting information, are maintained in a secure file room within the work area, with access controlled by staff, and are locked when the work area is unoccupied.
4.6.2ANSI Accreditation Services utilizes ANSICA, an online portal which is a recordkeeping and process tracking tool. Access to this source of information is restricted to the appropriate personnel through the use of password protection and other online security features
4.6.3All ANSI Accreditation Services personnel, including subcontracted employees, assessors and accreditation committee members sign statement of confidentiality and conflict of interest statements. ANSI maintains reported conflicts of interest by these parties in the Affiliations Log in ANSICA. This log is updated regularly.
4.6.4ANSI shall not disclose confidential information about a particular CAB to the outside parties without written consent of the CAB, except where the law requires such information to be disclosed without such consent.
4.7IMPARTIALITY
4.7.1ANSI is organized and shall operate so as to safeguard the objectivity and impartiality of its activities.
4.7.2Accreditation committees serve as the effective vehicle for interested stakeholders to get involved with ANSI’s Accreditation Programs and influence the determination and maintenance of the of the related principles and major policies. Operating procedures of these committees ensure a balanced representation of interested parties with no single party predominating.
4.7.3ANSI policies and procedures shall be non-discriminatory and shall be administrated in a non-discriminatory way. ANSI shall make its services available to all applicants who meet the eligibility criteria as defined in the publically available procedures and subject to the limitations defined in this document. Access shall not be conditional upon the size of the applicant CAB or membership of any association or group, nor shall accreditation be conditional upon the number of CABs already accredited. Services may be restricted without discrimination where there is unacceptable risk to the reputation of ANSI. Such risks include, but are not limited to, unreliable service delivery and inadequate credibility.
4.7.4All ANSI personnel, contractors and accreditation committees shall act objectively and shall be free from any undue commercial, financial and other pressures that could compromise impartiality.
4.7.5In order to assure that each decision on accreditation is taken by persons different that those who carried out the assessment, assessors shall not be eligible for membership in accreditation committee serving the Program for which they have been qualified.
4.7.6ANSI shall not offer or provide any service that affects its impartiality, such as certification, validation / verification services or consultancy. ANSI shall not present its accreditation activities as linked with consultancy or in any way imply that accreditation would be simpler, easier, faster or less expensive if any specified person(s) or consultancy were used.
4.7.7ANSI shall ensure that the activities of its related bodies do not compromise the confidentiality, objectivity and impartiality of its Accreditation Programs. With the input from accreditation committees and any other relevant sources, ANSI shall maintain and annually update the list of its related bodies. Relationships with these related bodies shall be analyzed and if a potential or actual conflict of interest has been determined ANSI shall take appropriate actions.
4.8OUTSOURCING
4.8.1In no circumstances will ANSI outsource any component of its accreditation services delivery.
5Management System
5.1INTRODUCTION
5.1.1The ultimate purpose of the ANSI Accreditation Services Management System is to ensure that all organizations accredited by ANSI are accredited in accordance with national and / or internationally recognized Standards / Guides, and are regarded as being competent to provide services at levels acceptable to the consumer.
5.1.2The Management System of ANSI Accreditation Services Programs is designed to implement the ANSI policy in a cost-effective manner, utilizing resources, facilities and manpower to the best advantage and in compliance with ISO/IEC 17011.
5.1.3The ANSI Accreditation Services Management System is made up of the integration of the ANSI staff, CAPC, accreditation committees and accredited organizations and this documented Management System Policy Manual.
5.2QUALITY POLICY AND OBJECTIVES
5.2.1ANSI Accreditation Services continually strives toward excellence in pursuit of the ANSI mission and its quality objectives are to:
a)comply with ISO/IEC 17011;
b)continually Improve.
5.2.2ANSI President and CEO delegates the responsibility for implementation of the ANSI Accreditation Services Quality Policy and Objectives to the Vice President of Accreditation Services.
5.2.3All members of the staff and members of the accreditation committees shall be aware of the policies set out in this manual and any other approved procedures as related to their areas of responsibility.
5.3RESPONSIBILITIES FOR QUALITY
5.3.1As top management, the ANSI Vice President, Accreditation Services is ultimately responsible for the implementation and maintenance of the ANSI Accreditation Services Management System.
5.3.2Director of Accreditation Services is charged with:
a)ensuring that procedures needed for the management system are established; and
b)reporting to top management on the performance of the management system and any need for improvement.
5.3.3The ANSI Program Directors are further empowered by the Vice President of Accreditation Services to ensure that all elements of the Management System described in this Policy Manual are implemented and comply with the principles and best practices of accreditation defined in the ISO/IEC 17011.
5.3.4The Director of Accreditation Services, in coordination with the Program Directors and the Vice President, Accreditation Services leads the annual Management Review of the Management System in accordance with ISO/IEC 17011 and ANSI procedures. The Director of Accreditation Services, in collaboration with the Program Directors is responsible for scheduling and execution of annual internal audits of the Management System in accordance with ISO/IEC 17011 and ANSI procedures as well as carrying out the corrective action effort.
5.4DOCUMENTATION
5.4.1ANSI Accreditation Services Management System documentation is made up of:
a)the ANSI By-Laws;
b)ANSI-PL-100: ANSI Accreditation Services Management System Policy Manual (this document);
c)ANSI policies and procedures as appropriate;
d)policies governing each accreditation program;
e)records associated with the accreditation process;
f)program procedures and forms;
g)personnel and training records.
5.4.2ANSI maintains documented procedures to control all documents and data that relate to accreditation activities. All controlled documents are managed in accordance with the established internal procedures that define the controls needed in such areas as approving documents for adequacy prior to issue, review, updating and approval of documents as needed, prevention of the unintended use of obsolete documents and safeguarding the confidentiality of documents where relevant. Documents are available to personnel, contractors, assessors and experts of the accreditation body, CABs and the general public as appropriate.
5.4.3The documents are controlled online electronically in the ANSICA platform and describe the accreditation processes that include the policies, procedures and operations of the programs.
5.4.4ANSI shall notify appropriate stakeholders of any significant changes in ANSI documentation pertinent to the accreditation processes.
5.5RECORDS
5.5.1A record is a document stating results achieved or providing evidence of activities performed in the ANSI accreditation process. ANSI maintains a documented procedure detailing the identification, collecting, indexing, accessing, filing, storing, maintaining, and disposing of records resulting from the ANSI accreditation programs.
5.5.2All quality records shall be legible, stored and maintained in such a way that they are readily retrievable. Storage facilities are provided to prevent damage, deterioration, or loss. All electronically stored data is being backed up on a daily basis.
5.5.3Files may not be removed from the ANSI office without the permission of the responsible Program Director or Director of Accreditation Services. Access to all specific accreditation files is restricted. Only authorized individuals are given access. Access to all other records is consistent with the relevant confidentiality arrangements.
5.6INTERNAL NON-CONFORMITIES AND CORRECTIVE ACTION PROCESS
5.6.1Non-conformity (a.k.a. “NCR”, “finding” or a “problem”) is non-fulfillment of a specified requirement. NCRs may be identified / reported through internal or external sources, such as internal audits, documentation/data receipt process, accreditation review process, assessor review panel, management reviews, international/regional peer evaluations, the NIST/NVCASE program and employee awareness.
5.6.2Client-identified non-conformities should be considered a customer complaint and handled according to the complaint process. Other items identified by external sources, including the accreditation committee may be handled within the procedures for corrective actions. After investigation, appeals may also result in an NCR and the initiation of a corrective action process
5.6.3ANSI internal procedures provide the means for identifying and documenting an internal non-conforming process including determining the root causes of nonconformity, the plan for corrective action, authorized personnel involved, actions taken, review the effectiveness of the corrective action as well as the records to be maintained.
5.6.4An opportunity for improvement (OFI) is used in the internal audit process to identify an area where there is weak evidence of compliance with the relevant requirements, yet an NCR is not warranted. This does not mandate corrective action.
5.7PREVENTIVE ACTION PROGRAM
5.7.1It is the responsibility of all employees of ANSI to initiate action to prevent the occurrence of any non-conformities relating to the accreditation process and the management system.
5.7.2ANSI Accreditation Services preventive action program is implemented in accordance with relevant procedure and includes identification of a potential NCRs, determination and implementation of the preventive action needed, recording the results of the actions taken and review of the effectiveness of these actions
5.8COMPLAINTS
5.8.1It is the policy of ANSI Accreditation Services to investigate and document all valid incoming complaints in accordance with complaints procedure. ANSI views complaints as a potential opportunity for improvement.
6Personnel
6.1GENERAL POLICIES
6.1.1ANSI Accreditation Services shall ensure that it has access to a sufficient number of personnel (internal, external, temporary or permanent, full time or part time) including lead and technical accreditation assessors, having the education, training, technical knowledge, skills and experience necessary for handling the type, range and volume of work performed.
6.1.2ANSI Human Resources functions under the auspices of its Director of Human Resources and encompasses employee hiring and orientation, salary and benefits administration, human resources filings and forms, employee policy administration including education assistance program, performance appraisal administration, administration of such matters as reduction in force, communications to staff, and complaints and issues raised by staff.
6.1.3Job descriptions defining levels of competence, qualifications, experience, responsibilities and authority levels are available for all positions and are the basis for recruiting new personnel. Assessor responsibilities are detailed in the assessor procedures, forms and manuals. All persons involved in accreditation process are required to be closely familiar with the extent of their duties, responsibilities and authorities.
6.1.4All personnel commit themselves formally by a signature or equivalent to comply with the rules defined by ANSI. The commitment considers aspects relating to confidentiality and independence from commercial and other interests and any existing or prior association with CABs to be assessed.
6.1.5ANSI Accreditation Services shall follow the appropriate procedure related to staff and assessors.
6.2ASSESSORS
6.2.1Where appropriate, ANSI contracts with, and utilizes assessors, lead assessors and technical assessors in the assessment and evaluation (respectively) of the capabilities of a CAB. These assessors acting on behalf of ANSI agree to act in accordance with ANSI procedures and rules of operation.
6.2.2Contracted assessors are required to meet specific qualifications and satisfactorily complete initial and annual training under ANSI procedures.
6.2.3ANSI lead assessors are authorized to organize and direct assessments, report findings and evaluate proposed CAB corrective actions or corrective action plans. ANSI provides the assessment team with up-to-date assessment instructions and all relevant information on accreditation arrangements and procedures. This information is provided in adherence with assessor procedures.
6.3TRAINING AND MONITORING
6.3.1ANSI shall employ only highly qualified and proficient personnel and assessors. ANSI shall provide both staff and assessors with initial and ongoing training in accordance with existing procedures to ensure that they have the up to date skills to perform their tasks. ANSI assessors participate in meetings and workshops on accreditation. ANSI maintains and updates files for each staff member and assessor, as appropriate.
6.3.2In accordance with ANSI procedures, staff performance is regularly reviewed against their stated responsibilities and agreed upon annual objectives. This performance appraisal is one of the tools used to determine training needs and ensure the continuing competence of the staff.
6.3.3Assessor performance is monitored on an on-going basis in accordance with ANSI procedures to assure there is sufficient supporting evidence that assessors continue to perform competently.
7Accreditation Activity
7.1GENERAL PRINCIPLES
7.1.1Specific policies and procedures governing accreditation process for each program shall be contained in the appropriate program-specific policies and procedures.
7.1.2ANSI may develop / adopt guidance documents or participate in their development. ANSI shall ensure that such documents have been formulated by committees or persons possessing the necessary competence and, where appropriate, with participation of interested parties. Where international application or guidance documents are available, these should be used.
7.1.3If CAB documents are not in English or CAB personnel do not speak English, it is the responsibility of the CAB to provide an interpreter(s), subject to ANSI?s approval, to assist the ANSI assessors during the onsite assessment. The interpreters will assist the assessors with conversing directly with CAB management and technical staff and with reviewing CAB documentation. Documents such as quality manuals, procedures, standards and other documents sent to ANSI prior to onsite assessment or reviewed during assessments may be required to be provided in English to verify conformance with ANSI requirements.
7.1.4ANSI shall publicize its accreditation actions including granting of initial accreditation, extension and reduction of scope, suspension and withdrawal of accreditation in an online publication “Standards Action”.
7.1.5ANSI shall publicize accreditation information in an online, ANSICA-driven, program-specific accreditation directory. This information includes listings of accredited CABs, applicants, scope extensions and suspensions. PCAC program also publicizes the list of approved preliminary applicants that have paid their application fee. Individual CAB listings in the directory contain the following information:
a)name of the CAB;
b)accreditation ID;
c)headquarters address and addresses of other sites where ANSI accredited activity occurs, if applicable;
d)contact person(s) contact information;
e)scope(s) of accreditation;
f)effective date of accreditation;
g)expiration date of accreditation, if applicable;
7.1.6ANSI shall, where applicable, provide information about international arrangements in which it is involved.
7.2INFORMATION ON ACCREDITATION CRITERIA
7.2.1ANSI shall make publicly available and update at adequate intervals, the following information not explicitly covered in this document:
a)detailed information about assessment and accreditation processes, including arrangements for granting, maintaining, extending, reducing, suspending and withdrawing accreditation;
b)policies, procedures and reference documents containing the requirements for accreditation, including technical requirements specific to each field of accreditation, where applicable;
c)information about the fees relating to the accreditation;
d)information on procedures for lodging and handling complaints and appeals.
7.3ACCREDITATION AGREEMENT
7.3.1Every applicant CAB is required to sign an Agreement of Accreditation with ANSI prior to becoming accredited.
7.3.2Amendments to the Agreement are identified, reviewed, approved and communicated to all concerned parties according to documented internal ANSI procedures. Records of amendment reviews are maintained.
7.4OBLIGATIONS OF THE CAB
7.4.1The CAB shall conform to the following:
a)the CAB shall commit to fulfill continually the requirements for accreditation set by ANSI for the areas where accreditation is sought or granted. This includes agreement to adapt to changes in the requirements for accreditation;
b)when requested, the CAB shall afford such accommodation and cooperation as is necessary to enable ANSI to verify fulfillment of requirements for accreditation. This applies to all premises where the conformity assessment services take place;
c)the CAB shall provide access to information, documents and records as necessary for the assessment and maintenance of the accreditation;
d)the CAB shall provide access to those documents that provide insight into the level of independence and impartiality of the CAB from its related bodies, where applicable;
e)the CAB shall arrange the witnessing of CAB services when requested by the accreditation body;
f)the CAB shall claim accreditation only with respect to the scope for which it has been granted accreditation;
g)the CAB shall not use its accreditation in such a manner as to bring the accreditation body into disrepute;
h)the CAB shall pay fees as shall be determined by the accreditation body.
7.4.2Whenever significant changes occur that affect the agreement, the accredited CAB is required to formally notify ANSI. These changes include, but are not limited to, the following:
a)legal, commercial, ownership, name or organizational status;
b)top management and key personnel;
c)main policies;
d)physical relocation;
e)acquisition of another organization
f)reduction, suspension or expansions of the accreditation scope;
g)other such matters that may affect the ability of the CAB to fulfill accreditation requirements.
7.4.3Applicant and accredited CAB shall make available to ANSI the records (except for any privileged records) and processes used in the decisions / actions taken on any complaints and appeals related to activities conducted by them. This is part of the all assessments conducted by ANSI.
7.5CHANGES IN ACCREDITATION REQUIREMENTS
7.5.1ANSI shall inform the accredited and if applicable, applicant CABs of any changes in the accreditation requirements in a timely manner. The timeframe for the accredited bodies to implement the new requirements shall be defined by ANSI in conjunction with the accredited bodies and other appropriate stakeholders such as government agencies. ANSI must set a deadline for all accredited bodies to conform to the new requirements. A process is put in place to document evidence that the accredited bodies have conformed to the new requirements
7.6APPEALS
7.6.1Appeals shall be handled in accordance with ANSI?s documented procedures and the appellant shall be notified of the outcome in a timely manner as well as informed of the options.
7.7EXTENDING AND DISCONTINUING ACCREDITATION ACTIVITY
7.7.1Parties (e.g., government agencies, trade associations, industry conformity assessment schemes) interested in the establishment of new accreditation programs at ANSI for use by conformity assessment bodies are encouraged to communicate their needs to Accreditation Services Management Staff, who should also stay aware of developments in the marketplace that substantiate a demand for accreditation services.
7.7.2New program initiatives that have been identified and considered viable by the Vice President of Accreditation Services should be summarized in a program proposal that should include:
a)feasibility of launching or extending an accreditation scheme;
b)analysis of its present competence and resources;
c)accessing and employing expertise;
d)the need for application or guidance documents;
e)training of accreditation body personnel;
f)implementation or transition arrangements;
g)views of interested parties.
7.7.3If the new program is considered a scope extension of an existing program, the program proposal should be presented to the respective existing accreditation committee for endorsement. A proposal for a completely unprecedented service should be presented to the CAPC for advice and consent.
7.7.4New program proposals that have garnered consensus should inform the development of operational planning, usually in the form of a trial program to pilot the implementation and launch of the new service.
7.7.5New programs shall have process documentation that will fulfill all requirements of ISO/IEC 17011 and relevant policies of the ANSI Accreditation Services department.
7.7.6Before discontinuing an accreditation scheme in part or in full, at least the following shall be considered:
a)Views of interested parties;
b)Contractual duties;
c)Transition arrangements;
d)External communication regarding the discontinuation;
e)Information published by the accreditation body.
8Accreditation Symbols and Reference to Accreditation
8.1ACCREDITATION SYMBOLS AND CERTIFICATES
8.1.1The conditions and requirements for the use of accreditation certificates and the accreditation symbol by accredited organizations are specified in ANSI procedures. The accreditation symbols are registered with the US Patent and Trademark Office. This registration is maintained according to the laws governing accreditation marks in the United States
8.1.2ANSI shall take suitable action to deal with incorrect references to accreditation status or misleading use of accreditation symbols found in advertisements, catalogues etc.
AAnnex A: ANSI Accreditation Services Organizational Chart
BAnnex B: Reference Matrix of Conformance with ISO/IEC 17011 - 2017
B.1The following matrix shall be updated on a regular basis by ANSI staff and such updated shall be considered administrative updates.
B.2REFERENCE MATRIX

How is accreditation like an onion?