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Application and Initial Assessment Process

PUBLIC PROCEDURE PCAC-PR-515 Issued: 2017-4-6, Revision: 3

References 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
PCAC-FR-503: Preliminary Application for ANSI Accreditation under ANSI/ISO/IEC 17024
PCAC-FR-504: Application for ANSI Accreditation Under ANSI/ISO/IEC 17024
PCAC-PL-502: Manual of Operations for Accreditation of Personnel Certification Programs
PCAC-PR-519: Conditions for Granting, Maintaining, Extending, Reducing, Suspending or Placing on Probation and Withdrawing Accreditation
PCAC-PR-522: Fees - Accreditation of Personnel Certification Bodies
PCAC-PR-545: Assessor Manual for Personnel Certification Accreditation
ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
ISO/IEC 17024:2012, Conformity assessment - General requirements for bodies operating certification of persons
Contents
1Objective
1.1The objective of this procedure is to document the application and initial assessment process for personnel certification bodies (herein, CBs) applying for ANSI accreditation.
2Definitions
CB: Certification Body CoI: Conflict of interest ETG: Evaluation Task Group
3Informational Visit
3.1If an informational visit (preliminary visit) has been determined necessary by ANSI or requested by the applicant, ANSI staff shall select one of the qualfied assessors and coordinate arrangements for the visit.
3.2The purpose of an informational visit is to clarify issues arising from the accreditation requirements. During the information visit, the assessors shall not engage in any consultancy.
4Preliminary Application Process
4.1CBs interested in pursuing ANSI accreditation must first fill out and submit the preliminary application form PCAC-FR-503 available on the web or by request. This form must be submitted by the duly authorized representative of the CB. The purpose of the preliminary application process is for ANSI to determine the basic eligibility of the CB and for the CB to inform ANSI of the specific scope(s) that it intends to apply for.
4.2Preliminary application includes the following 3 basic requirements:
a)conforms with the definition of CB per ANSI/ISO/IEC 17024;
b)is a legal entity or part of a legal entity;
c)provides evidence of a published scope(s) of certification.
4.3Upon receipt of the preliminary application and related required information, shall review the information to determine whether the preliminary applicant is eligible for ANSI accreditation. If appropriate, ANSI staff shall issue a written statement indicating eligibility of the CB to proceed with the full application; an Accreditation Agreement shall be sent to the preliminary applicant for signature.
4.3.1If ANSI staff determine that the preliminary applicant does not meet the basic eligibility requirements for entering the application process, the preliminary applicant shall be advised in writing of the specific requirement(s) not sufficiently documented in the submitted materials. In this case, the preliminary applicant may submit further documentation within 90 calendar days of its receipt of ANSI’s written notification. Otherwise, the preliminary application is automatically rejected.
4.3.2If the CB disagrees with the determination in 4.3.1, it may follow the ANSI appeals process in accordance with ANSI’s appeals procedures.
4.4ANSI staff shall conduct a review of its capability to carry out the assessment in terms of technical competence and timeliness and log the results in ANSICA.
5Application for Accreditation
5.1Receipt of initial application
5.1.1From the time the preliminary applicant receives a statement of eligibility per clause 4.3, preliminary applicant shall have 12 months within which they must submit all documents that are required as part of the full application package. If the application package is not complete within the timeframes indicated, preliminary applicant shall be notified that they must resubmit the application and pay a new application fee in order to restart the accreditation process.
5.1.2A CB must submit the completed application package (PCAC-FR-504 and supporting materials) in 3 paper copies or electronically. Supporting materials shall demonstrate how the CB conforms to ISO/IEC 17024 and any applicable requirements.
5.1.3ANSI shall not proceed with the formal application review unless the application package includes the elements listed in 5.1.2, application fee is paid and ANSI is in possession of a signed Accreditation Agreement that was sent earlier to the applicant for signature per clause 4.3.
5.2Review of Application
5.2.1ANSI staff shall review the application for completeness to ensure that all the appropriate questions have been answered and supporting documentation has been provided.
5.2.2ANSI staff may request additional information and / or clarification from the applicant. Response for additional documentation must be received within 90 days of the request, otherwise the application shall be considered withdrawn and the applicant CB shall be required to start the application process from the beginning by submitting a new preliminary application. The applicant shall be notified in writing if this action is taken.
5.2.3After approval of the application package, ANSI staff shall:
a)send confirmation to the applicant;
b)select PCAC members to serve on the PCAC Evaluation Task Group (herein, ETG);
c)update the status of the CB to “applicant” in ANISCA;
6Document Review
6.1Selection of the assessment team
6.1.1ANSI shall select candidates for the assessment team. The assessment team members shall be selected based on absence of conflict of interest (herein, CoI) and competence requirements as per PCAC-PR-545.
6.1.2A CoI is any financial, business, or other interest that impairs an assessor’s objectivity or impartiality, or creates an unfair competitive advantage for any organization or individual. Areas that should be considered when determining actual, perceived or potential CoI for a particular assignment include:
a)organization / business relations — current or projected financial / business relations with individuals or entities that may be materially affected by accreditation decisions;
b)employment and financial relations of family / associates – status of financial / business relations of spouse, other partners, children, professional associates;
c)memberships and affiliations – business and professional collaborations, associations, partnerships and other relationships that may strain the assessor’s objectivity or impartiality with respect to assessment activities and decisions.
6.1.3The applicant shall be provided with the resumes of the proposed members of the assessment team. Based on perceived or actual CoI, the applicant may object to the named assessor(s) in writing within 10 days from receipt of the proposed assessment team members’ resumes. Assessor objections will be reviewed on a case by case basis by ANSI staff in consultation with the PCAC Chair if needed.
6.1.4If no objection is received per 6.1.3, the assessment team shall be considered approved. All selected assessors must have signed the ANSI confidentiality and CoI form, ANSI-TP-001.
6.2Document Review
6.2.1The assessment team shall review the application package and accompanying documentation for conformity with ANSI/ISO/IEC 17024 and ANSI requirements. The Lead Assessor conducts the review with input from the other assessor(s).
6.2.2If additional documentation is required by assessors, the same timelines and consequences regarding the submission of materials as listed in 4.3.1 shall apply.
7Onsite Assessment
7.1ANSI may decide not to proceed with an onsite assessment based on the nonconformities (herein, NCRs) found during document review. In such cases, the NCRs shall be reported in writing to the applicant.
7.2Upon completion of the document review process and in accordance with PCAC-PR-545: Assessor Manual for Personnel Certification Accreditation, the ANSI lead assessor shall arrange with the applicant for a mutually acceptable schedule for the onsite assessment the purpose of which is to assess the CB for conformity with ISO/IEC 17024 and ANSI requirements and ensure that the CB implements its own documented procedures.
7.3Assessors, in conjunction with the applicant and ANSI staff, shall develop an assessment plan. The plan shall include:
a)dates and expected length of onsite assessment;
b)tentative schedule for the assessment;
7.3.1Any disagreement between the assessors and the applicant regarding the assessment plan shall be reviewed by ANSI staff and if necessary, the PCAC representative(s).
7.4ANSI assessors shall begin the onsite assessment with an opening meeting that shall include the CB’s representatives. The purpose of the opening meeting is for ANSI assessors to clearly define the assessment and accreditation criteria and to confirm the assessment schedule and scope of assessment.
7.4.1If the CB operates programs that spread across multiple sites, assessment shall cover as many additional sites as necessary to collect objective evidence to verify that the documented policies and procedures are implemented. ANSI assessors shall witness practical examination/s where relevant.
7.5The ANSI assessment team shall analyze all relevant information and evidence gathered during the document review as well as the onsite assessments. The analysis shall be sufficient to allow the ANSI assessment team to determine the extent of fulfillment of accreditation requirements, including conformance to the applicant’s own policies and procedures. While conducting the onsite assessment, ANSI assessors shall apply the general principles of ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing.
7.6At the conclusion of the assessment, the ANSI assessment team shall hold a closing meeting with the CB representatives. At the closing meeting, the ANSI assessment team shall present its findings identified during the assessment—including strengths, opportunities for improvement (herein, OFIs), and NCRs. If necessary, the assessment team shall also inform the applicant of the appeals process.
7.7Within 15 business days of the closing meeting, the Lead Assessor is responsible for preparing an assessment report covering all of the assessment activities and submitting the report to ANSI staff. After ANSI staff reviews the report, it is sent to the applicant for their review of any misstatement of facts. All requests for changes shall be reviewed by the assessors.
7.7.1The report will contain the following information:
a)personnel interviewed;
b)any activities observed;
c)additional document(s)/data reviewed onsite;
d)determination for each requirement: met / commendation / OFI / NCR;
e)evidence for identified NCRs.
7.8Assessment report and the findings are made available to the ETG for their review. An in-person meeting or a conference call may be set up by ANSI staff between the ETG members and the assessment team to discuss the results of the assessment. The ETG may direct the assessors to make modifications to the report and findings if necessary. The ETG and the assessors shall work to reach a consensus regarding the findings. If a consensus cannot be reached, it is referred to PCAC.
7.9If the final report authorized by PCAC differs from the initial report, the report will be submitted to the applicant with an explanation of the differences from the previous report.
7.10All NCRs must be closed within 12 months and before accreditation can be awarded by PCAC. If there are open NCRs, the ETG may recommend to PCAC a timeframe to be allotted to the applicant CB in order to provide satisfactory corrective actions. In some cases, the NCRs may be serious enough for ETG to recommend that the accreditation be denied.
7.11Once all the NCRs are closed, PCAC shall consider accreditation action based on the ETG recommendation in accordance with PCAC-PR-519 and PCAC-PL-502.
8Decision on Accreditation
8.1If accreditation is awarded by PCAC, the ANSI staff shall prepare certificate of accreditation signed by the ANSI Vice President, Accreditation Services and promptly send it to the CB. The effective date of accreditation shall be the day of the accreditation decision by PCAC. The certificate shall indicate:
a)identity and logo of the accreditation body;
b)name and the unique accreditation ID of the accredited CB;
c)a list of accredited certification schemes as well as all the accredited key locations;
d)the effective and expiry date of the accreditation period;
e)any appropriate normative documents or standards.
8.2ANSI shall include the newly accredited CB in its online directory. This posting shall include the following: demographic information and contact person(s), website, beginning and end dates of accreditation and a list of accredited certification schemes.

Gerald H. Ritterbusch Conformity Assessment Medal