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Information on the Application Process

PUBLIC PROCEDURE PRO-PR-112 Issued: 2016-4-5, Revision: 1

References ANSI-PR-004: Appeals
ANSI-PR-005: Complaints
PRO-FR-104: Application for Accreditation of Product Certification Program
PRO-FR-105-ISO/IEC Guide 65: Checklist for Accreditation Requirements: ISO/IEC Guide 65
PRO-FR-107-IAF: Checklist for Accreditation Requirements: IAF Guidance on ISO/IEC Guide 65
PRO-FR-128: Report of the Evaluation Task Group
PRO-FR-150: PRO Assessor Field Evaluation Report
PRO-PL-101: Policy and Criteria for Accreditation of Product Certification Programs
PRO-PL-102: Manual of Operations for Accreditation of Product Certification Programs
PRO-PL-103: Operating Procedures of the Accreditation Committee
PRO-PR-122: PRO Fee Schedule
PRO-PR-127: Rules For Governing the Use of the ANSI Accreditation Symbol and Notification of the Consequence of Withdrawal of Accreditation
PRO-PR-140-GGAP: Sector Specific Accreditation program for GLOBALGAP - Program
PRO-PR-145: Assessor Manual
PRO-PR-148-SQF: Sector Specific Accreditation Program for SQF - Program
PRO-PR-155-SFI: Procedure for the Accreditation of Certification Bodies for the Sustainable Forestry Initiative Chain of Custody and/or PEFC Chain of Custody programs
PRO-PR-157-AECO: Sector Specific Accreditation Program for Product Safety Evaluation of Elevators and Escalators
PRO-PR-161-BRC: Sector Specific Accreditation Program for BRC - Program
PRO-PR-163-EPAES: Sector Specific Accreditation for EPA Energy Star® Program
PRO-PR-166-PGFS: Sector Specific Accreditation Program for PrimusGFS
PRO-PR-167-GAA: Sector Specific Accreditation Program for Global Aquaculture Alliance -- Best Aquaculture Practices (GAA-BAP)
PRO-PR-168-CGAP: Sector Specific Accreditation Program for CHC CanadaGAP, Component 3: Conformity Assessment System v3.0
PRO-PR-169-TE: Sector Specific Accreditation Program for Textile Exchange Standards
PRO-PR-171-ISCC: Sector Specific Accreditation Program for International Sustainability and Carbon Certification (ISCC)
PRO-PR-172-EPA-FES: Accreditation Program for US Environmental Protection Agency Formaldehyde Emission Standard for Composite Wood Products
PRO-PR-174-FDA-FSMA: Accreditation Program for US Food & Drug Administration
PRO-PR-174-FDA-FSMA VQIP: Accreditation Program for US Food & Drug Administration
PRO-PR-174-FDA-FSMA-VQIP: Accreditation Program for US Food & Drug Administration
ISO/IEC 17065:2012, Conformity assessment – Requirements for bodies certifying products, processes and services
Contents
1Objective
1.1The purpose of this procedure is to provide information on the ANSI Product Certification Accreditation process to enable applicants to comply with all necessary requirements and conditions for accreditation.
2Definitions
2.1The applicable definitions are those contained in ISO/IEC 17000:2004.
2.2SCOPE OF THE ACCREDITATION APPLICATION: The scope of the accreditation application specifies the scope of accreditation requested by a body applying for accreditation or an extension of accreditation.
2.3SCOPE OF ACCREDITATION: Scope of accreditation of a certification body means the area(s) of competence for which the body's certification activity is covered by accreditation. The scope of accreditation specifies:
a)For industrial products:
1)Type of certification system
2)Standards and/or other normative documents and mandatory requirements with respect to the products that are certified
3)Industrial sectors concerned
4)Product categories concerned
b)For services:
1)Type of Certification system(s)
2)Identification of certification references (standards and other normative or mandatory documents)
3Procedure
3.1Program Status and Authority
3.1.1The American National Standards Institute, incorporated in the state of New York, is a private, non-profit membership organization serving the standards and conformity assessment needs of its diverse constituencies. The ANSI accreditation program responds to (7) in the Purpose Section (1.02) of the ANSI By-Laws, which states that it shall be the purpose of the institute “To establish, promulgate, and administer procedures and criteria for recognition and accreditation of certification and related programs and to encourage organizations to prepare and submit such programs for accreditation by the Institute.”
3.2Accreditation
3.2.1ANSI accreditation is the official recognition that a certification body is competent to perform specifically defined functions and has a documented Quality Management System in place to facilitate this process. An accredited organization will have demonstrated through formal on-site assessment that it is competent to perform the defined functions and that it satisfies both national and international criteria in this respect.
3.2.2Accredited Product Certification bodies shall satisfy the requirements of ISO/IEC 17065 and additional ANSI requirements or sector specific requirements.
3.3Application Package
3.3.1The applicant is advised to read the ANSI documents listed below prior to completing the ANSI application form:
a)Boiler Plate Application Letter Package - includes the following documents:
1)General Documents:
i.Letter - Guideline and Checklist for Preparing a Preliminary Letter of Application
ii.PRO-PL-101: Policy and Criteria for Accreditation of Product Certification Programs
iii.PRO-PL-102: Manual of Operations for Accreditation of Product Certification Programs
iv.PRO-PL-103: Operating Procedures of the Accreditation Committee
v.PRO-FR-104: Application For Accreditation Of Certification Program
vi.PRO-FR-105-ISO/IEC 17065: Checklist for Accreditation Requirements: ISO/IEC 17065
vii.ANSI-PR-004: Appeals
viii.ANSI-PR-005: Complaints
ix.PRO-PR-122: Fees - Accreditation of Product Certification Bodies
x.ISO/IEC 17065 Conformity assessment - Requirements for bodies certifying products, processes and services
xi.A list of applicable ANSI program documents can be found on the ANSI official website: http://www.ansi.org
2)Documents for certification programs that apply for TCB program in accordance with FCC requirements:
i.FCC-PR-139: Specific Rules To Be Verified During Assessment By ANSI ACP for Telecommunications Certification Bodies
3)Documents for certification programs that apply for CB program in accordance with Industry Canada (IC) requirements:
i.IC-PR-039: Sector Specific Accreditation Program for IC Certification Program
4)Documents for certification programs that apply for CB program in accordance with IDA Singapore requirements:
i.IDA-PR-039: Specific Rules To Be Verified During Assessment By ANSI ACP For Telecommunications Certification Bodies
5)Documents for certification programs that apply for CB program in accordance with MIC Japan requirements:
i.MIC-PR-039: Specific Rules To Be Verified During Assessment By ANSI ACP For Japanese Registered Certification Body (RCB) Program
6)Documents for certification programs that apply for CB program in accordance with OFTA Hong Kong requirements:
i.OFTA-PR-039: Specific Rules To Be Verified During Assessment By ANSI ACP For Telecommunications Certification Bodies
7)Documents for certification programs that apply for GlobalGAP requirements:
i.PRO-PR-140-GGAP: Sector Specific Accreditation program for GLOBALGAP - Program
8)Documents for certification programs that apply for SQF Program:
i.PRO-PR-148-SQF: Sector Specific Accreditation Program for SQF - Program
9)Documents for Certification programs that apply for SFI/PEFC Chain of Custody Program
i.PRO-PR-155: Procedure for the Accreditation of Certification Bodies for the Sustainable Forestry Initiative Chain of Custody and/or PEFC Chain of Custody programs
10)Documents for Certification programs that apply for AECO Program:
i.PRO-PR-157-AECO: Sector Specific Accreditation Program For Product Safety Evaluation Of Elevators & Escalators
11)Documents for Certification programs that apply for BRC Program:
i.PRO-PR-161-BRC: Sector Specific Accreditation program for BRC - Program
12)Documents for Certification programs that apply for IFS Program:
i.PRO-PR-150-IFS Sector Specific Accreditation Program for IFS
13)Documents for Certification programs that apply for EPA ENERGY STAR Program:
i.PRO-PR-163-EPAES - Sector Specific Accreditation Program for EPA Energy Star? Program
14)Documents for Certification programs that apply for PrimusGFS Program:
i.PRO-PR-166-PGFS - Sector Specific Accreditation Program for PrimusGFS Program
15)Documents for Certification programs that apply for GAA-BAP Program:
i.PRO-PR-167-GAA - Sector Specific Accreditation Program for Global Aquaculture Alliance -- Best Aquaculture Practices (GAA-BAP) Program
16)Documents for Certification programs that apply for CHC CanadaGAP Program:
i.PRO-PR-168-CGAP - Sector Specific Accreditation Program for CHC CanadaGAP, Component 3: Conformity Assessment System
17)Documents for Certification programs that apply for TE Program:
i.PRO-PR-169-TE - Sector Specific Accreditation Program for Textile Exchange Standards
18)Documents for Certification programs that apply for ISCC Program:
i.PRO-PR-171 - ISCC - Sector Specific Accreditation Program for International Sustainability and Carbon Certification
19)Documents for Certification programs that apply for EPA FES Program:
i.PRO-PR-172 ? EPA FES - Accreditation Program for US Environmental Protection Agency Formaldehyde Emission Standard for Composite Wood Products
20)Documents for Certification programs that apply for FDA ? FSMA VQIP Program:
i.PRO-PR-174 ? FDA ? FSMA- VQIP - Accreditation Program for US Food & Drug Administration
3.4Preliminary Application
3.4.1Application package contains the instructions on submitting the preliminary letter of application (See Annex A).
3.4.2Upon receiving the preliminary letter of application and corresponding documents ANSI staff will review the information submitted by the certification body and confirm that it conforms to clause 4 of PRO-PL-102.
3.4.3ANSI will provide a deficiency form if applicable, detailing what additional information is required to be sent by the organization to ANSI.
3.4.4After reviewing the preliminary application documents, ANSI staff will develop an eligibility report that informs the applicant if eligibility requirements are met.
4Receiving the Application
NOTE: The application package requires comprehensive information from the organization. This information is necessary to allow ANSI to determine the extent to which its documented Management system satisfies ANSI accreditation requirements. The applicant is required to complete all sections of the application PRO-FR-104: Application For Accreditation Of Certification Program. If a section is not applicable to the organization, it should be indicated on the form. It is also a requirement that the applicant submit the Quality Manual and a completed PRO-FR-105-ISO/IEC 17065: Checklist for Accreditation Requirements together with the application form. The application will not be processed until the application package, including the Quality Manual, and the appropriate application fee has been received by ANSI.
4.1Upon receipt of an application, the ANSI staff will assign an activity code and create a file for the applicant in ANSICA.
4.2ANSI will confirm receipt of application to the applicant.
4.3ANSI will also notify the applicant that the application is being processed and will estimate the time needed for completing the task.
4.4All applications received by ANSI are published in the appropriate directory on the ANSI website in “ANSI-Standards Action” with the information as listed below (public comments are requested at that time):
Title: ANSI Accreditation Program for Third Party Product Certification Bodies Application for ANSI Accreditation a) Name of the applicant b) Location c) General description of the certification program and its scope Please send your comments by MM/DD/YYYY to Reinaldo Balbino Figueiredo, Senior Program Director, Product Certification Accreditation, American National Standards Institute, 1899 L Street, NW, 11th Floor, Washington, D.C. 20036, Fax: 202-293 9287 or e-mail: rfigueir@ansi.org
4.5If comments are received regarding the applicant, ANSI will evaluate the information and provide any relevant data to the assessment team for their consideration during the assessment. ANSI's evaluation of each comment will be confirmed to the originating organization.
4.6If the applicant is located outside of the US or has multiple sites that perform key activities in the certification process, ANSI will inform the client about the principles defined in the IAF Guidance on cross frontier accreditation that may be applicable.
5Application Review
5.1The program director determines if all documents have been received and processed in accordance with PRO-PL-102: Manual of Operations for Accreditation of Product Certification Programs, and also verifies the following points regarding the ANSI accreditation program:
a)accreditation scope requested by the applicant body;
b)qualified assessors and technical experts;
c)development of internal procedures;
d)establishment of an Evaluation Task Group (ETG);
e)new system of certification scheme in the application;
f)availability of assessors and technical experts; and
g)regulation of the product at the federal, state, or local level.
5.2If required documents or equivalent information have not been received or processed, responsible parties are contacted to provide required documents or information for processing before the application is reviewed and accepted.
5.3If an application and/or supporting documents are found unacceptable after review, the applicant is notified in writing. If application and documentation are found to be acceptable, ANSI notifies the applicant accordingly.
5.4After ANSI reviews and accepts the application documentation, ANSI will notify the ACC Chair. ANSI requests ACC volunteers to participate in an ETG.
5.5ANSI submits the names of the ETG members to the applicant or accredited certification body for acceptance. The certification body may, at any time, object to the inclusion of any member on its respective ETG.
6Document Review for the Initial Assessment
6.1An applicant for ANSI accreditation shall operate in accordance with ISO/IEC 17065 and all relevant ANSI policies. The requirements are applicable, even if a small section of a larger organization is applying for accreditation.
6.2After the assessment team, appointed by the Program Director, receives the Quality Manual and support documents, it will assess the contents of such documents against the requirements of ISO/IEC 17065 and ANSI requirements. An applicant shall be given a written report by ANSI on the document review. This report shall provide one of the following conclusions:
6.3When a documented Quality Management System has been found to be acceptable to ANSI, the applicant shall be notified of the proposed dates and number of days required for the initial assessment. The lead assessor may be required to visit the applicant before the initial assessment if applicable.
6.4The final composition of the assessment team shall be agreed upon between the applicant and ANSI subject to the conditions set out in the ANSI regulations. An applicant may request replacement of team members whom they perceive have conflicts of interest or other similar situations.
6.5The applicant shall be notified in writing of the dates and composition of the assessment team. The applicant is required to accept the dates in writing.
6.6Once the dates for the assessment have been agreed upon by the applicant and ANSI, any change in the dates by the applicant may be subject to a charge based on costs incurred to ANSI up to the date of the cancellation.
7Initial Assessment
7.1Selection of Assessment Sites
7.1.1The ANSI Program Director and the team leader select the certification body's site(s) to be assessed in accordance with PRO-PL-102. These sites will consist of the certification body’s headquarters, administrative offices (if not part of headquarters), participant's manufacturing plants, testing laboratories (either in-plant or independent), inspection activities, warehouses, and any other sites where the certified products may be available.
7.1.2The assessments will be prearranged through an authorized representative of the certification body whose name and location will be made known by ANSI staff as part of the program document package
7.2Assessment at Certification Body Headquarters
7.2.1The ANSI assessment team will hold an opening meeting with the applicant in accordance with PRO-PR-145.
7.2.2The purpose of visiting program headquarters is to give the assessor the opportunity to examine the records system that describe and document on-going activities, actions, and operations of the program. This also allows the assessor to meet with principal staff members and discuss any aspects of mutual interest or concern. The initial visit serves to acquaint both the assessor and the certification body staff with each other's activities as they relate to accreditation.
7.3Witness Assessments
7.3.1While it is recognized that witness assessments are intrusive, it is necessary that ANSI obtain first hand evidence that the certification body is carrying out its activities in accordance with its procedures.
7.3.2The assessment is one of the most important elements of the accreditation process, and it is from this activity that the assessor judges the level of confidence that can be expected in certification body activities. The witness assessment is confirmation that the judgment is justified.
7.3.3ANSI, together with the team leader, arranges with the applicant for a mutually acceptable schedule for the witness assessment(s). A witness assessment includes but is not limited to:
a)Witness audit conducted by the certification body on testing and/or inspection facilities, if appropriate;
b)Witness audit conducted by the certification body on at least one manufacturing or licensee facility; and
c)Observation of the operations of the program quality assurance functions.
7.3.4For certification bodies that apply for accreditation in the Telecommunications Certification Program Scope a witness assessment is not required.
7.4Assessment Report
7.4.1On completion of the initial assessment, the assessment team shall send the report to ANSI.
7.4.2Program Director shall send this report to the applicant and request that the organization comment on the report and describe the specific actions taken or planned to be taken within a defined time to remedy any non-conformity identified during the assessment.
7.4.3Program Director receives the applicant responses and uses those together with the assessment report and any other relevant information to present the applicant to the ETG for consideration.
8Approval Process and Accreditation Maintenance
8.1The ETG along with the ANSI staff will analyze the information received from the assessment team. ANSI staff will support the ETG to write summary report to be presented to the ANSI Accreditation Committee (ACC) for decision (PRO-FR-128).
8.2On behalf of ANSI, ACC is responsible for rendering one of the following decisions:
a)Reviewing the process of assessment and granting, maintaining, extending, reducing, suspending, and withdrawing accreditation (the accreditation decision) for all or part of the requested scope;
b)Put the decision on hold pending:
1)Information contained in additional documents;
2)Results of a supplementary assessment;
c)Refuse accreditation
Note: depending on the decision of the Accreditation Committee, the scope of accreditation granted may be more restricted than the scope requested.
8.3ANSI shall notify all applicants in writing of the Accreditation Committee decisions with respect to their application.
8.4A body that receives a favorable decision from ANSI regarding its accreditation shall sign an agreement with ANSI. ANSI also develops an accreditation certificate, and sends it to the accredited body.
8.5ANSI publishes in ANSI "Standards Action" the name, location and scope of the accredited certification program following its accreditation and requests public comments.
8.6After the initial assessment, ANSI will conduct a surveillance visit to the organization to ensure that all aspects of the system have been adequately implemented and are operational.
8.7ANSI operates a two-year accreditation cycle for all accredited product certification bodies. This will be comprised of annual surveillance visits by ANSI over the period and a full reassessment at the end of the assessment cycle. From time to time ANSI, on the basis of solid evidence, may request additional surveillance and/or assessment visits. All costs associated with such visits shall be borne by the accredited organization in addition to normal fees charged by ANSI.
8.8ANSI maintains a list of all accredited certification bodies with their respective scopes on the ANSI website (http://www.ansi.org), under Accreditation Services, Product Certification Accreditation.
9Duration and Validity of Accreditation
9.1Accreditation is initially authorized for a period of two years and is then renewed biannually. The accredited body informs ANSI immediately of any significant modifications in its certification program for which accreditation was granted. If accreditation is extended, it will extend the initial accreditation by another two-year period. Subsequent ANSI decisions to grant two year accreditation will require continued demonstration by the accredited body of conformance to ANSI accreditation requirements.
10Timeframe for Accreditation Process
10.1ANSI makes every effort to ensure that all applications are processed as efficiently as possible. The time taken to process an application depends on a number of factors, some of which are outside the control of ANSI. Examples are:
a)Quality of applicant's documentation and extent to which it complies with ANSI requirements. Delay can occur due to insufficient documented procedures and submission of inadequate quality manuals and support documents.
b)Technical complexity of the scope applied for and the availability of suitable assessors.
c)Compliance of the applicant response to the non-conformity(ies) after the initial assessment.
11Reference to Accredited Status
11.1The conditions and requirements for the use of accreditation certificates and the accreditation mark by accredited organizations have been specified in PRO-PR-127: Rules For Governing the Use of the ANSI Accreditation Symbol and Notification of the Consequence of Withdrawal of Accreditation
12Confidentiality
12.1All information submitted to ANSI in support of the application package and all information obtained during the accreditation process shall be treated in confidence. All assessors contracted by ANSI are required to sign confidentiality agreements.
13Access to records of appeals, complaints and disputes
13.1ANSI requires that each applicant and accredited certification body is to make available, when requested and during the assessments, the records of all complaints, appeals and disputes, and subsequent actions taken by the certification body.
14Change in the accreditation requirements
14.1ANSI informs the accredited certification body of any changes in the accreditation criteria. The timeframe defined for the accredited bodies implementing the new criteria shall be defined by ANSI in conjunction with the accredited bodies, taking into consideration suggestions made by international organizations. After the implementation of the new criteria by the accredited organizations, ANSI verifies if the adjustments made fully conform to the newly established requirements.
15Appeals and Complaints against ANSI decision
15.1If the applicant does not agree with the decision taken by ANSI regarding the accreditation decision, the applicant can appeal the decision in accordance with ANSI procedures.
15.2ANSI shall place a public notice of accreditation in ANSI's "Standards Action." Any interested body may appeal a decision to grant accreditation within 30 days after publication of that decision in accordance with ANSI policies.
16Accreditation Fees and Expenses
16.1The fees for the provision of accreditation services and for appeals process are defined in PRO-PR-122.
AAnnex A: Guideline and Checklist for Preparing a Preliminary Letter of Application
A.1The first step in the ANSI application procedure is submission of a preliminary letter of application by the certification body. The purpose is to enable ANSI to judge the eligibility of the certification program(s) for accreditation. Within 30 days of receipt of the letter, ANSI will issue a report of eligibility.
A.2The letter should contain the following minimum information (see Section 4.2 of PRO-PL-102):
a)Confirmation of the third party status of the program. A third party is independent of the parties involved in certification, i.e., the supplier ("first party") interests and the purchaser ("second party") interests. Describe how the program sponsoring body qualifies as a third party, and describe the interests represented on the body's governing board. If the certification program operates under the direction of a managing committee, the interests represented on the committee should be identified along with a description of the committee's independence from the governing board if applicable.
b)Evidence of ownership of a certification mark and or certificate of conformity. A copy of the U.S. Patent Office certificate of registration, copy of mark of conformity, and/or a copy of a certificate of conformity are examples of evidence of ownership.
c)Copy of publicly available documents describing the program. Provide copies of descriptive brochures, application forms, advertisements, etc.
d)A brief description of the program, including a list of the standard(s) utilized and the identity of the inspection and laboratory body(s), if different from the certification body. If outside inspection body(s) or testing laboratory(s) is used, identify them and describe the nature of their work in the certification program.

How is accreditation like an onion?