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Number: ANSI-ACP-CA-002

Date Issued: October 25th, 2006


MANUAL OF OPERATIONS FOR Version#: 01/2006
ACCREDITATION OF PRODUCT CERTIFICATION Developed by: ANSI/ACC
PROGRAMS Verified by: ANSI
Approved by: ANSI/ACC
Page: 1/17

1.0 Introduction

This Manual of Operations contains detailed procedures for accrediting programs under the
ANSI Policy and Criteria for Accreditation of Product Certification Programs (ANSI-ACP-CA-
001). It sets forth the duties and obligations of the parties involved and the necessary assessment
and monitoring procedures required to demonstrate initial and continuing compliance with
provisions of the accredited programs, ANSI Policy, and other requirements contained in this
document.

Assessment of the competence of certification bodies is carried out using review of the product
certification program and associated standards where applicable, assessment of the certification
program head office (and other locations if applicable), assessment of the test facilities (where
applicable), and witness assessment.

This document outlines how ANSI plans and conducts initial assessment, surveillance, and
reassessment to certification programs, working in accordance with ANSI accreditation
requirements and ISO/IEC Guide 65 on a two-year accreditation cycle.

2.0 References

• ANSI-ACP-CA-001: Policy and criteria for accreditation of certification programs


• ANSI-ACP-CA-003: Operating procedures of the accreditation committee
• ISO/IEC Guide 65: General requirements for bodies operating product certification
systems
• ISO/IEC 17011: Conformity Assessment - General requirements for accreditation bodies
accrediting conformity assessment bodies
• ISO/IEC 17000: Conformity Assessment – Vocabulary and general principles
• IAF/PAC Guidance on the application of ISO/IEC Guide 65. (This document is used
only in accreditation processes under the ANSI scope of participation in the International
Accreditation Forum/Pacific Accreditation Cooperation Multilateral Recognition
Arrangement – IAF/PAC MLA; see section 5.3.5 below.)

3.0 Preliminary Letter of Application for Accreditation

3.1 Upon receipt of a request for information for ANSI accreditation, ANSI staff shall
provide the requirements for accreditation along with instructions for submitting a
Preliminary Letter of Application.
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 2/18

3.2 To determine the eligibility of a certification body to apply for ANSI accreditation, ANSI
shall request that the certification body shall submit a letter of preliminary application for
accreditation of its certification program(s), and attach the following information:

a) confirmation of third party status;


b) proof of ownership of a certification mark and/or a certificate of conformity, e.g.,
mark registered with the U.S. Patent and Trademark Office;
c) copy of publicly available documents describing the CB’s program; and
d) brief description of the program, including a list of the standard(s) utilized and the
identity of the inspection and/or testing body( ies,) if different from the certification
body.

3.3 Within 30 days of receipt of a preliminary letter of application for accreditation and the
required information, ANSI staff shall review and issue a written report determining the
eligibility of the program(s) for ANSI accreditation and shall notify the Chairperson of
the ANSI Accreditation Committee.

3.4 If ANSI finds, on the basis of the information submitted by the prospective applicant, that
the program appears to meet the eligibility requirements contained in section 3.2, ANSI
shall provide the inquirer with an application form and instructions for completing and
submitting the application.

3.5 If ANSI finds, on the basis of the information submitted by the prospective applicant, that
the program appears not to meet the eligibility requirements contained in section 3.2, the
Chair of the ANSI Accreditation Committee is so informed.

3.5.1 The Chair, in consultation with ANSI staff and/or Committee members, shall determine
the appropriate action to be taken. If it is determined that the applicant's program does
not meet the eligibility requirements, the applicant shall be advised in writing.

4.0 Application for Accreditation

4.1 The application for accreditation shall be signed by an authorized representative and shall
be submitted along with a cover letter and a non-refundable application fee to ANSI.

4.2 The following information is required in conjunction with the application:

a) scope of the desired accreditation (certification programs to be accredited and


International Classification for Standards [ICS] codes for each);
b) whether the body is operating:
i. Product certification programs; or
ii. Process and service certification programs;
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 3/18

c) numbers of sites and number of persons who work in each site and the types of
activities tha t the site conducts regarding the certification program; and
d) a signed contract agreement provided by ANSI to the applicant (see ANSI-ACP-PR-
024).

4.3 The Accreditation Program Application Form requires that the applicant include the
following information:

a) general characteristics of the applicant such as corporate entity, its relationship in a


larger corporate entity if any, name, addresses, legal status, relevant staff contacts,
and technical resources;
b) description of the certification body's activities including copies of its charter and/or
constitution and bylaws;
c) organizational chart, a listing of names of all management persons who will be
involved in the certification program along with their individual certifications if
applicable;
d) disclosure of the relationship of the certification body to all program licensees;
e) description of how the applicant manages any real or apparent conflicts of interest
between parties involved in the program;
f) identity of the body(s) conducting surveillance, if other than the certification body,
and a copy of the contract agreement between the certification body and the body( ies)
conducting surveillance;
g) program policy manuals and procedures documents such as certification program
procedures;
h) few sample pages of the directory of certified products, unless available online;
i) marks and labels used to identify a product as being certified;
j) specific details on the validation process including sampling methods, inspection
levels, and acceptance criteria;
k) any other available material which will aid ANSI in evaluating the application; and
l) the bases of compliance to ISO/IEC 17025.

4.4 Upon receipt of the completed application form (ANSI-ACP-FR-004), all requested
information, and the application fee, ANSI staff shall acknowledge receipt within five
working days and notify the Committee of such receipt.

4.5 Upon receipt of a new application, ANSI staff shall inform the ANSI Accreditation
Committee Chair of this event and request his/her permission to request two volunteers
from the ACC acceptable to the applicant to serve as an evaluation task group. These
two volunteers will follow the processing of the application by ANSI staff and assist
ANSI and the Committee, as necessary, in processing and acting on the application.

4.6 ANSI staff shall evaluate the application for completeness, using ANSI requirements as
defined in ANSI Policy ANSI-ACP-CA-001, ISO/IEC Guide 65 (ANSI-ACP-FR-005),
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 4/18

and any other applicable sector specific requirements. Additional information and/or
clarification may be requested from the applicant.

4.6.1 ANSI staff shall review its capabilities to conduct the assessment on the applicant by
evaluating the following:

a) availability of assessors and technical experts with the appropriate competence to


perform the assessment in a timely manner;
b) ANSI’s own policies; and
c) if accreditation has already been granted by any other body for a certification
program involving the products in the application and, if so, how that accreditation
process has been handled.

4.7 If a preliminary visit has been defined by ANSI or requested by the applicant, ANSI
provides the prospective applicant with associated costs, assigns an appropriate assessor,
and coordinates arrangements for the visit. Following the visit, a report shall be prepared
to identify non-compliances, but will not provide any recommendations that would be
construed as consultancy.

4.7.1 The purpose of a preliminary visit is to clarify issues arising from the application and/or
document review, and to ensure that ANSI has a full understanding of the organization of
the certification program, the facilities for delivering the product certification program
(e.g., regional offices, interfaces with other partie s, etc.), the structure of the certification
program, and its ownership. This visit also ensures that both parties have a full
understanding of the accreditation process appropriate to the relevant product
certification program.

4.8 When it is determined that the application is complete and that the applicant has the
potential to meet the accreditation criteria, the application is accepted and the applicant is
so notified in writing. At this stage the evaluation task group is activated.

4.8.1 The name of the applicant is added to ANSI's published list of applicants (ANSI home
page).

4.8.2 The acceptance of the application is announced in ANSI Standards Action. A 30-day
comment period is established for comment on the application. The announcement also
contains instructions for submitting comments to ANSI.

4.8.3 ANSI shall acknowledge receipt of all comments received and provide the applicant with
a copy. Where appropriate, ANSI or the applicant will respond.

4.9 If, after the initial application evaluation and/or preliminary visit, it is judged that the
applicant does not have the potential to meet the accreditation criteria, ANSI will:
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 5/18

a) notify the applicant and identify the deficiency( ies) in the application;
b) advise the applicant that if the deficiency(ies) is corrected, and a revised application is
submitted to ANSI within 90 days, ANSI review of the documentation shall resume
and payment of an additional fee may be required;
c) advise the applicant that if the deficiency( ies) is not corrected and/or a revised
application is not submitted to ANSI within 90 days, the application shall be
considered to be withdrawn. A new application may be submitted at any time; and
d) notify the Committee of the final action by ANSI.

5.0 Document Review, Initial Assessment, and Evaluation for Accreditation

5.1 Upon acceptance of the application and receipt of any required initial application fee,
ANSI shall review the operations of the applicant's program. An assessment team led by
a member of ANSI staff or a contracted individual shall conduct the review. The
assessment team shall be selected on the basis of competence and absence of potential
conflict of interest.

5.1.1 The applicant is notified of the names of the proposed members of the assessment team,
including any technical expert(s), if needed, and the organization to which they belong.
The applicant has 10 days to provide any written objections to any team member(s)
and/or expert(s). If the applicant raises objections to any proposed team me mbers, ANSI
will provide the names of alternative assessors.

5.1.2 The assessment team, including technical experts(s), shall have no ties with the applicant
which may influence the assessments. Team members are required to maintain the
confidentiality of all information obtained about the applicant and its operations. The
assessment team shall have appropriate knowledge of the specific scope for which
accreditation is sought.

5.1.3 ANSI shall clearly define the assignment given to the assessment team. The task of the
assessment team is to review the documents collected from the product certification
program and to conduct the on-site assessment. ANSI shall ensure that the assessment
team is provided with the appropriate criteria, relevant document s, and records of the
product certification program.

5.2 The assessment team reviews the applicant's application and any accompanying
documentation. The applicant may be required by the team leader to provide additional
information/clarifications/corrections before the accreditation process proceeds. The
purpose of the review is to determine whether the program is operating in compliance
with ANSI requirements specified in ANSI - Policy (ANSI-ACP-CA-001), ISO/IEC
Guide 65, and any other applicable sector specific requirements.
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 6/18

5.2.1 ANSI may decide not to proceed with an on-site assessment based on the
nonconformities found during document review. In such a case, the nonconformities
shall be reported in writing to the applicant about the product certification program.

5.3 ANSI, together with the lead assessor, arranges with the applicant for a mutually
acceptable schedule for the on-site headquarters and witness assessment(s). Witness
assessment(s) include, but are not limited to:

a) assessment of testing and inspection facilities (internal or external), if appropriate;


b) assessment of program activities in at least two manufacturing or licensee facilities;
and
c) observation of the operations of the program management functions.

5.3.1 During initial assessment sites shall be selected to ensure that sufficient objective
information can be collected to verify that the documented certification procedures are
implemented.

a) If the certification body operates a certification process spread across multiple sites
with no one site housing all the certification activities, then assessments shall cover as
many additional sites and key activities as necessary to collect objective information
to verify that documented procedures are implemented.

Note: Key activities include: policy formulation, process and/or procedure


development and, as appropriate, contract review, planning conformity assessments,
review, approval, and decision on the results of conformity assessments.

b) If the certification body operates more than one certification process (more than one
documented set of procedures), then assessments shall cover as many additional sites
as necessary, to verify that the documented procedures are implemented.

5.3.2 For each certification process operated in whole at multiple sites, initial assessments shall
include:

a) a minimum of two sites to verify that the same procedures are being utilized at
different sites; and
b) a minimum of two sites, if applicable, to verify that the same procedures can be
used effectively in significantly different business environments (e.g., sites using
different languages, sites under different legal systems or sites that are
significantly different in size).

5.3.3 The minimum number of sites necessary to meet all the above guidelines shall be selected
for the initial assessment. If needed, additional sites shall be included as part of the initial
assessment to ensure that every site is assessed, either during the initial assessment or
during the first year of surveillance assessment.
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 7/18

5.3.4 To determine the minimum number of sites for the initial assessment:

a) first, select a site to satisfy requirements in paragraph 5.3.1;


b) select any additional sites necessary to satisfy paragraphs requirements in 5.3.1 - a &
b;
c) select any additional sites to satisfy requirements in paragraph 5.3.2 - a;
d) select any additional sites to satisfy paragraph requirements in 5.3.2 - b; and
e) verify that any unselected sites can be assessed during the first year of surveillance.

Note: Different certification processes arise when different techniques are used for the
initial assessment, any ongoing surveillance activity or the method used to identify
certified products.

Examples of different certification processes would be:

i) initial type testing, surveillance based on factory compliance audits, testing of


production samples, and the use of a mark of conformity;
ii) initial type testing, surveillance based on periodic assessment of the factory’s quality
management system, and the use of a mark of conformity;
iii) initial type testing, surveillance based on factory compliance audits, testing of
production samples, and the use of a certificate of conformance (no mark of
conformity) ; and
iv) initial design review of the product, surve illance based on factory production audits,
and the use of a mark of conformity.

The applicant is provided with a confirmation of the assessment schedule and a detailed
assessment plan for review and approval.

5.3.5 For initial assessment in accreditatio n processes under the ANSI scope of participation in
the International Accreditation Forum/Pacific Accreditation Cooperation Multilateral
Recognition Arrangement (IAF/PAC MLA) or as mandated by an external entity that
controls the certification program, in addition to visit ing the main office, visits shall be
made to all premises of the certification body from which one or more key activities are
performed and which are covered by the scope of accreditation.

Note: Key Activities include: policy formulation, process and/or procedure development
and, as appropriate, contract review, planning conformity assessments, review, approval,
and decision on the results of conformity assessments.

5.4 The assessment team conducts the on-site assessment with an opening meeting at which
the purpose of the assessment and accreditation criteria are clearly defined. The
assessment schedule and the scope of assessment are also confirmed. As well, witness
assessment(s), as defined in section 5.3, is carried out by the ANSI assessment team.
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 8/18

5.5 The ANSI assessment team shall analyze all relevant information and evidence gathered
during the document and records review as well as the on-site assessment. This analysis
shall be sufficient to allow the ANSI assessment team to determine the extent of
fulfillment of accreditation requirements, including competence, as contained in ANSI
Policy (ANSI-ACP-CA-001), ISO/IEC Guide 65, ANSI-ACP-CA-002, and the
applicant's own policies and procedures as well as any other applicable sector specific
requirements. If necessary or appropriate, formal nonconformity reports (NCRs) are
issued for identified deficiencies which require corrective action by the applicant. The
team’s observations on areas for possible improvement shall be reported in writing to the
applicant about the product certification program; however, consultancy shall not be
provided.

5.5.1 Where the ANSI assessment team cannot reach a conclusion about a finding, the team
should refer back to ANSI staff for clarification.

5.6 An exit meeting shall take place between the assessment team and the certification
program representatives prior to leaving the site. At the exit meeting, the ANSI
assessment team shall provide a summary report, its findings identified during the
assessment, and requirements for submitting corrective actions plans. All corrective
action plans shall be submitted within 30 days after the posting of the nonconformity on
the ANSICA database (see ANSI-ACP-PR-053).

5.7 An assessment report covering all assessment activities is prepared by the assessment
team (lead assessor and technical expert) and submitted to ANSI. The report includes
assessment details, NCRs issued, and concerns identified.

5.8 The certification body shall be invited to comment on the assessment report. ANSI staff
and the assessment team shall consider any comments submitted and finalize the report,
as appropriate.

5.9 If a response regarding corrective action(s) has been received from the applicant, the
response is reviewed by the assessment team (lead assessor and technical expert) for
acceptability and recording in NCR forms no later than 30 days after the date of receipt.
The response and any comments by the team lead assessor regarding its acceptability
shall be submitted to the certification body. The Program Director transmits the final
report to the applicant with a cover letter or e- mail stating the next step(s) to be taken in
the accreditation process.

5.10 Responses to all NCRs and expressed concerns must be accepted by the assessment team
and appropriate ANSI staff before the accreditation process proceeds. Acceptance of
these responses is based upon evaluation and review by the assessment team and
appropriate ANSI staff to see if the actions appear to be sufficient and effective. The
assessment team will verify whether all deficiencies and concerns have been adequately
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 9/18

addressed by the applicant. Additionally, evidence of effective implementation of actions


taken may be requested or a follow-up assessment(s) and/or additional witness
assessment(s) may be required to verify effective implementation of corrective actions.

5.11 The information provided to the evaluation task group and made available to ANSI
Accreditation Committee members shall include the following, as a minimum:
a) unique identification of the product certification program;
b) date(s) of the on-site assessment;
c) name(s) of the assessor(s) and/or experts involved in the assessment;
d) unique identification of all premises assessed;
e) proposed scope of accreditation that was assessed;
f) assessment report;
g) statement on the adequacy of the internal organization and procedures adopted by the
product certification program to give confidence in its competence, as determined
through its fulfillment of the requirements for accreditation;
h) information on the resolution of all nonconformities;
i) any further information that may assist in determining fulfillment of requirements and
the competence of the product certification program;
j) where applicable, a recommendation on granting, reducing or extending accreditation
for the proposed scope; and
k) bases of the compliance of each test laboratory from which data is being reviewed to
ISO/IEC 17025.

6.0 Decision on Accreditation

6.1 The evaluation task group reviews the assessment report (see 5.11) and determines if the
assessment is complete and the certification process complies with the procedural
requirements contained in ANSI Policy – ANSI-ACP-CA-001, ANSI-ACP-CA-002,
ISO/IEC Guide 65 and any other applicable sector specific requirements. If the task
group desires that the ANSI staff report be clarified and/or additional assessment tasks be
performed, ANSI staff shall respond accordingly and submit a revised report to the task
group. A copy of the revised report will be sent to the applicant for technical review and
comment. If, based on the revised report, the ETG determines any requirement has not
been fulfilled, ANSI staff shall offer the applicant in writing to either terminate the
accreditation process or to send a recommendation to deny accreditation to the
Accreditation Committee.

6.2 ANSI staff will prepare a recommendation based on the Evaluation Task Group
conclusion for the accreditation decision by the ANSI Accreditation Committee. The
recommendation is presented to the ANSI Accreditation Committee for a vote on
granting or denying accreditation in accordance with Committee Operating Procedures
(ANSI-ACP-CA-003). This vote may be conducted by letter ballot.
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 10/18

6.2.1 If the Committee votes to deny accreditation, the basis for denial shall be documented.

6.3 Following approval by the ANSI Accreditation Committee, ANSI staff will notify the
applicant in writing of the approval. This notification will include information related to
the scope of accreditation and an invoice for any applicable accreditation fee. The
applicant will provide a certificate of insurance or other evidence of fulfillment of
ISO/IEC Guide 65, clause 4.2h or have adequate arrangements to cover liabilities arising
from its operations and/or activities.

6.4 If the ANSI Accreditation Committee does not vote to approve the accreditation, ANSI
staff shall promptly notify the applicant in writing and include the basis for the
Committee's decision along with information on any additional steps to be taken by the
applicant, which may be deemed appropriate. The applicant may also appeal the decision
in accordance with section 11.0 (ANSI-ACP-CA-002).

6.4.1 The applicant, after correcting all outstanding deficiency( ies)/concern(s), may reapply to
ANSI for accreditation at any time. Resubmission may necessitate payment of an
additional fee.

6.4.2 Unsuccessful applicants must pay all ANSI's costs and fees associated with the
application for accreditation, as described in Section 4.0, upon resubmission of the
application.

7.0 Accreditation Fees and Expenses

7.1 ANSI staff shall determine fee amounts for each program based on the ANSI fee
schedule established in accordance with the contract agreement. The ANSI Accreditation
Committee shall approve the fee schedule. Any changes in the fee schedule shall be
incorporated into new and renewed contracts covering accredited certification programs,
as appropriate.

7.2 ANSI shall invoice the applicant for incurred costs and fees in accordance with the
current fee schedule.

7.3 Failure to pay the invoice by its due date may result in ANSI taking one of the following
actions:

a) refusal of any further consideration of the application;


b) non-execution of the accreditation agreement; or
c) termination of an existing accreditation agreement.
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 11/18

8.0 Accreditation

8.1 Following receipt of the certificate of insurance and any applicable fee payment, ANSI
staff shall prepare a certificate of accreditation signed by the ANSI Vice President for
Accreditation Services. The accreditation agreement defines the responsibilities of ANSI
as the accreditation body for the accredited certification program.

8.2 ANSI shall publish a public notice of accreditation in "ANSI Standards Action." Any
interested body may appeal a decision to grant accreditation within 30 days after
publication of that decision in accordance with Section 11 (ANSI-ACP-CA-002).

8.3 ANSI shall send to the newly accredited body the Certificate of Accreditation. This
Certificate of Accreditation shall identify (on the front page, when possible):

a) identity and logo of the accreditation body;


b) unique identity of the accredited product certification body and program;
c) all premises from which one or more key activities are performed that are covered by
the accreditation;
d) unique accreditation number of the accredited product certification program;
e) effective date of granting of accreditation and, as applicable, the expiry date;
f) brief indication of, or reference to, the scope of accreditation;
g) statement of conformity and a reference to the standard(s) or other normative
document(s), including issue/revision used for assessment of the product certification
program; and
h) effective date of accreditation (first day of the month following the date of the
accreditation decision).

The accreditation certificate shall also identify

i) type of certification program, where applicable


1) standards, normative documents, regulatory requirements or types thereof to
which products are certified.

9.0 Continuing accreditation

9.1 Continuing accreditation assessment activities shall be conducted at least annually. The
first surveillance assessment shall be carried out no later than 12 months from the date of
initial accreditation. Subsequent re-assessments shall be carried out no later than 12
months from the date of surveillance. The purpose of these activities shall be to:
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 12/18

a) determine that the program continues to operate in compliance with ANSI


requirements and the requirements of ISO/IEC Guide 65 and any other applicable
sector specific requirements; and
b) determine if the program continues to operate, as described in the accredited body's
documentation governing the program.

Continuing accreditation activities shall include, but not be limited to:

i) assessment of headquarters and other locations, if applicable, to selected requirements


(ISO/IEC Guide 65);
ii) assessments of program functions to ensure that systems and personnel operations
continue to be properly conducted in compliance with program document(s) approved
by ANSI;
iii) witness assessment(s) of the conduct of the program at program licensee locations;
and
iv) other visits and assessments needed to confirm that the program is being operated
properly, as set forth in program documents approved by ANSI and in accordance
with ANSI requirements.

9.2 ANSI will schedule and plan on-site surveillance and re-assessment activities. For
accredited certification bodies with multiple sites, the criteria to select sites are defined in
items 5.3.1 to 5.3.5.

9.3 ANSI staff shall submit a report on the results of continuing accreditation assessments
prepared by the ANSI assessment team to the certification body and to the ANSI
Accreditation Committee. The report shall include any non-compliance findings together
with a copy of the request that ANSI be notified in writing within 30 days by the
certification body of its planned corrective actions. ANSI staff shall request creation of
an Evaluation Task Group to review the continuing assessment report and the
nonconformities, as they deem necessary.

When nonconformities are identified during surveillances or reassessments, ANSI staff


will take into consideration ANSI Accreditation Committee policies that define strict
time limits for corrective actions to be implemented by ANSI-accredited certification
bodies. This time limit is defined on a case-by-case basis.

ANSI staff and the assessment team shall determine if the proposed corrective actions are
satisfactory, and report the results of the continuing accreditation activity to the ANSI
Accreditation Committee. The report will include information on any corrective actions
determined to be satisfactory and any unresolved non-compliance issues. ANSI staff and
the assessment team shall ensure that proposed corrective actions are implemented in
subsequent assessments and evaluations.
MANUAL OF OPERATIONS FOR ACCREDITATION OF PRODUCT Number: ANSI-ACP-CA-002
CERTIFICATION PROGRAMS Date Issued: October 25th, 2006
Version#: 01/2006
Developed by: ANSI/ACC
Verified by: ANSI
Approved by: ANSI/ACC
Page: 13/18

9.4 ANSI staff shall review ongoing continuing accreditation activities and reports of their
status at each ANSI Accreditation Committee meeting, and provide information as the
basis for decisions on maintaining accreditation.

9.5 ANSI accreditation is continued if the results of continuing accreditation activities,


including evaluations of any corrective actions taken by the certification body, support
continued accreditation and the ANSI Accreditation Committee votes in favor of
continued accreditation.

9.6 If the results of continuing accreditation activities, including evaluations of corrective


actions taken by the certification body, do not support continued accreditation and
subsequent ly the ANSI Accreditation Committee decides to suspend or withdraw
accreditation, ANSI staff shall notify the certification body of this result in writing. The
provisions of Section 10.0 of ANSI-ACP-CA-002 will apply.

9.7 In conjunction with the evaluation task group, ANSI may decide to conduct extraordinary
assessments as a result of complaints, changes, etc. ANSI shall advise the product
certification program of this possibility.

9.8 ANSI shall, in response to an application for extension of scope of an accreditation


already granted, undertake the necessary activities to determine whether or not the
extension of scope may be granted. Where appropriate, assessment and granting
procedures shall be as defined in 4.0 to 7.0.

9.9 ANSI shall maintain records on accredited certification programs to demonstrate that
requirements for accreditation, including competence, have been effectively fulfilled.

9.9.1 Records on accredited certification program shall include:

a) relevant correspondence;
b) assessment records and reports;
c) records of committee deliberations, if applicable, and accreditation decisions; and
d) copies of accreditation certificates.

10.0 Suspending, reducing, withdrawing, and reinstating accreditation

10.1 ANSI may suspend, reduce or withdraw its accreditation of a certification program for
the reasons listed in the contract agreement or if any of the following occur:

a) filing of any voluntary or involuntary petition of bankruptcy;


b) making of any arrangement with creditors or holding of "composition of creditors"
action in regard to financial difficulties or bankruptcy proceedings;
c) appointment of a receiver for the business;
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d) voluntary or involuntary liquidation of the business or the organization;


e) discontinuance of the accredited certification program;
f) failure by the certification body to take appropriate and timely corrective action on
deficiencies in its program that have been requested by ANSI; and
g) persistent failure by an accredited certification program to meet the requirements of
accreditation or to abide by the rules for accreditation.

10.2 If at any time during the term of the contract the certification body defaults in any way on
its obligations to ANSI, ANSI shall call this infraction to the attention of the certification
body for immediate correction. The communication to the body shall include a notice
that if the matter is not immediately corrected, it will be brought to the attention of the
ANSI Accreditation Committee, which may vote to suspend the accreditation for 60 days
from the date of the ANSI Accreditation Committee decision. If the matter remains
unresolved, the ANSI Accreditation Committee may vote to terminate the accreditation.

10.3 When ANSI accreditation is suspended, reduced in scope or withdrawn, ANSI staff shall
publish a notice in Standards Action and otherwise publicize the action in any way that
the ANSI Accreditation Committee deems appropriate.

10.4 The accreditation of the certificatio n body will be reinstated, when it demonstrates
compliance with ANSI accreditation requirements.

11.0 Appeal between ANSI and an applicant or an Accredited Certification Program

11.1 Appeals may be made only by an applicant or an accredited certification body materially
interested in or affected by an action or inaction of the ANSI Accreditation Committee
that is within the scope of the committee and the accreditation being considered. The
non-refundable fee for filing a formal appeal is $ 1,000.00. The written appeal made by
the certification body shall be filed within 30 days of the action of the ANSI
Accreditation Committee or the ANSI assessment team. The ANSI Accreditation
Committee staff secretary shall contact the respondent included in the appeal and ask the
respondent if he/she wishes to submit a written statement opposing the substance of the
appeal.

11.2 An appeal between ANSI and an applicant or an accredited certification program shall be
handled in the following manner:

a) ANSI staff shall attempt to resolve the appeal; and

b) if ANSI staff is unable to resolve the appeal, either the accredited certification body
or ANSI staff may refer the appeal to the ANSI Accreditation Committee for
resolution. The appeal shall be then ha ndled by the procedure described in section
11.3 below.
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11.3 Upon receipt of notice of the appeal, the ANSI Accreditation Committee shall establish a
panel consisting of at least three ANSI Accreditation Committee voting members
selected on the basis of their competence and knowledge of certification programs and
absence of any conflict(s) of interest. The certification body shall be provided with the
list of panel members and will have 10 days from receipt of the list to file an objection to
any panel member whom the certification body believe s has a conflict of interest. The
panel shall act on behalf of the ANSI Accreditation Committee and proceed as follows:

a) panel shall elect a panel chair from among its members. ANSI shall notify the
accredited body involved in the dispute of the date on which the appeal shall be
heard. The hearing date selected should be no less than 10 days and no more than
thirty days from the date such a notice is transmitted (if there is no opposing
statement(s) submitted.

b) if there is a statement(s) submitted, the opposing party(s) may have 30 days to submit
a formal written justification for its opposition to the appeal. In this case, a hearing
shall be set up within 60 days of the receip t of the written justification opposing the
appeal.

c) at the hearing, the appellant's position shall be presented first followed by any written
statements opposing the appeal. Unless the appeals panel rules otherwise, one hour
shall be allotted for each side, with a limit of three speakers per side, and an additional
half hour shall be allotted for questions from the appeals panel. The appeals panel
shall then retire to discuss the appeal testimony in a closed session.

d) panel, after hearing statements from the accredited body involved and from ANSI
staff, shall reach a decision in closed session. The report of the Panel shall be
effective, when approved in writing by a majority of its members. The Panel Chair
shall transmit the decision to the parties involved and the ANSI Accreditation
Committee shall evaluate and approve the panel’s recommendations.

11.4 If the adversely affected party wishes to appeal the decision, the issue involved shall be
submitted to the ANSI Appeals Board. As an alternative, an appeal may be submitted to
arbitration, which shall be conducted by three arbitrators selected by the American
Arbitration Association. The arbitration shall proceed under the rules of that association,
including handling of arbitration costs. All parties to the dispute shall agree to abide by
the decision of the arbitration.

12.0 Complaints Regarding Accredited Certification Programs


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12.1 ANSI shall only consider complaints about accredited certification programs involving
their compliance with accreditation program criteria. ANSI shall, where appropriate,
ensure that a complaint concerning an accredited certification body is first addressed by
the accredited certification body itself.

12.2 The complainant shall submit a detailed written complaint statement to ANSI. ANSI
staff shall review the statement and present it along with a statement by ANSI staff at the
next ANSI Accreditation Committee meeting. The ANSI Accreditation Committee shall
decide on a course of action regarding the complaint, which may include holding an
Accreditation Committee hearing involving the complainant and the certification body
involved. Costs of any testing, examinations or investigations deemed necessary by the
ANSI Accreditation Committee shall be borne by the complainant, unless the ANSI
Accreditation Committee determines that the accredited program has failed to comply
with the approved program requirements or the requirements of ANSI Policy – ANSI-
ACP-CA-001 and ISO/IEC Guide 65 as well as any other applicable sector specific
requirements. In that case, the certification body involved shall bear the entire cost of
any such investigations.

12.3 The adversely affected party to the ANSI Accreditation Committee decision regarding
the complaint may appeal that decision in accordance with section 11.0 (ANSI-ACP-CA-
002). In this situation, the first sentence of section 10.1 (ANSI-ACP-CA-003) does not
apply.

13.0 Complaints Regarding the ANSI Accreditation program

13.1 Complaints regarding the ANSI Accreditation Program shall be handled in the following
manner:

a) ANSI staff shall attempt to resolve the complaint; or


b) if ANSI staff is unable to resolve the complaint, ANSI staff will refer the complaint to
the ANSI Accreditation Committee for resolution.

13.2 A complaint shall be filed by sending a registered letter to ANSI, which includes
appropriate substantiation for the complainant's position. ANSI will immediately
transmit this letter to the Chair of the ANSI Accreditation Committee.

13.3 The Chair of the ANSI Accreditation Committee will appoint a task group comprised of
members of the Committee to review the complaint and render a recommendation to the
Chair for consideration by the ANSI Accreditation Committee.

13.4 ANSI staff shall communicate the decision of the ANSI Accreditation Committee to the
complainant.
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13.5 If the decision is not favorable to the complainant, the appellant may file another
complaint by registered letter to ANSI. ANSI will immediately transmit this letter to the
Chair of the ANSI Accreditation Committee.

13.6 The procedures outlined in section 11.0 of ANSI-ACP-CA-002 shall be followed.

14.0 Public Notice and Information

14.1 ANSI staff shall publish an announcement in ANSI Standards Action about the granting,
extending, reducing, suspending, and withdrawing of accreditations and of applications
for accreditation.

14.2 ANSI shall maintain a current list of accredited third party product certification programs
and applicants. The information in the listing shall be made available on the internet
and/or in a hard copy upon request.

15.0 Annual Fee

15.1 The accredited certification body shall pay an annual fee, as shown in the current fee
schedule.

15.2 In case of premature termination of the accreditation agreement, a pro-rata payment of


the fee for the portion of the accreditation year during which accreditation was in effect is
payable in full upon termination.

16.0 Modification to Accreditation Policies and Criteria

16.1 The ANSI Accreditation Committee shall authorize modifications to the policies and
criteria for ANSI accreditation. When a decision has been made to modify program
policies and/or criteria, the ANSI Accreditation Committee shall also decide on the
effective date for the modifications.

16.2 ANSI staff will publish a request for public comment on any proposed modifications to
program criteria and procedures in ANSI Standards Action. ANSI staff will respond to
comments received after coordinating the response with the ANSI Accreditation
Committee. The proposed modifications may be revised as a result of the review and
public comment process. A final version of any revised document, which incorporates
agreed upon modifications, will be submitted to the ANSI Accreditation Committee for
formal approval.
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16.3 ANSI staff will announce the availability of the approved versions of the modified
program policies and criteria in ANSI Standards Action.

16.4 If the accreditation policies and criteria, including annexes, are modified, ANSI staff
shall immediately notify both accredited bodies and applicants for accreditation in
writing of the modifications. ANSI will specify whether a supplementary assessment is
necessary to determine conformance to the modifications. The date on which the
modifications become effective shall be specified. This date will be at least six months
from the date of notification of the modification(s).

16.5 If an applicant certification body informs ANSI that it will not accept the changes,
consideration of the application for accreditation will be terminated. ANSI staff will
notify the ANSI Accreditation Committee of this action.

16.6 If an accredited certification body informs ANSI that it accepts the changes, and if the
outcome of a supplementary assessment (if appropriate) is favorable, ANSI staff shall, if
applicable, issue new or renewed contracts covering the accredited certification
programs. The modifications will be considered to be part of the accreditation agreement
from the date on which the change(s) take place.

17.0 Confidentiality and Disclosure of Information

17.1 All information is confidential except the information the certification body itself makes
public. The notice of accreditation is published in ANSI standards action and ANSI home
page.

17.2 All other information acquired during ANSI accreditation activities is to be treated as
confidential by all program participants, including ANSI staff, its agents, members of the
ANSI Accreditation Committee, and any subcontractors.

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