Source: https://www.ansi.org/accreditation/product-certification/DocumentDetail?DRId=788
Timestamp: 2018-12-15 19:35:02
Document Index: 250390696

Matched Legal Cases: ['art 770', 'art 770', 'art 770', 'art 770', 'art 770', 'art 770', 'art 770', 'art 770']

Accreditation Program for US Environmental Protection Agency Formaldehyde Emission Standard for Composite Wood Products
PUBLIC PROCEDURE PRO-PR-172-EPA-FES Issued: 2018-6-6, Revision: 2
Attachments PRO-PR-172-EPA FES ANNEX .docx
References ANSI-FR-022: Non-Conformity/Corrective Actions
ANSI-PR-004: Appeals
ANSI-PR-005: Complaints
ANSI-PR-027: Rules Governing the Use and Protection of the ANSI Accreditation Mark and References to ANSI Accreditation
PRO-FR-104: Application for Accreditation of Product Certification Program
PRO-FR-105-ISO/IEC 17065: Checklist for Accreditation Requirements: ISO/IEC 17065
PRO-FR-119: Report of the Witness Assessment on Certification Bodies
PRO-FR-128: Report of the Evaluation Task Group
PRO-FR-153-EPA FES: Checklist for Accreditation Requirements: US EPA Formaldehyde Emission Standard for Composite Wood Products
PRO-PL-103: Operating Procedures of the Accreditation Committee
PRO-PR-112: Information on the Application Process
PRO-PR-116: Surveillance and Reassessment of Accredited Product Certification Bodies
PRO-PR-120: Assessment Report
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-146: Technical Assessor
40 CFR Chapter I, Subchapter R, Part 770 - Formaldehyde Standard for Composite Wood Products
ASTM D6007-02: Standard Test Method for Determining Formaldehyde Concentration in Air from Wood Products Using a Small Scale Chamber
ASTM E1333-10: Standard Test Method for Determining Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a Large Chamber
ISO/IEC 17011: Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC 17020: Conformity assessment - Requirements for the operation of various bodies performing inspection
ISO/IEC 17065: Conformity assessment - Requirements for bodies certifying products, processes and services
General Requirements - Application for Certification in accordance with ISO/IEC 17065 and the EPA - Formaldehyde Standard for Composite Wood Products
1.1 Objective of this procedure
This procedure provides the ANSI criteria, process and guidelines for the accreditation of certification bodies in accordance with ANSI procedures and ISO/IEC 17065. In addition, the requirements for Certification Bodies set forth in this procedure are specific requirements relating to performing certification to the standard owned by the Environmental Protection Agency (EPA) Formaldehyde Standard for Composite Wood Products including Subpart A "General Provisions", Subpart B "EPA TSC Title VI Third - Party Certification Program", and Subpart C "Composite Wood Products".
1.2 Scope of the Certification Scheme
The procedures and requirements as specified in this manual are applicable for Certification Bodies that apply for accreditation to certify against scheme requirements developed by EPA in the identified regulations as specified in 40 CFR Chapter I, Subchapter R, Part 770 - Formaldehyde Standard for Composite Wood Products. The scheme addressed the clauses of ISO/IEC 17065 as found in the regulations as presented in Annex A. The CB procedures must address any requirements not addressed by the regulations and required by ISO/IEC 17065.
2.1 As a general rule, definitions of ISO/IEC 17000:2004 and ISO 9000:2015 are applicable. Additionally, the definitions of the EPA Formaldehyde Standard for Composite Wood Products are applicable.
2.2 EPA Formaldehyde Program for Composite Wood Products: As a general rule, this term refers to 40 CFR Chapter I, Subchapter R, Part 770 - Formaldehyde Standard for Composite Wood Products.
2.3 EPA - US Environmental Protection Agency.
2.4 TSCA - Toxic Substance Control Act
2.5 CARB - California Air Resources Board
2.6 TPC - Third Party Certifier
3.1 EPA has issued a final rule to implement the Formaldehyde Standards for Composite Wood Products Act, which added Title VI to the Toxic Substances Control Act (TSCA). The purpose of TSCA Title VI is to reduce formaldehyde emissions from composite wood products, which will reduce exposures to formaldehyde and result in benefits from avoided adverse health effects. This final rule includes formaldehyde emission standards applicable to hardwood plywood, medium-density fiberboard, and particleboard, and finished goods containing these products, that are sold, supplied, offered for sale, or manufactured (including imported) in the United States. This final rule includes provisions relating to, among other things, laminated products, products made with no-added formaldehyde resins or ultra-low-emitting formaldehyde resins, testing requirements, product labeling, chain of custody documentation and other recordkeeping requirements, enforcement, import certification, and product inventory sell-through provisions, including a product stockpiling prohibition.
4 Accreditation Requirements
4.1 ANSI Requirements
4.1.1 In order to be eligible to be accredited by ANSI, the applicant CB shall comply with ANSI criteria as defined in PRO-PL-101 and PRO-PL-102. International consistency is further reinforced by ANSI's adherence to the requirements of the International Accreditation Forum, Inc./Pacific Accreditation Cooperation (IAF/PAC).
4.2 Sector Specific Requirements
4.2.1 EPA Accreditation Requirement
4.2.1.1 Sector specific accreditation requirements are contained in 40 CFR Chapter I, Subchapter R, Part 770 - Formaldehyde Standard for Composite Wood.
4.2.2 Scopes of Accreditation
4.2.2.1 The scope of an applicant body shall be defined in accordance with the requirements set forth in The EPA Standard for Composite Wood Products documents. Using the scheme and CB procedures ensures that applicants provide an accurate and unambiguous description of the areas of capability for which the certification body is accredited. The CB must not contradict ISO/IEC 17065 and the EPA requirements in 40 CFR Part 770.
4.2.2.2 For an extension of scope, the accredited certification program shall formally apply to ANSI by letter or e-mail . Each request for an extension of scope will be individually reviewed, and a decision on whether or not the request is accepted by ANSI or requires additional information will be determined by ANSI.
4.2.3 Administrative and Operational Requirements
4.2.3.1 The administrative and operational requirements imposed on the CB are contained in the EPA-Formaldehyde Standard for Composite Wood Products.
4.2.4 Subcontracting
4.2.4.1 A Certification Body may use subcontractors in accordance with the provisions in ISO/IEC 17065 and any requirement defined by the EPA - Formaldehyde Standard for Composite Wood Products.
4.2.5 EPA Recognition
4.2.5.1 After a CB has been accredited, the CB must apply to the EPA for recognition as a TPC.
5 Application for Accreditation
5.1 Information on the Procedure - Preliminary Letter of Application for Accreditation. ANSI evaluates inquiries from applicants to determine eligibility in accordance with clause 4.2 of PRO-PL-102: Manual of Operations for Accreditation of Product Certification Programs:
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 certification scheme (s), including a list of the standard(s) utilized and the identity of the inspection and testing body(ies), used by the CB.
5.2 Analysis of the Preliminary Letter of Application
5.2.1 The analysis of the Preliminary Letter of Application is conducted in accordance with PRO-PL-102: Manual of Operations for Accreditation of Product Certification Programs. Applicants who have demonstrated compliance with the eligibility requirements are sent an application package.
5.3 The Application
5.3.1 The documents, which ANSI provides to the CB Applicant, are listed in PRO-PR-112: Application Process. Applicants shall provide documents and background information to initiate the accreditation process in accordance with PRO-PL-102.
NOTE: Applicants are encouraged to provide electronic versions of application documentation. Where this is not possible, the applicant shall provide five copies of application documentation.
5.3.2 The application is processed in accordance with PRO-PL-102, PRO-PR-112, and EPA - Formaldehyde Standard for Composite Wood Products documentation. The applicant shall provide the following documents:
a) PRO-FR-104: Application for Accreditation of Product Certification Program
b) PRO-FR-105-ISO/IEC 17065: Checklist for Accreditation Requirements: ISO/IEC 17065
c) Copy of Quality Manual
d) Any and all procedures related to the certification scheme
e) Submittal of the names of the organizations used for inspection and testing, The testing labs must be accredited by an EPA TSCA Title VI Laboratory AB to ISO/IEC 17025 with the scope of accreditation to include "Formaldehyde Standards for Composite Wood Products" and the formaldehyde test methods ASTM E1333-14 and ASTM D6007-14, if used.
5.3.3 An application will be considered inactive if an applicant does not reply to written informational requests nor actions required by ANSI. ANSI will provide a written notice prior to the 70th day from the date of notification of receipt of application. One year from the notification of receipt of application, the applicant shall complete all its required actions in the accreditation process unless the process has been delayed by ANSI. At the discretion of the Program Director, the timeline may be extended but it cannot exceed eighteen months from the date of notification of receipt of application. If the applicant fails to complete the accreditation process within the time defined above, the applicant shall be obligated to reapply for accreditation and will have to submit a new application package and pay new initial fees.
5.4 Preparation for Assessment
5.4.1 The preparation for the initial assessment is described in PRO-PR-102.
5.4.2 Complete a checklist for the EPA TSCA Title VI TPC requirements in Part 770.7 (c) 4 for each assessment along with PRO-FR-105-ISO/IEC 17065.
5.5 Assessment/Competencies of ANSI assessment team
5.5.1 The assessment team will conduct the document review and a document review report will be submitted to the applicant. A conference call will be held between ANSI staff, the assessment team, and the applicant to discuss the results of the document review report.
5.5.2 Initial assessments are conducted at the applicant's head office facility and at other key location(s) that perform activities related to the certification process. Witness assessment is part of the initial assessment. See requirements defined in PRO-PL-102 and by the EPA - Formaldehyde Standard for Composite Wood Products requirements.
5.5.3 The assessment team will present to the certification body applicant a summary of the results of the on-site assessment that includes the non-conformity(ies) (if applicable).
5.6 Witness Assessment
5.6.1 During the initial assessment and continued accreditation, ANSI will conduct a witness assessment(s) to assess the competency of the Certification Body Applicant to conduct visits on its clients for each requested scope in accordance with the EPA - Formaldehyde Standard for Composite Wood Products requirements. This includes implementation of the requirements of ISO/IEC 17020 as stated in the EPA-Formaldehyde Standard for Composite Wood Products.
5.7 Assessment Report
5.7.1 The assessment and technical reports are developed in accordance with PRO-PR-120. For the technical assessment, the technical and lead assessors shall take into consideration the clauses mentioned in PRO-PR-146 as well in the PRO-FR-153-EPA-FES checklist. The assessment reports will be sent to the applicant within 30 days of the initial assessment.
5.8 Decision on Accreditation
5.8.1 The applicant shall send a corrective action plan to address any required actions. The response shall either provide evidence of completion of any required corrective actions or shall present a plan to address the Non-conformity (ies).
5.8.2 Corrective actions for all issued non-conformities shall be reviewed, and non-conformities closed before the application can proceed to the next stage.
5.8.3 Once all required actions are satisfied, ANSI forwards the following documents to the Evaluation Task Group (ETG) for its review:
a) Background Information about the Certification Body;
b) ANSI Lead Assessment Report and Technical Assessment Report with appropriate checklists;
c) Witness Assessment Report on Certification Body (PRO-FR-119) Including appendix for ISO/IEC 17020;
d) Non-conformity/Corrective Action Record (ANSI-FR-022); and
e) Report of the PRO Evaluation Task Group (PRO-FR-128).
5.8.4 During a conference call, the ETG members review the documents related to the applicant's initial assessment and based upon the review, make a decision to recommend/not recommend the accreditation of the applicant to ANSI Accreditation Committee. The assessment team participates in the initial part of the agenda of the conference to provide the background on the results of the on-site assessment and to answer questions.
5.8.5 In making accreditation decisions, the ANSI Accreditation Committee shall base such decisions on the applicant's capacity to meet requirements in ANSI accreditation criteria and the EPA program documentation.
5.8.6 The ANSI Accreditation Program provides recognition of attainment of accreditation to its accredited bodies in the form of a certificate signed by an ANSI representative. This certificate identifies all sites covered by the accreditation:
5.9 Surveillance and Reassessment Procedures
5.9.1 Surveillance and reassessments are conducted in accordance with PRO-PL-102, PRO-PR-116, PRO-PR-146 and the EPA - Formaldehyde Standard for Composite Wood Products Requirements. The witness assessment is conducted in accordance with PRO-PR-119 during surveillances and reassessments.
5.10.1 All records are maintained in accordance with, PRO-PL-102 and EPA - Formaldehyde Standard for Composite Wood Products.
5.11 Reference to Accreditation Status
5.11.1 ANSI will provide EPA representatives with the list of accredited certification bodies who comply with ANSI and the EPA - Formaldehyde Standard for Composite Wood Products. ANSI maintains this information in a database in accordance with ANSI-PR-007 and in ANSI directory of accredited certification bodies.
5.11.2 ANSI is the owner of an accreditation Symbol intended for use under the ANSI Accreditation Program. The ANSI Accreditation Program allows an accredited body to refer to its accreditation in certificates, reports, stationery and publicity materials related to its accredited activities.
5.11.3 ANSI does not allow the use of its accreditation symbol in any way that implies that ANSI has approved a product, process or service certified by an accredited body. The ANSI accreditation symbol shall not be used on a product or in any other way that may be interpreted as denoting product conformance or endorsement by ANSI. Refer to ANSI-PRO-NT-117.
5.11.4 ANSI will take suitable action, including corrective action, suspension or withdrawal of accreditation, publication of the transgression and, if necessary, any other legal action to deal with misleading references to the accreditation or a misleading use of the accreditation mark found in advertisement, catalogues, etc.
5.12 Certification body personnel
5.12.1 The certification body shall define requirements for the competence of staff, the auditors and technical experts that it uses to conduct application review, evaluation, and review and decision on the certification process, whether they are employees, employed on contract or provided by external bodies.
5.12.2 Auditors/Inspectors shall meet the requirements and be competent to inspect applicants in accordance with EPA requirements. In regard to an inspection conducted in accordance with the EPA - Formaldehyde Standard for Composite Wood Products Standards and other relevant requirements required by the CB's procedures..
5.12.3 All inspector and team leaders shall possess the competencies identified in the CB procdures and the EPA requirements, and meet the levels of education, work experience, auditor training, and inspection experience specified in the CB requirements
5.12.4 The knowledge and understanding specified at ISO/IEC 17021 and in the EPA requirements are demonstrated through educational qualifications, sector-specific training and/or on site experience, monitoring or a combination of these.
5.12.5 In selecting the inspection team, consideration, must be given to any specific competence necessary to meet the inspection objectives.
5.12.6 The certification body shall have personnel with appropriate, defined technical and management competency to:
a) Assess applications and conduct contract reviews;
b) Select inspectors and verify their competence;
c) Brief inspectors and arrange any necessary training;
d) Implement (inspection), procedures;
e) Decide on the granting, maintaining, withdrawing, suspending, extending or reducing of certification;
f) Set up/operate complaints and appeals procedures; and
g) Understand the requirements of the ISO/IEC 17065.
5.12.7 The certification body shall have procedures to ensure that each inspection team contains a staff member/inspector that has been trained to the EPA - Formaldehyde Standard for Composite Wood Products and accreditation requirements and found to be competent prior to authorizing the inspector or inspection team leader to inspect as an unsupervised inspector. Full evaluation means, where appropriate, evaluating the inspector's or inspection team leader's planning, leadership and auditing skills and technical knowledge as applicable. This should include evaluation against all of the technical elements of the EPA - Formaldehyde Standard for Composite Wood Products. Conversion from inspector to inspection team leader may only require evaluation where a previous evaluation verified the auditor's auditing skills and technical competence.
5.12.8 A positive written report on an audit witnessed by ANSI may be used as a demonstration of meeting the requirements at clause 5.12.13 within the scope of the witnessed audit.
5.12.9 If a certification body uses technical experts, its systems shall include details of how technical experts are selected and how their technical knowledge is assured on a continuing basis. The certification body may rely on external support, for example, from industry or professional institutions or associations. Technical experts shall not perform an independent auditing function within the team and shall be supervised by an auditor who meets the certification body's generic competence criteria for auditors, and at all times, work in close cooperation with such an auditor.
5.12.10 The certification body shall audit assess the conduct of a technical expert the first time he/she is used to assist with an assessment; and subsequently monitor his/her performance and keep records of these assessments.
5.12.11 The certification body should establish the frequency of witnessing activities to take account of the criticality and volume of the work being undertaken, the experience and performance history of the auditors/technical experts and any data obtained from other types of monitoring activity such as review of audit reports and market feedback.
5.12.12 All inspection teams operating on site shall include a member that has been trained to the EPA Formaldehyde Emissions standard and accreditation requirements.
5.13 Changes in the Accreditation Requirements
5.13.1 ANSI will give due notice of any changes to be made to its requirements for accreditation and will take into account views expressed by interested parties before deciding on the precise form and effective date of the changes. ANSI shall verify that each accredited body carries out any necessary adjustments to its procedures within a reasonable time period.
5.14 Appeals, Complaints, and Disputes
5.14.1 Appeals and Complaints brought before ANSI shall be reviewed in accordance with PRO-PL-102.
5.15 Access to Records of Complaints and Appeals
5.15.1 The Accreditation Program requires that each applicant and accredited body make available its records of all complaints and appeals as well as subsequent actions available to ANSI, when requested.
5.15.2 ANSI shall:
a) Maintain records of all complaints and appeals and mediations relative to accreditation;
b) Take appropriate corrective and preventive action; and
c) Document the actions taken and assess their effectiveness.
6 General Requirements - Application for Certification in accordance with ISO/IEC 17065 and the EPA - Formaldehyde Standard for Composite Wood Products
6.1 The CB is required by EPA to implement the requirements contained in the EPA - Formaldehyde Standard for Composite Wood Products and shall be accredited, or apply for accreditation from an Accreditation Body that complies with the ISO/IEC 17011:2004 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies.
6.2 Be a legal entity
6.3 Be able to demonstrate the applicable experience and qualification/competencies of the auditor involved in the certification process.
6.4 Be able to ensure certification to the standard is applied consistently by all its certification personnel through a documented management and training system.
6.5 Stay informed on the development of new and revised production methods in the industries of the scope(s) they have applied.
6.6 Be able to enter into a contract and comply with the EPA - Formaldehyde Standard for Composite Wood Products and ANSI procedures.
6.7 Have sufficient personnel and financial stability to properly, impartially, and effectively perform certification activities.
7 The Application
7.1 The CB shall implement the certification activities as defined by ISO/IEC 17065 and in 40 CFR Chapter I, Subchapter R, Part 770 - Formaldehyde Standard for Composite Wood. See Annex A: Reference Matrix of Conformance with ISO/IEC 17065.
7.2 ANSI must receive authorization from the EPA in the form of a recognition agreement before beginning the accreditation process. The CB shall implement the certification activities as defined by ISO/IEC 17065 and in 40 CFR Chapter I, Subchapter R, Part 770 - Formaldehyde Standard for Composite Wood as defined in the certification body's scheme.
7.3 ANSI must provide, in accordance with Section 770.8, an annual report on or before March 1st of each year for the AB services performed during the previous calendar year including the number and locations of assessment, reassessment, and surveillance on-site assessments performed for each EPA TSCA Title VI TPC.
7.4 ANSI must meet with EPA at least once every two years in person, via teleconference, or through other virtual methods to discuss the implementation of the EPA TSCA Title VI Third-Party Certification Program.
8 Certification Information
8.1 After accreditation has successfully occurred, the CB will provide evidence to EPA in the form of a certificate of Accreditation issued by ANSI. The EPA and the Certification Body will then enter into a formal contract.
A ANNEX A - Cross Reference Table for ISO/IEC 17065 and EPA Formaldehyde Emission Standard for Composite Wood Products requirements
A.1 This annex contains a cross reference between all clauses of ISO/IEC 17065 that make mention of the certification scheme and the certification scheme requirements being utilized (see attached)