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Other Conformity Assessment

Conformity Assessment Standards serve to provide a reference against which organizations can measure themselves as well as guiding third parties performing conformity assessment with a consistent and fair metric. The ISO/IEC 17000 series of standards is a broadly applicable conformity assessment guide that addresses impartiality, confidentiality, complaints and appeals, information disclosure, and the use of management systems, as well as a strong focus on requirements for bodies providing audit and certification of management systems. Conformity and certification of persons, products, processes, and services is a key element as well. Together, the ISO/IEC 17000 series of standards provides a thorough guide to conformity assessment for both those being assessed and those doing the assessing.

ISO 22000 Food Safety Management Systems Package

ISO 22000, ISO/TS 22003, ISO 22004 and ISO 22005

The ISO 22000 Food Safety Management Systems Package provides the requirements / management to control food safety hazards for any organization that prepares and or inspects food. The management of these hazards is required by crop, feed and primary food producers, food and secondary food manufacturers, wholesalers, retailers, food service operators and caterers. The package is complete with general requirements and the guidelines for any orgnaization in the food industry, requirements for providing audits / certifications for food safety management systems, conformity assessments for audits / certifications and quality / environmental management systems auditing for food safety. ISO 22000 Food Safety Management Systems Package includes: ISO 22000:2018 ISO 22003-1:2022 ISO 22004:2014 - Historical document ISO 22005:2007 Food Safety Management ISO 22000:2018 (Value Added Content) ISO 22000 Food Safety Management Systems - A Checklist for Small Business - Historical document How to use ISO 22000 Food Safety Management Systems - Historical document

Toy Safety Certification Standard Package

ASTM F963, ISO/IEC Guide 50, ISO/IEC Guide 51, ISO/IEC 17000, ISO/IEC 17011, ISO/IEC 17021, ISO/IEC 17025 and ISO/IEC 17065

This comprehensive Toy Safety Certification Standard Package includes of all the necessary standards identified by the Toy Industry Association (TIA) to conform to the Consumer Product Safety Improvement Act (CPSIA) regarding the safety of toys in the United States. The Toy Safety Certification Standard Package provides consumer safety specifications for toys, guidelines for child safety and product certification systems. It also includes conformity assessment requirements, principles and general requirements for the competence of testing and calibration laboratories. The Toy Safety Certification Standard Package contains: ASTM F963-23 ISO/IEC Guide 50:2014 ISO/IEC Guide 51:2014 ISO/IEC 17000:2020 ISO/IEC 17011:2017 ISO/IEC 17021-1:2015 ISO/IEC 17025:2017 ISO/IEC 17065:2012 CPSC Age Determination Guidelines - (Value added content) CPSC Handbook for Manufacturing Safer Consumer Products document - (Value added content)

ISO 2859-4:2020

Sampling procedures for inspection by attributes - Part 4: Procedures for assessment of declared quality levels

This document establishes single sampling plans for conformance testing, i.e., for assessing whether the quality level of a relevant audit population (lot, process, inventory, file etc) conforms to a declared value. Sampling plans are provided corresponding to four levels of discriminatory ability. The limiting quality ratio (LQR) (see Clause 4) of each sampling plan is given for reference. For levels I-III, the sampling plans have been devised so as to obtain a risk no more than 5 % of contradicting a correct declared quality level. The risk of failing to contradict an incorrectly declared quality level which is related to the LQR is no more than 10 %. The sample sizes for level 0 are designed in a way that the LQR factors of the sampling plans are compatible with the LQR factors for level I. In contrast to the procedures in the other parts of the ISO 2859 series, the procedures in this document are not applicable to acceptance assessment of lots. Generally, this document mainly focuses on controlling type I error, which differs from the balancing of the risks in the procedures for acceptance sampling. This document can be used for various forms of quality inspection in situations where objective evidence of conformity to some declared quality level is to be provided by means of inspection of a sample. The procedures are applicable to entities such as lots, process output, etc. that allow random samples of individual items to be taken from the entity. The sampling plans provided in this document are applicable, but not limited, to the inspection of a variety of targets such as: end items; components and raw materials; operations; materials in process; supplies in storage; maintenance operations; data or records; administrative procedures; accounting procedures or accounting entries; internal control procedures. This document considers two types of quality models for discrete items and populations, as follows. i) The conforming-nonconforming model, where each item is classified as conforming or nonconforming, and where the quality indicator of a population of items is the proportion p of nonconforming items, or, equivalently, the percentage 100 p of nonconforming items. ii) The nonconformities model, where the number of nonconformities is counted on each item, and where the quality indicator of a population of items is the average number of nonconformities found on items in the population, or, equivalently, the percentage 100 of nonconformities on items in the population.

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ISO 3951-4:2011

Sampling procedures for inspection by variables - Part 4: Procedures for assessment of declared quality levels

ISO 3951-4:2011 establishes sampling plans and procedures by variables that can be used to assess whether the quality level of an entity (lot, process, etc.) conforms to a declared value. The sampling plans have been devised so that their operating characteristic curves match those of the corresponding attributes plans in ISO 2859-4 as closely as possible, so that the choice between using sampling by attributes and sampling by variables is not influenced by attempts to increase the chance of accepting an incorrectly declared quality level. In this part of ISO 3951, there is a risk of between 1,4 % and 8,2 % of contradicting a correct declared quality level. The risk is 10 % of failing to contradict an incorrect declared quality level which is related to the limiting quality ratio. Sampling plans are provided corresponding to three levels of discriminatory ability, and for the cases of unknown and known process standard deviation. In contrast to the procedures in the other parts of ISO 3951, the procedures in ISO 3951-4:2011 are not applicable to acceptance assessment of lots. Generally, the balancing of the risks of reaching incorrect conclusions in assessment procedures will differ from the balancing in the procedures for acceptance sampling. ISO 3951-4:2011 may be used for various forms of quality inspection in situations where objective evidence of conformity to some declared quality level is to be provided by means of inspection of a sample. The procedures are applicable to entities such as lots, process output, etc. that allow random samples of individual items to be taken from the entity. The sampling plans provided are applicable, but not limited, to inspection of a variety of products such as: end items; components and raw materials; operations; materials in process; supplies in storage; maintenance operations; data or records; administrative procedures. The procedures are intended to be used when the quality characteristics are measurable variables that are independent and normally distributed, and where the quantity of interest is the fraction of items that are nonconforming.

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ISO/IEC Guide 98-4:2012

Uncertainty of measurement - Part 4: Role of measurement uncertainty in conformity assessment

ISO/IEC Guide 98-4:2012 provides guidance and procedures for assessing the conformity of an item (entity, object or system) with specified requirements. The item might be, for example, a gauge block, a grocery scale or a blood sample. The procedures can be applied where the following conditions exist: the item is distinguished by a single scalar quantity (a measurable property) defined to a level of detail sufficient to be reasonably represented by an essentially unique true value; an interval of permissible values of the property is specified by one or two tolerance limits; the property can be measured and the measurement result expressed in a manner consistent with the principles of the GUM, so that knowledge of the value of the property can be reasonably described by (a) a probability density function, (b) a distribution function, (c) numerical approximations to such functions, or (d) a best estimate, together with a coverage interval and an associated coverage probability. The procedures developed in this document can be used to realize an interval, called an acceptance interval, of permissible measured values of the property of interest. Acceptance limits can be chosen so as to balance the risks associated with accepting non-conforming items (consumer's risk) or rejecting conforming items (producer's risk). Two types of conformity assessment problems are addressed. The first is the setting of acceptance limits that will assure that a desired conformance probability for a single measured item is achieved. The second is the setting of acceptance limits to assure an acceptable level of confidence on average as a number of (nominally identical) items are measured. Guidance is given for their solution. This document contains examples to illustrate the guidance provided. The concepts presented can be extended to more general conformity assessment problems based on measurements of a set of scalar measurands. The audience of this document includes quality managers, members of standards development organizations, accreditation authorities and the staffs of testing and measuring laboratories, inspection bodies, certification bodies, regulatory agencies, academics and researchers.

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ISO 17034:2016

General requirements for the competence of reference material producers

ISO 17034:2016 specifies general requirements for the competence and consistent operation of reference material producers. ISO 17034:2016 sets out the requirements in accordance with which reference materials are produced. It is intended to be used as part of the general quality assurance procedures of the reference material producer. ISO 17034:2016 covers the production of all reference materials, including certified reference materials.

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ASTM F2962-13

Standard Practice for Conformity Assessment of Protective Clothing Worn by Operators Applying Pesticides

1.1 This practice establishes the conformity assessment requirements for limited use and reusable garments that are worn while spraying field strength liquid pesticides. The testing requirements for supplier s declaration of conformity and certification are specified in Specification F2669 . 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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SAE AS 9101F-2016

Quality Management Systems - Audit Requirements for Aviation, Space, and Defense Organizations

This standard defines requirements for the preparation and execution of the audit process. In addition, it defines the content and composition for the audit reporting of conformity and process effectiveness to the 9100-series standards, the organization's QMS documentation, and customer and statutory/regulatory requirements. The requirements in this standard are additions or represent changes to the requirements and guidelines in the standards for conformity assessment, auditing, and certification as published by ISO/IEC (i.e., ISO/IEC 17000, ISO/IEC 17021-1). When there is conflict with these standards, the requirements of the 9101 standard shall take precedence. NOTE 1: In this standard, the term “9100-series standards” comprises the following Aerospace Quality Management System (AQMS) standards: 9100, 9110, and 9120; developed by the IAQG and published by various national standards bodies. NOTE 2: In addition to this standard, the IAQG publishes deployment support material on the IAQG website (see http://www.sae.org/iaqg/) that can be used by audit teams, when executing the audit process.

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IEC GUIDE 115 Ed. 2.0 b:2021

Application of uncertainty of measurement to conformity assessment activities in the electrotechnical sector

IEC GUIDE 115:2021 is available as IEC GUIDE 115:2021 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC Guide 115:2021 presents a practical approach to the application of uncertainty of measurement to conformity assessment activities in the electrotechnical sector. It is specifically conceived for use in IECEE Schemes as well as by testing laboratories engaged in testing electrical products to national safety standards. It describes the application of uncertainty of measurement principles and provides guidance on making uncertainty of measurement calculations. It also gives some examples relating to uncertainty of measurement calculations for product conformity assessment testing. IEC Guide 115 has been prepared by the IECEE Committee of Testing Laboratories (CTL) to provide guidance on the practical application of the measurement uncertainty requirements of ISO/IEC 17025 to the electrical safety testing conducted within the IECEE CB Scheme. The IECEE CB Scheme is a multilateral, international agreement, among over 40 countries and some 60 national certification bodies, for the acceptance of test reports on electrical products tested to IEC standards.The aim of the CTL is, among other tasks, to define a common understanding of the test methodology with regard to the IEC standards as well as to ensure and continually improve the repeatability and reproducibility of test results among the member laboratories. The practical approach to measurement uncertainty outlined in this document has been adopted for use in the IECEE Schemes, and is also extensively used around the world by testing laboratories engaged in testing electrical products to national safety standards.

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IEC 62479 Ed. 1.0 b:2010

Assessment of the compliance of low-power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHz to 300 GHz)

"IEC 62479:2010 provides simple conformity assessment methods for low-power electronic and electrical equipment to an exposure limit relevant to electromagnetic fields (EMF). If such equipment cannot be shown to comply with the applicable EMF exposure requirements using the methods included in this standard for EMF assessment, then other standards, including IEC 62311 or other (EMF) product standards, may be used for conformity assessment."

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IEC/TR 61000-1-6 Ed. 1.0 en:2012

Electromagnetic compatibility (EMC) - Part 1-6: General - Guide to the assessment of measurement uncertainty

IEC/TR 61000-1-6:2012(E), which is a technical report, provides methods and background information for the assessment of measurement uncertainty. It gives guidance to cover general measurement uncertainty considerations within the IEC 61000 series. The objectives of this Technical Report are to give advice to technical committees, product committees and conformity assessment bodies on the development of measurement uncertainty budgets; to allow the comparison of these budgets between laboratories that have similar influence quantities; and to align the treatment of measurement uncertainty across the EMC committees of the IEC. It gives a description for: - a method for the assessment of measurement uncertainty; - mathematical formulas for probability density functions; - analytical assessment of statistical evaluations; - correction of measured data; and - documentation. This Technical Report is not intended to summarize all measurement uncertainty influence quantities nor is it intended to define how measurement uncertainty is to be taken into account in determining compliance with an EMC requirement.

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ISO 22000:2018

Food safety management systems - Requirements for any organization in the food chain

This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain: a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use; b) to demonstrate compliance with applicable statutory and regulatory food safety requirements; c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them; d) to effectively communicate food safety issues to interested parties within the food chain; e) to ensure that the organization conforms to its stated food safety policy; f) to demonstrate conformity to relevant interested parties; g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document. All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials. This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer-distributor, a small retail or food service outlet) to implement externally-developed elements in their FSMS. Internal and/or external resources can be used to meet the requirements of this document.

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ANSI/ASIS PSC.2-2012

Conformity Assessment and Auditing Management Systems for Quality of Private Security Company Operations

This Standard provides requirements and guidance for conducting conformity assessment of the ANSI/ASIS PSC.1-2012, Management System for Quality of Private Security Company Operations - Requirements with Guidance Standard. It provides requirements for bodies providing auditing and third party certification of Private Security Company Operations (PSCs) - private security providers working for any client in conditions where governance and the rule of law have been undermined by conflict or disaster. It provides requirements and guidance on the management of audit programs, conduct of internal or external audits of the management system and private security company operations, as well as on competence and evaluation of auditors

CGATS TR 016-2014 (R2019)

Graphic Technology - Printing Tolerance And Conformity Assessment

This technical report defines a process that can be used in evaluating the conformance of printed material to a set of reference color characterization data, which are used as the intended printing aim. It also provides a conformance assessment procedure which includes evaluation of deviation, within-sheet variation, and production variation as well as a four-level tolerance schema for the combination of the weighted results into a single score.

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ISO/TS 22559-3:2011

Safety requirements for lifts (elevators) - Part 3: Global conformity assessment procedures (GCAP) - Prerequisites for certification of conformity of lift systems, lift components and lift functions

ISO/TS 22559-3:2011 specifies prerequisite requirements for application for a global conformity assessment procedure (GCAP) certificate of conformity for new lift (elevator) systems, lift components or lift functions.

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ISO/TS 22559-4:2011

Safety requirements for lifts (elevators) - Part 4: Global conformity assessment procedures (GCAP) - Certification and accreditation requirements

ISO/TS 22559-4:2011 specifies requirements for certification of conformity for model lifts, lift (elevator) systems, lift components or lift functions by global conformity assessment bodies (GCAB), related responsibilities of GCABs, and requirements for accreditation of GCABs, and guidance and clarification to ISO/IEC Guide 65.

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NSF/ANSI 223-2020

Conformity Assessment Requirements for Certification Bodies that Certify Products Pursuant to NSF/ANSI/CAN 60: Drinking Water Treatment Chemicals - Health Effects

This Standard establishes minimum requirements for certification bodies to be used when certifying products to NSF/ANSI/CAN 60 - Drinking Water Treatment Chemicals – Health Effects. These requirements are supplemental to those contained in ISO Guide 65 or ISO 17020 and do not replace the requirements of either ISO standard. By specifying this Standard, users of product certifications can communicate their expectation that certification activities addressed herein are performed in the particular manner described.

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IEC/TR 62839-1 Ed. 1.0 en:2014

Environmental declaration - Part 1: Wires, cables and accessory products - Specific rules

IEC TR 62839-1:2014(E) specifies the PSR (product specific rules) for wires and cables used for communication, data, control and command. This PSR covers the use, installation and end-of-life stages and provides methodological precisions to PEP/PCR writing for "wires and cables and accessories products used for communication, data, control and command. PSR and general rules all together form the product category rules. Three categories of wires and cables are covered: - communication and data wires and cables, which may have metal or optical fiber conductors; - control and command wires and cables, which can have metal or fiber optical conductors; - accessories. This document only deals with the "wires and cables" products. "Accessories products are for further study. This document is primarily intended for: - environment and/or product managers; - LCA (life cycle assessment) experts in companies, in charge of PEP/PCR development; - verifiers in charge of PEP/PCR conformity assessment in accordance with the defined rules.

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ISO/TS 14441:2013

Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment

ISO/TS 14441:2013 examines electronic patient record systems at the clinical point of care that are also interoperable with EHRs. ISO/TS 14441:2013 addresses their security and privacy protections by providing a set of security and privacy requirements, along with guidelines and best practice for conformity assessment. ISO/TS 14441:2013 includes a cross-mapping of 82 security and privacy requirements against the Common Criteria categories in ISO/IEC 15408 (all parts).

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ISO/TS 22475-3:2007

Geotechnical investigation and testing - Sampling methods and groundwater measurements - Part 3: Conformity assessment of enterprises and personnel by third party

ISO/TS 22475-3:2007 is applicable to the conformity assessment of enterprises and personnel performing specified parts of sampling and groundwater measurements according to ISO 22475-1 and complying with the technical qualification criteria given in ISO/TS 22475-2 by third-party control.

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ISO 15792-3:2011

Welding consumables - Test methods - Part 3: Classification testing of positional capacity and root penetration of welding consumables in a fillet weld

ISO 15792-3:2011 specifies the preparation and assessment of fillet weld test pieces for conformity assessment of positional usability and root penetration requirements for consumables classification standards for welding non-alloy and fine grain steels, low alloy steels, stainless steels, and nickel base alloys. ISO 15792-3:2011 does not specify acceptance requirements.

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ISO 21927-1:2008

Smoke and heat control systems - Part 1: Specification for smoke barriers

ISO 21927-1:2008 specifies the product performance requirements, classifications and test methods for smoke barriers, which comprise the barrier itself, with or without associated activation and drive devices, designed for use in smoke and heat control systems. ISO 21927-1:2008 provides the test methods for, and conformity assessment of, the smoke barrier systems. It covers only barriers installed in buildings; it does not cover barriers made of part of the building's structure. Smoke barriers are only covered by ISO 21927-1:2008 when calculation methods exist for the determination of the leakage rate of smoke. This requires the smoke barriers to be sufficiently fixed and guided on any free joints between two adjacent smoke barriers. An example is given of a design to which ISO 21927-1:2008 does not apply.

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ISO 15736:2006

Ships and marine technology - Pyrotechnic life-saving appliances - Testing, inspection and marking of production units

ISO 15736:2006 specifies production tests and inspections, conformity assessment procedures, and marking requirements for life-saving appliances that utilize pyrotechnic devices in functioning. Specifically, it applies to products which have been evaluated and tested in accordance with the IMO Recommendation on testing of life-saving appliances , and type approved by maritime administrations to the requirements of the IMO Life-Saving Appliance (LSA) Code for use on ships subject to the requirements of the 1974 Safety of Life at Sea Convention (as amended). The basic principles may be considered suitable for pyrotechnic life-saving appliances manufactured to other than the IMO requirements, however ISO 15736:2006 applies directly only to products for which it contains specific requirements.

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ANSI/AGMA ISO 1328-1-B14

Cylindrical gears - ISO system of flank tolerance classification - Part 1: Definitions and allowable values of deviations relevant to flanks of gear teeth

This standard establishes a tolerance classification system relevant to manufacturing and conformity assessment of tooth flanks of individual cylindrical involute gears. It specifies definitions for gear flank tolerance terms, the structure of the flank tolerance class system, and allowable values.

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ISO 22222:2005

Personal financial planning - Requirements for personal financial planners

ISO 22222:2005 defines the personal financial planning process and specifies ethical behaviour, competences and experience requirements for personal financial planners. ISO 22222:2005 is applicable to all personal financial planners regardless of their employment status. ISO 22222:2005 describes and addresses the various methods of conformity assessment and specifies requirements applying to each of them.

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ISO 11843-4:2003

Capability of detection - Part 4: Methodology for comparing the minimum detectable value with a given value

ISO 11843-4:2003 deals with the assessment of the capability of detection of a measurement method without the assumptions in ISO 11843-2 of a linear calibration curve and certain relationships between the residual standard deviation and the value of the net state variable Instead of estimating the minimum detectable value, ISO 11843-4:2003 provides a criterion for judging whether the minimum detectable value is less than a given level of the net state variable, and the basic experimental design for testing the conformity of this criterion.

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ISO/TR 13881:2000

Petroleum and natural gas industries -- Classification and conformity assessment of products, processes and services

This Technical Report describes: two classification methods (one based on calculated risk, the other on judgement of risk) which may be used to determine the appropriate conformity assessment system for products, processes and services; a set of five conformity assessment systems from which the most suitable is chosen when conformity assessment of products, processes and services is required.

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ETSI TR 134 907-v3.0.0-2000-01

Universal Mobile Telecommunications System (UMTS) - Report on electrical safety requirements and regulations (3G TR 34.907 version 3.0.0 Release 1999) (FOREIGN STANDARD)

The present document provides the information on electrical safety requirements for Information and Technical equipment including 3G mobile phone in each country and region. The present document summarises the difference between international standards and national standards relevant to IEC60950 and also refers to regulations with regard to the conformity assessment because each country has different standards from other countries in current situation. The present document does not define any new electrical safety requirements.

ANSI/MSE 50028-2016

Superior Energy Performance - Requirements for verification bodies for use in accreditation or other forms of recognition

This American National Standard specifies requirements for verification bodies performing certification and energy performance verification for the Superior Energy Performance (SEP) Program. This Standard only applies to the SEP 2017 Program. It does not apply to the SEP 2012 Program.

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