ASTM F3356-19a
(Practice)Standard Practice for Conformity Assessment of Metal Detectors Used in Safety and Security
Standard Practice for Conformity Assessment of Metal Detectors Used in Safety and Security
SCOPE
1.1 This specification establishes the conformity assessment requirements for security systems and equipment. The design and testing requirements for a product’s conformity assessment are specified in the applicable ASTM performance standards developed by the ASTM F12 Committee on Security Systems and Equipment.
1.2 Conformity assessment requirements ensure the consistent application of the ASTM performance standards and establishes requirements of the certification body’s accreditation process and operation of certification programs.
1.3 Certification bodies, to acquire or maintain accreditation, shall meet and continue to meet the requirements established by this specification, including any matter incorporated by reference.
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
- Status
- Published
- Publication Date
- 31-Jul-2019
- Technical Committee
- F12 - Security Systems and Equipment
- Drafting Committee
- F12.60 - Controlled Access Security, Search, and Screening Equipment
Relations
- Effective Date
- 01-Aug-2019
- Effective Date
- 01-Apr-2019
- Effective Date
- 01-Oct-2017
- Effective Date
- 01-Aug-2019
- Effective Date
- 01-Aug-2019
Overview
ASTM F3356-19a: Standard Practice for Conformity Assessment of Metal Detectors Used in Safety and Security provides a uniform framework for evaluating and certifying metal detectors applied in security systems. Developed by ASTM International’s F12 Committee on Security Systems and Equipment, this standard details the procedures and requirements for conformity assessment, ensuring metal detection equipment meets relevant ASTM performance standards such as those for hand-worn and hand-held metal detectors.
The standard is intended to promote confidence in the certification process used by third-party organizations, requiring certification bodies to maintain accreditation and adhere closely to quality and conformity assessment principles recognized internationally.
Key Topics
- Conformity Assessment Requirements: Establishes the procedures for certifying metal detectors, covering design, performance, and consistent application of ASTM performance standards.
- Certification Bodies: Outlines requirements for independent, accredited certification bodies responsible for evaluating, certifying, and providing ongoing surveillance of metal detector models.
- Quality Assurance: Details the expectations for suppliers and manufacturers, including product inspection, testing, and the implementation of robust quality management systems.
- Testing and Surveillance: Specifies annual and periodic product testing protocols to ensure continued compliance, including sample selection, inspection, and recertification.
- Labeling and Mark of Conformity: Requires certified products to bear a registered mark of conformity, ensuring traceability and authenticity.
- Handling Noncompliance and Safety Issues: Contains guidelines for dealing with product nonconformance, recalls, and safety alerts, ensuring accountability throughout the product lifecycle.
- International Alignment: Adheres to guidelines established by the World Trade Organization Technical Barriers to Trade (TBT) Committee for international standardization equivalency.
Applications
ASTM F3356-19a is essential in the following areas:
- Security Screening: Applied in settings requiring effective screening for concealed metal objects, such as airports, courthouses, critical infrastructure facilities, and public events.
- Product Certification: Used by manufacturers and certification bodies to demonstrate compliance of metal detector models with recognized, rigorous performance parameters.
- Quality Management: Informs the development of quality assurance programs and processes for product manufacturing and surveillance to enhance reliability and safety.
- Regulatory Compliance: Assists compliance with local, national, and international requirements for the procurement and deployment of security screening technology.
By standardizing conformity assessment, ASTM F3356-19a facilitates procurement decisions, enhances trust among stakeholders, and supports global trade in security equipment.
Related Standards
The practice refers to and harmonizes with several key standards:
- ASTM F3020: Performance Specifications and Test Methods for Hand-Worn Metal Detectors Used in Safety and Security
- ASTM F3278: Performance Specifications and Test Methods for Hand-Held Metal Detectors Used in Safety and Security
- ISO 9001:2008/2015: Quality Management Systems - Requirements
- ISO/IEC 17000: Conformity Assessment - Vocabulary and General Principles
- ISO/IEC 17025: Competence of Testing and Calibration Laboratories
- ISO/IEC 17065: Requirements for Bodies Certifying Products, Processes, and Services
Organizations operating within the safety and security sector should reference these standards alongside ASTM F3356-19a to ensure comprehensive conformity and robust market acceptance of security screening devices.
Keywords: conformity assessment, certification, metal detectors, security systems, quality assurance, product certification, accreditation, surveillance, safety and security equipment.
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Frequently Asked Questions
ASTM F3356-19a is a standard published by ASTM International. Its full title is "Standard Practice for Conformity Assessment of Metal Detectors Used in Safety and Security". This standard covers: SCOPE 1.1 This specification establishes the conformity assessment requirements for security systems and equipment. The design and testing requirements for a product’s conformity assessment are specified in the applicable ASTM performance standards developed by the ASTM F12 Committee on Security Systems and Equipment. 1.2 Conformity assessment requirements ensure the consistent application of the ASTM performance standards and establishes requirements of the certification body’s accreditation process and operation of certification programs. 1.3 Certification bodies, to acquire or maintain accreditation, shall meet and continue to meet the requirements established by this specification, including any matter incorporated by reference. 1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
SCOPE 1.1 This specification establishes the conformity assessment requirements for security systems and equipment. The design and testing requirements for a product’s conformity assessment are specified in the applicable ASTM performance standards developed by the ASTM F12 Committee on Security Systems and Equipment. 1.2 Conformity assessment requirements ensure the consistent application of the ASTM performance standards and establishes requirements of the certification body’s accreditation process and operation of certification programs. 1.3 Certification bodies, to acquire or maintain accreditation, shall meet and continue to meet the requirements established by this specification, including any matter incorporated by reference. 1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM F3356-19a is classified under the following ICS (International Classification for Standards) categories: 13.310 - Protection against crime. The ICS classification helps identify the subject area and facilitates finding related standards.
ASTM F3356-19a has the following relationships with other standards: It is inter standard links to ASTM F3356-19, ASTM F3278-19, ASTM F3278-17, ASTM F3278-20, ASTM F3020-20. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ASTM F3356-19a is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3356 − 19a
Standard Practice for
Conformity Assessment of Metal Detectors Used in Safety
and Security
This standard is issued under the fixed designation F3356; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F3278 Performance Specifications and Test Methods for
Hand-Held Metal Detectors Used in Safety and Security
1.1 This specification establishes the conformity assessment
requirements for security systems and equipment. The design 2.2 ISO Standards:
and testing requirements for a product’s conformity assessment ISO 9001:2008 Quality management systems – Require-
are specified in the applicable ASTM performance standards ments
developed by the ASTM F12 Committee on Security Systems ISO 9001:2015 Quality management systems – Require-
and Equipment. ments
ISO/IEC 17000 Conformity assessment – Vocabulary and
1.2 Conformity assessment requirements ensure the consis-
general principles
tent application of the ASTM performance standards and
ISO/IEC 17025 General requirements for the competence of
establishes requirements of the certification body’s accredita-
testing and calibration laboratories
tion process and operation of certification programs.
ISO/IEC 17065 Conformity assessment – Requirements for
1.3 Certification bodies, to acquire or maintain
bodies certifying products, processes and services
accreditation, shall meet and continue to meet the requirements
established by this specification, including any matter incorpo-
3. Terminology
rated by reference.
3.1 Definitions of Terms Specific to This Standard:
1.4 This standard does not purport to address all of the
3.1.1 accreditation, n—third-party attestation related to a
safety concerns, if any, associated with its use. It is the
conformity assessment body conveying formal demonstration
responsibility of the user of this standard to establish appro-
of its competence to carry out specific conformity assessment
priate safety, health, and environmental practices and deter-
tasks. ISO/IEC 17000
mine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accor- 3.1.2 audit, n—systematic, independent, documented pro-
cess for getting records, statements of fact, or other relevant
dance with internationally recognized principles on standard-
information and assessing them objectively to determine the
ization established in the Decision on Principles for the
extent to which specified requirements are fulfilled.
Development of International Standards, Guides and Recom-
ISO/IEC 17000
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
3.1.3 certification, n—a system whereby a third party inde-
pendent organization determines that a supplier has demon-
2. Referenced Documents
strated the ability to make a product that complies with the
2.1 ASTM Standards: requirements of the specification, authorizes the supplier to use
a label on products that comply with the requirements of the
F3020 Performance Specifications and Test Methods for
Hand-Worn Metal Detectors Used in Safety and Security specification, and conducts a follow-up surveillance program
to verify the methods the supplier uses to determine confor-
mance with the requirements of the specification.
This practice is under the jurisdiction of ASTM Committee F12 on Security
3.1.4 certification body, n—third-party conformity assess-
Systems and Equipment and is the direct responsibility of Subcommittee F12.60 on
ment body operating certification schemes and attests to the
Controlled Access Security, Search, and Screening Equipment.
conformity of products.
Current edition approved Aug. 1, 2019. Published September 2019. Originally
approved in 2018. Last previous edition approved in 2019 as F3356 – 19. DOI:
10.1520/F3356-19A.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from International Organization for Standardization (ISO), ISO
Standards volume information, refer to the standard’s Document Summary page on Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
the ASTM website. Geneva, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3356 − 19a
3.1.5 certified product, n—product that has successfully 4.1.1 Each product model shall be certified in accordance
been tested and found to conform by an appropriately accred- with Standard F3020 for hand-worn metal detectors or Stan-
ited certification body. dard F3278 for hand-held metal detectors. Product models that
are labeled as certified to either of those specifications shall
3.1.6 certified product listing, n—a publicly accessible list-
meet all applicable requirements of that specification.
ing of certified products.
4.1.2 Suppliers shall not claim compliance with any part of
3.1.7 complaint, n—expression of dissatisfaction, other than
the requirements of the applicable ASTM performance stan-
an appeal, from any source.
dard and shall not use the name or identification of either of
3.1.8 compliance/compliant, n—the condition of a model
those specifications in any statements regarding their respec-
meeting or exceeding all applicable requirements of the speci-
tive products unless the product is certified to that specifica-
fied standard as determined pursuant and subject to this
tion.
specification.
4.1.3 Each compliant product model that has been certified
3.1.9 conformity assessment, n—demonstration that speci-
and has entered the stream of commerce shall maintain its
fied requirements relating to a product, process system, person,
certification status throughout its shelf life.
or body that have been fulfilled. ISO/IEC 17000
4.1.4 A compliant product model shall have a product label
3.1.10 inspection, n—examination of a product, product
that meets the requirements specified in the applicable ASTM
design, service, process or manufacturing facility, and deter-
performance standard and 4.4.
mination of conformity with specific or (on the basis of
4.1.5 All certification shall be performed by a certification
professional judgment) general requirements.
body that is independent of any supplier and meets the
Adapted from ISO/IEC 17000
requirements specified in 4.2, in accordance with ISO/IEC
3.1.11 manufacturer, n—acommercialenterpriseengagedin
17065.
fabricating a product.
4.1.6 Certification bodies shall have a scope of accreditation
3.1.12 mark of conformity—legally registered certification to include this specification and the applicable ASTM perfor-
mark applied by or issued under the procedures of a third-party mance standard. The accreditation shall be issued by an
certification system for a product, process, or service that is in accreditation body that is a signatory to the International
conformity with specific standards or other technical specifi- Accreditation Forum (IAF) Multilateral Recognition Arrange-
cations. ment (MLA).
4.1.7 The certification body shall use a testing laboratory
3.1.13 model, n—the manufacturer’s design, with unique
that is independent of any supplier and is accredited to
specifications and characteristics, of a particular item.
ISO/IEC 17025 for the scope of this specification by an
3.1.14 product, n—one unit of a particular model.
accreditation body that is a signatory to the International
3.1.15 quality assurance, n—all the planned and systematic
Laboratory Accreditation Cooperation (ILAC) Mutual Recog-
activities implemented within the quality management system
nition Arrangement (MRA).
that can be demonstrated to provide evidence that a product or
4.1.7.1 The certification body may use more than one
service will fulfill claimed requirements with a verifiable and
testing laboratory for completion of all the required tests.
high degree of confidence.
However, the format of the data presented by the testing
3.1.16 safety alert, n—notification to users or the public of
laboratory shall conform to the format given herein to facilitate
an actual or potential safety issue with a specific product(s) or
accurate and consistent evaluation and comparison of the
model(s), including identification of the product(s) or mod-
model tested.
el(s); a description of the concern, its ramifications, and how it
4.1.8 The certification body shall have a program for initial
was identified; recommended actions to be taken; or other
determination of conformance of product models. At a
relevant information, or combinations thereof.
minimum, the program shall include inspection, audit, and
3.1.17 supplier, n—the entity that directs and controls the
testing as required by the specification, including the follow-
following: conformant product design, conformant product
ing:
manufacturing, conformant product quality assurance; or the
(1) Inspection of labeling and marking as specified in the
entity that assumes the liability for the conformant product or
applicable ASTM performance standard and 4.4,
provides the warranty for the conformant product.
(2) Visiting the supplier’s applicable manufacturing
3.1.18 surveillance, n—sampling, inspection, tests, or other
facilities, and
measures used on a periodic basis to determine the continued
(3) Auditing the supplier’s management systems and re-
conformance of products that are being made by the supplier to
lated procedures, records, and documentation.
the requirements of the specification, or to assess the effective-
4.1.8.1 For surveillance audits where the manufacturer
ness of the conformity assessment scheme.
holds an ISO 9001:2008 or ISO 9001:2015 registration, the
3.1.19 suspension, n—temporary invalidation. certification body shall perform a defined audit, which includes
a limited review of the manufacturer’s or supplier’s Quality
3.1.20 withdrawal, n—revocation or cancellation.
Management System. The audit shall include, at a minimum, a
4. Certification Program for Standard F3278 and Stan-
review of the ISO Certificate, the last two (2) audit reports
dard F3020
issued by the ISO Registrar / Certification Body and corrective
4.1 General Requirements: action close out report.
F3356 − 19a
4.2 Certification Body: 4.3.2 The inspection by the certification body shall deter-
mine compliance with the requirements specified in the appli-
4.2.1 For both initial determination of compliance and
cable ASTM performance standard.
surveillance, the certification body shall conduct inspection,
4.3.3 Product models that are identical to the product(s) that
audit, and testing as specified in this section or as otherwise
will be offered for sale shall be inspected and tested for
noted in this specification.
certification in accordance with the applicable ASTM perfor-
4.2.2 The cert
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3356 − 19 F3356 − 19a
Standard SpecificationPractice for
Conformity Assessment of Metal Detectors Used in Safety
and Security
This standard is issued under the fixed designation F3356; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This specification establishes the conformity assessment requirements for security systems and equipment. The design and
testing requirements for a product’s conformity assessment are specified in the applicable ASTM performance standards developed
by the ASTM F12 Committee on Security Systems and Equipment.
1.2 Conformity assessment requirements ensure the consistent application of the ASTM performance standards and
establishestablishes requirements of the certification body’s accreditation process and operation of certification programs.
1.3 Certification bodies, to acquire or maintain accreditation, shall meet and continue to meet the requirements established by
this specification, including any matter incorporated by reference.
1.4 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, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
F3020 Performance Specifications and Test Methods for Hand-Worn Metal Detectors Used in Safety and Security
F3278 Performance Specification Specifications and Test Methods for Hand-Held Metal Detectors Used in Safety and Security
2.2 ISO Standards:
ISO 9001:2008 Quality management systems – Requirements
ISO 9001:2015 Quality management systems – Requirements
ISO/IEC 17000 Conformity assessment – Vocabulary and general principles
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 accreditation, n—third-party attestation related to a conformity assessment body conveying formal demonstration of its
competence to carry out specific conformity assessment tasks. ISO/IEC 17000
3.1.2 audit, n—systematic, independent, documented process for getting records, statements of fact, or other relevant
information and assessing them objectively to determine the extent to which specified requirements are fulfilled.
ISO/IEC 17000
This specificationpractice is under the jurisdiction of ASTM Committee F12 on Security Systems and Equipment and is the direct responsibility of Subcommittee F12.60
on Controlled Access Security, Search, and Screening Equipment.
Current edition approved April 1, 2019Aug. 1, 2019. Published May 2019September 2019. Originally approved in 2018. Last previous edition approved in 20182019 as
F3356 – 18.F3356 – 19. DOI: 10.1520/F3356-19.10.1520/F3356-19A.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3356 − 19a
3.1.3 certification, n—a system whereby a third party independent organization determines that a supplier has demonstrated the
ability to make a product that complies with the requirements of the specification, authorizes the supplier to use a label on products
that comply with the requirements of the specification, and conducts a follow-up surveillance program to verify the methods the
supplier uses to determine conformance with the requirements of the specification.
3.1.4 certification body, n—third-party conformity assessment body operating certification schemes and attests to the conformity
of products.
3.1.5 certified product, n—product that has successfully been tested and found to conform by an appropriately accredited
certification body.
3.1.6 certified product listing, n—a publicly accessible listing of certified products.
3.1.7 complaint, n—expression of dissatisfaction, other than an appeal, from any source.
3.1.8 compliance/complaint,compliance/compliant, n—the condition of a model meeting or exceeding all applicable require-
ments of the specified standard as determined pursuant and subject to this specification.
3.1.9 conformity assessment, n—demonstration that specified requirements relating to a product, process system, person, or
body that have been fulfilled. ISO/IEC 17000
3.1.10 inspection, n—examination of a product, product design, service, process or manufacturing facility, and determination
of conformity with specific or (on the basis of professional judgment) general requirements.
Adapted from ISO/IEC 17000
3.1.11 manufacturer, n—a commercial enterprise engaged in fabricating a product.
3.1.12 mark of conformity—legally registered certification mark applied by or issued under the procedures of a third-party
certification system for a product, process, or service that is in conformity with specific standards or other technical specifications.
3.1.13 model, n—the manufacturer’s design, with unique specifications and characteristics, of a particular item.
3.1.14 product, n—one unit of a particular model.
3.1.15 quality assurance, n—all the planned and systematic activities implemented within the quality management system that
can be demonstrated to provide evidence that a product or service will fulfill claimed requirements with a verifiable and high
degree of confidence.
3.1.16 safety alert, n—notification to users or the public of an actual or potential safety issue with a specific product(s) or
model(s), including identification of the product(s) or model(s); a description of the concern, its ramifications, and how it was
identified; recommended actions to be taken; or other relevant information, or combinations thereof.
3.1.17 supplier, n—the entity that directs and controls the following: conformant product design, conformant product
manufacturing, conformant product quality assurance; or the entity that assumes the liability for the conformant product or
provides the warranty for the conformant product.
3.1.18 surveillance, n—sampling, inspection, tests, or other measures used on a periodic basis to determine the continued
conformance of products that are being made by the supplier to the requirements of the specification, or to assess the effectiveness
of the conformity assessment scheme.
3.1.19 suspension, n—temporary invalidation.
3.1.20 withdrawal, n—revocation or cancellation.
4. Certification Program for Performance Specification Standard F3278 and Performance Standard F3020
4.1 General Requirements:
4.1.1 Each product model shall be certified in accordance with Performance Standard F3020 for hand-worn metal detectors or
Performance Specification Standard F3278 for hand-held metal detectors. Product models that are labeled as certified to either of
those specifications shall meet all applicable requirements of that specification.
4.1.2 Suppliers shall not claim compliance with any part of the requirements of the applicable ASTM performance standard and
shall not use the name or identification of either of those specifications in any statements regarding their respective products unless
the product is certified to that specification.
4.1.3 Each compliant product model that has been certified and has entered the stream of commerce shall maintain its
certification status throughout its shelf life.
4.1.4 A compliant product model shall have a product label that meets the requirements specified in the applicable ASTM
performance standard and 4.4.
4.1.5 All certification shall be performed by a certification body that is independent of any supplier and meets the requirements
specified in 4.2, in accordance with ISO/IEC 17065.
4.1.6 Certification bodies shall have a scope of accreditation to include this specification and the applicable ASTM performance
standard. The accreditation shall be issued by an accreditation body that is a signatory to the International Accreditation Forum
(IAF) Multilateral Recognition Arrangement (MLA).
F3356 − 19a
4.1.7 The certification body shall use a testing laboratory that is independent of any supplier and is accredited to ISO/IEC 17025
for the scope of this specification by an accreditation body that is a signatory to the International Laboratory Accreditation
Cooperation (ILAC) Mutual Recognition Arrangement (MRA).
4.1.7.1 The certification body may use more than one testing laboratory for completion of all the required tests. However, the
format of the data presented by the testing laboratory shall conform to the format given herein to facilitate accurate and consistent
evaluation and comparison of the model tested.
4.1.8 The certification body shall have a program for initial determination of conformance of product models. At a minimum,
the program shall include inspection, audit, and testing as required by the specification, including the following:
(1) Inspection of labeling and marking as specified in the applicable ASTM performance standard and 4.4,
(2) Visiting the supplier’s applicable manufacturing facilities, and
(3) Auditing the supplier’s management systems and related procedures, records, and documentation.
4.1.8.1 For surveillance audits where the manufacturer holds an ISO 9001:2008 or ISO 9001:2015 registration, the certification
body shall perform a defined audit, which includes a limited review of the manufacturer’s or supplier’s Quality Management
System. The audit shall include, at a minimum, a review of the ISO Certificate, the last two (2) audit reports issued by the ISO
Registrar / Certification Body and corrective action close out report.
4.2 Certification Body:
4.2.1 For both initial determination of compliance and surveillance, the certification body shall conduct inspection, audit, and
testing as specified in this section or as otherwise noted in this specification.
4.2.2 The certification body will accept, in their conformity assessment program, certification from other ISO 17065 accredited
certification bodies for requirements in the ASTM standard that are described in other standards, which include: electromagnetic
compatibility, environmental tolerance, and safety.
4.2.3 The certification body shall refuse to certify products that do not comply with all applicable requirements of this
specification.
4.2.4 The contractual provisions between the certification body and the supplier shall specify that certification is contingent on
compliance with all applicable requirements
...








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