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Designation F3356 − 19Standard Specification forConformity Assessment of Metal Detectors Used in Safetyand Security1This standard is issued under the fixed designation F3356; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon ´ indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification establishes the conformity assessmentrequirements for security systems and equipment. The designand testing requirements for a product’s conformity assessmentare specified in the applicable ASTM performance standardsdeveloped by the ASTM F12 Committee on Security Systemsand Equipment.1.2 Conformity assessment requirements ensure the consis-tent application of the ASTM performance standards andestablish requirements of the certification body’s accreditationprocess and operation of certification programs.1.3 Certification bodies, to acquire or maintainaccreditation, shall meet and continue to meet the requirementsestablished by this specification, including any matter incorpo-rated by reference.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade TBT Committee.2. Referenced Documents2.1 ASTM Standards2F3020 Performance Standard for Hand-Worn Metal Detec-tors Used in Safety and SecurityF3278 Performance Specification for Hand-Held Metal De-tectors Used in Safety and Security2.2 ISO Standards3ISO 90012008 Quality management systems – Require-mentsISO 90012015 Quality management systems – Require-mentsISO/IEC 17000 Conformity assessment – Vocabulary andgeneral principlesISO/IEC 17025 General requirements for the competence oftesting and calibration laboratoriesISO/IEC 17065 Conformity assessment – Requirements forbodies certifying products, processes and services3. Terminology3.1 Definitions of Terms Specific to This Standard3.1.1 accreditation, nthird-party attestation related to aconformity assessment body conveying formal demonstrationof its competence to carry out specific conformity assessmenttasks. ISO/IEC 170003.1.2 audit, nsystematic, independent, documented pro-cess for getting records, statements of fact, or other relevantinformation and assessing them objectively to determine theextent to which specified requirements are fulfilled.ISO/IEC 170003.1.3 certification, na system whereby a third party inde-pendent organization determines that a supplier has demon-strated the ability to make a product that complies with therequirements of the specification, authorizes the supplier to usea label on products that comply with the requirements of thespecification, and conducts a follow-up surveillance programto verify the methods the supplier uses to determine confor-mance with the requirements of the specification.3.1.4 certification body, nthird-party conformity assess-ment body operating certification schemes and attests to theconformity of products.1This specification is under the jurisdiction of ASTM Committee F12 onSecurity Systems and Equipment and is the direct responsibility of SubcommitteeF12.60 on Controlled Access Security, Search, and Screening Equipment.Current edition approved April 1, 2019. Published May 2019. Originallyapproved in 2018. Last previous edition approved in 2018 as F3356 – 18. DOI10.1520/F3356-19.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standard’s Document Summary page onthe ASTM website.3Available from International Organization for Standardization ISO, ISOCentral 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 StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade TBT Committee.13.1.5 certified product, nproduct that has successfullybeen tested and found to conform by an appropriately accred-ited certification body.3.1.6 certified product listing, na publicly accessible list-ing of certified products.3.1.7 complaint, nexpression of dissatisfaction, other thanan appeal, from any source.3.1.8 compliance/complaint, nthe condition of a modelmeeting or exceeding all applicable requirements of the speci-fied standard as determined pursuant and subject to thisspecification.3.1.9 conformity assessment, ndemonstration that speci-fied requirements relating to a product, process system, person,or body that have been fulfilled. ISO/IEC 170003.1.10 inspection, nexamination of a product, productdesign, service, process or manufacturing facility, and deter-mination of conformity with specific or on the basis ofprofessional judgment general requirements.Adapted from ISO/IEC 170003.1.11 manufacturer, na commercial enterprise engaged infabricating a product.3.1.12 mark of conformitylegally registered certificationmark applied by or issued under the procedures of a third-partycertification system for a product, process, or service that is inconformity with specific standards or other technical specifi-cations.3.1.13 model, nthe manufacturer’s design, with uniquespecifications and characteristics, of a particular item.3.1.14 product, none unit of a particular model.3.1.15 quality assurance, nall the planned and systematicactivities implemented within the quality management systemthat can be demonstrated to provide evidence that a product orservice will fulfill claimed requirements with a verifiable andhigh degree of confidence.3.1.16 safety alert, nnotification to users or the public ofan actual or potential safety issue with a specific products ormodels, including identification of the products or mod-els; a description of the concern, its ramifications, and how itwas identified; recommended actions to be taken; or otherrelevant information, or combinations thereof.3.1.17 supplier, nthe entity that directs and controls thefollowing conformant product design, conformant productmanufacturing, conformant product quality assurance; or theentity that assumes the liability for the conformant product orprovides the warranty for the conformant product.3.1.18 surveillance, nsampling, inspection, tests, or othermeasures used on a periodic basis to determine the continuedconformance of products that are being made by the supplier tothe requirements of the specification, or to assess the effective-ness of the conformity assessment scheme.3.1.19 suspension, ntemporary invalidation.3.1.20 withdrawal, nrevocation or cancellation.4. Certification Program for Performance SpecificationF3278 and Performance Standard F30204.1 General Requirements4.1.1 Each product model shall be certified in accordancewith Performance Standard F3020 for hand-worn metal detec-tors or Performance Specification F3278 for hand-held metaldetectors. Product models that are labeled as certified to eitherof those specifications shall meet all applicable requirements ofthat specification.4.1.2 Suppliers shall not claim compliance with any part ofthe requirements of the applicable ASTM performance stan-dard and shall not use the name or identification of either ofthose specifications in any statements regarding their respec-tive products unless the product is certified to that specifica-tion.4.1.3 Each compliant product model that has been certifiedand has entered the stream of commerce shall maintain itscertification status throughout its shelf life.4.1.4 A compliant product model shall have a product labelthat meets the requirements specified in the applicable ASTMperformance standard and 4.4.4.1.5 All certification shall be performed by a certificationbody that is independent of any supplier and meets therequirements specified in 4.2, in accordance with ISO/IEC17065.4.1.6 Certification bodies shall have a scope of accreditationto include this specification and the applicable ASTM perfor-mance standard. The accreditation shall be issued by anaccreditation body that is a signatory to the InternationalAccreditation Forum IAF Multilateral Recognition Arrange-ment MLA.4.1.7 The certification body shall use a testing laboratorythat is independent of any supplier and is accredited toISO/IEC 17025 for the scope of this specification by anaccreditation body that is a signatory to the InternationalLaboratory Accreditation Cooperation ILAC Mutual Recog-nition Arrangement MRA.4.1.7.1 The certification body may use more than onetesting laboratory for completion of all the required tests.However, the format of the data presented by the testinglaboratory shall conform to the format given herein to facilitateaccurate and consistent evaluation and comparison of themodel tested.4.1.8 The certification body shall have a program for initialdetermination of conformance of product models. At aminimum, the program shall include inspection, audit, andtesting as required by the specification, including the follow-ing1 Inspection of labeling and marking as specified in theapplicable ASTM performance standard and 4.4,2 Visiting the supplier’s applicable manufacturingfacilities, and3 Auditing the supplier’s management systems and re-lated procedures, records, and documentation.4.1.8.1 For surveillance audits where the manufacturerholds an ISO 90012008 or ISO 90012015 registration, thecertification body shall perform a defined audit, which includesa limited review of the manufacturer’s or supplier’s QualityManagement System. The audit shall include, at a minimum, areview of the ISO Certificate, the last two 2 audit reportsF3356 − 192issued by the ISO Registrar / Certification Body and correctiveaction close out report.4.2 Certification Body4.2.1 For both initial determination of compliance andsurveillance, the certification body shall conduct inspection,audit, and testing as specified in this section or as otherwisenoted in this specification.4.2.2 The certification body will accept, in their conformityassessment program, certification from other ISO 17065 ac-credited certification bodies for requirements in the ASTMstandard that are described in other standards, which includeelectromagnetic compatibility, environmental tolerance, andsafety.4.2.3 The certification body shall refuse to certify productsthat do not comply with all applicable requirements of thisspecification.4.2.4 The contractual provisions between the certificationbody and the supplier shall specify that certification is contin-gent on compliance with all applicable requirements of thisspecification. There shall be no conditional, temporary, orpartial certifications. Suppliers shall not be authorized to useany label or reference to the certification body on products thatare not manufactured in compliance with all applicable require-ments of this specification.4.2.5 The certification body and the supplier shall identifyeach model for certification and the variants if any withineach model.4.2.6 The certification body shall require the supplier toestablish and maintain a quality assurance program to includeproduction inspection and testing that at least meets therequirements specified in 4.3. The certification body shall auditthe supplier’s quality assurance program to ensure that thequality assurance program provides continued product compli-ance with this specification.4.2.7 The certification body shall conduct a surveillancequality audit and inspection program of the manufacturingfacilities of the certified product with at least one visit pertwelve-month period. As part of the annual quality audit andinspection program, the certification body shall select samplesat random from the supplier’s production line, the supplier’sin-house stock, or the open market. These samples shall beinspected and tested by the certification body per 4.3 to verifythe product’s continued compliance. The number of samplessubmitted for initial certification testing shall be three.4.2.8 The certification body shall require the supplier tohave a product recall system as part of the supplier’s qualityassurance program.4.2.9 The certification body’s name and label shall beregistered and legally defendable.4.3 Inspection and Testing4.3.1 For both initial determinations of conformance andsurveillance, the certification body shall direct how inspection,audit, and testing shall be conducted as specified in this sectionor otherwise.4.3.2 The inspection by the certification body shall deter-mine compliance with the requirements specified in the appli-cable ASTM performance standard.4.3.3 Product models that are identical to the products thatwill be offered for sale shall be inspected and tested forcertification in accordance with the applicable ASTM perfor-mance standard and shall meet the performance requirementsof those specifications.4.3.4 After initial certification to the applicable ASTMperformance standard, product models from production shallbe inspected and tested annually and shall meet the applicableperformance requirements as specified in AnnexA1 and AnnexA2.4.3.5 Any change in the design, construction, or material ofa certified product model shall be reported to the certificationbody to determine what inspection and testing shall be con-ducted to verify compliance to all applicable requirements ofthis specification.4.3.6 For inspection and testing for certification, the certi-fication body shall accept from the supplier only productmodels that are identical in every respect to the final product orcomponent. The certification body shall not permit thesubstitution, repair, or modification of any product modelduring testing.4.4 Certification Mark/Logo4.4.1 The supplier shall not use a mark of conformity orreference to the certification body on any product other than acertified product.4.4.2 A certification body mark of conformity shall be partof, attached to, or immediately adjacent to a product label thatotherwise satisfies the requirements for labeling as specified inthe applicable ASTM performance standard.4.4.3 The certification body mark of conformity shall beleg
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