NIOSH Public MeetingPPT Conformity AssessmentSeptember 17, 2013Summary of Key Conformity Assessment Activitiesand Examples of U.S. ProgramsRichard W. MetzlerSenior ScientistNPPTL, Office of the Director“Demonstration that specified requirementsrelating to a product, process, system,person or body are fulfilled”ISO/IEC 17000:2004Conformity assessment Vocabulary and general principlesProvide consumers with added confidenceGive the company a competitive edgeHelp regulators ensure that health, safety orenvironmental conditions are metConformity AssessmentConformity Assessment in aQuality InfrastructureFunctional Approach toConformity AssessmentDevelops policy and publishes standardsPromote mutual recognition and acceptance ofnational and regional conformity assessmentsystems, and the appropriate use of InternationalStandards for testing, inspection, certification,assessment and related purposesPublished 28 conformity assessment standardsParticipating countries: 71 – ANSI is USrepresentativeObserving countries: 48ISO Conformity AssessmentCommittee on Conformity Assessment (CASCO)Main forms of conformity assessmentCertification - ISO/IEC 17065 – 2012, Requirements forbodies certifying products, processes and servicesInspection - ISO/IEC 17020 – 2012, Requirements forthe operation of various types of bodies performinginspectionTesting - ISO/IEC 17025 – 2005, General requirementsfor the competence of testing and calibrationlaboratoriesISO Conformity AssessmentMain forms of conformity assessment (cont.)Accreditation - ISO/IEC 17011- 2004, Generalrequirements for accreditation bodies accreditingconformity assessment bodiesSurveillance - ISO/IEC 17011, ISO/IEC 17065ISO/IEC 17020Supplier’s Declaration of Conformity - ISO/IEC 17050,Part 1: General requirementsPart 2: Supporting documentationISO Conformity AssessmentMain forms of conformity assessment (cont.)Quality management systems - ISO/9001 – 2008Requirements for a quality management system todemonstrate the ability to provide products that fulfillcustomer and applicable regulatory requirementsRegistration - ISO/IEC 17021 – 2011, Requirements forbodies providing audit and certification ofmanagement systemsISO Conformity AssessmentA uniform comprehensive program does not existConsensus standards do not typically contain CArequirements (ANSI, ASTM)OSHA basic health and safety requirements“incorporate by reference” U.S. consensus standardsConsequently, supplier's declaration of conformity withno third-party verification or follow-up marketsurveillance and enforcement is the normU.S. PPT Conformity AssessmentCurrent CA programs are product-directed anddesigned primarily for products that protect workersagainst serious (medium to high) hazardsConsequently, both private and public sectors applyCA requirements in different ways to like hazard levelsExamples:NIOSH (respirators) and NIJ (bomb suits)NFPA (fire and emergency services products)U.S. PPT Conformity Assessment11Certification ActivitiesEngineering EvaluationRespirator TestingQA Plan EvaluationPost Market ActivitiesManufacturing Site AuditsRespirator Product AuditsRespirator Evaluations42CFR84 NIOSH RespiratorConformity Assessment ActivitiesNIJ Standard – 0117.00 Public Safety Bomb SuitStandard, March 2012Voluntary performance standard providing for one level ofprotectionDefines both performance requirements and the methodsused to test performance“Incorporates by references” national and internationalstandards (NFPA, MIL, ANSI, ASTM, EDA, IEC, CSA)NIJ/DOJ/Office of Justice ProgramsPublic Safety Bomb SuitNIJ CR – 0117.00 Public Safety Bomb Suit CertificationProgram Requirements, March 2012Certification (ISO/IEC Guide 65) with additional NIJrequirements (e.g.surveillance frequencies, safety alerts,product recalls, independent third parties for testing andinspections)Testing (ISO/IEC 17025)Inspections (ISO/IEC 17020)Quality management system (ISO 9001)Registration (ISO/IEC 17021)NIJ/DOJ/Office of Justice ProgramsPublic Safety Bomb Suit13 PPT and PPE product standards apply Certification(Chapter 4) requirementsThird-party certification (ISO/IEC 17065)Notified body accreditation (ISO/IEC 17011)Inspection and testing (ISO/IEC 17025)Annual recertificationManufacturer's quality assurance program (ISO-9001)Registration (ISO/IEC 17021)Investigation of hazards (ISO Guide 27)Manufacturer's investigation of complaints and returnsManufacturer safety alert and product recall systemsNFPA - Fire and Emergency ServicesConformity AssessmentExisting PPT CA programs in the U.S. represent a widediversity of approachesCurrent requirements for pre-market CA and post marketsurveillance and enforcement varies across productsintended for like levels of hazardMerger of private and public sector CA programs could forma national framework to deliver a uniform comprehensiveprogram providing confidence in a standard level ofprotection for workersU.S. PPT Conformity AssessmentQuality Partnerships Enhance WorkerSafety & HealthVisit Us at:http://www.cdc.gov/niosh/npptl/Disclaimer:The findings and conclusions in thispresentation have not been formallydisseminated by the National Institute for Occupational Safety and Health andshould not be construed to represent any agency determination or policy.Thank you!