Content What is conformity assessment? What is ISO/CASCO? What is the ISO/CASCO Toolbox?
What is conformity assessment Is all the activities we complete to determine if a product orservice meets specific requirements (usually contained in astandard)definition the demonstration that specified requirements relatingto a product, process, system, person or body arefulfilled.
Conformity assessment activitiesTestingdetermination of one or more characteristics of an object of conformityassessmentCertificationthird party assurance that: product (services), process, personnel,organization or management system conforms to specific requirementsInspectionExamination of a product design, product, process or installation anddetermination of its conformity with specific requirements or, on the basis ofprofessional judgement, with general requirements.Supplier'sdeclaration ofconformityfirst-party attestationAccreditationthird-party attestation related to a conformity assessment body conveyingformal demonstration of its competenceMutualrecognition &PeerassessmentArrangement whereby more than two parties recognize or accept one another’sconformity assessment resultsAssessment of a body against specified requirements by representatives of otherbodies in, or candidates for, an agreement
Conformity assessment claimsObjectTest done by:1st party(the manufacturer,service provider) Requirements2nd party(the purchaser,the client)3rd party - independent(certification body, laboratory,inspection body.)Attestation typeSDoC(Self Declarationof Conformity)ContractCertificate3rd party bodies can be accredited.Accreditation bodies are assessed by their peers
Conformity assessment in actionHow do you determine if a product meets a technicalrequirement ?ActionConformity assessmentactivityDesign the TVTest design in laboratoryTV set meets the technicalspecification or standardTest TV samples fromproduction lineManufacture the TVQuality management system(QMS) in place in the factory(certification of QMS)TV sets in storageInspect samples of the TVsets prior to distribution tomake sure no damageDistribute the TV to shopsTake samples from the shopto ensure it meetsspecification (MarketSurveillance) the regulatormay do this
What is ISO/CASCO? ISO committee that works on issues relating toconformity assessment It publishes standards for the operation of conformityassessment bodies and develops policies related toconformity assessment (mostly together with IEC) 126 members of ISO participate in CASCO and 22external organizations are in liaison
ISO/CASCO Toolboxconformityassessment bodies(laboratories,certification bodies andinspection bodies)The ISO/CASCOToolbox is the set ofconformity assessmentstandard developed byISO CASCO for theoperation ofaccreditation bodiesfor peer evaluation andother associatedactivitiesISO/CASCO has over 35 published standards and guides
Conformity assessment bodies andCASCO standardsCertification bodiesuse ISO/IEC 17021 –requirements forcertification of ManagementSystems, ISO/IEC 17065for productsISO/IEC 17024 for personsInspection bodiesuse ISO/IEC 17020 –requirements forinspection of various itemsetc.Laboratoriesuse ISO/IEC 17025– requirements forcompetence of labs
Some CASCO standards–An short overview
Contents ISO/IEC 17025 Testing and calibration laboratories ISO/IEC 17020 Inspection bodies ISO/IEC 17065 Product certification (for products,processes and services) ISO/IEC 17021 Management system certification ISO/IEC 17024 Personnel certification ISO/IEC 17000 Vocabulary and general principles CASCO toolbox (over 35 standards and guides)
ISO/IEC 17025: RequirementsTesting and calibration laboratoriesBasic requirements that a laboratoryshould comply with to demonstrate it iscompetent to perform specified tests andcalibrations: Management system requirements arecommon to all laboratories irrespective of thetechnical work they perform. Technical requirements have to be appliedaccording to the specific field of work and requirethe laboratory to apply additional requirementsspecific to the field. This aspect of additional requirements isrecognized in Annex B (informative) and contains“Guidelines for establishing applications forspecific fields”.
ISO/IEC 17025: RequirementsTesting and calibration laboratoriesThe scope for which the laboratory does testing needs to be clearlyspecified and stated. Usually the scope is supported by listing the specific test methods thelaboratory uses in case of testing and specific measurements and associateduncertainty in the case of calibration laboratories. This detailed definition of the scope allows the laboratory to identifycompetent people to do the work within their scope of activity. It also allows for the customers of the laboratory to identify a suitablelaboratory for their purposes and have confidence in the tests andmeasurements made by the laboratory. When a laboratory is accredited to ISO/IEC 17025 its compliance is not onlyassessed to the generic standard ISO/IEC 17025 but also to any field specificrequirements and to the laboratories’ competence to perform the specific testmethods.
ISO/IEC 17020: RequirementsInspection bodiesInspection : Examination of a product design, product,process or installation and determination of itsconformity with specific requirements or, on thebasis of professional judgment, with ers, lifts, restaurants, road vehicles(annually) etc). Provides objective evidence that an inspecteditem meets the specified needs of the customer(purchaser, manufacturer regulator). Heavily relies on professional judgment of theinspector whose competence is crucial to thesuccess of this activity.
ISO/IEC 17020: RequirementsInspection bodiesInspection can be used as a riskmanagement tool: Many plants and installations use inspection toensure that equipment and plant facilitiescontinue to operate safely and correctly. Inspections are usually performed on site andallow for the clients to be informed immediately. Inspections of items before shipping orconfirmation with the order can preventshipment of the wrong materials, this is veryimportant in building material shipments.
Requirements Certification bodies3 main types of certification activities: Productcertification,ISO/IEC17065:2012 (products, processes andservices certified) Management system certification,ISO/IEC 17021-1:2015 (ISO 9001certified company) Personnel certification, ISO/IEC17024:2012 (Welder/Food safetycertified)
Requirements for product, processand service certification (ISO/IEC17065)The overall aim of certifying products, processes or services is to giveconfidence to all interested parties that a product, process or servicefulfills specified requirements.The value of certification is the degree of confidence and trust that isestablished by an impartial and competent demonstration of fulfillmentof specified requirements by a third-party.
Product, process and servicecertification (ISO/IEC 17065)4 basic drivers for product, process and servicecertification: provide consumers (users) of products with sufficientinformation to allow them to make informed decisions onproducts and services; assist the suppliers of certified products to achieve marketacceptance. If the product has a recognizable mark on itconsumers may be more willing to make the purchase; product certification plays a role in regulated products(subject to technical regulations); assists manufactures in selecting the components for theirown products; retailers have confidence in the products they are selling.
Product, process and servicecertification (ISO/IEC 17065)Product certification mayconsist of: initial product testing with assessment of the quality management system;followed up by testing of samples from factory and/or the open market;initial testing and surveillance testing;type testing : testing of a sample product.The type of productcertification schemechosen: will depend on the level of risk to the consumer as well as other factors; for a very low risk product you may have a once-off type test; for a high risk product you may have a scheme which has type testing,requires an ISO 9001 management system in place with regular producttesting from the factory and also products taken from the outlets for testing.ISO/IEC 17065Conformity assessment Requirements for bodiescertifying products,processes and services can be used in combination with a number of related product standards andguides to demonstrate that a product complies with specified criteria.
ISO/IEC 17065: Requirements forbodies certifying products, processesand services The requirements of ISO/IEC 17065 allow PRODUCT certification bodies todemonstrate that they are competent, impartial and reliable; There are hundreds of marks of conformity for products in the market place; This is the most visible form of certification.
Requirements for managementsystems certification (ISO/IEC 17021-1)Understanding the basicsWhat is a “management system”?management systemset of interrelated or interacting elements of an organization to establish policies andobjectives and processes to achieve those objectivesDefinition from: ISO/IEC Directives, ISO Supplement, Annex SL, Appendix 2, cl. 3.04 (2014))
Management system certificationbodiesThe management system implemented within an organization is certified as meeting specificrequirements.Best know of these is ISO 9001 certified companies (over 1 million worldwide).Other examples are ISO 14001 (environmental management), ISO 50001 energy efficiency, ISO 27001information security management systems and food safety management systems, ISO 22000.Management system standards have been developed by other organizations.Retailers have developed their own standards in many cases (BRC Global Gap farm to Fork etc).However they all use the ISO/CASCO Toolbox to determine conformity and the bodies they usehave to comply with the relevant CASCO standards when determining conformity with the standards.
Drivers for management systemcertificationBenefits of management system certification:Providesindependentassurance (anddemonstration) anorganization hasimplemented thesystem.Certification notonly demonstratesto the customersbut also internally, itcan providemotivation andsatisfaction to staffthat theorganizationoperates inaccordance withinternationalstandards.Provides thecompany withBenefits topmarketingmanagement andopportunities togives it confidencein the operation of potential customers.Provides access tothe organizationinternationaland its ability to(regulated ) marketsmeet customerwhere certificationexpectationsis an entryconsistently.requirement.
Management systems certificationprocessAcertificationbody thatcertifies anorganizationfor : Quality management systems (QMS), ISO 9001 Environmental management systems (EMS), ISO14001 Food safety management systems (FSMS), ISO/TS22000 Other management systems , e.g. ISO 27001, etc.SHOULD IMPLEMENT:ISO/IEC 17021:2011, Conformity assessment - Requirements forbodies providing audit and certification of management systems
Requirement for bodies providingcertification of persons t- Generalrequirementsfor bodiesoperatingcertificationof persons Certification of persons has the objective ofrecognizing the competence ofindividuals to perform specific tasks. It recognizes that competence is not solelyrelated to qualification but is based on thean individuals ability to apply knowledgeand skills to achieve intended results. A person can be well qualified but beincompetent. There are good doctors andnot so good doctors and bad doctors. Competence is not based on qualificationalone.
Examples of personnelcertification schemes (ISO/IEC17024) ISO 9001 (ISO/IEC 17021-3) Management system auditors ISO 22003 Food safety management system auditorsAuditors ISO 14001 (ISO/IEC 17021-2) Environmental management systemauditors Various FoodWelding operators ISO 9606Crane driversLift inspectorsPressure vessel inspectors (various)Scuba driving instructors Food safety inspectors Health inspectors
Drivers and benefits of personnelcertification (ISO/IEC 17024)Provides a consistent framework and set ofrequirements to allow recognition of competence.Facilitates employment of certified personsAllows for mobility of certified personsIt provides employers with confidence in theircertified employees and clearly identifies thecompetencies required for different categories ofprofessions and jobs.It allows for competencies to be up dated andmaintained as technologies change. This is of greatbenefit to the professions and employers.
Vocabulary & general principles(ISO/IEC 17000)Purpose of ISO/IEC 17000: definition of the main terms used in conformityassessment; description of the basic principles applied inconformity assessment (see Annex A5):- functional approach- selection- determination- review and attestation- need for surveillance
Useful referencesCASCO ity-assessment.htmResources for conformity rmityassessment/conformity-assessment resources.htmConformity assessment tools for s/index.htmlBuilding trust:http://www.iso.org/iso/casco building-trust.pdf
certification (ISO/IEC 17024) Provides a consistent framework and set of requirements to allow recognition of competence. Facilitates employment of certified persons Allows for mobility of certified persons It provides employers with confidence in their certified employees and clearly identifies the