Evaluation of conformity & credibility Prepared By AHMAD JALLAD Director of Palestinian Accreditation Committee Ahmad Jallad- Evaluation of conformity & credibility 1 • Introduction contents Societal Concerns. Business Concerns. Quality infrastructure Pillars. • Evaluation of conformity Definition. Relation with standardization. Relation with metrology. Evaluation of Conformity components. Testing. Inspection. Certification. • Credibility. Accreditation. Ahmad Jallad- Accerditation is technical competence 2 Introduction • what are our concerns in changing environment? • What are the changes that affect our concerns? • How can we assure that products and services meet our concerns and expectation? Ahmad Jallad- Accerditation is technical competence 3 Changes Affect our concerns • Globalization and economic growth (technology change, free trade, e-business, etc..). • Social equity (social responsibility, consumer protection, health and safety, fair trade, etc..). • Environmental integrity (climate changes, energy services, environmental management, etc). • Legislations and regulations. Ahmad Jallad- Accerditation is technical competence 4 Societal concerns Societal Concerns Health, Safety, Environment, Economic well-being, Fair trade, consumer protection, Governmental laws and regulations • • • • • • • Health Safety Environment Economic well-being Fair trade Consumer protection Governmental laws and regulations Ahmad Jallad- Accerditation is technical competence 5 Business Concerns • • • • • • • • • Trading Quality Profitability Manufacturing Distribution Purchasing Use Specification Contracts Business Concerns Trading, Quality, Profitability, Manufacturing, Distribution, Purchasing, use, Specifications. Ahmad Jallad- Accerditation is technical competence 6 Quality Infrastructure • To meet with concerns we need: Criteria, reference that we call it our standards Complying tools with the reference (conformity assessment or evaluation of conformity) Assuring the traceability and accuracy of the test ( metrology) Assuring credibility through (accreditation) • These forms Quality Infrastructure pillars Societal Concerns Health, Safety, Environment, Economic well-being, Fair trade, consumer protection, Governmental laws and regulations Standardization Metrology Conformity assessment Business Concerns Trading, Quality, Profitability, Manufacturing, Distribution, Purchasing, use, Specifications. Ahmad Jallad- Accerditation is technical competence 7 National chain value Accreditation ISO guides 65, etc ISO 9000, ISO 14000, HACCP, etc Product Certification Applicable to all products and processes - products - processes Testing Laboratories ISO 17025 Product with Certificate Reference Materials Intercomparisons Proficiency tests traceablility Calibration of Equipment ISO CODEX Standardization International Standards Investigation PAC APLAC Certification National Standards Testing, Analysis IAF ILAC ISO 17025 Metrology - Calibration - Reference Materials Ahmad Jallad- Accerditation is technical competence BIPM APMP 8 Evaluation of Conformity • ISO/ IEC 17000 defines conformity assessment as demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled. • Definition consists of the following terms: Demonstration methods: that include testing, inspection, suppliers’ deceleration and certification. Specified requirement: that relates to a standard or agreed specifications. Product, process, system, person or body that form object of conformity. Ahmad Jallad- Accerditation is technical competence 9 Benefits of Conformity Assessment • • • • • Conformity assessment provides benefits to everyone in the supply and demand chain. For consumer : it is a mechanism providing confidence to consumers that the products and services they purchase are fit for the purpose For manufacturers and suppliers: it allows them to have peace of mind that they have implemented systems within their own organizations to ensure that the products and services they deliver meet the necessary criteria. And competitiveness. For regulators: it allows them to use the conformity assessment infrastructure as part of the process they use to ensure health and safety as well as environmental conditions are being continuously met. conformity assessment provide confidence facilitates the free flow of goods and services between national boundaries. Ahmad Jallad- Accerditation is technical competence 10 Conformity Assessment Functional Approach • According to ISO/ IEC 17000 conformity assessment functional approach involves the basic process: Selection. Determination. Review & attestation Surveillance if required selection yes Information on selected items Determination surveillance Information on fulfillment of special requirements Review & attestation Fulfillment of specified requirements demonstrated Ahmad Jallad- Accerditation is technical competence No Selection • Involves planning and preparation activities: Specifications to be assessed for. Selection of the samples to be assessed. Specification of statistical sampling techniques. Ahmad Jallad- Accerditation is technical competence 12 Determination • involve activities undertaken to assess compliance with requirements: Testing to determine specified characteristic Inspection of physical characteristic Auditing of systems and records Evaluation of qualities Examination of specification Ahmad Jallad- Accerditation is technical competence 13 Review & attestation • Include activities related to reviewing results and evidences gathered in the previous stage: Reviewing evidences collected Resolving nonconformities Issuing conformity statement Marking with conformity mark Ahmad Jallad- Accerditation is technical competence 14 surveillance • Involves all activities used to assure continuous compliance with requirements: Ahmad Jallad- Accerditation is technical competence 15 Testing • “ determination of one or more characteristics of an object of conformity assessment, according to procedure” ISO/ IEC 17000. Ahmad Jallad- Accerditation is technical competence 16 Calibration • “Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step uses this information to establish a relation for obtaining a measurement result from an indication” International Vocabulary of metrology (VIM) Ahmad Jallad- Accerditation is technical competence 17 Testing & Calibration Labs • ISO/ IEC 17025 “General requirements for the competence of testing and calibration laboratories” specifies requirements related to: Management system. Competency of people. Validation of method. Maintained and calibrated equipments. Traceability. Sampling and handling of test items. Reporting of results. Assuring quality of tests and calibration. Ahmad Jallad- Accerditation is technical competence 18 Inspection • Some inspection activities are closely aligned with testing activities, others with certification. • “ examination of a product design, product, process or installation and determination of its conformity with specific requirements or, on the basis of professional judgment, with general requirements” ISO/ IEC 17000 Ahmad Jallad- Accerditation is technical competence 19 Cont: Inspection • Inspection may include: Visual examination of physical items. Measurements or testing of physical items. Examination of design drawings and specifications documents. Comparison of findings. Issuing a report of findings . • ISO/ IEC 17020 “General criteria for the operation of various types of bodies performing inspection” specifies requirements related to: Quality Management system. Personnel. Facilities and equipment. Methods and procedures. Handling of inspected items. Inspection reports and certificates. Complaints and appeals. Ahmad Jallad- Accerditation is technical competence 20 Certification Bodies • Product certification. • Management certification. • Personnel certification. Ahmad Jallad- Accerditation is technical competence 21 Product Certification • The requirements of product certification bodies are specified in ISO/ IEC Guide 65 “General requirements of bodies operating product certification systems”. This guide states requirements such as: Organization Quality management system Conditions and procedures of certifications. Confidentiality Certification body personnel Appeals, complaints and disputes. Evaluation. Decision on certification Surveillance Ahmad Jallad- Accerditation is technical competence 22 Management Certification Bodies • Include bodies that grant management certification according to standards such as ISO 9001, ISO 14001, ISO 22000, etc.. • Bodies operating management certification implement ISO/ IEC 17021 “ Conformity assessment- Requirements for bodies providing audit and certification of management systems”. • Main principles: Competence. Consistency. Impartiality. Ahmad Jallad- Accerditation is technical competence 23 Personnel Certification • Personnel certification bodies have the objective of recognizing the competence of individuals to fulfill specific requirements. • ISO/ IEC 17024 “Conformity assessmentGeneral requirements for bodies operating certifications of persons” Ahmad Jallad- Accerditation is technical competence 24 Accreditation Definition • Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks – ISO 17000 • Accreditation bodies are often appointed by national governments. Ahmad Jallad- Accerditation is technical competence 25 Why do we need an accreditation scheme? • To meet with TBT agreement paragraph no.6.1.1 of article 6. • To create confidence on testing results to help governor, producers, importers, exporters and to protect consumers. Ahmad Jallad- Accerditation is technical competence 26 Benefits of Accreditation Better control of laboratory operations Improves staff confidence and enhances business Enhanced customer confidence and satisfaction Reliability of data for R&D Companies can rely on test results Ensures better support in the event of legal cases Provides traceability in measurements to national and international standards • Provides global equivalence • Saving of time & money due to re-testing • • • • • • • Ahmad Jallad- Accerditation is technical competence 27 Thanks for kind attention Ahmad Jallad ajallad@hotmail.com Ahmad Jallad- Accerditation is technical competence 28