TQM S3 2023 PDF: Conformity Assessment and Accreditation

Conformity Assessment and Accreditation Total Quality Management APM 22092 D r. C h a t h u m i K a v i r a t h n a ( D. E n g & M. E n g , T I T, J a p a n ; B. S c. ( T L M ) H o n s , U O M , S r i L a n k a ) University of Kela...

Conformity Assessment and Accreditation Total Quality Management APM 22092 D r. C h a t h u m i K a v i r a t h n a ( D. E n g & M. E n g , T I T, J a p a n ; B. S c. ( T L M ) H o n s , U O M , S r i L a n k a ) University of Kelaniya Email: [email protected] Lesson Plan Session Topic 1 Introduction to Quality Management 2 Standardization 3 Conformity Assessment and Accreditation 4 Quality Management Principles 5 Quality Costs and 5S Concept 6 Standards Formulation Process and Product Certification Scheme 7 ISO 9001:2015 Standard requirements 8 ISO 14000 Standard requirements 9 ISO 22000 Standard Requirements 10 ISO 17025 Laboratory Management System Requirements, Quality Auditing 11 Introduction to Quality Management Tools 12 Sampling 13 Histogram 14 Control Charts, Variable/Attribute Control Charts 15 Process Capability Indices APM 22092 TOTAL QUALITY MANAGEMENT 2 Learning Outcomes On completion of this lecture, the student should be able to: ❑ Understand the terms conformity, conformity assessment, and accreditation ❑ Discuss the significance of conformity assessment ❑ Explain different techniques for conformity assessment ❑ Understand the process of conformity assessment APM 22092 TOTAL QUALITY MANAGEMENT 3 Recap of the Last Lesson? Recap ❑Standardization ❑Goal of standardization ❑Benefits of standardization ❑Types of standards ❑Preparing/amending standards ❑Basic methods using standardization ❑Principles of standardization ❑Levels of standards ❑Levels of standardization Levels of Standards ▪ Individual Level ▪ Organization Level ▪ Union and vocational associations level ▪ National level ▪ Regional and international level APM 22092 TOTAL QUALITY MANAGEMENT 6 Levels of Standards Individual level ▪ Identifies the basic requirement in a specified process ▪ The effectiveness of the standard often ends by the end of this process APM 22092 TOTAL QUALITY MANAGEMENT 7 Levels of Standards Organization Level Standards are maintained for organizing the work and identify their requirements and apply the specifications Eg: Health and Agriculture Eg: Customs laws which organize the import, export and conditions for compliance and identifies the procedures and circumstances APM 22092 TOTAL QUALITY MANAGEMENT 8 Organization Level Standards Standards of Raw materials necessary for the planning factor and intermediate products Machines and instruments necessary for productions and spare parts Standards of Testing and quality control methods production Practical system specifications Maintenance and Managing and assuring quality replacement standards standards APM 22092 TOTAL QUALITY MANAGEMENT 9 Levels of Standards Union's and vocational associations level ▪ Standards affect widely on all sectors ▪ Develop in industrial countries ▪ In the scope of integrating production standards, common purchases, requirement for common solutions Eg: Categorical committees such as Engineers’ Committees APM 22092 TOTAL QUALITY MANAGEMENT 10 Levels of Standards The National level ▪ It is a connecting link with other levels such as regional and international levels Characteristics of the National Level Standards ▪ Specific system/body is authorized to issue national standards ▪ Issued in accordance with a certain manner identifying the steps of preparation, issue, approval methods and represent the national requirements ▪ All concerned parties should participate in preparing and developing these standards which should express their interests ▪ Realize the national interest and represent the national requirements APM 22092 TOTAL QUALITY MANAGEMENT 11  Levels of Standards Regional and international level ❑ Important position in organizing the commercial transactions, identifying the level of commodities and services which are suitable for the expected circumstances ❑ International agreements emerging from World Trade Organization ❑ Important role in laying down different development processes on proper bases, reducing costs, raising the quality level, integrating markets, establishing economical blocks and facilitating commercial exchange ❑ Ensuring the common interests for all parties and countries APM 22092 TOTAL QUALITY MANAGEMENT 12 Levels of Standardization ❑ There is a varying level of standardization that can be applied to a facility ❑ There is not a one type “fits all” approach ❑ Each program will need to be reviewed and apply the appropriate level of standardization that makes sense for the facility APM 22092 TOTAL QUALITY MANAGEMENT 13 Levels of Standardization Example ▪ Compatibility ▪ Interchangeability ▪ Commonality ▪ Reference https://www.vskills.in/certification/tutorial/levels-of-standardization-2/ https://dycatsolutions.com/2020/04/what-is-facility-standardization-why-would-you-apply-it-to-your-oil-or-gas-program/ APM 22092 TOTAL QUALITY MANAGEMENT 14  What is Conformity? APM 22092 TOTAL QUALITY MANAGEMENT 15 Conformity ❑ Conformity: fulfilment of specified requirements ❑ Requirements can be general and detailed (exact dimensions) ❑ Requirements can be specified by a variety of sources (eg: legal provisions, regional arrangement, contracts, standards, etc) APM 22092 TOTAL QUALITY MANAGEMENT 16 What is Conformity Assessment? APM 22092 TOTAL QUALITY MANAGEMENT 17 What is Conformity Assessment? Does the product do what I expect? Is he competent to carry out my work? Will the shop provide the right item at the right price when I need it? Is my product safe? APM 22092 TOTAL QUALITY MANAGEMENT 18 Conformity Assessment ❑ Demonstration that specified requirements are met by a product or a person or a process or an organization ❑ The whole process of accreditation and certification and is the process of determining whether product, processes, systems, and people meet specified requirements ❑ Terminology for conformity assessment is found in standard ISO/IEC 17000 https://safetyequipment.org/isea-standards/standards-faq/what-is-conformity-assessment/ APM 22092 TOTAL QUALITY MANAGEMENT 19 Quality Infrastructure Source: ISO and UNIDO, The Conformity Assessment Toolbox APM 22092 TOTAL QUALITY MANAGEMENT 20 Conformity Assessment and Standards ❑Standards provide written instructions ❑Conformity assessment verifies that these instructions are properly maintained in practices ❑Conformity assessments: process of ensuring that a standard or technical specification are applied in the design, manufacturing, installation, maintenance or repair of a device or system https://www.iec.ch/conformity-assessment/what-conformity-assessment APM 22092 TOTAL QUALITY MANAGEMENT 21 Conformity Assessment and Standards ❑A series of international standards specifying how to maintain the conformity assessment have been published by the IEC (the international electrotechnical commission ) and ISO ❑These standards and guides are produced through the ISO Committee on conformity assessment (ISO/CASCO): CASCO toolbox APM 22092 TOTAL QUALITY MANAGEMENT 22 Conformity Assessment Model Source: ISO and UNIDO, The Conformity Assessment Toolbox APM 22092 TOTAL QUALITY MANAGEMENT 23 Conformity Assessment Certification Bodies ❑In charge of the certification of quality systems or products and personnel ✓ ISO/IEC 17025-Conformity assessment general requirements for the competence of testing and calibration laboratories ✓ ISO/IEC 17024-Conformity assessment general requirements for bodies operating certification of persons ✓ ISO/IEC 17050-General criteria for a supplier’s declaration of conformity in relation to international standards APM 22092 TOTAL QUALITY MANAGEMENT 24 Conformity Assessment ✓ ISO/IEC Guide 61- General requirements for assessment and accreditation of certification/ registration bodies ✓ ISO/IEC Guide 65- General requirements for bodies operating product certification systems ✓ ISO/IEC 17020-Confirmity assessment general criteria for the operation of various types of bodies performing inspection ✓ ISO/IEC Guide 62- General requirements for bodies operating assessment and certification/registration of quality systems APM 22092 TOTAL QUALITY MANAGEMENT 25 Expectation of the Conformity Assessment Community ❑Articulates the voice of consumers and influencing the development respected standards ❑Risk mitigation ❑Market surveillance ❑Technical arena and partnership ❑Legislative and political arena APM 22092 TOTAL QUALITY MANAGEMENT 26 Objects of Conformity Assessment ❑Products ❑Service ❑Process ❑System ❑Management ❑Person ❑Body ❑Claim APM 22092 TOTAL QUALITY MANAGEMENT 27 Conformity Assessment Techniques APM 22092 TOTAL QUALITY MANAGEMENT 28  Functional Approach to Conformity Assessment Source: ISO and UNIDO, The Conformity Assessment Toolbox APM 22092 TOTAL QUALITY MANAGEMENT 29 Functional Approach to Conformity Assessment Selection ❑Specification of standard(s) for assessing conformity ❑Selection of the examples of the object ❑Specification of statistical sampling techniques if applicable APM 22092 TOTAL QUALITY MANAGEMENT 30 Functional Approach to Conformity Assessment Determination ❑Testing to determine specified characteristics of the object ❑Inspection of physical features of the object ❑Auditing of systems and records relating to the object ❑Evaluation of qualities of the object ❑Examination of specifications and drawings APM 22092 TOTAL QUALITY MANAGEMENT 31 Functional Approach to Conformity Assessment Review and attestation ❑ Reviewing the evidence collected from the determination stage ❑ Referring to determination stage to resolve nonconformities ❑ Drawing up and issuing a statement of conformity ❑ Placing a mark of conformity on conforming products APM 22092 TOTAL QUALITY MANAGEMENT 32 Functional Approach to Conformity Assessment Surveillance ❑Carrying out determination activities at the point of production or in the supply chain ❑Carrying out determination activities in the marketplace ❑Carrying out determination activities at the place of use ❑Reviewing the outcome from the determination activities and attestation APM 22092 TOTAL QUALITY MANAGEMENT 33  Parties Involved in conformity Assessment ❑First-party: person or organization that provides the object ❑Second-party: person or organization that has a user interests in the object ❑Third-party: person or body that is independent of above two APM 22092 TOTAL QUALITY MANAGEMENT 34 Conformity Assessment Techniques ❑Testing and calibration ❑Inspection ❑Auditing ❑Evaluation ❑Accreditation ❑Certification APM 22092 TOTAL QUALITY MANAGEMENT 35 Testing and Calibration Testing Determination of one or more characteristics of an object of conformity assessment according to a procedure Calibration Under specified conditions, ❑ 1st step: Establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties ❑ 2nd step: Uses this information to establish a relation for obtaining a measurement result from an indication APM 22092 TOTAL QUALITY MANAGEMENT 36 Inspection ❑ Examination of a product design, product, process or installation and determination of its conformity with specific requirements ❑ Inspection of a process may include inspection of persons, facilities, technology and methodology ✓ Visual examination of physical items ✓ Measurement or testing of physical items ✓ Examination of specification documents such as design drawings ✓ Comparison of the findings with the requirements of specification documents or with generally accepted good practice in the field ✓ Drawing up a report on the results of the inspection APM 22092 TOTAL QUALITY MANAGEMENT 37 Auditing ❑ A systematic, independent and documented process for obtaining audit evidence ❑ Evaluating it objectively to determine the extent to which the audit criteria are fulfilled ✓ Identification of sources of information ✓ Collecting information by appropriate sampling and verifying ✓ Establishing audit evidence from the information ✓ Evaluating information and evidence against audit criteria ✓ Identifying audit findings ✓ Reviewing the audit findings and evidence ✓ Audit conclusion APM 22092 TOTAL QUALITY MANAGEMENT 38 Evaluation ❑ The range of activities concerned with gathering evidence of conformity ❑ These activities can include testing, inspection and auditing APM 22092 TOTAL QUALITY MANAGEMENT 39 Accreditation ❑ A conformity assessment technique specifically related to the assessment of the conformity of conformity assessment bodies by a third party (an accreditation body) ❑ Involves the use of auditing techniques by assessment teams including experts in the organizational aspects such as management systems and also in the technical activities APM 22092 TOTAL QUALITY MANAGEMENT 40 Typical Use of Accreditation ❑To assess and ensure/enhance ongoing conformity assessment body and program for competence, management and technical requirements ❑To attain needed confidence in laboratory testing operation and results ❑To attain needed confidence in certification system APM 22092 TOTAL QUALITY MANAGEMENT 41 Concluding the Conformity Assessment ❑Statement of conformity ❑Declaration of conformity ❑Certificate of conformity ❑Marks of conformity APM 22092 TOTAL QUALITY MANAGEMENT 42 Concluding the Conformity Assessment Statement of conformity ❑ Issue at the end of the conformity assessment process ❑ Statement should provide unambiguous identification of the object and of the specified requirements with which it has been found to conform ❑ Statement may be on paper or in some other retrievable means such as photographic or digital media APM 22092 TOTAL QUALITY MANAGEMENT 43 Concluding the Conformity Assessment Declaration of conformity ❑ Issued by a 1st party (supplier of a product) or a 2nd party (the purchaser) ❑ Adopted to differentiate these statements from those issued by a 3rd party (certificates of conformity) ❑ ISO/IEC 17050 provides information on the content of a supplier’s declaration of conformity APM 22092 TOTAL QUALITY MANAGEMENT 44 Concluding the Conformity Assessment Certificate of conformity ❑A statement of conformity issued by a 3rd party ❑The terms and the specific contents can vary according to the object and the nature of the specified requirements ❑The ISO/ CASCO standards provide information on the nature and content of the conformity statements APM 22092 TOTAL QUALITY MANAGEMENT 45 Concluding the Conformity Assessment Marks of conformity ❑ It is common for products to bear marks of conformity ❑ The supplier’s own trademark ❑ A certification mark controlled by a certification body ❑ A conformity mark required by legislation The use of a mark of conformity is controlled through a licence issued by the owner of the mark or a certification body acting on behalf of the owner APM 22092 TOTAL QUALITY MANAGEMENT 46 Conformity Assessment Schemes and Systems Scheme ❑A particular group of objects having sufficiently similar characteristics ❑The same set of rules and procedures can be carried out ❑The same management for assessing conformity ❑Same set of specified requirements APM 22092 TOTAL QUALITY MANAGEMENT 47 Conformity Assessment Schemes and Systems Systems ❑ A conformity assessment system uses a common set of rules, procedures and management for several conformity assessment schemes ❑ The rules and procedures may need to be detailed in different ways for different schemes ❑ Advantages in terms of efficiency and consistency to working within a common framework APM 22092 TOTAL QUALITY MANAGEMENT 48 Conformity Assessment Schemes and Systems Scheme Owner ❑ A manufacturing organization could set up a scheme for its products ❑ A certification body for sole use of its clients ❑ An organization such as a regulatory body or a trade association ❑ A group of certification bodies (perhaps in different countries) might together set up a certification scheme APM 22092 TOTAL QUALITY MANAGEMENT 49 Need for Conformity Assessment ❑ Means for testing the compliance of products and services with expectations, in accordance with relevant standards, regulations and other specifications ❑ Establishing and monitoring appropriate requirements for protection of health, safety and environment ❑ Protection of consumers through control of unfair trading practices ❑ Ensuring the compatibility and interoperability of components in products and systems ❑ Assisting the quarantining of harmful commodities, products, pests and diseases from entry into in an economy APM 22092 TOTAL QUALITY MANAGEMENT 50 Benefits from Conformity Assessment Consumers ❑ Provides basis for selecting products/services ❑ More confidence in products/services that are supported by a formal supplier’s declaration, or bearing a mark or certificate of conformity Manufacturers and service providers ❑ Assessing products/services in accordance with International Standards helps them to meet the current state of the art ❑ Avoid the costs of product failures in the market APM 22092 TOTAL QUALITY MANAGEMENT 51 Benefits for the Parties Regulators ❑Means to enforce national health, safety and environmental legislation and achieve public policy goals ❑Harmonizing practices and procedures around the world APM 22092 TOTAL QUALITY MANAGEMENT 52 Conformity Assessment Needs of Developing Countries ❑ Access to specialist calibration services to support their own testing and measurement ❑ Access to reference materials and certified reference materials ❑ Access to proficiency testing services ❑ Access to equipment ❑ Access to research and development expertise ❑ Training of technical, management and support staff APM 22092 TOTAL QUALITY MANAGEMENT 53 Conformity Assessment for International Trade ❑ International recognition ❑ Conformity to certain standards of its exports and imports ❑ International trade negotiations and agreements ❑ Understanding of international trade rules ❑ Confidence in participating international trade ❑ Remove unnecessary obstacles to international trade APM 22092 TOTAL QUALITY MANAGEMENT 54 Recap ❑ Conformity ❑ Conformity assessment ❑ Objects of conformity assessment ❑ Parties involved in conformity assessment ❑ Conformity assessment techniques ❑ Conformity assessment schemes and systems ❑ Concluding the conformity assessment ❑ Benefits from conformity assessment ❑ Conformity assessment needs of developing countries ❑ Conformity assessment for international trade References ISO and UNIDO, Building Trust, The Conformity Assessment Toolbox, ISO - Building trust - The Conformity Assessment Toolbox APM 22092 TOTAL QUALITY MANAGEMENT 56