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Quality Standards Application: Quality Management Certification and Accreditation

Quality Standards Application: Quality Management Certification and Accreditation Karl Heinrich Möller Gaertnerstr. 29 D-82194 Groebenzell Tel: +49(8142)570144 Fax: +49(8142)570145 Email: Karl-Heinz.Moeller@t-online.de. Definitions History of the ISO 9000 Family

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Quality Standards Application: Quality Management Certification and Accreditation

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  1. Quality Standards Application: Quality Management Certification and Accreditation Karl Heinrich Möller Gaertnerstr. 29 D-82194 Groebenzell Tel: +49(8142)570144 Fax: +49(8142)570145 Email: Karl-Heinz.Moeller@t-online.de

  2. Definitions History of the ISO 9000 Family Compatibility of Management Standards (Quality, Environment, Safety, etc.) Process Orientation The 4 Main Standards of the Year 2000 Revision Documentation Requirements Accreditation Topics

  3. Conformity (EN 45 020; 12.1):Fulfilment by a product, process or service of specified needs Conformity assessment (EN 45 020; 12.2):Any activity concerned with determining directly or indirectly that relevant requirements are fulfilled (see product and quality management certification, accreditation, etc.) Conformity evaluation (EN 45 020; 14.1):Systematic examination of the extent to which a product, process or service fulfils specified requirements (better, worse, see awards) DefinitionsPart 1

  4. Certificate of conformity (EN 45 020; 15.5):Document issued under the rules of a certification system, providing confidence that a duly identified product, process or service is in conformity with a specific standard or other normative document Suppliers declaration (EN 45 020; 15.1.1):Procedure by which a supplier gives written assurance (confidence) that a product, process or service conforms to specified requirements DefinitionsPart 2

  5. Certification (EN 45 020; 15.1.2):Procedure by which a third party gives written assurance (confidence) that a product, process or service conforms to specified requirements Accreditation (EN 45 020; 12.11):Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks DefinitionsPart 3

  6. First Release 1987 (ISO 9001,2,3 und 9004) In the language to construct big Power Plants, Traffic Projects etc. Guidance Documents for Software (1991), Processed Material (1993) und Services (1991) First Standards for Tools (ISO 10011: Audits, ISO 10012: Measurement equipment) First Revision 1994 (development, software, services) Standards for industry sectors (medical equipment, Automotive, etc.) Additional standards for tools Second Revision 2000 (all Industry sectors) Applicable for hardware, software, processed material und services; small companies Process oriented Several guidance document no longer needed. Development of Quality Management Standards

  7. Group1: Standards Derived from ISO 9001 Medical equipment ISO TR 16 949 (based on ISO 9001:1994) ISO TR 16 949 (based on ISO 9001:2000, in preparation) QS-9000 (Chrysler, Ford und GM) VDA 6.1 (Verband der Automobilindustrie) different structure TL 9000 (Quality Excellence for Suppliers of Telecommunication Equipment AS 9000 (Aviation Industry) Group2: Different Management System Standards Quality Management Systems (ISO/TC 176; ISO 9001) Environmental Management Systems (ISO/TC 207; ISO 14001) Security Management Systems (BS 7799) Group3: Guidance Documents Road haulage, warehouse management Environmental Management Systems Maintenance Management Standards for Management SystemsDifferent Groups of Standards

  8. How to bring the different management systems together One management system standard (rejected) Compatible standards for Quality, Environment, safety, etc. Goal: Compatible standards Identical structure Common nucleus Partly identical text Special addenda's for Quality, Environment, safety, etc. Standards for Management SystemsTo Deal with Different Management Systems

  9. Improve compatibility betweenISO 9001 und ISO 14001, as well as ISO 9004 und ISO 14004 Release of ISO 9001 und ISO 9004 in 2000 Release ISO14001 und ISO 14004 not yet scheduled Combine the audit standards ISO 10011 und ISO 14 010 – 14 012 to a single Standard ISO 19 011 Improve Compatibility between Quality Managementand Environmental Management

  10. Management responsibility Policy Management responsibility Objectives Objectives and purpose of the management system Planning Interfaces between quality, environment, etc. Management Responsibilities Authorities Structure of the managementdocumentation Common Requirements for all Management Standards • Documentation and Communication • Description of the management system • Documents • Records • Engagement of employees • Control • Results (processes, products) • Reviews/Audits • Analysis • Non conformities/corrections • Process management • Process definitions • Improvement processes

  11. Structure follows quality elements Quality management system documentation is only for quality professionals Employees read procedure descriptions Structure follows Processes Quality management system documentation is read by employees New structure of the standard: Process oriented Structure of ISO 9001 and ISO 9004Quality Elements versus Processes

  12. Input Output process specifications, requirements, expectations product, fulfilment of needs value adding activities Structure of ISO 9001:2000Process definition Controlling processes customer, market, society customer supporting processes Improvement processes

  13. Process Process Process Process Process Input Output Output Input Input Output Output Input Input Output value adding activities value adding activities value adding activities value adding activities value adding activities product, fulfilment of needs specifications, requirements, expectations product, fulfilment of needs specifications, requirements, expectations specifications, requirements, expectations product, fulfilment of needs product, fulfilment of needs specifications, requirements, expectations product, fulfilment of needs specifications, requirements, expectations Structure of ISO 9001:2000Subdivision of processes

  14. Controlling processes Definition and improvement of policy Definition and improvement of objectives etc. Supporting processes Performing internal audits Measuring and assessing of processes, inputs and outputs etc. Requirements of customers, markets and society Definition and refinement of customer requirements Definition and refinement of market expectations etc. Structure of ISO 9001:2000Examples for processes

  15. 9000:2000 (formerly ISO 8402) Concepts and Terminology 9001:2000 Quality Management Systems; Requirements In order to provide confidence as a result of demonstration... 9004:2000 Quality Management Systems; Guidance for performance improvements Achieve benefits for all stakeholder groups 19011:2002 Guidelines for quality and/or environmental management systems auditing ISO 9001 Family Product Line for the Year 2000

  16. ISO 9001:2000: The organization must have at least “documented procedures” for the following six activities: 4.2.3 Control of documents 4.2.4 Control of records 8.2.2 Internal audit 8.3 Control of nonconforming product 8.5.2 Corrective action 8.5.3 Preventive action ISO 9001:2000Documentation Requirements 1

  17. The only documents specifically mentioned in ISO 9001:2000 are: Quality policy (clause 4.2.1.a) Quality objectives (clause 4.2.1.a) Quality manual (clause 4.2.1.b) ISO 9001:2000Documentation Requirements 2

  18. ISO 9001:2000Records required by ISO 9001:2000 5.6.1 Management reviews 6.2.2 (e) Education, training, skills and experience 7.1 (d) Evidence that the realization processes and resulting product fulfil requirements 7.2.2 Results of the review of requirements related to the product and actions arising from the review 7.3.2 Design and development inputs relating to product requirements 7.3.4 Results of design and development reviews and any necessary actions 7.3.5 Results of design and development verification and any necessary actions 7.3.6 Results of design and development validation and any necessary actions 7.3.7 Results of the review of design and development changes and any necessary actions 7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations 7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement

  19. 7.5.3 The unique identification of the product, where traceability is a requirement 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use 7.6 (a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist 7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements 7.6 Results of calibration and verification of measuring equipment 8.2.2 Internal audit results and follow-up actions 8.2.4 Indication of the person(s) authorizing release of product. 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained 8.5.2 Results of corrective action 8.5.3 Results of preventive action ISO 9001:2000Records required by ISO 9001:2000

  20. certification body Accredit. supplier supplier supplier certification body Conformity Assessmentand Accreditation Level of assessment without accreditation with accreditation mutual recognition Accredit. certification body certif. body certif. body certif. body supplier supplier supplier same level same level Level of assessment always the same - Requirements for certification body - Requirements for supplier Level of assessment differs - Requirements for certification body - Requirements for supplier

  21. Non signatories European Co-operation for Accreditation (EA)Multilateral Agreement (Signatories until May 2001) Calibration ; testing ; products quality systems and personnel certification Calibration ; testing ; products and quality systems certification Calibration ; testing ; quality systems certification Environnemental management systems certification Calibration ; testing Calibration ; testing ; products certification

  22. Effort of Conformity AssessmentSeveral Suppliers with an Unique Quality System

  23. number of suppliers random sample random sample First and Re Audit annual 1 - 3 1 1 4 - 8 2 2 9 - 15 3 3 16 - 25 5 4 26 - 50 7 5 51 - 100 10 6 101 - 150 13 8 151 - 200 16 10 >200 >20 >12 Effort of Conformity AssessmentsSeveral Suppliers with an Unique Quality System

  24. Management requirement Structure of the documentation Preparation of the documentation Implementation of the documentation Selection of the certification body Agreement with the certification body ISO 9001:2000 ImplementationQuestions

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