1. Quality Standards Mö/3.6.2002 Folie 1 Quality Management Certification and Accreditation ICEL 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. Quality Standards Mö/3.6.2002 Folie 2 Quality Management Certification and Accreditation ICEL Topics 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

3. Quality Standards Mö/3.6.2002 Folie 3 Quality Management Certification and Accreditation ICEL Definitions Part 1 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)

4. Quality Standards Mö/3.6.2002 Folie 4 Quality Management Certification and Accreditation ICEL Definitions Part 2 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

5. Quality Standards Mö/3.6.2002 Folie 5 Quality Management Certification and Accreditation ICEL Definitions Part 3 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

6. Quality Standards Mö/3.6.2002 Folie 6 Quality Management Certification and Accreditation ICEL Development of Quality Management Standards 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.

7. Quality Standards Mö/3.6.2002 Folie 7 Quality Management Certification and Accreditation ICEL Standards for Management Systems Different Groups of Standards Group 1: 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) Group 2: 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) Group 3: Guidance Documents –Road haulage, warehouse management –Environmental Management Systems –Maintenance Management

8. Quality Standards Mö/3.6.2002 Folie 8 Quality Management Certification and Accreditation ICEL Standards for Management Systems To Deal with Different Management Systems 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.

9. Quality Standards Mö/3.6.2002 Folie 9 Quality Management Certification and Accreditation ICEL Improve Compatibility between Quality Management and Environmental Management Improve compatibility between ISO 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

10. Quality Standards Mö/3.6.2002 Folie 10 Quality Management Certification and Accreditation ICEL Common Requirements for all Management Standards 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 management documentation 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. Quality Standards Mö/3.6.2002 Folie 11 Quality Management Certification and Accreditation ICEL Structure of ISO 9001 and ISO 9004 Quality Elements versus Processes 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

12. Quality Standards Mö/3.6.2002 Folie 12 Quality Management Certification and Accreditation ICEL Structure of ISO 9001:2000 Process definition Controlling processes supporting processes customer process value adding activities Input specifications, requirements, expectations Output product, fulfilment of needs customer, market, society Improvement processes

13. Quality Standards Mö/3.6.2002 Folie 13 Quality Management Certification and Accreditation ICEL Structure of ISO 9001:2000 Subdivision of processes Input specifications, requirements, expectations Output product, fulfilment of needs Process value adding activities Input specifications, requirements, expectations Output product, fulfilment of needs Process value adding activities Input specifications, requirements, expectations Output product, fulfilment of needs Process value adding activities Input specifications, requirements, expectations Output product, fulfilment of needs Process value adding activities Input specifications, requirements, expectations Output product, fulfilment of needs Process value adding activities

14. Quality Standards Mö/3.6.2002 Folie 14 Quality Management Certification and Accreditation ICEL Structure of ISO 9001:2000 Examples for processes 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.

15. Quality Standards Mö/3.6.2002 Folie 15 Quality Management Certification and Accreditation ICEL ISO 9001 Family Product Line for the Year 2000 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

16. Quality Standards Mö/3.6.2002 Folie 16 Quality Management Certification and Accreditation ICEL ISO 9001:2000 Documentation Requirements 1 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

17. Quality Standards Mö/3.6.2002 Folie 17 Quality Management Certification and Accreditation ICEL ISO 9001:2000 Documentation Requirements 2 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)

18. Quality Standards Mö/3.6.2002 Folie 18 Quality Management Certification and Accreditation ICEL ISO 9001:2000 Records 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. Quality Standards Mö/3.6.2002 Folie 19 Quality Management Certification and Accreditation ICEL ISO 9001:2000 Records required by ISO 9001:2000 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

20. Quality Standards Mö/3.6.2002 Folie 20 Quality Management Certification and Accreditation ICEL Conformity Assessment and Accreditation with accreditation Level of assessment differs -Requirements for certification body -Requirements for supplier Level of assessment always the same - Requirements for certification body - Requirements for supplier certif. body Accredit. supplier same level Accr edit. mutual recognition Level of assessment certification body supplier certification body without accreditation certification body supplier

21. Quality Standards Mö/3.6.2002 Folie 21 Quality Management Certification and Accreditation ICEL 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 Calibration ; testing ; quality systems certification Calibration ; testing ; products certification Non signatories Environnemental management systems certification

22. Quality Standards Mö/3.6.2002 Folie 22 Quality Management Certification and Accreditation ICEL Effort of Conformity Assessment Several Suppliers with an Unique Quality System employeesInitial assessment auditor days Initial assessment auditor days annual surveillance auditor days annual surveillance auditor days re- assessment auditor days re- assessment auditor days totalon-sitetotalon-sitetotalon-site less than 52110.51.51 5 - 92.51.510.51.51 10 -19321121 20 -2942.51.5132 30 - 5964.52142.5 60 - 1007521.543 100 - 250862.5253 250 - 5001073264.5 500 - 10001294385.5 1000 - 2000151254106.5

23. Quality Standards Mö/3.6.2002 Folie 23 Quality Management Certification and Accreditation ICEL Effort of Conformity Assessments Several Suppliers with an Unique Quality System number of suppliers random samplerandom sample First and Re Auditannual 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

24. Quality Standards Mö/3.6.2002 Folie 24 Quality Management Certification and Accreditation ICEL ISO 9001:2000 Implementation Questions Management requirement Structure of the documentation Preparation of the documentation Implementation of the documentation Selection of the certification body Agreement with the certification body