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Introduction on ISO 9000 Series Standards

Introduction on ISO 9000 Series Standards. What is ISO?. International Organization for Standardization Worldwide federation of national standards bodies Non-governmental organization Established in 1947. ISO: Management System Standards. Two “ Management System ” standards:

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Introduction on ISO 9000 Series Standards

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  1. Introduction on ISO 9000 Series Standards

  2. What is ISO? • International Organization for Standardization • Worldwide federation of national standards bodies • Non-governmental organization • Established in 1947

  3. ISO: Management System Standards • Two “Management System” standards: • ISO 9000 – Quality • ISO 14000 – Environmental • Provide model for setting up & operating management system • Built on firm foundation of state-of-the-art practices

  4. ISO 9000 Family Standards: 2000 • ISO 9000:QMS - Fundamentals and Vocabulary • ISO 9001:QMS - Requirements • ISO 9004: QMS - Guidelines for Performance Improvements • ISO 19011:Guidelines for QMS & EMS Audit

  5. ISO 9000 Registrations Worldwide Source: www.iso.ch

  6. ISO 9000 Family Standards: 2000 • Eight QM principles • What is the most important principle? • And why?

  7. Continual improvement Customer (and other interested party) Customer (and other interested party) Management Responsibility Satisfaction Measurement, Analysis & Improvement Resource Management Input Output Requirements Product Realization Product 图释 Value-added activities Information flow Process-based QMS model

  8. Major contents of ISO 9001: 2000 • 4 Quality Management System • 4.1 General Requirements • 4.2 Documentation Requirements • 4.2.1 General • 4.2.2 Quality Manual • 4.2.3 Control of Documents • 4.2.4 Control of Records

  9. Major contents of ISO 9001: 2000 • 5 Management Responsibility • 5.1 Management Commitment • 5.2 Customer Focus • 5.3 Quality Policy • 5.4 Planning • 5.4.1 Quality Objectives • 5.4.2 Quality management system planning

  10. Major contents of ISO 9001: 2000 • 5 Management Responsibility • 5.5 Responsibility Authority and Communication • 5.5.1 Responsibility and Authority • 5.5.2 Management Representative • 5.5.3 Internal communication • 5.6 Management Review • 5.6.1 General • 5.6.2 Review inputs • 5.6.3 Review outputs

  11. Major contents of ISO 9001: 2000 • 6 Resource Management • 6.1 Provision of Resources • 6.2 Human Resources • 6.2.1 General • 6.2.2 Competence, awareness and training • 6.3 Infrastructure • 6.4 Work Environment

  12. Major contents of ISO 9001: 2000 • 7 Product Realization • 7.1 Planning of Product Realization • 7.2 Customer Related Processes • 7.2.1 Determination of requirements related to the product • 7.2.2 Review of product requirements • 7.2.3 Customer Communication

  13. Major contents of ISO 9001: 2000 • 7 Product Realization • 7.3 Design and Development (D&D) • 7.3.1 Planning of D&D • 7.3.2 Inputs of D&D • 7.3.3 Outputs of D&D • 7.3.4 Reviewof D&D • 7.3.5 Verificationof D&D • 7.3.6 Confirmation of D&D • 7.3.7 Control of changes in D&D

  14. Major contents of ISO 9001: 2000 • 7 Product Realization • 7.4 Purchasing • 7.4.1 Purchasing Process • 7.4.2 Purchasing Information • 7.4.3 Verification of purchased product • 7.5 Production and Service Provision • 7.5.1 Control of processes • 7.5.2 Validation of processes • 7.5.3 Identification and Traceability • 7.5.4 Customer Property • 7.5.5 Preservation of Product • 7.6 Control of Monitoring and Measuring Devices

  15. Major contents of ISO 9001: 2000 • 8 Measurement, Analysis & Improvement • 8.1 General • 8.2 Monitoring and Measurement • 8.2.1 Customer Satisfaction • 8.2.2 Internal Audit • 8.2.3 Monitoring and Measurement of Processes • 8.2.4 Monitoring and Measurement of Product

  16. Major contents of ISO 9001: 2000 • 8 Measurement, Analysis & Improvement • 8.3 Control of Non Conforming Product • 8.4 Analysis of Data • 8.5 Improvement • 8.5.1 Continual Improvement • 8.5.2 Corrective Action • 8.5.3 Preventive Action

  17. Interaction of key elements under ISO 9001:2000

  18. Establishing QMS • When to establish QMS? • --gain access to the international market • --create or strengthen the brand • --clear/standardize/improve the internal processes • --more emphasis on quality and the culture concerned

  19. ACT PLAN CHECK DO Establishing QMS • PDCA --Deming’s contribution --base of process improvement Deming

  20. Steps to ISO 9001 Registration • Identify key processes • Design & document system • Implement and operate system • Internal audits • Registrar audit • Maintain registration

  21. Steps to Registration 1. Identify key processes “Process map” shows relationship between processes throughout organization

  22. QMS Model for AIOU’s External MBA Degree Program

  23. Steps to Registration 2. Design & document system Documentation • Quality Policies & Objectives • Quality Manual • Procedure documents • Supportive documents: Work Instructions, Regulations • Quality Records - demonstrate conformance to system

  24. Steps to Registration 3. Implement and operate system • Communicate throughout organization • Departments perform work as described in procedures

  25. Steps to Registration 4. Internal Audits • Trained Internal Auditors • Documented internal audit plan • Audit results reviewed by management • Make corrections & improvements to quality system

  26. Steps to Registration 5. Registrar Audit • Documentation reviewed by auditor • Registrar sends audit team • On-site audit – typically 2-3 days • Auditors verify that system operates as outlined in procedure manual • Recommend for registration • Certificate issued

  27. Third Party Registration System

  28. Steps to Registration 6. Maintain Registration • Continue to operate quality system • Surveillance audits (annual / semi-annual) • 3-year cycle

  29. CFSO Registration: Key Milestones • December 31, 2002: Quality Management System Documentation completed (Head Office) • January 31, 2003: Internal Audit team trained

  30. CFSO Registration: Key Milestones • April 30, 2003: Internal Audits completed on all Quality System Procedures • June 30, 2003: ISO 9001 Registration achieved (Head Office)

  31. CFSO Registration: Key Milestones • December 31, 2003: Quality Management System Documentation completed (Regional Centers) • June 30, 2004: ISO 9001 Registration expanded to Regional Centers (Sample Basis)

  32. Argument about the Standards’ effectiveness • An issue that has long occupied both the business world and researchers is whether the development and certification of a quality management system according to ISO 9000 standards can finally guarantee real improvement to the certified organizations.

  33. Argument about the Standards’ effectiveness • Literature review on the standards’ effectiveness reveals two schools of thought. One school of thought supports that the standards offer a good first step towards TQM and business excellence, while the other school of thought is based on the view that organizations are mainly interested in quick and easy certification without real commitment to quality, leading to the development of “static” quality systems that cannot guarantee customer satisfaction [Tsiotras & Gotzamani, 1996]

  34. Argument about the Standards’ effectiveness • The revised ISO 9000:2000 version is much closer to the business excellence models. The new series is based on a set of quality management principles that have a good deal in common with the principles of TQM, and there is a remarkable convergence with the quality management principles of the most popular business excellence models. In fact, the Baldrige criteria have had a profound effect on the ISO 9001:2000 revision [Hampton, 2000] and as a result, the new ISO 9000:2000 requirements are more customer, process and continuous improvement oriented.

  35. Argument about the Standards’ effectiveness • However, there are serious doubts and reservations again concerning the degree to which the new standards will really boost companies’ performance more than the previous ones [Bendell, 2000, Biazzo & Bernardi, 2003, Costa & Martinez-Lorente, 2003, Janas & Luczac, 2002, Larsen & Haversjo, 2000, Laszlo, 2000, Wealleans, 2002]

  36. What Others Say… • “ISO 9001 has helped management establish a transparent internal organization that is clear to all employees.” • Wieslaw Vic Uzieblo, Director of Marketing, Protektor, Poland

  37. What Others Say… • ”Each dollar invested generates at least a four-fold return if the standard is implemented well.” • Robert Doré, Coordinator for Service Quality, Municipality of Saint-Augustin-de-Desmaures, Canada

  38. What Others Say… • “At IBM, the ISO 9000 standards have proven to be a template for the creation of a sound quality system. By embarking on the ISO 9000 journey, it is reasonable to expect lower costs, improved customer satisfaction, greater brand loyalty, and stronger market performance associated with this quality effort.” • Dr. Jack E. Small, Director ISO 9000, IBM, USA

  39. Case of the franchised car dealer--supply chain view • Management responsibility --Quality policy …

  40. Case of the franchised car dealer--supply chain view • Resource management --Supply of resources --Infrastructure and work environment …

  41. Case of the franchised car dealer--supply chain view • Product realization --Identification of requirements relevant to the product --Communication with customer --Purchase --Sign and traceability …

  42. Case of the franchised car dealer--supply chain view • Measurement, analysis and improvement --Customer satisfaction --Supervision and Measurement --Control of the nonconformity --Improvement …

  43. Assignment 1# Your opinion? • There is a quality inspection executive (QIE) in the company who is strict with quality inspection. In a recent inspection, he found the non-conforming products. He took the measure of preventing them from being deliver and reported this case to the top management (TM) in time. TM usually gives him great support. But this time, TM communicated with him to ask for delivery as that order is very urgent and failure to deliver on time will cause big loss. But QIE refused to do so with the support of quality manual and product quality requirements. Finally, TM commanded deliver of those products and meanwhile promised not to do so next time.

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