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“ ISO 9000 :2000”

“ ISO 9000 :2000”. 2nd INTERNATIONAL QUALITY CONGRESS MEXICO CITY - JUNE 19-20 2000. THE PRESENT - THE FUTURE & BEYOND. Dr John Davies (Chairman, ISO/TC-176/SC2). “ISO 9000:2000”. Working Group WG 18. Approximately 150 Experts from over 50 member bodies

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“ ISO 9000 :2000”

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  2. THE PRESENT - THE FUTURE & BEYOND. Dr John Davies (Chairman, ISO/TC-176/SC2) “ISO 9000:2000”

  3. Working Group WG 18 • Approximately 150 Experts from over 50 member bodies • People with sound practicalexperience • Includes representatives from Industry, Non-Profit organizations, Government, Certification Bodies, Accreditation Bodies, Standards Bodies,Consultants, and Consumer Bodies, among others.

  4. Principal Activities of WG18 • TG1.1 - Project Planning & Operations • TG1.2 - Customer Needs Analysis & Communication • TG1.3 - Key Concepts for the Consistent Pair • TG1.4 - Relationship to Other Standards • TG1.5 - Structure of the Consistent Pair • TG1.6 - Approach to Drafting the Consistent Pair • TG1.7 - Drafting the Consistent Pair • TG1.8 - Verification & Validation • TG1.9 - Introduction of the Consistent Pair • TG1.10 - Product Support

  5. Other ISO 9000 Standards Technical Reports 10006* 10007* 10013 10014 10015* 10017 TS16949 Future ISO 9000 Family(Subject to Ballot) ISO 9000 Core Standards Brochures Withdraw or transfer to other TC Technical Specs 9000 9001 9004 19011 10012 • QMP • Sel & Use • Small Bus • Handbook 9000-3 9000-4 9004-2 9004-3 9004-4 10005 * Document status TR to be considered at next revision

  6. “ISO 9000 2000” CORE STANDARD.ISO DIS 9001.Quality management systems - Requirements.

  7. “ISO 9000:2000”C0RE STANDARDISO/DIS 9004.Quality management systems -Guidelines for performance improvements.

  8. “ISO 9000: 2000”CORE STANDARDISO CD2 19011 2001.Guidelines on quality and environmental management systems auditing.

  9. Development process for ISO 9001 and ISO 9004 • User surveys • Specifications • Project approach • Review of comments received • Verification process • Validation pilot studies • Extensive use of electronic communications

  10. Why revised QMS standards? • Evolving user and customer needs • Process-oriented management • Required 5-year standards review • Problems with current 20-element model • Multiple management systems • Difficult for small businesses • Oriented towards manufacturing • Proliferation of guideline standards • Beyond certification towards performance improvement

  11. 381 182 Survey participants Total: 1120 Argentina Australia Austria Belgium Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Iceland India Indonesia Ireland Israel Italy Japan Korea Kuwait Malaysia Mauritius Mexico New Zealand Norway Poland Portugal Singapore Slovenia South Africa Spain Sweden Switzerland The Netherlands Turkey UK USA Zimbabwe

  12. Survey Summary • Significant user and customer needs • Common structure based on process model • Increased compatibility with ISO 14000 • Provide for reduced application of ISO 9001 requirements. • Include requirement for continual improvement • Suitable for all size organizations in any sector • User/customer friendliness • Easy to transition to Year 2000 standards

  13. “To provide confidence, as a result of demonstration, in product conformance to established requirements” ISO 9001:2000 - Requirements

  14. “Benefits for all interested parties through sustained customer satisfaction” ISO 9004:2000 - Guidelines

  15. Relationship ISO 9001/ISO 9004 • 2 stand-alone standards, each being part of a “consistent pair” • Common structure based on “Process Approach” • Harmonized terminology • Based on 8 “Quality Management Principles” previously endorsed by ISO/TC176

  16. Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationship Quality Management Principles

  17. “ISO 9000 2000.” An ISO BrochureQuality management principlesIs planned to be published in SEPTEMBER 2000.

  18. “ISO 9000 2000”. Principal Changes to ISO 9000, ISO 9001, ISO 9004

  19. Disclaimer • Although the information provided here today is meant to give an accurate picture of the revision work on the ISO 9000 family of standards, any opinions expressed by the presenter are not necessarily official views of ISO/TC176, or of the Working Group responsible for developing these revisions. • As the revisions are still in progress, the contents are subject to change and should not be used in any contractual or legally binding agreements.

  20. Management responsibility Policy, objectives, planning, system, review Resource management Human resources, information, facilities Product realization Customer, design, purchasing, production, calibration Measurement, analysis and improvement Audit, process/product control, improvement Process-based structure


  22. CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM Management S responsibility a C t C i u u R s Measurement , e Resource s s f q analysis , a t management u t c o improvement i t o r m i e o m e m n e r e n Product realization r t Input Output s Product Process Model (ISO 9001:2000)

  23. CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM I n t e r e s t e d P a r t i e s I n t e r e s t e d P a r t i e s Management S responsibility a t i R s Measurement , e Resource f q analysis , a management u c improvement i t r i e o m n e n Product realization t Input Output s Product Process Model (ISO 9004:2000)

  24. Structure changes • New structure of the standards should not oblige organizations to change their system documentation to match the structure of the standards. • System documentation is unique to each organization.

  25. New Terms and Definitions • Terminology more in line with common useage: • Back to “Product” instead of “Product and/or Service” used in CD2 • “Product” defined in ISO 9000:2000 “Supplier” “ Organization” “Customer”

  26. ISO 9001:2000 - General • Single QMS requirements standard (no ISO 9002, 9003) • “Permissible exclusions” allowed where all requirements not applicable. • More emphasis on customer needs • Less emphasis on documented procedures

  27. ISO 9001:2000 - Management Responsibility • More emphasis on top management commitment. • Customer focus. • Consideration of legal and regulatory requirements (relating to product/service) • Policy deployment and objectives at relevant functions and levels

  28. ISO 9001:2000 - Management Responsibility • Need for good internal communication • Specific items for Management Review • Audit results • Customer feedback • Process performance • Product/service conformance

  29. ISO 9001:2000 - Resource Management • Define and provide resources needed to establish, maintain and improve QMS • Determination of training effectiveness • Ensure employee awareness • Relevance and importance of activities • Contribution to Quality Objectives • Need to “Manage Human/Physical factors of Work Environment”

  30. ISO 9001:2000 - Product Realization • Identification of customer requirements • Fitness for use • Regulatory/Legal Requirements • Customer communication to address: • Product information • Order handling and changes • Customer feedback, including complaints

  31. ISO 9001:2000 - Product Realization • Need for process validation • Control of Measuring/Monitoring Equipment SIMPLIFIED TEXT!

  32. ISO 9001:2000 - Measurement, Analysis & Improvement • Need to define applicable methodologies and Statistical techniques • Analysis of data to include • Information on Customer Satisfaction and/or Dissatisfaction • Conformance to requirements • Trends of processes & products • Suppliers

  33. ISO 9001:2000 - Measurement, Analysis & Improvement • “Plan and manage processes necessary for continual improvement of QMS”

  34. Main Changes to ISO 9001 from CD2 to DIS • Significant reduction in documentation requirements; DIS is less prescriptive. • DIS now requires: • Quality Manual • 6 specific documented procedures • Other procedures where needed to ensure effective operation and control of processes

  35. Main Changes to ISO 9001 from CD2 to DIS • Other changes include: • Legal and regulatory requirements now addressed under Management Commitment • “Infrastructure” changed to “Facilities” • “Work Ethics” and other subjective elements eliminated • Internal audit more aligned with ISO 10011 and new ISO 19011 (under development)

  36. ISO 9004:2000 • ISO 9004 completely re-written • Revised terminology, harmonized with ISO 9001 • Annex on self-assessment added • Includes the requirements from ISO 9001 (in clearly delineated boxes). • More “user-friendly” • Benefits “For all interested parties”

  37. Main Changes to ISO 9004 from CD2 to DIS • New Sections 0.3 and 0.4 added to clarify relationship between ISO 9004 and ISO 9001 / other management systems. • Better structuring of text; use of bullets to avoid long phrases • Self-assessment model better explained

  38. Main Changes to ISO 9004 from CD2 to DIS • Annex B added to describe Process Methodology for Improvement: • “Strategic Breakthroughs” • “Small Steps” • Internal Audit section more compatible with latest draft of ISO 19011

  39. Validation Program • Organizations in TC 176 member countries participated in validation of CD2’s; organizations have been invited to participate in validation of DIS’s • Validation program in two parts: • Questionnaire addressing both 9001 & 9004 (based on earlier validation studies) • Impact Assessment on ISO/CD2 9001 (including some assessment on 9004)

  40. Draft standards Specs Verification / Validation VERIFICATION Customer needs Drafting process VALIDATION

  41. Other Related Activities • Activities Within ISO/TC 176 • PMG “Selection & Use” Brochure • Incorporate ISO 19011 and others (TR’s etc) • PMG Interpretations • PMG Translation Guidance • PMG Brochure on Quality Management Principles.

  42. Other developments • Auditing • Recognition of need for harmonization of QMS and EMS auditing. • Auditing Joint Working Group between ISO/TC176 and ISO/TC207. • ISO-CS decision to join ISO 10011 and 14010/11/12 auditing standards • New ISO 19011 to be published 3Q 2001

  43. Potential Benefits and Opportunities for Organisations

  44. Who can benefit most? YOU!!

  45. What the new standard means for your organisation • Customer focus • Need to stop and think: • “Who are my customers?” • “What do they really want?” • “What are my key processes to be sure they get what they want?” • “Does that tie in with what I want??” • More emphasis on defining objectives • Providing leadership

  46. Better integration of QMS • Better integration of QMS into the Day-to-Day running of the Business • Need to define and understand key processes • Inputs • Outputs • Measurements

  47. Less “Bureaucracy” • Only 6 specified requirements for “documented procedures” • More flexibility for organization to define where procedures are necessary • More results-oriented (P-D-C-A approach) • Standardization • Operation • Feedback of results

  48. Stepping-Stone to Excellence • Alignment ISO 9001 and ISO 9004 • ISO 9004 for self-assessment of maturity • Focus on improvement in performance • Compatibility with Quality Awards

  49. Think Performance Improvement… Think ISO 9004!! • Increase profits • leadership and customer focus • clear objectives • increased efficiency • improved employee performance • employee and customer satisfaction • efficient use of resources

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