1. April 2001www.qimpro.com1 ISO 9000: 2000 Orientation Training Qimpro Standards Organization

2. April 2001www.qimpro.com2 Session Outline  Background  ISO 9000 : 1994  Need for revision  Process model  ISO 9000: 2000 concepts  ISO 9001: 2000 requirements  Implementation approach.

3. Background

4. April 2001www.qimpro.com4 ISO 9000 : 1994  Quality assurance management system standard  First version in 1987, revised in 1994  Internationally accepted  Guidelines – 9000, 9004  Family of standards – 9001/2/3  20 clauses, generic in nature  Certification agencies and accreditation boards  Standardized work methods  Implementation improves team work.

5. April 2001www.qimpro.com5  Need to address limitations of ISO 9000:1994  Documentation worshipped  Silo based approach glorified  Reduction of chronic waste marginal  Customer neglected  Company-wide involvement not achieved  Inadequate management commitment  Inadequate attention to supplier partnership. Need for Revision …

6. April 2001www.qimpro.com6  Continual improvement  Customer satisfaction  Management with total quality principles  Work environment  User friendly documents. Need for Revision (Contd.)

7. April 2001www.qimpro.com7 Revision Summary  Process model – faster, better, cheaper  Customer satisfaction addressed  Continual improvement essential  Human resources enhanced  Service industry friendly  ISO 9004 : 2000 improved  Compatible with ISO 14001: 1996  ISO 9002/3 abolished.

8. Process Model

9. April 2001www.qimpro.com9 Process Model Management responsibility Measurement, analysis, improvement Product and service realization Resource management Customer requirements Customer satisfaction QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT QUALITY MANAGEMENT SYSTEM Input Output Product/ Service

10. ISO 9000: 2000 Concepts

11. April 2001www.qimpro.com11  Customer focus  Leadership  Involvement of people  Process approach  System approach to management  Continual improvement  Factual approach to decision making  Mutually beneficial supplier relationships. 8 Basic Principles …

12. April 2001www.qimpro.com12  Customer focus Organizations depend on their customers, and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.  Leadership Leaders establish unity of purpose, direction and the internal environment of the organization. They create the environment in which, people can become fully involved in achieving the organization's objectives. Basic Principles (Contd.) …

13. April 2001www.qimpro.com13  Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations’ benefit.  Process approach A desired result is achieved more efficiently when related resources and activities are managed as a process.  System approach to management Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization. Basic Principles (Contd.) …

14. April 2001www.qimpro.com14  Continual improvement A permanent objective of the organization is continual improvement.  Factual approach to decision making Effective decisions are based on the logical or intuitive analysis of data and information.  Mutually beneficial supplier relationships The ability of the organization and its suppliers to create value is enhanced by mutually beneficial relationships. Basic Principles (Contd.)

15. April 2001www.qimpro.com15 New Requirements  Continual improvement  Increased emphasis on the role of top management  Legal and regulatory requirements  Establishment of measurable objectives  Monitoring customer satisfaction  Increased attention to resource management  Determination of training effectiveness  Measurements for system, processes, and product  Analysis of collected data.

16. April 2001www.qimpro.com16 Revised Structure  Quality management system (2 elements)  Management responsibility (6 elements)  Resource management (4 elements)  Product realization (6 elements)  Measurement, analysis, and improvement (5 elements). …

17. ISO 9000: 2000 Requirements

18. April 2001www.qimpro.com18 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. Only six documents essential. …

19. April 2001www.qimpro.com19 5. Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review. Seek and provide feedback Change authorization and initiation of improvement Continually meet customer needs Quality objectives for each function or process. …

20. April 2001www.qimpro.com20 6. Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment. Determine and deploy resources Human, facilities, equipment, etc. Resources to implement quality system. …

21. April 2001www.qimpro.com21 7. Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices. Customer related processes Design, purchasing, production, and service Receipt to delivery processes. …

22. April 2001www.qimpro.com22 8. Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement. Measure and analyze results Internal audit, nonconformity control Continual improvement Process/product/service conformity Data initiates action for continual improvement.

23. April 2001www.qimpro.com23 ISO 9000: 2000 Family  Applicable  9000, 9001, 9004.  Withdrawn  8402, 9002, 9003.

24. April 2001www.qimpro.com24 Registration/Certification  Permissible exclusions on line with QS 9000  Three year transition  Early transition recommended.

25. Implementation Approach

26. April 2001www.qimpro.com26 Approach  Senior management interaction  Baseline assessment  Gap analysis and action plan  Senior management training  Orientation and awareness training  Change process – document and implement  Internal auditor training  Audits  Reviews and improvements  Certification.

27. April 2001www.qimpro.com27 Senior Management Interaction  Understand requirements  Seek and gain management support  Explain budgetary estimates  1 to 2 days – pre proposal stage.

28. April 2001www.qimpro.com28 Baseline Assessment  Detailed assessment of systems  Interview with key personnel  Assessment of existing efforts  Assessment of training needs (ISO related)  Core team formation  Management representative  2 to 3 days - post contract.

29. April 2001www.qimpro.com29 Gap Analysis and Action Plan  Adequacy analysis based on ISO 9000 : 2000  Review by expert panel at Qimpro  Initial recommendation report  Time frame estimation  Revision of time and budgetary estimates  Action plan – draft and final  Responsibility – RACI  Resources  3 days.

30. April 2001www.qimpro.com30 Senior Management Training  ISO 9000 : 2000 basics  Senior management role  Review mechanism  Role as auditor  Project management roles  Role as trainer  Publicity responsibility  Seek commitment as auditor, trainer, and coach  1 day.

31. April 2001www.qimpro.com31 Orientation and Awareness  Company-wide training  Train the trainer concept  Course material copyrights  Material developed internationally (QCI, DHI…)  Detailed input on ISO 9000 : 2000  2 days per batch.

32. April 2001www.qimpro.com32 Change Process  Visits – facilitation and guidance  Guidance on documentation  Hands-on help on implementation  Continued training sessions  Project review with management representative  Review with senior management  eGuidance.

33. April 2001www.qimpro.com33  Quality Council of Indiana and David Hutchins  In-house program  ISO 9000 : 2000 interpretations  Auditing skills  Report writing skills  Review skills  Behavioral skills/ interdependent paradigm  3 days per batch. Internal Auditor Training

34. April 2001www.qimpro.com34 Audits  Qimpro team to facilitate audits  Audit simulation  Operational and skill support  Areas for improvement  Reports  Pre-certification audit.

35. April 2001www.qimpro.com35 Review and Improvement  Review by core team  Review by senior management  Identify improvement actions  Assign responsibility – RACI  Review and record improvement  Positive constructive involvement  eGuidance.

36. April 2001www.qimpro.com36 Certification  Shortlist agencies  Select agency  Submit documents  Seek results of desk/adequacy audit  Confirm audit dates  Audit  Recommendation for certification.

37. April 2001www.qimpro.com37 Time Scales  Don’t rush it!  Change takes time  4-6 months is expected  Include slack in project schedule  Review vigorously  Demonstrate sincerity  Be involved!

38. Qimpro

39. April 2001www.qimpro.com39 Qimpro  Established in 1987 by Suresh Lulla

40. April 2001www.qimpro.com40 InputModel World Class ManagementIMC - RBNQA Infrastructure for WCMIQRS Process Management for WCMQC 3 Customer Focus for WCMValency Systems for WCMISO 9000 : 2000 Tools for WCMQMC Tool Box Professionals for WCMASQ Certification Qimpro Specialization

41. April 2001www.qimpro.com41  Indian Merchants’ Chambers, Mumbai  Det Norske Veritas, Norway  ORG-MARG, Mumbai  Dhi, UK  GOAL/QPC, USA  QCI, USA  Aptech, Mumbai. Qimpro Principals / Partners

42. April 2001www.qimpro.com42  Sectors Serviced  Manufacturing  Service  IT.  Geographical Coverage  India  Thailand, Malaysia, Singapore  Pakistan, Oman, Kenya. Qimpro Reach

43. April 2001www.qimpro.com43 Cumulative Savings Rs 4000 Crores in terms of COPQ Qimpro Benefits

44. April 2001www.qimpro.com44  Knowledge Park  Qimpro Quarterly Online  eXpert eView  Quality Dictionary  Quality Headlines  Careers  Global Events Calendar  Quality Newsletter. www.qimpro.com

45. April 2001www.qimpro.com45 Online Education ISO 9000 : 2000  Qimpro College on www.OnlineVarsity.com  Forthcoming courses developed by Qimpro  Free orientation tour  4 hours awareness  16 hours implementation  24 hours auditing skills  Opportunity to train in volumes  Affordable and convenient.

46. April 2001www.qimpro.com46 Qimpro Advantage  Consulting and eConsulting  Auditing  Training and eTraining  500 man-years of professional experience  International authorities as sources of know-how  Collaboration with specialists in India  Conventions  Awards  www.qimpro.com.

47. Thank You www.qimpro.com standards@qimpro.com