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ISO 9001: Year 2000 Revisions

ISO 9001: Year 2000 Revisions. Center for International Standards and Quality 1-800-859-0968. AT&T Bank of America Beaulieu of America BellSouth Telecommunications The Coca-Cola Company* General Motors Corporation Georgia Power Company* Interface Kimberly-Clark Corporation

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ISO 9001: Year 2000 Revisions

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  1. ISO 9001: Year 2000 Revisions Center for International Standards and Quality 1-800-859-0968

  2. AT&T Bank of America Beaulieu of America BellSouth Telecommunications The Coca-Cola Company* General Motors Corporation Georgia Power Company* Interface Kimberly-Clark Corporation NIST Manufacturing Extension Partnership State of Georgia Sykes Enterprises *founding members CISQ Sponsors

  3. Georgia Tech Industrial Extension Albany 912-430-4188 Athens 706-542-8900 Augusta 706-737-1414 Brunswick 912-262-2346 Carrollton 770-836-6665 Cartersville 770-387-4002 Columbus 706-649-1661 Dalton 706-272-2702 Douglas 912-384-1121 Dublin 912-275-6543 Gainesville 770-535-5728 Griffin 770-412-4081 Macon 912-751-6190 Newnan 770-254-7592 Rome 706-295-6008 Savannah 912-651-2551 Warner Robins 912-953-3155

  4. Checklist of Center Services For ISO 9001, ISO 14001, QS-9000, and Integrated Management Systems: • System Assessments • Training -- continuing education, on-site, multimedia, web-based • CISQ Implementation Programs • Licensing Program • User Networks (cont’d)

  5. Checklist of Center Services (cont’d) • CE Marking • Standards Information • Reading Room • www. CISQ.gatech.edu

  6. Other Services Available • Energy Management • Environmental Management • Information Technology • Lean Enterprise • Marketing and Strategic Planning • Process Productivity

  7. Why Change?

  8. Why change? Shift to process model Not just manufacturing anymore Required 5-year review

  9. 1999 2000 1st 2nd 3rd 4th 1st 2nd 3rd 4th Publication Schedule FDIS Final Draft InternationalStandard Ballot Sept 14, 2000 CD2 Committee Draft Ballot Feb. 22, 1999 IS InternationalStandardPublished Dec. 15, 2000 DIS Draft International Standard Ballot Nov. 25, 1999

  10. Year 2000 FamilyQuality Management Systems • ISO 9000 Quality management systems - Fundamentals and vocabulary • ISO 9001 Quality management systems - Requirements • ISO 9004 Quality Management Systems –Guidelines for performance improvements

  11. ISO 9000:2000 • Incorporates ISO 8402 • Introduces quality concepts • Lists new vocabulary

  12. ISO 9004:2000 • Not an implementation guide to ISO 9001:2000

  13. TQMBaldrigeAwardDemingPrize ISO 9001: 2000 ISO 9004:2000Bridge ISO 9004: 2000 ISO 9004:2000

  14. ISO 9001:2000Vocabulary Changes 2000lSupplier-Organization-Customer 1994l Subcontractor-Supplier-Customer 1994 l Stakeholders 2000 l Interested parties 1994 l Inspection and test 2000 lMonitoring and measurement

  15. ISO 9001:2000 Overview Quality Management Principles • Customer focus • Leadership • Involvement of people • Process approach (continued)

  16. ISO 9001:2000 OverviewQuality Management Principles (continued) • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships

  17. Exercise Principle Checkup How do these principles compare to those of your management team for EM Industries?

  18. ISO 9001:2000

  19. The Process ModelQuality Management System CONTINUAL IMPROVEMENT Management Responsibility C u s t o m e r S a t i s f a c t i o n C u s t o m e r R e q u i r e m e n t s Resource Management Measurement, Analysis, Improvement Product Realization Input Output Product

  20. Planning of product realization • Customer-related processes • Design and development • Purchasing • Production and service provision • Control of monitoring and measuring devices ISO 9001:2000 OverviewQMS - Process Model Management Responsibility • Provision of resources • Human resources • Infrastructure • Work environment • Management commitment • Customer focus • Quality policy • Planning • Responsibility, authority, and communication • Management review CONTINUAL IMPROVEMENT Resource Management Measurement, Analysis, Improvement Product Realization • General • Monitoring and measurement • Control of nonconforming product • Analysis of data • Improvement Management Responsibility Management Responsibility C u s t o m e r S a t i s f a c t i o n C u s t o m e r R e q u i r e m e n t s Resource Management Resource Management Measurement, Analysis, Improvement Measurement, Analysis, Improvement Product Realization Product Realization Quality Management System Input Output Product

  21. ISO 9001:2000Quality Management System • General requirements • Documentation requirements • General • Quality manual • Control of documents • Control of records

  22. Management Responsibility Resource Management Production Realization Measurement Analysis QMS Management Business Processes Purchasing Approved Supplier List Activities Tasks Place Order ISO 9001:2000 OverviewA System of Interacting Processes

  23. Exercise Process Definition • For your assigned process, prepare a graphical representation on which your team agrees. Production Process ISO process 2. Be prepared to share your results with the class.

  24. Exercise Process Sequence & Interaction • Identify the sequence and interaction of processes at your company. • Prepare a high-level flow chart based on your quality manual. • Keep flow chart to one page. • Prepare to share information.

  25. Management Responsibility5.1 Management commitment • Top management evidence of its commitment to: • Development • Implementation • Continual improvement (continued)

  26. Management Responsibility5.1 Management commitment (continued) • Ensure effectiveness of the QMS by: • Communicate importance of customer, statutory, and regulatory requirements • Establish the quality policy • Ensure establishment of quality objectives • Conduct management reviews • Ensure availability of resources

  27. Management Responsibility 5.2 Customer focus Top management ensures the organization: • Determines customer requirements • Met them with aim of enhancing customer satisfaction (CS)

  28. Management Responsibility5.3 Quality policy Top management must ensure the quality policy is: • Appropriate to organization • Committed to requirements and continual improvement • Framework for establishing and reviewing objectives • Communicated and understood • Reviewed for suitability

  29. Does this quality policy meet the requirements of ISO 9001:2000? CISQ CISQ exists to serve industry in Georgia and the nation by promoting industry’s awareness and understanding of international standards, management systems, and quality. We will maintain a center of excellence, to be able to meet or exceed our customer’s needs and requirements, and to ensure we continually improve the quality of our service and management system.

  30. Management Responsibility5.4 Planning5.4.1 Quality objectives Top management ensures objectives are (including those for product): • Established for relevant functions and levels • Measurable • Consistent with quality policy • Included to meet product requirements

  31. Management Responsibility5.4.2 Quality management system planning • Top Management shall ensure the organization: • Plans the QMS to meet the requirements given in Section 4.1 (General requirements) • Maintains the QMS during changes to the QMS

  32. Management Responsibility5.5 Responsibility, authority, and communication 5.5.1 Responsibility and authority • Defined • Communicated

  33. Management Responsibility 5.5.2 Management representative • Appointed by top management • Must be member of management • Duties include: • Ensure QMS processes are established, implemented, and maintained • Report to top management on QMS including need for improvement • Ensure promotion of the awareness of customer requirements

  34. Management Responsibility5.5.3 Internal communication System must ensure appropriate communication processes are: • Established • Take place regarding the effectiveness of the QMS

  35. Management Responsibility5.6.1 Management Review - General • Purpose: review QMS to ensure proper function • Conducted by top management • Reviewed at planned intervals • Ensures suitability, adequacy, and effectiveness (continued)

  36. Management Responsibility5.6.1 Management Review – General (continued) • Includes assessing opportunities for improvement • Evaluates need for changes to: • QMS • Quality policy • Quality objectives • Maintains records of management review

  37. Management Responsibility5.6.2 Review input • Inputs to management review include the following: • Results of audits • Customer feedback • Process performance and product conformity • Status of preventive and corrective action • Follow-up actions • Changes affecting QMS • Recommendations for improvement

  38. Management Responsibility5.6.3 Review output • Standard requires specific documented outputs • Outputs shall include any decisions and actions related to: • Improvement of the effectiveness of the QMS & its processes • Improvement of product related to customer requirements • Resource needs

  39. ISO 9001:2000Resource Management • Provision of resources • Human resources • General • Competence, awareness and training • Infrastructure • Work environment

  40. ISO 9001:2000Product Realization • Planning of product realization • Customer-related processes • Determination of requirements related to the product • Review of requirements related to the product • Customer communication • Design and development(seven sections) CONT’D

  41. ISO 9001:2000Product Realization • Purchasing • Purchasing process • Purchasing information • Verification of purchased product CONT’D

  42. ISO 9001:2000Product Realization • Production and service provision • Control of production and service provision • Validation of processes for production and service provision • Identification and traceability • Customer property • Preservation of product • Control of monitoring and measuring devices

  43. ISO 9001:2000Measurement, Analysis and Improvement • General • Monitoring and measurement • Customer satisfaction • Internal audit • Monitoring and measurement of processes • Monitoring and measurement of product • Control of nonconforming product CONT’D

  44. ISO 9001:2000Measurement, Analysis and Improvement • Analysis of data • Improvement • Continual improvement • Corrective action • Preventive action

  45. Outsourcing Review of documents Measurable quality objectives Internal communication Management review - defined inputs and outputs Competency Evaluation of training effectiveness Training includes awareness Infrastructure Work Environment ISO 9001:2000Snapshot of additional requirements CONT’D

  46. ISO 9001:2000Snapshot of additional requirements • Customer communication • Review of suppliers • Customer Satisfaction • Analysis of data • Continual Improvement

  47. So What Does This Mean ?

  48. Documentation Quality Manual Numbering System Style and usability New issues Reorganization/ Re-writes Internal audits Existing system New/Revised items Training Resources Time People Training Work Load Existing responsibilities Change responsibilities What are the impacts of theses changes?

  49. Getting StartedMaking the Decision • Top Management makes evaluates their commitment to continue ISO registration. • Management representative advises what resources are needed. • Management representative ensures communication with registrar. • Top management allocates resources.

  50. ISO 9001:2000 OverviewBenefits of ISO 9001 • Process focus • Allows organizations to align business objectives with QMS objectives • Results oriented • Flexible • Easier to apply to non-manufacturing

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