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ISO 9000 : 2000 Outline
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ISO 9000 : 2000 Outline

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  • 1. ISO 9000:2000 OUTLINE Quality Management System
  • 2. Background MIL Std US Military & NATO Standards AQAP National Standards BS 5750 CANADA FRANCE GERMANY SPAIN JAPAN USA UK + others International Standards Organisation (ISO) Committee ISO 9000: 1987 International Standard ISO 9000: 1994 ISO 9000: 2000
  • 3. What is ISO 9000? [1]
    • ISO 9000 is an internationally recognised quality management system developed by ISO (International Organisation for Standardisation)
    UNIVERSALLY RECOGNISED - SOUND QUALITY SYSTEM
  • 4. What Is ISO 9000? [2]
    • ISO 9000 Series
    ISO 9000 : 2000 QUALITY MANAGEMENT SYSTEMS - Fundamentals and vocabulary - supersedes ISO 8402 and ISO 9000-1:1994 ISO 9001: 2000 QUALITY MANAGEMENT SYSTEMS - Requirements - supersedes ISO 9001/2/3:1994 ISO 19011: 2002 Guidelines on auditing quality and environmental management systems - supersedes ISO 19011:1994 ISO 9004 : 2000 QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement - supersedes ISO 9004-1
  • 5. What Is ISO 9000? [3]
    • Standard based on 8 quality management principles
      • customer focus
      • leadership
      • involvement of people
      • process approach
      • system approach to management
      • continual improvement
      • factual approach to decision making
      • mutually beneficial supplier relationships
  • 6. Process approach model CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM Customer Customer Requirements Satisfaction Resource management Product realisation Input Product Output Measurement analysis improvement Management responsibility
  • 7. ISO 9001 Requirements
    • 4. Quality management system
    • 5. Management responsibility
    • 6. Resource management
    • 7. Product realisation
    • 8. Measurement, analysis and improvement
  • 8. 4. Quality management system
    • General requirements
      • identify QMS processes
      • sequence & interaction of processes
      • criteria & measures for effective operation
      • information to support processes
      • measure, monitor, analyse, action & improvement
    • General documentation requirements
      • procedures
      • other documents
  • 9. 5. Management responsibility
    • Management commitment
    • Customer focus
    • Quality policy
    • Planning
      • quality objectives
      • quality planning
        • permissible exclusions
        • resources
        • continual improvement
    • Administration
      • responsibility & authority
      • management representative
      • internal communication
      • quality manual
      • control of documents
      • control of quality records
    • Management review
      • inputs (results)
      • outputs (actions / resources)
  • 10. 6. Resource management
    • Provision of resources
      • relating to QMS
      • customer satisfaction
    • Human resources
      • competency
      • training
      • effectiveness of training
      • contribution to quality objectives
      • staff records
    • Facilities
      • workspace & facilities
      • equipment, h/ware, s/ware
    • Work environment
      • human & physical factors
  • 11. 7. Product realisation
    • Planning of realisation processes
    • Customer related processes
    • Design & development
      • planning
      • inputs
      • outputs
      • review
      • verification
      • validation
      • changes
    • Purchasing
      • control
      • information
      • verification
    • Production & service operations
      • control
      • identification & traceability
      • customer property
      • preservation
      • measuring & monitoring
  • 12. 8. Measurement, analysis & improvement
    • Planning
    • Measurement & monitoring
      • customer satisfaction
      • internal audit
      • processes
      • product
      • control of noncomformity
      • analysis of data
    Continued --->
  • 13. 8. Measurement, analysis & improvement (continued)
    • Improvement
      • planning for continual improvement
      • corrective action
        • identifying non-conform.
        • causes
        • solutions
        • action
        • results
        • review
      • preventive action
        • potential non-conformance
        • preventive actions
        • results of actions
        • review
  • 14. Certification Milestones 2. Prepare quality manual, policy, processes, planning 3. Prepare procedures, work instructions & records 10. Certification 9. External assessment ISO 9000 Certificate Proced -ures Work Instructs Quality Records 1. Brief management team 4. Implement procedures 5. Train internal auditors 6. Conduct internal audits 7. Conduct management review 8. Preliminary assessment Quality Policy Quality Manual QMS Processes Quality Plan
  • 15. Who requires ISO 9000?
    • Credible suppliers
    • Major customers
    • Government agencies
    • Retailers
    NO LONGER A FEATURE - INCREASINGLY AN EXPECTATION
  • 16. What Are The Benefits?
    • Sound quality system
    • Single systems audit
    • Eligibility for tenders
    • Evidence of compliance
    • Recognition of standard achieved
    • Opportunity to improve existing processes
    • A process for continual improvement
    ADDED VALUE, MARKET ACCESS & PRIDE
  • 17. How long will it take?
    • It has been done in less than 6 months…
    • It has taken longer than 18 months…
    • It can normally be done COMFORTABLY within 12 months
    SET YOUR OWN SCHEDULE - AND HOLD IT!
  • 18. Responsibilities
    • Management representative - for overall project & process control
    • Prime & support - to develop & implement each ISO 9000 section
  • 19. Schedule - short term LUNCH DOCUMENT PREPARATION REVIEW & ACTION PLANNING LUNCH LUNCH LUNCH PRESENTATIONS, QUESTIONS & ASSIGNMENTS PLANT TOUR CONSULTING DAY 1 DAY 2 DAY 3 DAY 4 TOUR TEAM SOLO GROUP 0830 1000 1100 1230 1330 1430 1530 1700 0830 0930 1130 1230 1330 1500 1600 1700 4. QUALITY MANAGEMENT SYSTEMS 5. MANAGEMENT RESPONSIBILITY 7.1 REALISATION PROCESS 7.2 CUSTOMER RELATED PROCESSES 7.3 DESIGN AND OR DEVELOPMENT 7.4 PURCHASING 7.5 PRODUCTION & SERVICE OPERATIONS 7.6 CONTROL OF MEASURING & MONITORING DEVICES 8.2 MEASURING & MONITORING 8.3 CONTROL OF NONCONFORMITY 8.4 ANALYSIS OF DATA 8.5 IMPROVEMENT
  • 20. ISO 9001 Outline Questions Prepared for Electranet Partners by : Ray Spencer - Systex Services Tel: +1279 321 352 Fax: +1279 310 749 E-mail: ray.spencer@ntlworld.com