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  • 2. Objectives Introduce the Concept of ISO 9001:2000 Standard Highlight the Important Areas and Changes of the New Standard Briefly introduce the system requirements of the Standard
  • 3. What is ISO 9001: 2000 2nd revision of Quality Management System Requirement Standard from International Organization for Standards Replacement of the previous ISO 9001 / 9002 and 9003: 1994 version of the Standards Introduced considerable conceptual changes Applicable to all types of Organizations with possible permissible omissions of certain requirements
  • 4. New ISO 9001:2000 QMS Resource Management Measurement, Analysis & Improvements Product Realization Management Responsibility Continual Improvements cycle General Requirements General Requirements
  • 5. ISO 9001:2000 – Process Model CUSTOMER’S CUSTOMER ISO 9001:2000 Quality Management System 5.Management Responsibility 7. Product Realization 6. Resource Management 8 . Measurement Analysis and Improvements Requirements Satisfaction Continual Improvement of the Quality Management System Consumption Product
  • 6. 8 Principles of the New Standard Based on eight quality management principles. Leadership Process approach Involvement of people System approach to Management Continual improvement Factual approach to decision making Mutual beneficial supplier relationship Customer focus
  • 7. Process Approach
    • Process Definition:
      • Set of interrelated or interacting activities which transforms Inputs into Outputs
    Ensure Continual I mprovements Do it for all “Value Adding Processes” Identify the Processes Establish Measuring Criteria Identify the Interactions to other Processes Identify the Inputs & Outputs
  • 8. Process Approach – Continual Improvements of All Processes PDCA Cycle Processes in terms Of Added Value DO Continual Improvements of Processes Based on Objective Measurements ACTION Measure Results of Process Performance and Effectiveness - Objective Measurements CHECK Understanding & Meeting the Requirements PLAN
  • 9. E.g. - Purchasing Process
    • Performance Measurements
    • Delivery status – On-time, On spec, NCP etc
    • Supplier evaluation
    • Outputs
    • Receipt of Materials on right conditions
    • Right Quality, Right Quantity
    • Right Time.
    Purchasing Procedure
    • Interactions to
    • Storage
    • Inspection and Testing
    • Manufacturing
    • Finance
    • Inputs
    • Required item / quantity / date
    • Applicable specs
    • Supplier source
    • Suppliers capability to meet our requirements
  • 10. System Requirements / Structure of the Standard 4 Quality Management System Requirements Provision of Resources Human Resources Infrastructure Work Environment 6 Resource Management General Requirements Documentation Requirements Planning Customer Related Processes Design & Development Purchasing Production & Service Provision Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority & Communication Management Reviews 5 Management Responsibility 8 Measurement Analysis & Improvements 7 Product Realization General Monitoring & Measurements Control of NCP’s Analysis of Data Improvements
  • 11. Criteria for Measurements System Performance
    • Internal Audits
      • Effectiveness & Efficiency of Processes
      • Opportunities for Improvements
      • Use of Data / Information
      • Effective & Efficient Use of Resources
      • Adequacy, Accuracy and Performance of Measurements
      • Relationships with customers/ suppliers/ other interested parties
    • Financial Measurements
      • Prevention cost
      • Non conforming / failure cost
      • Lifecycle cost
    Self Assessment
    • Satisfaction Surveys for customers and other interested parties
      • Feedback on products
      • Customer & market requirements
  • 12. Criteria for Measurements Products Processes
      • Inspection and testing of incoming, in process and final products
      • Product verification
      • Product validation
      • Process Capability / Process validation
      • Reaction time
      • Cycle time / throughput (Capacity)
      • Utilization of new technology
      • Waste reduction
      • Cost reduction
  • 13. Challenges in Implementing the Standard Communication Management Support Other employee Support ISO 9001 Encouragement
  • 14. Thank you for your time.