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ISO 9001:2008 QMS_Rajesh

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ISO 9001:2008 QMS_Rajesh

  1. 1. ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS
  2. 2. AGENDA <ul><li>Introduction </li></ul><ul><li>What is ISO? </li></ul><ul><li>ISO Family </li></ul><ul><li>Certification & Registration </li></ul><ul><li>Benefits </li></ul><ul><li>What is QMS? </li></ul><ul><li>Quality Manual </li></ul><ul><li>Importance of Documentation </li></ul><ul><li>Quality Manual Outline </li></ul><ul><li>Facts </li></ul><ul><li>Certification Audit Procedure </li></ul><ul><li>Action Items </li></ul>
  3. 3. INTRO <ul><li>Every organization would like to improve the way it operates </li></ul><ul><li>A quality management system gives you the framework you need </li></ul><ul><li>to monitor and improve performance in any area you choose. </li></ul><ul><li>ISO 9001 is the world’s most established quality framework, </li></ul><ul><li>currently being used by over ¾ million organizations in 161 </li></ul><ul><li>countries. </li></ul><ul><li>It helps all kinds of organizations to succeed through improved </li></ul><ul><li>customer satisfaction, staff motivation and continual </li></ul><ul><li>improvement. </li></ul>
  4. 4. WHAT IS ISO? <ul><li>ISO is a standard for Quality </li></ul><ul><li>Management System </li></ul><ul><li>ISO 9001:2008 is a model for </li></ul><ul><li>a Quality management system </li></ul>
  5. 5. WHAT IS ISO? <ul><li>The term ‘ISO’ actually stands for </li></ul><ul><li>the ‘International Organization for </li></ul><ul><li>Standardization’ </li></ul><ul><li>The Organizations short name was </li></ul><ul><li>taken from the Greek word “isos”, </li></ul><ul><li>meaning “equal”. </li></ul>
  6. 6. ISO FAMILY <ul><li>ISO 9000:2005 Consists of 3 areas </li></ul><ul><ul><li>ISO 9000:2005 – Quality Management Systems-Fundamentals and Vocabulary </li></ul></ul><ul><ul><li>ISO 9001:2008 – QMS – Requirements (required for certification) </li></ul></ul><ul><ul><ul><li>Management Responsibility </li></ul></ul></ul><ul><ul><ul><li>Resource Management </li></ul></ul></ul><ul><ul><ul><li>Product/Service realization </li></ul></ul></ul><ul><ul><ul><li>Measurement, analysis, improvement </li></ul></ul></ul><ul><ul><li>ISO 9004:2009 – QMS – Gu idelines for performance improvement </li></ul></ul>
  7. 7. CERTIFICATION AND REGISTRATION <ul><li>Certification is known as Registration in some countries </li></ul><ul><li>An Independent, external body has audited an organizations </li></ul><ul><li>management system and verified that it conforms to the </li></ul><ul><li>requirements specified in the standard (ISO 9001). </li></ul><ul><li>ISO does not carry out certification and does not issue or approve </li></ul><ul><li>certificates. </li></ul>
  8. 8. BENEFITS <ul><li>The major reason why many companies want ISO 9001 certification is that they want to portray themselves as a worthy company to do business with, many of them do not really realize the benefits (some direct and others indirect): Direct Benefits: • Improved customer satisfaction; • Improved quality of products and services; • Employees satisfaction and more commitment to the organization; • Better management and a more effective organization; • Improve relations with suppliers; • Improved promotion of corporate image. </li></ul>
  9. 9. BENEFITS <ul><li>Indirect Benefits: It helps companies to </li></ul><ul><li>• Review business goals, and assess how well the organization is meeting those </li></ul><ul><li>goals; </li></ul><ul><li>• Identify processes that are unnecessary or inefficient, and then remove or </li></ul><ul><li>improve them; </li></ul><ul><li>• Review the organizational structure, clarifying managerial responsibilities; • Improve internal communication, and business and process interfaces; • Improve staff morale by identifying the importance of their output to the </li></ul><ul><li>business, and by involving them in the review and improvement of their </li></ul><ul><li>work. </li></ul>
  10. 10. WHAT IS QMS? <ul><li>QMS – Interconnected processes that are used to manage a </li></ul><ul><li>business. </li></ul><ul><li>Basic Requirements of a Quality Management System </li></ul><ul><ul><li>Able to offer products and services that satisfy a customer’s expectations; </li></ul></ul><ul><ul><li>Agree with the relevant standards and specifications of a contract; </li></ul></ul><ul><ul><li>Available to provide products and services at competitive prices; </li></ul></ul><ul><ul><li>Supply deliverables at a cost that will still bring a profit to that organization </li></ul></ul>
  11. 11. QMS PRINCIPLES <ul><li>Any organization can benefit from implementing ISO 9001 as its requirements are underpinned by </li></ul><ul><li>8 management principles: </li></ul>
  12. 12. QUALITY MANUAL <ul><li>A Quality Manual is the main, top-level document which establishes the quality policies and objectives of an organization. </li></ul><ul><li>It describes our intent to establish a QMS with an emphasis on continual improvement. </li></ul><ul><li>The Quality Manual is at the very heart of an organization's </li></ul><ul><li>QMS and describes the interrelationships between: Process, </li></ul><ul><li>Quality Procedures and Work Instructions </li></ul>
  13. 13. QUALITY MANUAL
  14. 14. WHAT WILL A QUALITY MANUAL PROVIDE TO A COMPANY? <ul><li>Overall it provides evidence of what specific controls are implemented to ensure product/service quality. </li></ul><ul><li>Who will benefit ? </li></ul><ul><ul><li>Customers </li></ul></ul><ul><ul><li>Suppliers </li></ul></ul><ul><ul><li>Employees The Company </li></ul></ul><ul><ul><li>ISO </li></ul></ul>
  15. 15. THE IMPORTANCE OF DOCUMENTATION
  16. 16. 4 LEVELS OF DOCUMENTS
  17. 17. SO, WHAT EXACTLY DO WE FIND IN A TYPICAL QUALITY MANUAL? You might just find things like…
  18. 18. QUALITY MANUAL OUTLINE <ul><ul><ul><li>Introduction </li></ul></ul></ul><ul><ul><ul><li>Policy and Objectives </li></ul></ul></ul><ul><ul><ul><li>Definitions </li></ul></ul></ul><ul><ul><ul><li>Quality System </li></ul></ul></ul><ul><ul><ul><li>Organization </li></ul></ul></ul><ul><ul><ul><li>Authority and Responsibilities </li></ul></ul></ul><ul><ul><ul><li>Compliance </li></ul></ul></ul><ul><ul><ul><li>Internal Review and Audit </li></ul></ul></ul><ul><ul><ul><li>Documentation and Change </li></ul></ul></ul><ul><ul><ul><li>Purchasing </li></ul></ul></ul><ul><ul><ul><li>Inspection and Testing </li></ul></ul></ul><ul><ul><ul><li>Training </li></ul></ul></ul>
  19. 19. SOME FACTS <ul><li>ISO 9001 certification cost is tax deductible(“Cost incurred by a taxpayer to obtain, maintain, and renew ISO 9000 certification are deductible as ordinary and necessary business expenses under section 162 of the Code”) </li></ul><ul><li>Getting Compliance/Certification does increase sales by 4% </li></ul><ul><li>Customer satisfaction increase by 8%. </li></ul>
  20. 20. <ul><li>The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows: </li></ul><ul><li>Stage 1 – the purpose of the auditor visit is to confirm the readiness of the organization for full assessment. </li></ul><ul><li>Stage 2 – the purpose of the auditor visit is to confirm that the quality management system fully conforms to the requirements of ISO 9001:2008 in practice. </li></ul>INITIAL CERTIFICATION AUDIT PROCEDURE
  21. 21. <ul><li>Presentation on ISO 9001:2008 importance to our Internal Teams. </li></ul><ul><li>Finalize the Internal Auditor which suits to our Organization. </li></ul><ul><li>Set and start implementing the standards and procedures to comply with ISO. </li></ul><ul><li>Target timeline to acquire ISO 9001:2008 certification is JULY 2012 . </li></ul>ACTION ITEMS
  22. 22. <ul><li>BIS (Bureau of Indian Standards) – Founder member of ISO and BIS represents India, in ISO </li></ul><ul><li>NQA (Bangalore) </li></ul><ul><li>NQAQSR (New Delhi) </li></ul><ul><li>Smart Edge Consulting (Hyderabad) </li></ul><ul><li>TUV Sud South Asia (Hyderabad) </li></ul>AUDITORS LIST

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