Procedure of ISO 9001:2008 QMS


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  • Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. A quality management system gives you the framework you need to monitor and improve performance in any area you choose. ISO 9001 is by far the world’s most established quality framework, currently being used by over ¾ million organizations in 161 countries, and sets the standard not only for quality management systems, but management systems in general.
  • Generic Standards: ISO 9001 is a generic standards. Generic means that the same standards can be applied: to any organization , large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. no matter what the organization's scope of activity if it wants to establish a quality management system , ISO 9001 gives the essential features
  • Customer satisfaction – through delivery of products that consistently meet customer requirements. Reduced operating costs – through continual improvement of processes and resulting operational efficiencies. Improved stakeholder relationships – including staff, customers and suppliers. Legal compliance – by understanding how statutory and regulatory requirements impact on the organization and its your customers. Improved risk management – through greater consistency and traceability of products and services. Proven business credentials – through independent verification against recognized standards. Ability to win more business – particularly where procurement specifications require certification as a condition to supply.
  • Introduction: Who is the Company? What does it do? Policies and Objectives Why would anyone go to the trouble of assembling a Quality Manual anyway? Definitions: Maybe you already know exactly what ‘technotronic process management’ refers to, but in case you’re a little foggy… Quality System: How will we ensure that this company produces a quality product? Organization: Just use Organizational chart for this one… Authority and responsibilities The various departments of a company, such as Sales, Marketing, ID, VD, Production, Quality, HR & Finance, etc… and what the people there are supposed to be doing. Compliance Obviously, the company needs to stay in line with whatever governing body they’ve been certified by (ISO, etc…) Internal Review and Audit Things SEEM to be rolling along nicely, but how would we really know if there was a problem? By waiting for our customers to tell us? Documentation and Change Control Obviously, you can’t have people fiddling with important documents on a whim, but documents WILL need occasional updating, so… Purchasing You want to produce a high-quality product, so do you REALLY want to do business with “Jethros baRgun SupPliz” because they’re cheap as borscht, or a fully certified and accredited company? Inspection and Testing Your company may prefer to let its’ customers tell them that last shipment screwed up $150,000 worth of THEIR production, or… Training Who knows? Maybe the company can readily find people who already know how to operate Zweiger Loopertronic TJ1453-A1F’s, but in case no one has a clue…
  • Stage1: The assessor will: Confirm that the quality manual conforms to the requirements of ISO 9001. Confirm its implementation status. Confirm the scope of certification. Check legislative compliance. Produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required. Produce an assessment plan and confirm a date for the Stage 2 assessment visit Stage2: The assessor will: Undertake sample audits of the processes and activities defined in the scope of assessment. Document how the system complies with the standard. Report any non-compliances or potential for non-compliance. Produce a surveillance plan and confirm a date for the first surveillance visit.
  • Procedure of ISO 9001:2008 QMS

    2. 2. AGENDA <ul><li>Introduction </li></ul><ul><ul><ul><li>What is ISO? </li></ul></ul></ul><ul><ul><ul><li>What are the Clauses and benefits? </li></ul></ul></ul><ul><ul><ul><li>Quality Management System? </li></ul></ul></ul><ul><li>Quality Manual </li></ul><ul><li>Elements of a Quality Manual </li></ul><ul><li>How to achieve certification </li></ul><ul><li>Initial Certification Audit </li></ul><ul><li>Advantages & Summary </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 to monitor and improve performance in any area you choose. </li></ul><ul><li>ISO 9001 is the world’s most established quality framework, currently being used by over ¾ million organizations in 161 countries. </li></ul><ul><li>It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement. </li></ul>
    4. 4. WHAT IS ISO? <ul><li>ISO is a standard for Quality Management System </li></ul><ul><li>ISO 9001:2008 is a model for a Quality management system </li></ul>
    5. 5. WHAT IS ISO? <ul><li>The term ‘ISO’ actually stands for the ‘International Organization for Standardization’ </li></ul><ul><li>The Organizations short name was taken from the Greek word “isos”, 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 – Guidelines 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 management system and verified that it conforms to the requirements specified in the standard (ISO 9001). </li></ul><ul><li>ISO does not carry out certification and does not issue or approve 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 • Review business goals, and assess how well the organization is meeting those goals; • Identify processes that are unnecessary or inefficient, and then remove or improve them; • 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 business, and by involving them in the review and improvement of their work. </li></ul>
    10. 10. WHAT IS QMS? <ul><li>QMS – Interconnected processes that are used to manage a business. </li></ul>
    11. 12. 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><ul><li>A customer focused organization </li></ul><ul><li>Leadership </li></ul><ul><li>The involvement of people </li></ul><ul><li>Ensuring a process approach </li></ul><ul><li>A systematic approach to management </li></ul><ul><li>A factual approach to decision making </li></ul><ul><li>Mutually beneficial supplier relations </li></ul><ul><li>Continuous improvement. </li></ul>
    12. 13. 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>
    13. 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>
    14. 15. A QUALITY MANUAL SHOULD…. <ul><li>Address all Quality System elements </li></ul><ul><li>Contain or refer to quality procedures </li></ul><ul><li>“ Documentation” </li></ul>
    16. 17. BENEFITS OF DOCUMENTATION: QUALITY MANUAL <ul><li>The Key is to move towards: </li></ul><ul><ul><li>Consistently repeating the best practices </li></ul></ul><ul><ul><li> and </li></ul></ul><ul><ul><li>Improving those processes which are lacking </li></ul></ul>
    18. 19. SO, WHAT EXACTLY DO WE FIND IN A TYPICAL QUALITY MANUAL? You might just find things like…
    19. 20. BASIC QUALITY MANUAL OUTLINE <ul><li>Introduction </li></ul><ul><li>Policy and Objectives </li></ul><ul><li>Definitions </li></ul><ul><li>Quality System </li></ul><ul><li>Organization </li></ul><ul><li>Authority and Responsibilities </li></ul><ul><li>Compliance </li></ul><ul><li>Internal Review and Audit </li></ul><ul><li>Documentation and Change </li></ul><ul><li>Purchasing </li></ul><ul><li>Inspection and Testing </li></ul><ul><li>Training </li></ul>
    20. 21. <ul><li>To prevent risks </li></ul><ul><li>To detect deviations </li></ul><ul><li>To correct errors </li></ul><ul><li>To improve efficiency </li></ul><ul><li>To reduce costs </li></ul><ul><li>To meet customer needs </li></ul><ul><li>To market company </li></ul>ADVANTAGES OF QUALITY MANUAL
    21. 22. 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>
    22. 23. <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
    23. 24. <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