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ISO 9001:2008  QUALITY MANAGEMENT  SYSTEMS
AGENDA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
INTRO ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
WHAT IS ISO? ,[object Object],[object Object],[object Object],[object Object]
WHAT IS ISO? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ISO FAMILY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
CERTIFICATION AND REGISTRATION ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BENEFITS ,[object Object]
BENEFITS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
WHAT IS QMS? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
QMS PRINCIPLES ,[object Object],[object Object]
QUALITY MANUAL ,[object Object],[object Object],[object Object],[object Object],[object Object]
QUALITY MANUAL
WHAT WILL A QUALITY MANUAL PROVIDE TO A COMPANY? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
THE IMPORTANCE OF  DOCUMENTATION
4 LEVELS OF DOCUMENTS
SO, WHAT EXACTLY DO WE FIND IN A TYPICAL QUALITY MANUAL? You might just find things like…
QUALITY MANUAL OUTLINE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SOME FACTS ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],INITIAL CERTIFICATION AUDIT PROCEDURE
[object Object],[object Object],[object Object],[object Object],ACTION ITEMS
[object Object],[object Object],[object Object],[object Object],[object Object],AUDITORS LIST
 

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ISO 9001:2008 QMS_Rajesh

Editor's Notes

  1. 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.
  2. 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 In the year 1985 the QMS concept came in to the existence by ISO In 1987 first guidelines as requirements of QMS has published for Certification In 1994 first revision took place to make it practical for implementation and simple to understand. In 2000 2 nd revision took place to make it generic for the application in any type of industry and simplified form the audit point of view. 15 th Nov 2008 – 3 rd revision published to give more clarity for implementation and use.
  3. 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.
  4. OPERATING QUALITY MANAGEMENT SYSTEMS AS PER IS/ISO 9001 STANDARD LEADS TO DOING RIGHT THINGS ON TIME ALL THE TIME AND ALWAYS TO THE CUSTOMER'S SATISFACTION Benefits to customers ·        Provides assurance and satisfaction that their needs for quality will be met. ·        Saves time and money by reducing the need for assessment of their suppliers. ·        Reduces incoming inspection costs. ·        Work with reduced inventory levels, effecting significant cost reductions. ·        Simplifies purchase decisions. ·        Creates confidence in their suppliers because of the approval by an independent third party. ·        Better service, better and quick complaint redressal.
  5. Customer Focus : Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Leadership : Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. Involvement of People: People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. A Process Approach: A desired result is achieved more efficiently when activities and related resources are managed as a process. Continual Improvement: Continual improvement of the organization's overall performance should be a permanent objective of the organization. Factual Approach to Decision making: Effective decisions are based on the analysis of data and information. Mutually Beneficial Supplier Relationships: An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. System approach to Management: Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.
  6. A process – an outline of its objective, scope and key performance indicators; Quality procedures (QPs) – an enlargement of the process explaining how it is controlled; Work instructions (WIs) – the ‘fine print’ required to perform a specific activity.
  7. Is a means of defining the responsibilities and interrelated activities of every member of the organization; Is a vehicle for auditing, reviewing and evaluating the organization's QMS. The Quality Manual will identify the organization's business-critical processes and their associated QPs and WIs. The Quality Manual will also provide examples of the various forms and documentation used by the organization – such as production control forms, inspection sheets and documents used to purchase components, systems and software from subcontractors.
  8. 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…
  9. 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.
  10. NQA: India Contact: Mr Ganesh Shastri T: +91-80-32722698, 23142208 F: +91-80-41178952 E: [email_address] W: www.nqa.com NQA - India Operations #15/1, 8th Main, Hampi Nagar (RPC Layout) Behind Govt. Central Library, Vijayanagar II Stage Bangalore Karnataka 560040 PlotNo: MIG-89,Flat NO: 303, Shambhavi Nilayam, Dharmareddy Colony,Phase-1,KPHB Hyderabad 09676887662 ISO Consultants Hyderabad www.smartedgeconsulting.com/ NQAQSR Certification Pvt. Ltd. 107/55,1st Floor Madhuban Building , Nehru Place New Delhi - 110019, India http://www.nqacertification.com/enquiry/contact-us.html http://www.tuv-sud.in/hyderabad.html http://www.tuv-sud.in/ S.No. 305 & 306, 3rd Floor, Navketan Complex, Opposite Clock Tower, Sarojini Devi Road Secunderabad 040 66321871 TUV Sud South Asia www.tuv-sud.in/