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Published byHeather Stevenson Modified over 8 years ago
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Submitted By: Tanveer Khan M.Tech(CSE) IVth sem
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The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are 25 documents in the collection altogether.
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ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems.
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ISO 9001:2008 Quality management systems – Requirements This is the only ISO 9000 standard intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction.
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ISO 9004:2000 Quality management systems - Guidelines for performance improvements. Covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.
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The organisation needs to demonstrate its ability to consistently provide product that meets customer and regulatory requirements. The organisation must aim to enhance customer satisfaction through the effective application of the quality management system. This includes processes for continuous improvement of the system.
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The requirements in ISO 9001 include: a set of procedures that cover all key processes in a business monitoring processes to ensure they are effective keeping adequate records checking output for defects, with appropriate and corrective action where necessary regularly reviewing individual processes and the quality system itself for effectiveness Focus on continuous improvement
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The ISO 9001:2008 Standard consists of the following sections: Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement
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ISO 9001:2008 refers specifically to only 6 documented procedures. Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3) In addition to these ISO 9001:2008 requires a Quality Policy and Quality Manual.
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Control of Documents (4.2.3) The ISO 9001:2008 standard requires that an organization needs a documented procedure to control quality documents. All employees must have access to up-to-date documents and be aware of how to use them. Corrective Action (8.5.2) The ISO 9001:2008 standard requires that you take Corrective Action to rectify non-conformances. It is a requirement to keep records of these activities and monitor their effectiveness. Preventive Action (8.5.3) The ISO9001:2008 standard requires that you need to take Preventative Action to eliminate potential causes of problems. It is a requirement to keep records of these activities and monitor their effectiveness.
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ISO 9001:2008 requires a Quality Policy and Quality Manual The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. Your procedures will be maintained in your Quality Manual.
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An organization intending to obtain ISO 9000 certification applies to a ISO 9000 registrar for registration. The ISO 9000 registration process consists of following stages: Application Stage: Once an organization decides to go for ISO certification, it applies to a registrar for registration. Pre-assessment: During this stage the registrar makes a rough assessment of the organization. Document review and adequacy audit: During this stage, the registrar reviews the documents submitted by the organization and makes suggestions for possible improvements.
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Compliance audit: During this stage, the registrar checks whether the suggestions made by it during reviews have been compiled to by the organization or not. Registration: The registrar awards the ISO 9000 certificate after successful complition of all previous phases. Continued surveillance: The registrar continuous monitoring the organization periodically.
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Document control: All documents concerned with the development of a software product should be properly managed, authorized and controlled. Planning: Proper plan should be prepared and then progress against these plans should be monitored. Review: Important documents across all phases should be independently checked and reviewed for effectiveness and correctness. Testing: The product should be tested against specification.
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