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Introduction to ISO9001:2008

Introduction to ISO9001:2008. TCISys.com. What is ISO?.

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Introduction to ISO9001:2008

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  1. Introduction to ISO9001:2008 TCISys.com

  2. What is ISO? • The International Organization for Standardization (ISO) was established in 1947 and is an association of 157 members, which each represent their own country. ISO employs a system of Technical Committees and Working Groups to develop International Standards. • British Standards Institute is the National Standards Body that represents the United Kingdom at ISO www.bsigroup.com TCISys.com

  3. What are the ISO 9001 requirements for a Quality Management System? • 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 continual improvement of the system. TCISys.com

  4. What are the ISO 9001:2008 Quality Management System requirements? The ISO9001:2008 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 TCISys.com

  5. ISO 9001:2008 Quality Management System requirements: Section 4: Quality Management System from our Manual ISO 9001:2008 Clause Our Procedure TCISys.com

  6. What are the ISO 9001:2008 Quality Management System requirements? The standard specifies six compulsory documents: • 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 TCISys.com

  7. What are the ISO 9001:2008 Quality management systems requirements? The ISO9001:2008 standard has an absolute requirement to maintain the following records: • Management Review Minutes • Training Record • Product Release Record • Design and Development Records - Results of the review of customer requirements - Design and development inputs relating to product requirements - Results of design and development reviews and actions - Results of design and development verification and actions - Results of design and development validation and actions - Results of the review of design and development changes • Supplier Assessment Record * All of these records are provided in our manual packs TCISys.com

  8. What are the 8 Quality Management Principles? TCISys.com

  9. Why is customer satisfaction included in ISO 9001? "Customer satisfaction" is one of the main driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor and measure customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. Your customers will gain confidence that your products will meet their needs and increase their satisfaction. TCISys.com

  10. ISO 9001:2008 Process Approach to Management TCISys.com

  11. What is the PDCA cycle? The PDCA cycle is an established, logical, method that can be used to improve a process. This requires: • (P) planning (what to do and how to do it), • (D) executing the plan (do what was planned), • (C) checking the results (did things happened according to plan) and • (A) act to improve the process (how to improve next time). The PDCA cycle can be applied within an individual process, or across a group of processes. TCISys.com

  12. PDCA Cycle TCISys.com

  13. What are the requirements for auditors? The standards require that auditors are able to understand the organization's activities and processes and appropriately audit against the requirements of the ISO 9001 in relation to the organization's objectives. Auditors should be able to demonstrate competency in: • Quality Management Systems. • The requirements of the ISO 9001:2008. • A general understanding of ISO 9000:2005 and ISO 9004. • Auditing techniques. TCISys.com

  14. How will the implementation of the ISO9001:2008 standard help us? It saves you money: • Evidence shows that the financial benefits for companies that have invested in and certified their quality management systems to ISO 9001 include operational efficiencies, increased sales, higher return on assets and greater profitability. TCISys.com

  15. What is the next stage for us? View our Guide to the process of Implementing an ISO9001:2008 compliant manual at TCISys.com TCISys.com

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