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Quality Management Systems

Quality Management Systems. Anurag Sharma Alfred Borget Anoye. Introduction. Why develop quality standard?. To increase quality oriented customers To generalize norms of quality To prepare credible benchmarking. Most prevalent standards.

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Quality Management Systems

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  1. Quality Management Systems Anurag Sharma Alfred Borget Anoye

  2. Introduction

  3. Why develop quality standard? • To increase quality oriented customers • To generalize norms of quality • To prepare credible benchmarking

  4. Most prevalent standards • ISO 9000: specifies necessary components of a quality management system • ISO 14001: manages environment processes and impacts • QS 9000: supplement of IS0 9000:1994 for continuous improvement, prevention of nonconformance, and scrap and rework reduction • ISO/TS 16949: specific to the Automotive industry

  5. Most prevalent standards (cont’d) • AS 9100: specific to aerospace industry • TL 9000: specific to telecommunications industry • ISO 13485 & 88: specific to medical devices • TE Supplement: specific to US automotive suppliers

  6. History of ISO • Found in 1946 • International standards for quality systems published in 1987 • Republished and updated version in 1994

  7. Benefits of ISO regulation Significant improvement on: • Internal quality • Production reliability • External quality • Time performance • Cost of poor quality

  8. ISO 9000 series of Standards • ISO 9000: 2000 –focus on fundamentals and vocabulary • ISO 9001: 2000—focus on requirements • ISO 9004: 2000—focus on guidelines for performance improvement

  9. ISO 2001 Requirements • It is the standard used for registration by acquiring conformity of the quality management system • More details of IS0 9001 found in www.praxiom.com

  10. Implementing ISO • Management Interest • Management representation • Awareness and communication • Assigning a team • Training and practices • Time Frame • Element ownership

  11. Implementing ISO (cont’d) • Revision of the current system • Documentation • Identifying flaws • Installing new system • Auditing • Management assessment • Registration

  12. Documentation (why is it needed?) • Records or proofs • Future references • Planning and updating • Traceability

  13. Cascading documentation Policy Procedure Work Instructions Document Development

  14. Document development • Policies, procedures and work instruction brought together • Revision • Discarding irrelevant documents • Changes and amendments • Updating • Reader friendly format

  15. Documentation • Simplicity • Brevity and Conciseness • Attractive format • Good fonts and designs • Relevant information • Traceability • Underscoring important issues

  16. Creating Manuals • Statement of purpose • Company’s policy • Making controlled copies • Inclusion of ISO 9001 • Flow diagrams and figures instead of verbiage • Procedure manuals (refer to flow diagram in text)

  17. Auditing One of the key elements of ISO standard, audit is performed in order to make sure if the system is being followed and the expected results are obtained. It is done by the qualified individuals who are trained in auditing principles and procedures.

  18. Objectives of Auditing • Conformance of actual performance • Identifying deficiencies and implementing corrective actions • Improvising the system • Inculcating flawless process to employees

  19. Auditing techniques • Examining documentation • Observing activities • Listening to employees • Identifying significant issues from trivial • Generating appropriate questionnaire

  20. Auditing procedure Auditing procedure comprises of making audit plan and checklist first. The plan should contain department, its activity, list of procedures and regulatory requirement. The checklist on the other hand is a form of questions based on procedures, records and work instruction to ensure the well running of system.

  21. Registration Quality systems registration is an assessment and audit of a quality system by a third party; a registrar. Selecting a registrar is based upon the qualifications, recognition, process of registration and time limits.

  22. Registration process • Application • Review • Preassessment • Assessment • Registration • Follow-up surveillance

  23. Questions • What is more important, implementation of an ISO or its registration? • Case study Company A has an ISO 9001 registration, all its processes are well governed and follow ISO regulations. It delivers excellent products to customers. Company B does not have ISO registration, but it still manufactures products as good as Company A. How can we prove company A superior to company B?

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