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ISO 9000: The Global Quality Standard

ISO 9000: The Global Quality Standard . Marcel Ingels Gretchen Hartley. ISO 9000: Overview. ISO 9000 encompasses a family of standards for quality management systems Must be certified to be able to state “ISO 9000 Certified/Registered” Versions of ISO 9000

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ISO 9000: The Global Quality Standard

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  1. ISO 9000: The Global Quality Standard Marcel Ingels Gretchen Hartley

  2. ISO 9000: Overview • ISO 9000 encompasses a family of standards for quality management systems • Must be certified to be able to state “ISO 9000 Certified/Registered” • Versions of ISO 9000 • AS: Aerospace Basic Quality System Standard • PS: Pharmaceutical Packaging Materials • QS: Automotive Manufacturers • ISO 13485: 2003 is medical industry equivalent • Requires only that quality system is implemented and maintained • In 2000, ISO 9001, 9002 & 9003 were combined to make ISO 9001 • Placed process management front and center

  3. ISO 9001-2008 Sections 1.0 Scope 2.0 Normative referenced 3.0 Terms and definitions - ISO 9000:2005 4.0 Scope (the way we run our business – structure) 5.0 Management Responsibility 6.0 Resource Management (people, buildings, machines, software) 7.0 Product Realization (the way we make our product) 8.0 Measurement, Analysis, & Improvement (product & process)

  4. Why ISO 9000? Ensures that a company has a quality system in place and is using that system Creates a competitive edge Increases Customer Confidence Foster employee confidence

  5. Certification • The International Organization of Standardization does not itself certify companies. • Authorized accreditation bodies give certification by auditing. • Accreditation body members must declare their common intention to join the IAF. • International Accreditation Forum has the full list of accreditors. • Fees are involved for this service.

  6. Certification • The applying organization is reviewed based on an extensive appraisal of its sites, functions, products, services, and processes. • A list of problems is made known to the management. • ISO 9001:2008 certificate is issued • If the problems are minor, • Corrective plan is produced by the management. • An ISO certificate renewal is every three years.

  7. Certification • A company or organization may publicly stateits conformance with ISO 9001:2008. DOs • Certified or Registered DON’Ts • ISO 9000 • Accredited • Certification to the ISO 9001:2008 standard applies to the process not the product.

  8. Process for Certification

  9. When standards are absent, we soon notice • Products • Poor quality • Lack of fit • Incompatibility with equipment that we already have • Unreliability • Danger!

  10. ISO 13485:2003 – Medical devices • ISO 13485:2003 - quality management system for the design and manufacture of medical devices. • In general ISO 13485:2003 is very similar to ISO 9001 but there is one significant difference • ISO 9001 requires organizations to demonstrate continuous improvement • ISO 13485 requires the quality system only demonstrate that it is implemented and maintained.

  11. Current Good manufacturing practices (cGMP) • Applied to Medical Devices in 1978 by the FDA • GMP governs • Methods • Facilities • Controls • Used in Medical Device • Design • Manufacture • Packaging • Labeling • Storage • Installation • Servicing

  12. Current GMP Versus ISO 9001 • Medical device manufactures must comply with the quality system requirements laid down in Current Good Manufacturing Practice (cGMP) • GMP modifications were made by the FDA (in 1997) to bring the standard closer to ISO 9001/13485 requirements but did not exactly mirror it.

  13. Pros and Cons of ISO 9000 Pros cons Timely and costly Prone to failure when a company is interested in certification before quality Customer contractual requirements force certifications rather than a desire to improve quality Certification by an independent auditor is often a problem ISO actually advises ISO 9001 implementation without certification, simply for the quality benefits that can be achieved • A more efficient, effective operation • Increased customer satisfaction and retention • Enhanced marketing • Improved employee motivation, awareness, and morale • Promoted international trade • Increased profit • Reduced waste and increased productivity

  14. Questions?????? • NCR video • www.youtube.com/watch?v=G8WI2MgyS7w • Quality & ISO video • http://www.youtube.com/watch?v=y4iIO9Db5rk&feature=channel • http://www.youtube.com/watch?v=0YAy79hyJII&feature=channel

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