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Quality, ISO, and You

Quality, ISO, and You. JENN SHAFNER BRIAN KROUSE CLINT KEHRES. Brief History of ISO . Pre ISO 9000 The BS 5750 standard required factories to document manufacturing procedures.

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Quality, ISO, and You

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  1. Quality, ISO, and You JENN SHAFNER BRIAN KROUSE CLINT KEHRES

  2. Brief History of ISO Pre ISO 9000 • The BS 5750 standard required factories to document manufacturing procedures. • BS 5750 was known as a management standard because it did not specify what to manufacture, but how to manage manufacturing processes. • In 1987, the British Government persuaded the International Organization for Standardization (ISO) to adopt BS 5750 as an international standard. • BS 5750 therefore became ISO 9000

  3. ISO 9000 Family • ISO 9000 is a family of standards for quality management systems. • It is maintained by ISO, the International Organization for Standardization • Administered by accreditation and certification bodies which monitor processes to ensure they are effective • Some requirements: • Keeping adequate records • Checking output for defects, with appropriate corrective action where necessary • Regularly reviewing individual processes and the quality system itself for effectiveness • Facilitating continual improvements

  4. ISO 9000 Family • ISO 9001:2000: Quality management systems –Requirements • Intended for organizations which designs, develops, manufactures, installs and/or services any product or provides any form of service. • Provides requirements to achieve customer satisfaction and expectations. • Includes a requirement for the continual improvement of the Quality Management System • The only standard which auditors may grant certification.

  5. ISO 9000 Family • ISO 9004:2000 Quality management systems - Guidelines for performance improvements. • Covers continual improvement and gives advice on how to enhance a mature system. • ISO 9000:2005: Quality management systems - Fundamentals and vocabulary. • Covers the basics of what quality management systems are and contains the language of the ISO 9000 series of standards.

  6. ISO 9001:2000 • Most well known standard is ISO 9001:2000 • Combined three standards of ISO 9000:1994 (9001, 9002, and 9003) into one. • The 2000 version placed process management front and center. • Process management is the monitoring and optimizing of a company's tasks and activities. • Another goal was to improve effectiveness via process performance metrics • Metrics: numerical measurement of the effectiveness of tasks and activities.

  7. ISO 9001 Elements

  8. Certification • The International Organization of Standardization does not itself certify companies. • Authorized accreditation bodies give certification by auditing those applying for ISO 9001 compliance certification. • Commonly referred to as ISO 9000:2000 certification, the actual standard certified to is ISO 9001:2000. • Both the accreditation bodies and the certification bodies charge fees for this services.

  9. 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. • If these problems are minor, an ISO 9001 certificate is issued by the accreditation body for the visted site once a plan explaining how the problems will be resolved is produced by the management. • An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals (3yrs).

  10. Certification • A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is: • "ISO 9001 certified“ • "ISO 9001 registered." • Certification to an ISO 9000 standard does not guarantee the compliance and therefore the quality of end products and services • Certification attests that consistent business processes are being applied.

  11. Auditing • Two types required: • external certification body • internal staff trained in ISO certification • The aim is a continual process of review and assessment in order to: • verify the system is working as it should • find out where it can improve and to correct or prevent problems identified. • Internal auditors should audit outside their usual management line, so their judgments are not biased.

  12. Auditing • The 2000 standard uses the process approach. • Auditors are expected to decide what is effective, rather than what was formally prescribed. • Under the 1994 version, the question was broadly "Are you doing what the manual says you should be doing?“ • The 2000 version, the question is more "Will this process help you achieve your stated objectives or is there a better way?

  13. Advantages ISO 9001 • ISO 9001 certification could yield the following advantages: • 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. Problems with ISO 9001 • 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

  15. Versions of ISO 9000 • AS 9000: Aerospace Basic Quality System Standard • PS 9000: Pharmaceutical Packaging Materials. • QS 9000: is an interpretation agreed upon by major automotive manufacturers • ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. • Compliance with ISO 13485 does not necessarily mean compliance with IS0 9001:2000.

  16. 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.

  17. Current Good Manufacturing Practices Versus ISO 9001 • Medical device manufactures must comply with the quality system requirements laid down in Current Good Manufacturing Practice (cGMP) • cGMP governs methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices • cGMP modifications were made by the FDA to bring the standard closer to ISO 9001 requirements but does not exactly mirror it.

  18. 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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