1. JENN SHAFNER BRIAN KROUSE CLINT KEHRES

2. 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 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 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 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.  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 1. Management Responsibilities 2. Quality System 3. Contract Review 4. Design Control 5. Document Control 6. Purchasing 7. Control of Customer Supplied Product 8. Product Identification and Traceability 9. Process Control 10. Inspection and Testing 11. Inspection Measuring and Test Equipment 12. Nonconforming Product 13. Corrective and Preventative Action 14. Handling, Storage, Packaging… 15. Control of Quality Records 16. Internal Audits 17. Training 18. Servicing 19. Statistical Techniques

8.  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.  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.  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.  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.  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.  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.  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.  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 - 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.  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.  NCR video  www.youtube.com/watch?v=G8WI2MgyS7w www.youtube.com/watch?v=G8WI2MgyS7w  Quality & ISO video  http://www.youtube.com/watch?v=y4iIO9Db 5rk&feature=channel http://www.youtube.com/watch?v=y4iIO9Db 5rk&feature=channel  http://www.youtube.com/watch?v=0YAy79hy JII&feature=channel http://www.youtube.com/watch?v=0YAy79hy JII&feature=channel