1. Allison Kotchman Victoria Gilbride Raechel Huebner

2. MIL-Q- 9858 (1959) NATO AQAP (1969) BS 5750 (1974) ISO 9000: 1987 ISO 9000: 1994 ISO 9000: 2000 ISO 9000: 2008

3.  ISO 9000 is a family of standards for quality management systems.  It is maintained by ISO, the International Organization for Standardization  A set of rules in which to be followed in order to meet needs (i.e. consumer)  A standard in which to conduct business  IOS?? - ISO was derived from the greek word isos meaning equal

4.  ISO 9004:2000 Quality management systems - Guidelines for performance improvements.  ISO 9000:2005: Quality management systems - Fundamentals and vocabulary.

5.  ISO 9001:2008  First Published in 1987  Revised in 1994  Revised in 2000  Current revision in the 11/15/2008 Hence it’s called ISO 9001:2008

6.  8 Sections total – req. found in 4-8  1.0 Scope  2.0 Normative referenced  3.0 Terms and definitions - ISO 9000:2005

7.  4.0 Scope (the way we run our business – structure)  5.0 Management Responsibility (management supports the structure)  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)

8.  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

11. 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

13.  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.

14.  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.

15.  A company or organization may publicly state its 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.

16. Applying organization is reviewed based on appraisal of its sites, functions, products, services, and processes A list of problems is made known to the management ISO 9001:2008 certification is awarded If problems are minor, a resolution plan must be set in place pre certification

17. RankCountryNumber of Certificates 1China297,037 2Italy138,892 3Russian Federation62,265 4Spain59,854 5Japan59,287 6Germany50,583 7United Kingdom44,849 8India33,250 9United States25,101 10Korea, Republic of24,778

18.  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.

19.  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?

21. “Without the international agreement contained in ISO standards on metric quantities and units, shopping and trade would be haphazard, science would be unscientific and technological development would be handicapped.”

22. “Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability ” When things work well we tend not to notice…

23.  Products  Poor quality  Lack of fit  Incompatibility with equipment that we already have  Unreliability  Danger!

24.  Screw Threads  Helps assembly of products  Solves repair and maintenance problems  Symbols  Provide danger warnings and information across language barriers  Can you match the symbol to the meaning?

25.  Creates a more efficient & effective operation  Raises customer satisfaction & retention  Enhances marketing  Improves employee motivation, awareness, and morale  Promotes international trade  Increases profit & productivity  Reduces waste

26.  Time and Money  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

27.  ISO 13485:2003 - quality management system for the design and manufacture of medical devices.  Seen as first step in achieving European regulatory requirements.  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.

28.  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

29.  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.

30.  Next version is expected to be published December 2015.  Committee will vote to approve in March 2015.

31.  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