Version 1.0, August 31, 2001, Copyright, Hugh Jack 1993-2001

16. ISO9000

 

· Originally developed by the ISO Technical Committee TC 176.

 

· A standard aimed at certifying products for quality (e.g., when taking a drivers licence test, they don't care how you learned to drive, only if it conforms to the legal requirements).

 

· This is the first Globally accepted quality designation, and it is replacing many existing quality certification programs, such as those of,

  1. - GM, Chrysler, and Ford
  2. - NATO,
  3. - Telecommunication companies
  4. - US Department of Defense
  5. - etc

 

· There are designated certification agencies throughout the world.

 

· The philosophy,

  1. - should be open about all processes, no hiding, no "back-rooms" where `skeletons' are hidden.
  2. - common agreement about quality objectives between suppliers, producer, customers.
  3. - a product, and quality responsibility should be traceable from start to end.
  4. - documentation is required to indicate how production goes from the front end to the customer.
  5. - the documents are to be signed and copies given to everybody responsible. It becomes a "quality bible" for a product.

 

· The standards,

  1. - ISO9000 - directs the selection of the other ISO900x standards and general management policies.
  2. - ISO9001 - The most stringent quality standard requiring conformance from design to service.
  3. - ISO9002 - Looser than ISO9001, requiring excellence in production and installation.
  4. - ISO9003 - Best when only capable of inspection and testing. Even easier than ISO9002.

 

· Overview

 

 

· Approach to certification.

 

 

· Information is available from,

  1. - (USA) the National Institute of Science and Technology (NIST), the Department of Commerce, Phone:(301) 975-4031, Fax:(301) 963-2871

 

· What is required for an effective quality system?

  1. - Organizational Structure and Responsibilities
  2. - Processes and Procedures
  3. - Documentation and Implementation of Quality Policy

 

· Standard compliance can be determined by,

  1. - Second party - a customer may audit the suppliers quality system, and verify compliance to one of the standards, with periodic reviews.
  2. - Third party - The accreditation body certifies the program, and conducts periodic monitoring of procedures.

 

· Basic steps for implementation

  1. 1. Make a decision to seek certification

- is it required for commercial needs?

- is the organization committed to certification?

  1. 2. Determining the state of the existing facility

- assess and identify gaps in processes and documentation

- determine existing compliance

- begin promoting and training for compliance

- select a registration body

  1. 3. Compliance

- continue training

- conduct internal and external audits

- close quality gaps

  1. 4. Registration

- auditors will visit and review the application, and the state of the document, etc.

- continued monitoring

 

· ISO 9001 is the most stringent standard, and the ISO 9002, and ISO 9003 standards are subsets of this, as shown in the table below,

 

 

· The principles that must be applied to the above areas are,

  1. - each element must be addressed
  2. - the process must be defined
  3. - process documentation
  4. - develop and maintain evidence of implementation

 

· The most typical initial impacts on a company are,

  1. - a culture change where procedures must now be followed
  2. - addition of a system for controlling documents

 

· Significant long term impacts on a company are,

  1. - use of documents to direct work
  2. - ongoing review of quality methods