• 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,
• There are designated certification agencies throughout the world.
- should be open about all processes, no hiding, no “back-rooms” where ‘skeletons’ are hidden.
- common agreement about quality objectives between suppliers, producer, customers.
- a product, and quality responsibility should be traceable from start to end.
- documentation is required to indicate how production goes from the front end to the customer.
- the documents are to be signed and copies given to everybody responsible. It becomes a “quality bible” for a product.
- ISO9000 - directs the selection of the other ISO900x standards and general management policies.
- ISO9001 - The most stringent quality standard requiring conformance from design to service.
- ISO9002 - Looser than ISO9001, requiring excellence in production and installation.
- ISO9003 - Best when only capable of inspection and testing. Even easier than ISO9002.
• Information is available from,
- (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?
- Organizational Structure and Responsibilities
- Documentation and Implementation of Quality Policy
• Standard compliance can be determined by,
- Second party - a customer may audit the suppliers quality system, and verify compliance to one of the standards, with periodic reviews.
- Third party - The accreditation body certifies the program, and conducts periodic monitoring of procedures.
• Basic steps for implementation
1. Make a decision to seek certification
- is it required for commercial needs?
- is the organization committed to certification?
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
- conduct internal and external audits
- auditors will visit and review the application, and the state of the document, etc.
• 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,
- each element must be addressed
- develop and maintain evidence of implementation
• The most typical initial impacts on a company are,
- a culture change where procedures must now be followed
- addition of a system for controlling documents
• Significant long term impacts on a company are,
- use of documents to direct work
- ongoing review of quality methods