1. 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,

- GM, Chrysler, and Ford

- NATO,

- Telecommunication companies

- US Department of Defense

- etc

 

• There are designated certification agencies throughout the world.

 

• The philosophy,

- 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.

 

• The standards,

- 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.

 

• Overview

 

 

• Approach to certification.

 

 

• 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

- Processes and Procedures

- 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

- select a registration body

3. Compliance

- continue training

- conduct internal and external audits

- close quality gaps

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,

- each element must be addressed

- the process must be defined

- process documentation

- 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

 

 

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