ABOUT ISO 9001:2000
The standards are available from International Organization for Standardization, Geneva Switzerland, use your credit card and download a copy. Also lots of interesting information. The standards are available in the USA from the American Society for Quality (ASQ).
ISO (International Organization for Standardization, Geneva Switzerland) is in the business (non-profit) of promoting international trade. Their way to do this is to establish internationally accepted standards for goods traded from nation to nation. Most of the thousands of ISO standards specify products , like basic materials or photographic film (many are familiar with ISO 200 film).
ISO started publishing standards in the 50s, and international trade (the global economy) exploded. By the 80s the problem was no longer a lack of specifications to define products, but some company's inability to make the product to meet the specification. So ISO 9000 was developed to establish a minimum standard for Quality Management Systems which would ensure that product shipped conformed to the specifications (hopefully ISO standards) agreed to by the buyer and seller.
With global trade came global competition and price pressure. It is inefficient for a company to send a representative to a foreign land to check up on a quality management system for a minimum purchase. And despite the best efforts of the Quality Gurus Juran and Deming (and others), companies were not doing a good job staying with quality programs. These two circumstances lead to the decision to establish registration to ISO 9000 (see more about registration below).
ISO 9000 was a series of 5 standards:
ISO 9000 a guideline for use of the ISO 9000 standards
ISO 9001 Quality Management Systems for Manufacturing, Design and Development
ISO 9002 Quality Management System for Manufacturing (no design)
ISO 9003 Quality Management System for Final Inspection
ISO 9004 Guide to continuous Improvement
Frequently people are concerned with which standard to chose; 9001, 9002, 9003. The selection is simple, use the one which fits. Design and Development mean you are design responsible. The customer wants a solution to a problem, you design, develop, and make it. If so, you are 9001. However, if the customer is responsible for the design, even though you might help and offer comments, then you are 9002. Basically no one is 9003 any more, it is going away in 2000.
The ISO standards are "consensus" standards which are developed by technical committees (with members to represent USA), and published as Draft International Standards (DIS) which are then approved by 2/3 of the 127 member ISO countries and become ISO standards. The ISO 9000 series of standards are written by technical committee TC 176 .
ISO 9000 was first published in 1987, and about 90,000 companies were registered to it. Then in 1994 the standard was revised to the current version. The changes were minor and pretty much to clarify what was there, not to make changes. Another 150,000 companies registered to the 94 revision, and the others "upgraded." A new version was published 12/13/00. Organizations registered to the '94 version will have to transition to the '00 version in 3 years, or by 12/13/03. And yes, TC 176 is busy on a new ISO 9001:2006.
Registration to ISO 9000 means hiring an accredited registration firm to come and audit your organization to the appropriate ISO 9000 standard. Upon successfully completing the audit, and closing any open nonconformances, the registrar's committee decides to enter you in their list of registered companies and issue a certificate to attest to that. Its like getting married. The signing of the registry is the crucial act, the marriage certificate merely indicates what you did. So people in Europe refer to being "certified" to ISO 9000 and in the USA we normally refer to being "registered." Both mean the same thing. Midwest helps you with this phase of implementing your ISO 9000 Quality Management System. |