Chapter 2: The ISO 9001:2000 QMS

2.1 The ISO 9000 QMS Design Context

The process used to create an effective QMS based on the ISO 9001:2000 International Standard extends directly to the creation of any QMS based on a standard.

By a standard, we mean a document published by either a national or international organization that has achieved a relatively high level of industry recognition and credibility in its specific area of expertise. There are of course ad hoc standards that are created and distributed within specific technical fields. Such ad hoc standards are extremely useful but are generally not recognized at so high a national or international level.

Examples of widely recognized national and international standards include QS-9000 for the automotive industry; AS9100 and IAQS 9100:2000 for aerospace; the Baldrige National Quality Program for total quality management; TL 9000 for telecommunications; and the FDA/CGMP 820, EN46001, and ISO 13485 standards for medical devices.

In many cases, a specific standard is complemented by a series of additional mandatory standards. For medical companies that wish to deliver product into countries that require a product certification (CE mark), it is necessary to comply with the Medical Device Directive 93/43/EEC. Health Canada provides its own Medical Devices Regulations that require specific licensing. In addition, the ISO 14000 standard is used for environmental management systems.

QMS mastery is a journey not a destination. There are literally thousands of standards and supplemental guidelines in use throughout the world. However, no matter how complex the set of standards, the underlying process to create an effective QMS is the same. The mastery of this process is no different than the mastery of any technical regimen.

In our text, we focus this optimization process on the international standard, ISO 9001:2000 Quality Management System: Requirements ^[1]. Throughout the text, the term Standard (capitalized) is used to denote the ISO 9001:2000 International Standard.

^[1]References to ISO 9000 documentation are based on either the Ninth Edition of the ISO Standards Compendium, ISO 9000 Quality Management, International Organization for Standardization , Geneva, Switzerland, www.iso.ch; or the American National Standard series by the ANSI/ISO/ASQ. They are equivalent.