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.

Practical Considerations In practice, ISO 9000 systems exist somewhere between the two limits of either a fully responsive QMS based on clearly defined and stated organizational policies or a QMS based on policies formed from just a repetition of the Standard's phrases. In my experience, the primary reason that fully responsive QMS structures are hard to find is that the documentation teams are unaware that there is a systematic design approach upon which to base their efforts. Once the teams are made aware of such an approach, their ability to optimize the flow of information throughout the QMS significantly improves. The response time in resolving organizational issues decreases and the overall gain in productivity improves via an enhanced knowledge by every employee on just what the organization's objectives are.