The Chartered Quality Institute

Quality management systems

What is a quality management system (QMS)?

A QMS is a system that outlines the policies and procedures necessary to improve and control the various processes that will ultimately lead to improved business performance. The trend today is to think of them as business management systems. Implementation of a QMS will provide reassurance, to current and future customers, of the commitment of the organisation to provide a consistently high level of quality of service or product. Although it may seem obvious that quality systems are necessary, many small or start-up companies function with only some areas covered.

A quality system is very often an essential requirement for product certification such as CE marking or ATEX certification.

Does this mean ISO 9000 certification

Although ISO 9001 is an internationally recognised standard against which a QMS can be certificated, it is by no means the only approach.

The Management Consultants Register has created the Small Business Standard which is a self assessment tool to assist small companies not wishing to go down the ISO 9001 certification route.

ISO 9001 and related standards

The latest revision of ISO 9001 in 2000 was intended to make the standard more widely applicable to all sectors of industry.

The framework of ISO 9001 has been used as a basis for a number of industry specific standards. These follow the layout of ISO 9001 and impose additional requirements. Examples of this are ISO TS 16949 the automotive standard; AS9100 the aerospace standard; ISO 13980 for the application ISO 9001 to products for use in potentially explosive atmospheres. ISO 9001 was used by the IQA Pharmaceutical Quality Group to produce the standard PS 9100. This list is by no means complete.

The Medical Devices Standard follows the layout of ISO 9001 but differs in that it is directed towards implementation and maintenance of the effectiveness of the quality system rather requiring continual improvement.

Other QMS standards

There are a number of other standards that do not follow the ISO 9001 layout. An example of this would be ISO/IEC 17025, which is the standard applicable to test and calibration laboratories.

References