The makeup of Quality Management Systems

A Quality Management System - or QMS - offers a systematic approach to managing quality. John Oakland, one of the world’s top 10 gurus in quality & operational excellence, defines a quality management system as: “an assembly of components, such as organisational structure, responsibilities, procedures, processes, and resources, for implementing quality”.

​He says that a good example would:

• be a written system
• ensure that customers’ requirements were met
• ensure that the organisation’s needs were met
• apply to and interact with all the activities of the organisation.

Accordingly, he lists the requirements of such a system as:

1. a written quality plan, quality manual and policy, understood, implemented and maintained at all levels of the organisation. Such items should be updated regularly
2. an organisation chart defining the responsibilities of all those who affect quality
3. a review of accepted orders to ensure that customers' requirements are clear, and procedures which control the design of goods or services to ensure that these requirements are met
4. procedures to ensure that purchased goods and services conform to the requirements of the organisation and that their progress can be traced through to the finished goods
5. systems that ensure the suitability for use of any materials or services supplied by a customer
6. a fully documented process manual with sufficient detail to enable the process to be carried out under specified conditions
7. the control, calibration and maintenance of all measuring and testing equipment
8. a documented system which identifies and segregates all non-conforming goods and services and which specifies corrective action
9. quality protection (for example packaging) for finished goods to ensure they reach customers undamaged
10. procedures for any servicing operation to document and verify that it satisfies customers' requirements
11. quality records which provide objective evidence that the work is being carried out in accordance with documented procedures
12. procedures which identify training needs and carry out and record training for all employees
13. the use of statistical techniques
14. self-policing through internal audits and reviews.

So where does ISO 9001 fit in?

The ISO 9000 series is a set of world-wide standards which offer a framework against which organisations of all kinds can build quality management systems. The standard has its origins in Britain as BS 5750, first published in 1979.

However, in the UK it is now known as BS EN ISO 9000, the BN denoting that it complies with British Standards, the EN that it complies with European Standards, and the ISO that it complies with the system of the International Organization for Standardization.

ISO 9000, when first published in 1987, used the concepts and vocabulary of manufacturing. Its revision in 1994 went some way towards making the standards more user-friendly for service industries, and this process continued in the simplifications incorporated in the ISO 9000:2000 series in 2000, and the last update to ISO 9001 in 2015.

In simple terms, ISO 9000 requires organisations to ‘say what they do, and do what they say’. They ‘say what they do’ by detailing all their operating procedures, explaining how quality is monitored and controlled. They must then demonstrate that they ‘do what they say’ as they operate their quality systems. This usually involves keeping permanent records of all quality checks, tests and other activities, so that the system can be audited.

Next week we’ll look at the benefits of getting ISO 9001 accreditation.