What is the Documented Quality System ?

This is the text of an article published by Peter Griffin

What is the Documented Quality System ?

ISO9000 requires the development of a documented quality system describing the policies and operations of a Company. This provides an accurate description of the organization and advice on the "best practice" adopted in order to consistently satisfy customer expectations. As with all parts of ISO9000 series, it states the requirements; it is then up to the company to decide which is the best system [to suit the company] to meet the requirements.

A documented quality system would commonly consist of a number of levels (or tiers) of documentation as follows:

Independent Registration to ISO 9000 is achieved when the Company has a documented quality system which address each clause of ISO 9000, and the procedures can be demonstrated to work in practice.

Quality Manual
- This document normally describes the policy, organization and responsibilities of the organization. It would also commonly contain a brief policy statement on each of the individual clause requirements of ISO 9000

Procedures
- These documents describe the processes of the organization, and the best practice to achieve success in those processes. It is a good idea to ensure that the procedures answer the following questions about each process:

Why?
Who?
When?
Where?
What?
How?

Work Instructions
- These documents normally describe a sub-process in some detail, answering one of the above questions (e.g. what or how).

Documents
- These are the items completed while undertaking the process, forming a means of communication and a record of events.

There are no "hard and fast" rules for the production of quality system documents. Compliance to ISO 9000 should be found in the documented quality system; not solely in the quality manual.

Design of the system can be difficult as, above all else, it must also be usable. It is possible to document every facet of a process in great detail. The resulting document will be so large that staff do not want to use it because it appears difficult to find the precise information required, and it is so full of details that are already known to the expert doing the job.

The art is to reduce the content to that which is really useful to the staff, and to omit that which is already known to all.

For example, the vast majority of adults know how to drive a car, they have been taught in the past and transfer the skills from one vehicle to another ........without ever looking at a procedure! This is fine until something unexpected happens, when a drivers' manual is consulted for advice.

This is the correct use of a procedure.

More information on procedures ......

Editor's Notes

Peter Griffin is managing consultant of P Griffin & Associates (PGA); one of the leading quality management consultancies operating in Europe and the USA.

P Griffin & Associates have assisted 260 companies (ranging from 3 employees to multi-national corporations) to achieve improvements in quality and ISO9000 Registration.

While the majority of companies fail to achieve ISO9000 certification at the first attempt, 98% of PGA's quality assurance clients have achieved first-time success.

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Last Updated November 19, 1995
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