This text is from the second edition of ISO 9001, The Standard Companion. It is based on the now obsolete 1987 version of the ISO 9001 Standard. The third edition, based on the current 1994 standard, is available from Simply Quality.

4.2 Quality System

Document Quality Procedures

Keep an updated set of documents to control and direct all work activities affecting product and service quality. Carry out day to day work in accordance with these documents. Prepare a Quality Manual, identify and acquire the resources and skills needed to achieve the required quality, update and improve procedures, identify and prepare quality records.


The concept of a Quality System is fundamental to the Standard and is formally defined in the glossary.

The scope of the Quality System is work that affects the quality of products or services delivered to your customer. This includes on-time delivery, correct invoicing, and resolving complaints about a product, in addition to the design and manufacture of the product.

In practice, a four-tiered system of documentation is generally used to define the Quality System. It consists of:

A short Quality Manual that prescribes compliance with each of the ISO 9001 requirements as a matter of corporate policy. It also specifies responsibilities and identifies specific procedural manuals to be used in carrying out work. To illustrate compliance with the Standard and to make it readily understood by the auditors, the Quality Manual is best organized with the same section numbers and titles as the ISO 9001 Standard.

A set of manuals, called procedural manuals, briefly describing the principles and strategy of each procedure, and using flow charts to illustrate each process.

A set of work instructions that describe each detailed practice making up the defined processes.

Forms and records that result from use of the system, known as Quality Records (see 4.16)

These documents must be controlled and authorized as described in section 4.5.

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