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ISO 9001:2008 4.2.2 Quality Manual

The standard itself denotes just one line and three sub-clauses a) to c) for the requirement of a quality manual.

In reality whole books have been written around defining and developing an organizational quality manual, and certainly much more than my few meandering thoughts documented here...

ISO 9001:2008, element 4.2.2 describes a quality manual as a document containing:

ISO 9001:2008 4.2.2a - the scope of the QMS, including detail of and justification for any exclusions;

ISO 9001:2008 4.2.2b - the documented procedures or reference to them;

ISO 9001:2008 4.2.2c - a description of the interaction between the processes of the quality management system

There are many examples of quality manuals to be found on the world wide web, many will have lots in common in the fact they appear to be no more than a collection of ISO 9001:2008 clauses padded out by statements such as, "At ABC we shall....", "The ABC QMS documentation includes...", "ABC shall implement a procedure to..." etc etc. This might look good on paper, it might get you accreditation, I doubt it will add real value to the organisation and may well struggle to add efficiency and effectiveness in the longer term.

A good quality manual will provide a summary of all the quality management activities undertaken by the organization, vaguely comparable to a party political manifesto. Its purpose is to provide a practical reference guide to the quality management system, and act as a focal point in which the organization defines itself. It is normally produced in hard copy to aid interested parties like new and existing customers, new employees, auditors, regulatory bodies etc, to understand the scope, purpose and size of the organizational set-up.

The quality manual is an important document, it is the main 'top-level' document of a quality system. It establishes the commitment of the organization to the ISO 9001:2008 standard, normally in a short and concise form. It will also list any permissible exclusions, which are restricted to only those requirements in section 7 of ISO 9001:2008.

The first part (after the introduction) of many quality manuals is the organizations quality policy, this is a very important statement, it is about the organizations commitment to it's customers, similar to a mission statement. It should state how the organization intents to meet it's customers requirements in the products or services it provides. The quality policy should be endorsed by the highest level of management, i.e. the Managing Director or Chief Executive Officer, this to show support to both the customer and the quality management system. Often these 'signed' quality policy statements will be extracted from the quality manual and posted at strategic locations throughout the organization, this to allow all interested parties to read and understand.

Within ISO 9001:2008 section 5.3 is specific to defining the requirements of an organisations quality policy.

A typical quality manual may have six sections, as detailed below;

Introduction
Policy Statement
Organizational Structure
Management responsibility and authority
Management Review, and
QMS relationship to ISO 9001:2008 requirements
(often supported with a document to clause matrix)

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