Quality Management System Manual 

To formulate a Quality Management System Manual may not be as difficult as you originally thought. 

Let us start with a definition of what a Manual is: 

The ISO9000 standard describes the requirements on a Quality Managment Manual in Clause 4.2.2., stating that:

the organization shall establish and maintain a quality manual that includes;

• the scope of the quality management system, including details of and justification for any exclusions (see 1.2)
•  the documented procedures established for the quality management system, or reference to them, and
• a description of the interaction between the processes of the quality management system.

Source: ISO9000 Standard

Quality Is Everyone's Responsibility. W.E. Edwards.

A.      Scope

The Quality Manual should describe how far-reaching the Quality Management System reaches, to which sites, to which employees and where.

It will give a timeline for the validity of the Quality Management System Manual

The Quality Policy may be added.

B. Documented Procedures

The ISO9000 requires documented and communicated procedures to 6 central issues and these are:

1. How Document Control takes place: Release, Validity, Traceability, archiving, etc.
2. Record Control: How records are kept, maintained, archived, etc.
3. Control of Non-conforming Products: How non-conforming products are to be handled, including preventing them from returning to the main stream production.
4. Corrective Actions: These procedures will govern how, in the case of defects or non-conformance, actions are to be undertaken to correct the situation.
5. Internal Audits: these procedures will govern the concept of internal regulation of the Quality management system as to its conformance to the decisions made by the system.
6. Preventive action: These procedures will highlight the activities undertaken to prevent non-conformity taking place.

I have also read of recommendations to include two further procedures in the Quality Management System Manual:

1. Competence, Awareness and Training. (Clause 6.2.2) as this is an issue that is often overlooked by companies and is deserving of the more intensive focusing.
2. Purchasing (Clause 7.4). As suppliers and supplier management are the key inputs to any company, this area too needs special platform, higher than that initially suggested by the standard. If a company sub-contracts out much work, this is where the activities undertaken with the subcontractor to ensure quality are described.

C.      Interaction of the Processes

The Quality Manual must include an overview as to how processes will be managed within the organisation. Typically this will include:

• An overview or "Landscape" describing the main or core processes and their interactions
• Brief guideline on how businesses are to be mapped out and are organised: how these processes are inter-related.
• The responsibilities of the people involved. These are typically the Process Owner, Process User and perhaps even Process Champion, depending on the size of the organisation.

Conclusion: The ISO9000 Standard does not specify a length or format for the Quality Management System Manual, so keep your information clear and concise. In fact, the Manual could be only 6 pages long. The main thing is to keep it real and have it reviewed by each Management Review.