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Iso 9001 What is a quality manual for ISO 9001?

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Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 9001 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your management in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 9001 QMS should be:

ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, gives detailed suggestions for creating a quality manual. It defines a quality manual, among other requirements, as a document that should "consist of, or refer to, the documented quality system procedures intended for planning and administration of activities which impact on quality" ISO 9001, element 4.2.2 describes a quality manual as a document containing:

- the scope of the QMS and details of and justification for any exclusions;

- the documented procedures or reference to them;

- relationships between the processes of your quality management system.

Let's follow these simple instructions and see how easy it is to create a quality manual to document the scope of your quality management system and exclusions; ensure that procedures are referenced and specify relationships or interactions between your processes.

Typically, companies state the scope of their QMS in a scope or introduction sections of their quality manuals, similar to these: "ABC Enterprises, LLC assembles and distributes pre-cooked meals for elderly citizens in the St. Newtown region" or "ABC Enterprises, LLC designs, manufactures and services high poser vacuum cleaners"

Now, after we established the scope of our ISO 9001 QMS, we need to describe the processes we use to achieve the results stated in our scope. While we are doing this, we need to remember to reference corresponding procedures. Per my experience, the easiest way to do it, is to transform the standard from a list of requirements into your organization's dedication to satisfy those requirements. For example: Element 4.2.4 of ISO 9001 requires that "Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system" our manual will affirm: "XYZ Corporation ensures that records are established and maintained to provide evidence of conformity to requirements and the effective operation of the QMS per the Records Procedure"

Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the second requirement for a quality manual. Continuing in a similar way, addressing all applicable elements of the standard and referencing corresponding procedures, we will develop a quality manual satisfying ISO 9001 requirements.

Interaction between the processes may be documented in a number of ways. Some companies choose to define top-level interaction by using derivatives of Figure 1 in ISO 9001 standard. Combining such a diagram with references to procedures, will define interactions between your processes. For more detailed process interaction tools, type "process interaction matrix" into your browser and you will find numerous examples.

Another important function of a quality manual, very often overlooked, is as a marketing tool. Well written and professionally published, a quality manual may become a powerful marketing instrument. It can communicate to your potential customers, suppliers and subcontractors that your company is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality.

Surprisingly, many companies do not recognize that their quality manual may be a powerful communication tool. These organizations mark their manuals with "internal use only" and "confidential" stamps, while those quality manuals can serve a company externally. We recommend to all our customers make their quality manuals public, assuming that your manual does contain proprietary information.

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Thinking of simplifying your ISO 9001 QMS manual? Check our ISO 9001 Quality Manual programs and ISO 9001 Quality Management System Manuals.

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