A quality manual is the top-level document of a quality management system. It is similar to a constitution of a country or a manifesto of a party. This type of document establishes the policy-level position of a government, party or in the case of a quality manual, a company' QMS. There are at least two definitions of what a quality manual for an ISO 13485 quality management system 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 13485:2003, element 4.2.2 requires a quality manual to include:

1 - the scope of the QMS

2 - details of and justification for any exclusion or non-application;

3 - the documented QMS procedures or reference to them;

4 - relationships between the processes of your quality management system.

5 - an outline of the structure of the documentation used in the quality management system

Most companies I worked with, stated the scope of their quality management system in a scope or introduction sections of their manuals, similar to these: "ABC Nephrology, Inc. designs, manufactures, distributes and services dialysis equipment and accessories"

When the scope of the QMS is determined, we can define the processes we need to achieve the results stated in the scope. Also, remember referencing supporting procedures for those processes. The easiest way to do it is to translate the standard from a list of requirements into your organization's commitment to satisfy those requirements. For example: Clause 6.4.a ISO 13485:2003 states: "The organization shall establish documented requirements for health, cleanliness and clothing of personnel ? " our manual will state: "The company has established a documented Clean Environment Procedure to maintain health, cleanliness and clothing requirements for personnel?"

Following this simple method, we can address all the requirements of ISO 13485:2003 standard and reference procedures supporting corresponding elements of your manual and quality management system. So we will comply with two three requirements of the standard.

Various methods are used to document process interactions. Some companies utilize Figure 1 from ISO 9001:2000 standard to document relations between main processes. Use of such an illustration and references to your procedures, will define interactions between your processes. You can find additional models for process interactions on the Internet. Just, type "process interaction matrix" into your browser and you will find your answers.

The only requirement of the element 4.2.2 left is to describe the structure of your documentation. Some businesses I have consulted described their documentation tree as 4- or 5-level structure in the documentation management section of the manual.

After completion of your quality manual, think about other benefits a well prepared quality manual may bring you. It can communicate to your prospects, customers and vendors that your business is not only a quality-conscious organization, but that it also understands benefits of a well-documented commitment to QMS through your quality manual.

It was always a mystery to me why some companies mark their quality manuals with a big red stamp "FOR INTERNAL USE ONLY". Our clients are strongly encouraged to make their quality manuals public, assuming that your manual did not include any proprietary information.