Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 13485 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 organization in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 13485:2003 QMS should be:

ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, provides 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 describes a quality manual as a document containing:

1 – the scope of the QMS

2 – description of processes that are excluded, including non-applicable elements;

3 – quality management system procedures or reference to them;

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

5 – definition of the QMS structure

Typically, companies state the scope of their QMS in the Scope or Introduction sections of their quality manuals, similar to „XYZ Corporation assembles, packages and distributes personal hygiene product packs to hospitals and doctors‘ offices“

Now, after we established the scope of our ISO 13485:2003 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 5.5.2.c of ISO 13485:2003 requires a Management Representative to ensure „? promotion of awareness regulatory and customer requirements ?“ our manual will affirm: „The Management Representative ensures that regulatory and customer requirements are clearly communicated throughout the organization per the Purchasing Procedure and Regulatory Compliance Procedure.“

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.

Now we need to choose a method to document interactions between our processes. There are a few ways to do it. One typical method is to utilize Figure 1 in ISO 9001:2000 standard. This figure shows a model of a process-based QMS. In addition to that, referenced documents will show what processes relate to those listed in our quality manual. Some models are available on the Internet. Enter „process interaction matrix“ into the search field of your Explorer 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.