Quality Manual for ISO 13485:2003 Standard

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, 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 describes a quality manual as a document containing:

1 - your QMS scope

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

3 - quality management system procedures or reference to them;

4 - specified interaction between the processes of your QMS.

5 - description of the QMS documentation.

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"

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 fifth requirement of the element 4.2.2 is to address the structure of the documentation. Many organizations I worked with defined their documentation structures as a 4- or 5-level structure in the documentation management section of the manual.

Now, when we addressed the requirements of ISO 13485:2003 standard for quality manual, consider this. A quality manual may become a strong marketing tool. It can tell your potential clients and vendors that your organization is not only a quality-conscious organization, but that it also realizes benefits of a well documented commitment to quality and compliance with regs.

I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters "CONFIDENTIAL". As far as I am concerned, a quality manual is a company's resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their quality manuals public!

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Learning from your own mistakes is costly! Check out our ISO 13485 page to learn more about Quality Management systems

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