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ISO 13485 Quality Manual
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 - justified exclusions or non-applicable clauses;
3 - references to the documented procedures;
4 - relationships between the processes of your quality management system.
5 - description of the QMS documentation.
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?"
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third 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 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 last requirement of the element 4.2.2 is to outline of the structure of the documentation. Very often I see companies defining their structures as four- or five-level documentation 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.
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