What is a quality manual for ISO 13485?

by Mark Kaganov

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 describes a quality manual as a document containing:

1 – your QMS scope

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

3 – references to the documented procedures;

4 – relationships between the processes of your quality management system, and

5 – definition of the QMS structure

The scope of the QMS is usually located in the corresponding section of the quality manual (QM). It simply states what activities your company performs within the scope of your certification. For example: “My Company, Inc. designs, manufactures and distributes laser generators for cosmetic surgery applications”

When the scope of the QMS is documented, 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 of ISO 13485:2003 standard states: “The organization shall establish documented requirements for health, cleanliness and clothing of personnel “. In response to this requirement, our manual will state: “QW Medical, LLP has established a documented Clean Environment Procedure to maintain health, cleanliness and clothing requirements for personnel”

As you can see, a reference to a specific procedure satisfies the third requirement for a quality manual (above). Following this approach by addressing all applicable elements of the standard and referencing corresponding procedures, we will establish a manual that meets the requirements of ISO 13485:2003 standard.

Various methods are used to document process interactions. Some companies utilize Figure 1 from ISO 9001 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.

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-focused organization, but that it also realizes benefits of a well documented commitment to quality and compliance with regulations, such as FDA QSR, Canadian MDR and others.

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 does not include any proprietary information, which it should not.

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