Quality Manual for ISO 13485 2003 Standard

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Written by Mark Kaganov

Thursday, 11 March 2010 08:46

by MarkKaganov

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 - the scope of the quality management system

2 - justified exclusions or non-applicable clauses;

3 - references to the documented procedures;

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

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"

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 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.

Another important function of a quality manual, very often overlooked, is as a marketing tool. Well written and professionally published, a quality manual may become a powerful marketing instrument. It can communicate to your potential customers, suppliers and subcontractors that your company is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality and compliance with regulatory requirements.

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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If you are working on your your ISO 13485 quality management system, and wish to avoid common mistakes, take a look at our ISO 13485 Quality Assurance consulting services.