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 requires a quality manual to include:

1 – the scope of the QMS

2 – justified exclusions or non-applicable clauses;

3 – quality management system procedures or reference to them;

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

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“

After we defined the scope and exclusions, let’s describe used processes and references to the corresponding procedures. As I found through my consulting and auditing work, the best way to start this step is to transform ISO 13485 standard from a set of applicable requirements into your company’s commitments to satisfy those requirements. For example: If element 7.1 requires that the company shall establish „?documented requirements for risk management?“ our manual will state: „ABC Medical, Inc. has established and maintains documented procedure for risk management?. This process is documented in the Risk Analysis 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.

Interaction between the processes may be documented in a number of ways. Some companies choose to define interaction of the top level processes by using variations of Figure 1 in ISO 9001:2000. Combining such a diagram with references to procedures, will define interactions between your processes. For more detailed process interaction tools, type „process interaction matrix“ into your browser and you will find numerous examples.

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.

Surprisingly, many companies do not recognize this benefit. Those organizations mark their manuals with „internal use only“ and „confidential“ stamps, while those quality manuals can serve a company externally. We recommend to all our customers make their quality manuals public. One company I worked with, simply posted their quality manual on their Website ? go and look!