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 quality management system
2 - details of and justification for any exclusion or non-application;
3 - the documented QMS procedures or reference to them;
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
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"
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.
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.
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.
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!
