Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 13485 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your organization in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 13485:2003 QMS 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 – quality management system procedures or reference to them;
4 – specified interaction between the processes of your QMS.
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.”
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 9001:2000 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.
I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters “CONFIDENTIAL”. As far as I am concerned, a quality manual is a company’s resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their quality manuals public!
If you are working on your your ISO 13485 quality management system, and want to avoid common mistakes, take a look at our ISO 13485 Quality Management consulting services.