Quality Manual for ISO 13485 2003 Standard

Formally there are a number of definitions of what a quality manual should be. These definitions are in ISO 10013, ISO 13485 and other standards. In fact, a quality manual is a document defining your quality management system. A quality manual establishes the policy level position of your corporation 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 QMS

2 – justified exclusions or non-applicable clauses;

3 – references to the documented procedures;

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 Risk Analysis Procedure.”

Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third requirement for a quality manual. Continuing addressing all applicable elements of the standard and referencing supporting procedures, we will develop a quality manual satisfying 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 commitments in our quality manual. Some models are available on the Internet. Simply enter “process interaction matrix” into the search field of your Explorer and you will find helpful links.

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.

Another important function of a quality manual, very often overlooked, is to be 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!

If you are working on improving your ISO 13485Quality Management System documentation, let us help you. We developed simple and esy to implement ISO 13485 Quality Assurance programs and documentation sets.