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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 - quality management system procedures or reference to them;

4 - specified interaction between the processes of your QMS.

5 - definition of the QMS structure

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.”

Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third requirement for a quality manual. Continuing in a similar way, addressing all applicable elements of the standard and referencing corresponding procedures, we will develop a quality manual satisfying 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 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.

Now, when we addressed the requirements of ISO 13485:2003 standard for quality manual, consider this. A quality manual may become a strong marketing tool. It can tell your potential clients and vendors that your organization is not only a quality-conscious organization, but that it also realizes benefits of a well documented commitment to quality and compliance with regs.

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.