What is a Quality Manual for ISO 13485?
A quality manual is a high-level definition of a quality management system of your company. It is similar to an expanded mission or vision statement. Quality manual establishes the policy-level position of your management in the area of quality management system (QMS) and compliance with applicable regulations. There are two definitions of what a quality manual for an ISO 13485 QMS should be:
ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, provides 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 QMS
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 - 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”
Now, after we established the scope of our ISO 13485:2003 QMS, we need to describe the processes we use to achieve the results stated in our scope. While we are doing this, we need to remember to reference corresponding procedures. Per my experience, the easiest way to do it is to transform the standard from a list of requirements into your organization’s dedication to satisfy those requirements. For example: Element 5.5.2.c of ISO 13485:2003 requires a Management Representative to ensure “? promotion of awareness regulatory and customer requirements ?” our manual will affirm: “The Management Representative ensures that regulatory and customer requirements are clearly communicated throughout the organization per the Purchasing Procedure and Regulatory Compliance 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 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.
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.
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!
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