What Is A Quality Manual For Iso 13485?
An ISO 13485 quality manual is the top-level definition of a quality management system (QMS) of your company
. It is similar to an expanded mission or vision statement. Quality manual establishes the position of your management team in the area of quality management system and compliance with applicable regulations, such as FDA 21 CFR 820. There are two definitions of a quality manual for an ISO 13485 QMS:
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 QMS
2 - details of and justification for any exclusion or non-application;
3 - references to the documented procedures;
4 - a description of interaction between the processes of the QMS
5 - an outline of the structure of the documentation used in the quality management system
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."
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 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.
After completion of your quality manual, think about other benefits that a well prepared quality manual may bring you. It can communicate to your prospects, customers and vendors that your business is a quality-conscious organization and that it understands benefits of a well-documented commitment to quality and regulations.
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!
by: Mark Kaganov
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