| What is a Quality Manual for ISO 13485? |
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| Written by Mark Kaganov |
| Monday, 01 September 2008 21:05 |
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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 - your QMS scope 2 - justified exclusions or non-applicable clauses; 3 - quality management system procedures or reference to them; 4 - a description of interaction between the processes of the 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 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 as 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 ? go and look! About the Author: Before you start working on or optimizing your ISO 13485 Quality Manual visit our ISO 13485 page to learn more about Quality Management systems for medical device manufacturers |