Quality Manual for ISO 13485 2003 Standard
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by: Mark Kaganov
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Word Count: 600
Date: Thu, 11 Mar 2010 Time: 11:40 AM
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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 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.
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."
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.
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.
I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters "CONFIDENTIAL". As far as I am concerned, a quality manual is a company's resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their quality manuals public!
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If you are optimizing your ISO 13485 quality management system, and wish to avoid common mistakes, take a look at our ISO 13485 Quality Management consulting services.
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