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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 - your QMS scope
2 - details of and justification for any exclusion or non-application;
3 - the documented QMS procedures or reference to them;
4 - a description of interaction between the processes of the QMS
5 - definition of the QMS structure
The scope of the QMS is usually located in the corresponding section of the quality manual (QM). It simply states what activities your company performs within the scope of your certification. For example: "My Company, Inc. designs, manufactures and distributes laser generators for cosmetic surgery applications"
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."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third requirement for a quality manual. Continuing addressing all applicable elements of the standard and referencing supporting 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 2008. 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 fifth requirement of the element 4.2.2 of ISO 13485 standard is to address the structure of the documentation. Many organizations I worked with defined their documentation structures as a 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.
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 does not include any proprietary information, which it should not.
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 - your QMS scope
2 - details of and justification for any exclusion or non-application;
3 - the documented QMS procedures or reference to them;
4 - a description of interaction between the processes of the QMS
5 - definition of the QMS structure
The scope of the QMS is usually located in the corresponding section of the quality manual (QM). It simply states what activities your company performs within the scope of your certification. For example: "My Company, Inc. designs, manufactures and distributes laser generators for cosmetic surgery applications"
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."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third requirement for a quality manual. Continuing addressing all applicable elements of the standard and referencing supporting 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 2008. 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 fifth requirement of the element 4.2.2 of ISO 13485 standard is to address the structure of the documentation. Many organizations I worked with defined their documentation structures as a 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.
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 does not include any proprietary information, which it should not.
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Sruggling with your ISO 13485 QMS? If you are working on developing or improving your ISO 13485 QMS documentation, check out our ISO 13485 quality management documentation page.
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