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 - description of processes that are excluded, including non-applicable elements;
3 - quality management system procedures or reference to them;
4 - relationships between the processes of your quality management system.
5 - description of the QMS documentation.
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"
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."
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 two three requirements of the 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 fifth requirement of the element 4.2.2 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.
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.
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 did not include any proprietary information.
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 - description of processes that are excluded, including non-applicable elements;
3 - quality management system procedures or reference to them;
4 - relationships between the processes of your quality management system.
5 - description of the QMS documentation.
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"
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."
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 two three requirements of the 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 fifth requirement of the element 4.2.2 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.
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.
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 did not include any proprietary information.
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