A quality manual is the main, 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. There are two published definitions of what a quality manual for an ISO 9001 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 9001:2000, element 4.2.2 describes a quality manual as a document containing:
- the scope of the QMS and details of and justification for any exclusions;
- references to the documented procedures, and
- a description of interaction between the processes of the QMS.
Let's follow these simple instructions and see how easy it is to create a quality manual to document the scope of your quality management system and exclusions; ensure that procedures are referenced and specify relationships or interactions between your processes.
Definition of the scope is usually placed into the ?Scope? section of the manual. It simply states what activities your company performs. For example: ?My Company, Inc. designs, manufactures and distributes card board boxes for high volume customers? or ?My Company, Inc. provides ISO 9001 consulting and training services for service companies?
Now, after we established the scope of our ISO 9001:2000 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 4.2.4 of ISO 9001:2000 requires that "Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system" our manual will affirm: "XYZ Corporation ensures that records are established and maintained to provide evidence of conformity to requirements and the effective operation of the QMS per the Records Procedure"
Following this simple method, we can answer to all the requirements of ISO 9001:2000 standard and reference procedures supporting corresponding elements of your manual and quality management system. SO we will comply with two first requirements of the standard.
Various methods are used to document process interactions. Some companies utilize Figure 1 in ISO 9001:2000 standard to document relations between main processes. Blend of the Figure 1 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.
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.
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 9001:2000, element 4.2.2 describes a quality manual as a document containing:
- the scope of the QMS and details of and justification for any exclusions;
- references to the documented procedures, and
- a description of interaction between the processes of the QMS.
Let's follow these simple instructions and see how easy it is to create a quality manual to document the scope of your quality management system and exclusions; ensure that procedures are referenced and specify relationships or interactions between your processes.
Definition of the scope is usually placed into the ?Scope? section of the manual. It simply states what activities your company performs. For example: ?My Company, Inc. designs, manufactures and distributes card board boxes for high volume customers? or ?My Company, Inc. provides ISO 9001 consulting and training services for service companies?
Now, after we established the scope of our ISO 9001:2000 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 4.2.4 of ISO 9001:2000 requires that "Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system" our manual will affirm: "XYZ Corporation ensures that records are established and maintained to provide evidence of conformity to requirements and the effective operation of the QMS per the Records Procedure"
Following this simple method, we can answer to all the requirements of ISO 9001:2000 standard and reference procedures supporting corresponding elements of your manual and quality management system. SO we will comply with two first requirements of the standard.
Various methods are used to document process interactions. Some companies utilize Figure 1 in ISO 9001:2000 standard to document relations between main processes. Blend of the Figure 1 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.
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.
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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