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:
- your QMS scope and justified exclusions;
- the documented procedures or reference to them;
- a specified interaction between the processes of your QMS.
Instructions above are really not that difficult to follow. We just need to ensure that our quality manual includes the sections to include the scope of your quality management system and exclusions; reference the procedures that describe your quality management system and define interactions of you QMS processes.
Most companies I worked with, state the scope of QMS in a scope or introduction sections of their manuals, similar to these: "XYZ Corporation designs, develops, manufactures and sells industrial application flow meters" or "XYZ Corporation provides paper and plastic recycling services to municipalities in the Great Newtown area"
When the scope is defined and exclusions are determined, it?s time to describe used processes and determine reference to the corresponding procedures. As I found through my consulting and auditing work, the best way to start this step is to transform the standard from a set of applicable requirements into your company?s commitment to satisfy those requirements. For example: If the standard in element 5.6.1, requires that the "Top management shall review the organization?s quality management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness," our manual will state: "My Company, Inc.?s top management review the quality management system on at least a quarterly basis to ensure its continuing suitability, adequacy and effectiveness per the Management Review Procedure."
As you can see, a reference to a specific procedure satisfies the second requirement for a quality manual. 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 9001:2000 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.
Now, when we addressed the requirements of ISO 9001:2000 standard for quality manual, consider this. A well written and professionally designed quality manual may become a powerful marketing tool. It can communicate to your prospects and customers that your organization is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality through your quality manual.
Surprisingly, many companies do not recognize that their quality manual may be a powerful communication tool. These 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, assuming that your manual does contain 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:
- your QMS scope and justified exclusions;
- the documented procedures or reference to them;
- a specified interaction between the processes of your QMS.
Instructions above are really not that difficult to follow. We just need to ensure that our quality manual includes the sections to include the scope of your quality management system and exclusions; reference the procedures that describe your quality management system and define interactions of you QMS processes.
Most companies I worked with, state the scope of QMS in a scope or introduction sections of their manuals, similar to these: "XYZ Corporation designs, develops, manufactures and sells industrial application flow meters" or "XYZ Corporation provides paper and plastic recycling services to municipalities in the Great Newtown area"
When the scope is defined and exclusions are determined, it?s time to describe used processes and determine reference to the corresponding procedures. As I found through my consulting and auditing work, the best way to start this step is to transform the standard from a set of applicable requirements into your company?s commitment to satisfy those requirements. For example: If the standard in element 5.6.1, requires that the "Top management shall review the organization?s quality management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness," our manual will state: "My Company, Inc.?s top management review the quality management system on at least a quarterly basis to ensure its continuing suitability, adequacy and effectiveness per the Management Review Procedure."
As you can see, a reference to a specific procedure satisfies the second requirement for a quality manual. 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 9001:2000 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.
Now, when we addressed the requirements of ISO 9001:2000 standard for quality manual, consider this. A well written and professionally designed quality manual may become a powerful marketing tool. It can communicate to your prospects and customers that your organization is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality through your quality manual.
Surprisingly, many companies do not recognize that their quality manual may be a powerful communication tool. These 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, assuming that your manual does contain proprietary information.
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