Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 9001 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your management in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 9001:2000 QMS 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;
- quality managemet system procedures or reference to them;
- a description of interaction between the processes of the QMS.
If we follow the requirement 4.2.2.a of ISO 9001:2000 Standard, we simply need our quality manual to clearly define the scope of our QMS, exclusions, if any; reference our procedures and define interactions between the 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."
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.
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.
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. - 16747
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;
- quality managemet system procedures or reference to them;
- a description of interaction between the processes of the QMS.
If we follow the requirement 4.2.2.a of ISO 9001:2000 Standard, we simply need our quality manual to clearly define the scope of our QMS, exclusions, if any; reference our procedures and define interactions between the 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."
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.
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.
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. - 16747
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