A quality manual is the top-level definition of a quality management system of your company. It is similar to an expanded mission or vision statement. Quality manual establishes the policy level position of your management in the area of quality management system (QMS). There are two definitions of what a quality manual for an ISO 9001 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:
- the scope of the quality management system, including details of and justification for any exclusions;
- the documented procedures or reference to them;
- relationships between the processes of your quality management system.
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."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the second requirement for a quality manual. Continuing in a similar way, addressing all applicable elements of the standard and referencing corresponding procedures, we will develop a quality manual satisfying ISO 9001:2000 requirements.
Interaction between the processes may be documented in a number of ways. Some companies choose to define top-level interaction by using derivatives of Figure 1 in ISO 9001:2000 standard. 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.
After completion of your quality manual, think about other benefits a well written and professionally designed quality manual may bring you. It can communicate to your prospects, customers and vendors 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.
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 quality management system, including details of and justification for any exclusions;
- the documented procedures or reference to them;
- relationships between the processes of your quality management system.
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."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the second requirement for a quality manual. Continuing in a similar way, addressing all applicable elements of the standard and referencing corresponding procedures, we will develop a quality manual satisfying ISO 9001:2000 requirements.
Interaction between the processes may be documented in a number of ways. Some companies choose to define top-level interaction by using derivatives of Figure 1 in ISO 9001:2000 standard. 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.
After completion of your quality manual, think about other benefits a well written and professionally designed quality manual may bring you. It can communicate to your prospects, customers and vendors 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.
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