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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:
- the scope of the quality management system, including details of and justification for any exclusions;
- quality managemet system procedures or reference to them;
- a specified interaction between the processes of your 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.
Typically, companies state the scope of their QMS in a scope or introduction sections of their quality manuals, similar to these: "ABC Enterprises, LLC assembles and distributes pre-cooked meals for elderly citizens in the St. Newtown region" or "ABC Enterprises, LLC designs, manufactures and services high poser vacuum cleaners"
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"
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.
Now we need to choose a method to document interactions between our processes. There are a few ways to do it. One typical method is to utilize Figure 1 in ISO 9001:2000 standard. This figure shows a model of a process-based QMS. In addition to that, referenced documents will show what processes are "attached to those listed in our quality manual. Some models are available on the Internet. Just, type "process interaction matrix" and you will find your answers.
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;
- quality managemet system procedures or reference to them;
- a specified interaction between the processes of your 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.
Typically, companies state the scope of their QMS in a scope or introduction sections of their quality manuals, similar to these: "ABC Enterprises, LLC assembles and distributes pre-cooked meals for elderly citizens in the St. Newtown region" or "ABC Enterprises, LLC designs, manufactures and services high poser vacuum cleaners"
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"
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.
Now we need to choose a method to document interactions between our processes. There are a few ways to do it. One typical method is to utilize Figure 1 in ISO 9001:2000 standard. This figure shows a model of a process-based QMS. In addition to that, referenced documents will show what processes are "attached to those listed in our quality manual. Some models are available on the Internet. Just, type "process interaction matrix" and you will find your answers.
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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Developing or tuning up your ISO 9001 QMS manual? Check our ISO 9001 programs and ISO 9001 Quality Management System Manuals.
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