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 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.
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.
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"
Since the scope defines our activities and we established our scope, we can define the processes that we need to achieve the results stated in the scope. Also, remember referencing corresponding procedures for those processes. The easiest way to do it, is to transform the standard from a list of requirements into your organization's commitment to satisfy those requirements. For example: Element 5.4.1 of ISO 9001:2000 requires that "Top management shall ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels with in the organization." our manual will state: "ABC Enterprises, LLC's top management ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels per the Quality Objective Matrix."
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.
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:
- 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.
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.
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"
Since the scope defines our activities and we established our scope, we can define the processes that we need to achieve the results stated in the scope. Also, remember referencing corresponding procedures for those processes. The easiest way to do it, is to transform the standard from a list of requirements into your organization's commitment to satisfy those requirements. For example: Element 5.4.1 of ISO 9001:2000 requires that "Top management shall ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels with in the organization." our manual will state: "ABC Enterprises, LLC's top management ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels per the Quality Objective Matrix."
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.
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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