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:
- your QMS scope and justified exclusions;
- references to the documented procedures, and
- 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.
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"
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. - 15266
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;
- references to the documented procedures, and
- 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.
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"
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. - 15266
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