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;
- quality managemet system procedures or reference to them;
- a description of interaction between the processes of the 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"
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.
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.
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.
I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters ?CONFIDENTIAL?. As far as I?m concerned, a quality manual is a company?s resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their quality manuals public! - 15246
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 description of interaction between the processes of the 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"
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.
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.
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.
I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters ?CONFIDENTIAL?. As far as I?m concerned, a quality manual is a company?s resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their quality manuals public! - 15246
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