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 QMS and details of and justification for any exclusions;
- the documented 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"
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.
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.
Another important function of a quality manual, very often overlooked, is as a marketing tool. Well written and professionally published, a quality manual may become a powerful marketing instrument. It can communicate to your potential customers, suppliers and subcontractors that your company is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality.
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 QMS and details of and justification for any exclusions;
- the documented 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"
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.
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.
Another important function of a quality manual, very often overlooked, is as a marketing tool. Well written and professionally published, a quality manual may become a powerful marketing instrument. It can communicate to your potential customers, suppliers and subcontractors that your company is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality.
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.
About the Author:
Developing or tuning up your ISO 9001 2000 quality manual? Check our ISO 9001 programs and ISO 9001 Quality Management System Manuals.
0 commentaires:
Enregistrer un commentaire