A quality manual is a high-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) and compliance with applicable regulations. There are two definitions of what a quality manual for an ISO 13485 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 13485:2003, element 4.2.2 describes a quality manual as a document containing:
1 - the scope of the quality management system
2 - description of processes that are excluded, including non-applicable elements;
3 - the documented QMS procedures or reference to them;
4 - a description of interaction between the processes of the QMS
5 - an outline of the structure of the documentation used in the quality management system
Typically, companies state the scope of their QMS in the Scope or Introduction sections of their quality manuals, similar to "XYZ Corporation assembles, packages and distributes personal hygiene product packs to hospitals and doctors' offices"
When the scope of the QMS is determined, we can define the processes we need to achieve the results stated in the scope. Also, remember referencing supporting procedures for those processes. The easiest way to do it is to translate the standard from a list of requirements into your organization's commitment to satisfy those requirements. For example: Clause 6.4.a ISO 13485:2003 states: "The organization shall establish documented requirements for health, cleanliness and clothing of personnel ? " our manual will state: "The company has established a documented Clean Environment Procedure to maintain health, cleanliness and clothing requirements for personnel?"
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third 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 requirements of the 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 relate to those listed in our quality manual. Some models are available on the Internet. Enter "process interaction matrix" into the search field of your Explorer and you will find your answers.
The last requirement of the element 4.2.2 is to outline of the structure of the documentation. Very often I see companies defining their structures as four- or five-level documentation structure in the documentation management section of the manual.
Now, when we addressed the requirements of ISO 13485:2003 standard for quality manual, consider this. A quality manual may become a strong marketing tool. It can tell your potential clients and vendors that your organization is not only a quality-conscious organization, but that it also realizes benefits of a well documented commitment to quality and compliance with regs.
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. - 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 13485:2003, element 4.2.2 describes a quality manual as a document containing:
1 - the scope of the quality management system
2 - description of processes that are excluded, including non-applicable elements;
3 - the documented QMS procedures or reference to them;
4 - a description of interaction between the processes of the QMS
5 - an outline of the structure of the documentation used in the quality management system
Typically, companies state the scope of their QMS in the Scope or Introduction sections of their quality manuals, similar to "XYZ Corporation assembles, packages and distributes personal hygiene product packs to hospitals and doctors' offices"
When the scope of the QMS is determined, we can define the processes we need to achieve the results stated in the scope. Also, remember referencing supporting procedures for those processes. The easiest way to do it is to translate the standard from a list of requirements into your organization's commitment to satisfy those requirements. For example: Clause 6.4.a ISO 13485:2003 states: "The organization shall establish documented requirements for health, cleanliness and clothing of personnel ? " our manual will state: "The company has established a documented Clean Environment Procedure to maintain health, cleanliness and clothing requirements for personnel?"
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third 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 requirements of the 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 relate to those listed in our quality manual. Some models are available on the Internet. Enter "process interaction matrix" into the search field of your Explorer and you will find your answers.
The last requirement of the element 4.2.2 is to outline of the structure of the documentation. Very often I see companies defining their structures as four- or five-level documentation structure in the documentation management section of the manual.
Now, when we addressed the requirements of ISO 13485:2003 standard for quality manual, consider this. A quality manual may become a strong marketing tool. It can tell your potential clients and vendors that your organization is not only a quality-conscious organization, but that it also realizes benefits of a well documented commitment to quality and compliance with regs.
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. - 15246
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