An ISO 13485 quality manual is the top-level definition of a quality management system (QMS) of your company. It is similar to an expanded mission or vision statement. Quality manual establishes the position of your management team in the area of quality management system and compliance with applicable regulations, such as FDA 21 CFR 820. There are two definitions of a quality manual for an ISO 13485 QMS:
ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, provides suggestions for creating a quality manual. This standard describes a quality manual as a document that “consists of, or refer to, the documented QMS 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 QMS
2 – description of processes that are excluded, including non-applicable elements;
3 – quality management system procedures or reference to them;
4 – relationships between the processes of your quality management system, and
5 – definition of the QMS structure
The scope of the QMS is usually located in the corresponding section of the quality manual (QM). It simply states what activities your company performs within the scope of your certification. For example: “My Company, Inc. designs, manufactures and distributes laser generators for cosmetic surgery applications”
Now, when we established the scope of our ISO 13485:2003 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 5.5.2.c of ISO 13485 2003 requires a Management Representative to ensure ” promotion of awareness of regulatory and customer requirements ” our manual will affirm: “The Management Representative ensures that regulatory and customer requirements are clearly communicated throughout the organization per the Purchasing Procedure and Regulatory Compliance Procedure.”
Following this simple method, we can address all the requirements of ISO 13485:2003 standard and reference procedures supporting corresponding elements of your manual and quality management system, so we will comply with requirements of the standard.
Various methods are used to document process interactions. Some companies utilize Figure 1 from ISO 9001 standard to document relations between main processes. Use of such an illustration 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.
The fifth requirement of the element 4.2.2 of ISO 13485 standard is to address the structure of the documentation. Many organizations I worked with defined their documentation structures as a 4- or 5-level 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-focused organization, but that it also realizes benefits of a well documented commitment to quality and compliance with regulations, such as FDA QSR, Canadian MDR and others.
Surprisingly, many companies do not recognize this benefit. Those 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. One company I worked with, simply posted their quality manual on their Website!
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