Writing ISO 13485 Quality Manual – Need a tip?

A quality manual is a document that outlines the company’s intentions for managing processes in quality management. It may include rules for all parts of business that affect its capability to produce high quality outcome and meet clients and ISO requirements. These rules define how department managers will implement procedures within the limits defined in the manual.

So, what should be content of your Quality Manual?

These are essential things that are required:

  1. Structure of the documents – this should be shown in Quality Manual, because it will help understand the categories of documents that are used in the system.
  2. Scope – this is a relevant part of the quality manual, as it outlines how far the QMS spreads inside the company, and facts any exclusion from the ISO requirements and their justification.
  3. Procedures– they can be included within Quality Manual, but better yet they can be referenced within it.
  4. Processes and their interaction – this should be included, preferably in form of a flowchart.

These are essential parts which Manual should include, but these are minimum requirements which should be fulfilled. But, since the it is the mirror of company’s QMS, in order to be more attractive and clearer, additional information can be added.

Recommendation is to add brief description of the company with its mission and vision. Quality policy could be included in the Manual as well. The quality policy is the exact definition of quality that counts within organization and for that reason it should be communicated and understood.

The best way is if it is the part of the Manual.

This also applies for an Organizational chart. An organizational is a diagram that shows the structure of an organization and the relationships and ranks of its parts and positions/jobs within the company. If company is selling their products all over the world, it’s also important to reference which regulation and standards they are following. So, the main standards that company use to implement their quality system.

Let’s summarize – include following in your Manual:

  • Process interaction diagrams
  • Statements of applicable processes
  • Justifications for exclusion

  • Organizational chart
  • Quality objectives and policy
  • References to relevant documents

The Quality Manual is a very valuable document that not only provides guidance to the company’s own staff, but also because both your suppliers and your customers use it as the basic measure to determine and evaluate if your company meets your quality commitment. If it is well created, it can be used as a tool to “sell” the company – it can demonstrate how good the company is and how really it takes its QMS.


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8 replies to “Writing ISO 13485 Quality Manual – Need a tip?”

  1. gos lol says:

    I am not sure where you’re getting your info, but good topic. I needs to spend some time learning more or understanding more. Thanks for magnificent information I was looking for this information for my mission.

  2. You completed various fine points there. I did a search on the theme and found the majority of folks will agree with your blog.

  3. Lan Peatross says:

    Hey very interesting blog!|

  4. Selma Watson says:

    The quality manuals content and length really depends on the experience of the quality manager who has wrote it. Since, in the earlier version of ISO 13485, quality manual wasn’t a requirement, it can represent a difficulty to write a good one. I guess it is just a matter of time and practice to make the initial quality manuals better and better. Also, more and more electronic solutions are available on the web that can make writing of quality manual easy.

  5. Karen Miller says:

    General problem is that most Quality Manuals are rewrites of the standard and have no value at all. The Quality Manual should be a short explanation to all the staff of what the company does, what it intends to do and how it intends to do it. The best manuals are very short, visual and actual have something to say.

  6. Søren Petrussen says:

    Hi! Sometimes less is more, and in this case I agree with the author. As a QMS specialist for ISO 13485, I met companies where the Quality Manual was built like a book with lot of unnecessary information. Is that hard to write a short and straight manual? I am really interested in experiences and comments from external audits related to Quality Manual.

    1. Sophie Zimmerman says:

      Hi Soren! As I see you are a QMS specialist. Do you have any suggestion about where can I find a good sample or template or tool to make a good quality manual? Thanks

      1. Søren Petrussen says:

        I have found an eQMS software called qmsWrapper. They offer a quality manual builder tool. Here is a link: https://www.qmswrapper.com/quality-manual-creator take a look! It seems a good solution.

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