The importance of the Quality Manual?

Quality systems, like everything in the regulatory world, have a structure. This structure is defined within the quality manual a.k.a. the QMS “Bible”. Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters.

Everything starts with the manual! How it is written will have a big influence on how effective the system will be. No other document in QMS is greater than Manual.

A good quality manual should give the reader a clear picture of how the organization addresses the requirements of the standard. ISO defines quality as the ability to meet requirements. The standard is the requirement, and the policy manual is the plan for meeting that requirement.

This is the document which needs to be provided to all members within an organization and each of them should know about it, because this is the document which “drive” QMS. Manual should outline policies and procedures of the company which team should follow to produce quality outcomes and compliance to the Standard.

Quality Manual could be used to introduce overall company and QMS capabilities to customers, vendors, other organizations and, of course, to auditors.

The content of quality manual is completely up to company. But, for everything which is said that is done, you evidence that is really done must be shown! So, when creating manual, companies should be careful what include and they should make sure the policies reflect actual practices.

The structure and the content of the manual can differ depending on the size of the organization, the complexity of operations, and the capability of the people. Small organizations can document the complete QMS in one manual. On the other side, big global organizations may have numerous diverse quality manuals. Generally, the manual contains the QMS scope, exclusions from the standard, references to relevant documents, and the business process model. The quality policy and the objectives can be part of the manual as well.

It can also represent a big piece of work and if you buy one, it can be pretty pricey. Look for an eQMS that includes a quality manual template which you can assemble to create your own quality manual. Also, if you look for the right eQMS and manual, the manual could be integrated into the eQMS so that various processes defined in the QMS system, can be included in the manual.


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5 replies to “The importance of the Quality Manual?”

  1. Harris Wells says:

    @David Baker! Thanks for the tip! I am really trying hard to find something useful, but I have stuck with collecting only some general stuff.

  2. Harris Wells says:

    Does anyone have a good general template for Quality Manual?

    1. David Baker says:

      I can’t recommend a good template, but you can read great tips to write it on Advisera. Hope you heard about them. Also, address the following article from here for tips as well: Writing ISO 13485 Quality Manual – Need a tip?

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