Making Amendments to a Quality Manual



We have an uncontrolled copy of Issue 1 of our Quality Manual; when making amendments should these be typed and then Issue 1 reprinted?

Many thanks
Elsmar Forum Sponsor
We have an uncontrolled copy of Issue 1 of our Quality Manual; when making amendments should these be typed and then Issue 1 reprinted?

Many thanks
Hi - welcome to the Cove

Can I first ask, what does your document control procedure state? When you state "uncontrolled", why are you asking about making changes to an uncontrolled document?

Also, if you make a change, it can't remain at "issue 1" can it? It was approved at issue 1 and now isn't the same - which usually means "issue 2" - but your own controls should describe this. Some may tell you it is now "1a" or similar, so your organization has to decide and put it in the document control (or similar) procedure...


If the quality manual is currently uncontrolled and there is a risk of two copies in existence, different, and both identified as issue 1, there are several risks:

  1. People will follow the wrong issue 1 instead of the correct issue 1;
  2. The documented procedure for document control referenced in the quality manual is somehow wrong (cannot be understood, omits elements of 4.2.2, isn't effective, etc.);
  3. The quality manual sets a poor example of quality management within the organization;
  4. The quality manual demonstrates an inability to control documents should customers see it.
The quality manual must, according to clause 4.2.2 include "the documented procedures established for the quality management system, or reference to them." It must therefore include or reference the procedure for controlling documents.

I would suggest getting document control properly described in a documented procedure in accordance with 4.2.2 and approving it, before issuing the amended version.

It may be that you are constructing a QMS from scratch and do not yet have document control in place. If so, it's common practice in my experience to establish document control first, to avoid confusion in documentation as the system is built - before writing the quality manual.

Hope this helps
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