Quality Management Documentation and Quality Manuals

For those of you waiting for my MadCap adventures, I apologize. It’s been a difficult transition but I am working on it and will be writing about it shortly. Meanwhile, I have been involved in a lot of discussions about Quality Systems and related documentation. In the LinkedIn group Technical Writer of Writers, the following question was posed by a member named Oana:

Does the Quality Manual depend on the business field and organization?

I was asked to create a Quality Manual template. After some research I did, my conclusion is that you cannot create a Quality Manual template to be used by businesses operating in different fields. A Quality Manual template is specific to business. I would appreciate your expertise here.

Very good question, Oana! I answered in the group (and can only hope I rose to the level of “expertise” she desired), but I will expand on my discussion here.

If you are concerned about ISO certification, clause 4. 2.2 requires that the organization have a Quality Manual. The Manual must document the scope of the quality management system, the documented procedures established for the quality management system (see clause 4.2.1) and a description of interactions between processes. And that is pretty much the extent of it.

This is really good news for those wanting to develop their quality systems. The lack of rigid structure means organizations can develop a structure that works for them, not for some auditor.

The answer to Oana’s question is yes, the quality system will be specific not just to the type of business, but the individual organization as well. The issue is not so much to develop and define a template, but to study their operation and determine what is done, how it is best done and how it is best controlled, and develop their documentation based on what will enable success for the organization. Designing a “template,” which I presume means a standardized structure, would actually be secondary.

Oana, if you are reading this, first of all thank you for reading it, and second, you will want to get ahold of my Writing Operating Procedures course/book. In Section 4 I discuss task analysis, which is foundational to identifying the documents you need. You or anyone else interested can obtain it, free of charge, by writing me at mrprocedure@gmail.com.

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About Tim James "Mr. Procedure"

A communicator; all-purpose capability in writing, designing and presenting training for all facets of organizational function. While my focus has been manufacturing, my training/development experience includes supervisory and lead person development, audit processes, continuous improvement and Lean, and Quality Management System implementation.
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