• PQA International

Creating, Updating, Simplifying Documentation

Writing the Quality Management System documentation is often the most dreaded part of preparing for certification. Here are some concepts we hope will help you!

The QMS is the whole of the company’s system of managing the creation of products and services. So what and how do you document?

First, determine the processes needed to create and control your outputs (whether your product is burgers, parts, or consulting).

How much detail depends on what you do. ISO requires that you “maintain documented information needed to support the operation of [your] processes.” If your processes are very simple, and/or you have a lot of automation, the amount of written direction (“documented information”) is minimal. But the more complex and variable, or the more risks involved in either the process or in the product created, the tighter the controls must be. Our advice is, K.Y.S.S.: Keep Your System Simple where possible.

What must you include in your documentation?

a) Documents/records required by the specific standard itself

b) What you’ve determined you need for your QMS to be effective

Requirements for documentation. You should include:

a) ID and description, so the user knows what it is and how it’s used

b) Format: language(s) used, how it’s created (MS Word, etc)

c) Review by the appropriate authority/users, and approval for readiness

What format to use? You can use words, pictures, charts, drawings, video, bullet points, physical models, holograms...if it clearly meets requirements, and can be followed by your staff, your documentation is valid.

Control: Once you’ve gone to that much work, access and protection are crucial! Everyone who uses it must have access, but NOT those who shouldn’t. Access control can be locked cabinets, passwords for drives or file folders, etc. These requirements also apply to records (documentation to prove conformity), and to documentation supplied by a customer or other third party. Those must be protected from unintended alterations or deletion, and records may not be altered without appropriate evidence.

Updating documents: Version control is important so you’re all on the same page. Only authorized editors should be able to change a document, and as you improve a process, change the documentation, then mark and lock the old one away so it can’t be used. And collect any printed copies!

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