Document Control - Part 1

Below is a cut and paste from the standard with [comments from me].

Documents required by the quality management system are controlled [and therefore by definition, those that aren’t, aren’t. In the bad old days, this meant that every other piece of paper has to identified as not being part of the system. Today, you can be clever with definition, registers, location, etc.].

Records are controlled according to the requirements given in 4.2.4. [records demonstrating document control need to be generated, legible, readily retrievable. They can be hard copy, electronic, in a register or embedded in the document itself].

A documented procedure has been established to define the controls needed [this means you have to have a procedure and you have to have it documented. No exceptions]

a) to approve documents for adequacy prior to issue, [set some rules, set some definitions, name names or titles]

b) to review and update as necessary and re-approve documents, [deem when is necessary, explain what the triggers are, what mechanisms you use to record the update and then define who re-approves, which is normally the person or title who approved the original document]

c) to ensure that changes and the current revision status of documents are identified, [identified is the key word here. It doesn’t mean embedded but it could. It means that either within the procedure, the register, amendment or the document itself. There are just so many options here. Pick the one that suits you, your readers, your organisational culture and stick with it].

Part two to follow shortly.