Do documents I create need to be controlled?

One of things I find in most audits are process deficiencies with the organization’s QMS (Quality Management System) documents. I usually find obsolete documents in circulation and/or documents that are not controlled. What happens is that the organization sometimes does not realize the difference between the types of documents or the levels or where employees have posted documents.

Let us first discuss levels of documented information:

The Quality Manual describes your processes within your QMS on how the organization meets the requirements of the standard (in this case, ISO9001:2015). Procedures are documented information that outline specific work processes, such as: Sales, Purchasing, and Production. Work Instructions are documented information that give step by step directions on how a task should be done. Forms are documented information used to make a record completing all or part of the process described in your Quality Manual, Procedure, and/or Work Instruction.

We will examine the process of entering a room, for example. A procedure would identify the what the person has to do. It might say I open the door to the room and walk inside. A work instruction would be step by step to enter the room. I get up from my chair. I walk over to the door. I grab the knob. I turn the knob. I push the door forward. I walk into the room.

One of the best practice for ensuring obsolete documents are not kept in circulation is to ensure employees do not keep copies at their work stations. If an employee needs access to it then identify its distribution. The best practice is to have a controlled documented register of all your documents to ensure current status and location.

For more tips on ISO, please click here.

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