What is a Process??

We hear this question all the time. The official definition from the ISO High Level Structure is “a set of interrelated or interacting activities which transforms inputs into outputs”. So what does that mean? It means you can basically define anything you do as a process. Based on the requirements in ISO 9001 you simply have to establish, implement, maintain and continually improve your processes and interactions in accordance with the standard. Maintain infers that you must document them. The rest of the shall’s say they have to be determined (inputs and outputs, sequence and interaction, methods to ensure effective operation, resources needed), Assign (responsibilities and authorities), Address risks and opportunities and evaluate.

So, as long as you meet all of those requirements you are OK. My personal opinion is that you should limit the number of processes because it causes your certification auditors to document more in a report, especially for AS 9100. At times it is not a bad idea to make your auditor happy.

The format of the documentation is also up to you, flowcharts, word documents, charts, even a video could work.

The ISO 9001 standard does not call out any other type of documentation, it only refers to documented information. This means it doesn’t matter if you call it a procedure, work instruction, manual, policy, SOP or whatever. Although, if you want to you can.

So this document that used to be in everyone company’s quality manual is no longer needed.

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