Many of the Quality Management Systems requirements in the ISO 9001: 2015 manual include the verbiage “shall be determined.” I need to be sure that I understand exactly what this means in this context. For example, “4.4 QMS and its processes 4.4.1 a) The inputs required and the outputs expected of the QMS processes are determined.” Does this mean that there should be process or work instruction written describing this? Does it mean that there should be documentation showing the development of this information?
Thank you for your question. It might be useful to look at the definition of the word determine. According to the Oxford Dictionary: Determine means to “Ascertain or establish exactly be research or calculation”, Merriam Webster has a similar definition: “to find out about or come to a conclusion about by investigation, reasoning, or calculation.
Now to your question. There does not need to be a procedure about how things are determined. The output, or the determination itself, will serve as evidence that you did it. But determine things in an honest way. You and your CB auditor will assess the reasonableness of your determinations based on the context of your organization. For example, if you are a hospital, and you “determine” that surgeons do not need to wash their hands, you should be subject to a nonconformance for getting that wrong. In your example, taken from clause 4.4, the best way to do this is to create a flowchart(s) showing a series of process steps and their interactions. The arrows in and out of each box along with explanatory text, will demonstrate that you have determined the inputs and outputs of each process step.