ISO 9001:2015 Requirements for processes (not the interactions between them) per 4.4.1

[AHumanPerson]

ISO 9001 4.4.1 requires the organization to determine the processes needed for a QMS.
ISO 9000 defines a process as a "set of interrelated or interacting activities that use inputs to deliver an intended result"

Question: can a QMS process be considered to have been "determined" if the set of interrelated or interacting activities within it has not been defined?

 

[Randy]

How can you manage that which you do not know what it does?

 

[AHumanPerson]

How can you manage that which you do not know what it does?

I'm inclined to say that you can't, but I've heard arguments along the lines that its all good so long as the process is named appropriately, the inputs and outputs are known, and it's KPIs are being met. I think the idea there is flexibility, but to me it seems like running blind.

 

[Randy]

its all good so long as the process is named appropriately,

Doesn't matter what you call it as long as you control the thing as needed. I don't care if you call the slurry for catalytic convertors a milkshake as long as what goes in, what happens and what comes out is controlled and you get what you want in the end.

 

[toniriazor]

ISO 9001 4.4.1 requires the organization to determine the processes needed for a QMS.
ISO 9000 defines a process as a "set of interrelated or interacting activities that use inputs to deliver an intended result"

Question: can a QMS process be considered to have been "determined" if the set of interrelated or interacting activities within it has not been defined?

Naming a process is not sufficient, but a place to start. Typically you would have the inputs for this process and the outputs. What activities involve the process, how the elements interact and what is the flow of events. And this is not one time event as processes are often improved, modified and etc.

 

[qualitymanagerTT]

ISO 9001 4.4.1 requires the organization to determine the processes needed for a QMS.
ISO 9000 defines a process as a "set of interrelated or interacting activities that use inputs to deliver an intended result"

Question: can a QMS process be considered to have been "determined" if the set of interrelated or interacting activities within it has not been defined?

"determine" [verb] find out (one or more characteristics)

source: https://committee.iso.org/files/live/sites/tc176sc1/files/ISO9000GlossaryENv5FA2025

 

[Big Jim]

Define, yes you need to do so, but nowhere does it say you have to document it. As long as you can explain it, you have defined it, but a requirement to document it is NOT attached.

 

[ChrisM]

Forget the word "quality" - how can you run a business if you don't know who does what, and why they do what they do?
Start by looking at why someone does what they do - what are the "inputs" to their work process, and what do they produce or do that makes someone or something else (e.g. a machine) do something - their "process outputs"

 

[AHumanPerson]

Define, yes you need to do so, but nowhere does it say you have to document it. As long as you can explain it, you have defined it, but a requirement to document it is NOT attached.

Forget the word "quality" - how can you run a business if you don't know who does what, and why they do what they do?
Start by looking at why someone does what they do - what are the "inputs" to their work process, and what do they produce or do that makes someone or something else (e.g. a machine) do something - their "process outputs"

There is a partially automated step in the process where the person who initiates it wasn't sure what the output is; they have work instructions that tell them to do it, but not why or what it does or who needs it to happen.

Also, documentation does exist in the form of a "process sheet" (like a process turtle but in a more report-like form) and an SOP, but they don't agree with eachother. The outputs listed on the process sheet are what you would expect this process to produce, but the SOP only describes a subprocess (it does not produce the final outputs listed on the process sheet, but it does produce an input to the activity that does).

The "set of interrelated activities" that make up this process are not described anywhere.

 

[AHumanPerson]

"determine" [verb] find out (one or more characteristics)

source: [source]

Thank you for sharing this glossary, that's very helpful.

I would think it safe to assume that if the object being "determined" has more than one characteristic, then for it to be "determined" would mean to obtain knowledge of all of it's (or at least it's most important) characteristics, which, in this case, would include the set of interrelated activities within the process, and how they interact.