ISO 9001 Quality Management System and its processes

[Sarahc]

Hi All and thanks in advance for your help,

I have been recently promoted to a QC Role in a construction company where we have held 9001 for multiple years. Everyone is saying the system is fine as it has held the certification for years but I see gaps.

I am concerned with ISO clause 4.4.1 QMS and its processes specifically a,b and g- determining inputs/outputs, sequences and processes interactions and evaluating processes. I will post below all that is referenced in our manual but it is basically a generic sequence of words that aren't actually processes or how we do anything e.g. 'Inputs - Outputs - Control - Resources- Responsibilities- Risks & opportunities - Review - improvement' is in a flow chart with reference to two appendices - 1 is just the plan do check act model with ISO clause numbers next to it and the other is a generic chart with Risks/Ops, Resource management, continual improvement, leadership, customer contracts, purchasing, service provision and measurement' but again no more actual specific information. I feel this does not meet the act requirements at all but correct me if I am wrong.

I have been trying to create a more comprehensive flow chart but this also requires inputs/outputs and measurements for each process which is a lot of work and I am not wanting to set up audits for functions of the business i don't need to be auditing.

For example, I perceive our processes to be: Quotes/Tendering, Project Planning/mobilisation, project construction and project handover. Supporting processes include monitoring and measuring equipment, Admin, HSE, finances, HR etc. These supporting processes support our QMS but are not our core function of what we do. Do they need to be evaluated under clause 4.4.1g (Evaluation of QMS processes) or only those processes listed that are our actual activities?


It would be great if people have some examples of what they have done!

 

[Jen Kirley]

Hi Sarahc,

If you don't already have a copy of ISO 9002:2016, this seems like a good time to invest in one. Its section on processes (4.4.1) could help you.

We should include support processes that play a role in activities that result in conformance to the standard. That would certainly include monitoring and measuring equipment, and very often HR if they have a role in resourcing and/or developing personnel with skills the QMS requires. Admin may be included depending on what they do. Many have argued that Finance is not a QMS process, but again I think that depends on what they contribute.

Processes that contribute to the QMS do need to be evaluated, but nothing in the standard says you need to be responsible to do that.

Inputs and outputs are very often identified in procedures. I don't see why you should need to make a document just to show that. However:
Process Flow diagrams are usually drawn up to show sequence and interaction (support processes such as HR, Calibration, Maintenance and Document Control could be shown in boxes outside the set of main production processes with some indication that they support Production processes) but I would not spend a lot of time doing that. It is good to use them to show you recognize the processes supporting the QMS. If you used Excel to draw this map, you could even embed a comment that briefly summarizes inputs and outputs. I can imagine this document having the primary usefulness as an introduction to the system for the new supervisors and managers.

I hope this helps.

 

[Sarahc]

Hi Sarahc,

If you don't already have a copy of ISO 9002:2016, this seems like a good time to invest in one. Its section on processes (4.4.1) could help you.

We should include support processes that play a role in activities that result in conformance to the standard. That would certainly include monitoring and measuring equipment, and very often HR if they have a role in resourcing and/or developing personnel with skills the QMS requires. Admin may be included depending on what they do. Many have argued that Finance is not a QMS process, but again I think that depends on what they contribute.

Processes that contribute to the QMS do need to be evaluated, but nothing in the standard says you need to be responsible to do that.

Inputs and outputs are very often identified in procedures. I don't see why you should need to make a document just to show that. However:
Process Flow diagrams are usually drawn up to show sequence and interaction (support processes such as HR, Calibration, Maintenance and Document Control could be shown in boxes outside the set of main production processes with some indication that they support Production processes) but I would not spend a lot of time doing that. It is good to use them to show you recognize the processes supporting the QMS. If you used Excel to draw this map, you could even embed a comment that briefly summarizes inputs and outputs. I can imagine this document having the primary usefulness as an introduction to the system for the new supervisors and managers.

I hope this helps.

Hi Jen,

Thanks for this. Do the support processes need monitoring and KPI's (as per clause 4.4.1c) or only those core function processes?

 

[Funboi]

Hi Jen,

Thanks for this. Do the support processes need monitoring and KPI's (as per clause 4.4.1c) or only those core function processes?

What’s important to management? “What gets measured gets managed”, as the saying goes…

 

[Dazzur]

Hi Jen,

Thanks for this. Do the support processes need monitoring and KPI's (as per clause 4.4.1c) or only those core function processes?

That's up to you, Monitor and create KPIs or any other monitoring method for what ever you deem is important. If you consider the support processes critical to the success of your core process you can create methods to monitor these and use that feedback/information to gauge their effectiveness and then use that to determine if your processes are effective.

 

[Funboi]

Monitor and create KPIs

All that’s required is Quality objectives…

 

[Dazzur]

All that’s required is Quality objectives…

Yeah that's all that is required but I personally monitor several other things, It's easier for me as we use a central database where *everything* is inputted/recorded (PLM system) and it can collate and manipulate that data how we see fit (with limitations) and export it into several different visual charts, some of the data sets I monitor fall outside of my defined quality objectives.

 

[Funboi]

KPIs can include many measures, none of which relate to the things that ISO 9001 is intended to achieve. We must be careful not to carelessly throw around terms which aren’t universal.

 

[Jen Kirley]

What’s important to management? “What gets measured gets managed”, as the saying goes…

True. Accrediting bodies are pressuring registrars to ask for some measure for all processes. But it isn't a good practice to just think up something so you can say you have it. Consider what other processes need from that process in order to do well. Consider too, other interested parties - do you have any training required by regulations? If so, would it make sense to keep an eye on that being up to date? Is billing a part of finance? If so, what would happen if the bills are incorrect or late? Is that a concern for management? If so, it might be a good idea to keep watch over it. This is about your organization first, not obeying a standard.

Keep in mind too, that metrics can change as the business changes. It's up to your management. Have you asked them? This is their QMS, not yours.

 

[John C. Abnet]

Reminder @Sarahc that the term "key " process and "core" process and "support" process, and even "process map", are not prescribed /assigned/nor defined terms within ISO 9001.

I'm a fan of a simple 'process map', and indeed the other terms can be helpful at times. However, they are not required nor expected terms or 'items' to act on.

As others have mentioned within this post, be selfish and do what is best for the organization. If it is helpful to have a process map and OBJECTIVELY define and delineate between 'key' processes and 'support' processes, then certainly do so. I would counsel , however, to never do anything for the sake of an auditor.

Hope this helps.
Be well.