ISO9001:2015 Section 4.4.1 - Support Processes

[Sentinel]

ISO9001:2015 Section 4.4.1

With regard to this paragraph, and the requirement:
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a) Determine the inputs required and the outputs expected from these processes.

We have a QMS which has a "SIPOC" spine of core processes and then a number of support processes such as Calibration, Maintenance, Document and Data Control, etc. Do we have to define the inputs and outputs for every process detailed on our process definition document or just the "core" SIPOC processes? I like this idea and the process flow document that we use for manufacturing utilises a format with inputs and outputs.

I would be interested to hear how people have gone about this and any experience with CB's.

Thanks.

 

[Marc]

Re: ISO9001:2015 Section 4.4.1

Are you asking if you have to document support processes in addition to your core SIPOC processes?

 

[Sentinel]

Re: ISO9001:2015 Section 4.4.1

Thank-you for your reply. I tried to allude to the fact that we utilise Input and Output based process flow methodolgy within our manufacturing processes and most people within the organisation are advocates of that type of approach.

I guess that I am asking because I am trying to decide whether we update our standard business process template to include the input and output requirements or have a separate process definition document for the core processes.

For example if Maintenance is a support process, would there be much benefit in adding inputs and outputs to this process?

As for my interest in the CB, I am trying to scope the size of the task and what resource is involved in getting ready for the ISO9001:2015 audit, i.e. do we have to do every process or the core processes. It m,ay be that we can do support processes further down the line.

 

[Sentinel]

Re: ISO9001:2015 Section 4.4.1

Are you asking if you have to document support processes in addition to your core SIPOC processes?

I am trying to understand if the input/output requirement is applicable to every business process inlcuding support processes or just the core processes. For example we have a procedure on maintenance, but it does not list inputs/outputs, etc.

 

[dsanabria]

Re: ISO9001:2015 Section 4.4.1

ISO9001:2015 Section 4.4.1

With regard to this paragraph, and the requirement:
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a) Determine the inputs required and the outputs expected from these processes.

We have a QMS which has a "SIPOC" spine of core processes and then a number of support processes such as Calibration, Maintenance, Document and Data Control, etc. Do we have to define the inputs and outputs for every process detailed on our process definition document or just the "core" SIPOC processes? I like this idea and the process flow document that we use for manufacturing utilises a format with inputs and outputs.

I would be interested to hear how people have gone about this and any experience with CB's.

Thanks.

At a minimum the CORE process are considered those processes in Manufacturing, Production or Services (Clause 8 in ISO 9001:2015) and at a minimum measure the items per Clause 9.1.3

 

[JoShmo]

Re: ISO9001:2015 Section 4.4.1

Thank-you for your reply. I tried to allude to the fact that we utilise Input and Output based process flow methodolgy within our manufacturing processes and most people within the organisation are advocates of that type of approach.

I guess that I am asking because I am trying to decide whether we update our standard business process template to include the input and output requirements or have a separate process definition document for the core processes.

For example if Maintenance is a support process, would there be much benefit in adding inputs and outputs to this process?

As for my interest in the CB, I am trying to scope the size of the task and what resource is involved in getting ready for the ISO9001:2015 audit, i.e. do we have to do every process or the core processes. It m,ay be that we can do support processes further down the line.

Sounds like you and everyone has the correct and effective approach! If this is the way everyone sees things, then your documentation should reflect that, if for no other reason than it's consensus. Don't know what your template is or why a separate document is an option, but do whatever is a) established and b) everyone uses and c) is least problemmatic/bureaucratic.

I still don't understand why the CB is part of this discussion. The scope of your quality system is what you say it is (subject to certain limitations like product design being exlcuded, for example) Also, your organization has to identify what process are needed. You can't get certified to core processes and later add support processed. YOu can expand the scope later, but the system of process has to include those core and support process needed to satisfy customers and internal requirements.

 

[LUV-d-4UM]

Re: ISO9001:2015 Section 4.4.1

I am trying to understand if the input/output requirement is applicable to every business process inlcuding support processes or just the core processes. For example we have a procedure on maintenance, but it does not list inputs/outputs, etc.

We just got our upgrade to ISO9001:2015. Yes the Core processes and support processes were included. The SIPOC is still being monitored as appropriate for our internal use. Was reviewed during the management review and will be reviewed again for adequacy. The important thing that was looked at during the audit was the interaction between the core and support processes and measurement of effectiveness and the linkage to the overall Quality objectives and strategic direction of the organization. I hope this helps you. Good luck.

 

[Colin]

Re: ISO9001:2015 Section 4.4.1

Support processes are not necessarily less important to the well-being of a business. In fact, I would normally consider finance as a support process but it is equally important to a manufacturing business as is production.

Support processes should be included in the normal flow diagrams whether there are procedures in place to control them or not.

 

[somashekar]

Re: ISO9001:2015 Section 4.4.1

I am trying to understand if the input/output requirement is applicable to every business process inlcuding support processes or just the core processes. For example we have a procedure on maintenance, but it does not list inputs/outputs, etc.

Understanding from what you say, the Input >> Activity >> Output way of describing any process is a very easy way to understand and capture the process in its entirety. This also will include the generation of any waste or scrap which will get its due attention in the handling and disposal. This will also address the requirement of records at the right place as generation of records is a very vital output. The approach could be common for any process., Core or Support.

 

[Sebastian]

Re: ISO9001:2015 Section 4.4.1

Are you able to get expected outputs from your core processes without supporting processes giving you expected inputs?
I do not think so, therefore you need to manage supporting processes in a same manner as core ones. This way supporting processes have to be included in your quality management system.