ISO9001 and The Quality Management System and Processes

ISO 9001:2015 Clause 4.4 is an interesting one, it says that you shall establish, implement, maintain and continually improve a quality management system. It says you should  include the processes needed & their interactions as well, its your job to determine the processes that are needed to meet the standard. It doesn't say anywhere that you actually have a hard copy manual actually for that matter it doesn't say you even have to write anything down but lets face it you are a bit mad if you don't, what happens when that institutional knowledge leaves for a new job or retires? Of course you are going to document it you just need to decide how, follow the old tree consumption method and print it all out (then try and keep track of where everything is) or get a more integrated system that helps manage things for you (I know what I prefer).

So What Processes are In the QMS?

What Processes should you cover in your Quality Management System? Well actually the answer is, that's almost up to you. You need to decide which parts of your business will fall under your Quality management System for ISO9001:2015. You may for instance decide to exclude Finance as it's a shared resource with another part of the organisation or HR for that matter, you may decide you will only cover the processes involved in your core manufacturing area, it's up to you. However, you should have a really good reason why you are not including some areas or processes into your ISO9001:2015 set up.

Once you have decided what's in and what's not you need to think how you will demonstrate you understand the processes that are involved in your Quality Management System. Since ISO9001:2015 is focused on the process approach the expectation is there that you will do this in structured way. You need to review the following things for your processes

1. What inputs & outputs are required for each process
   
2. What is the sequence of these processes and how to they interact
3. Understand how you will ensure that they operate effectively and are in control (hint.. you need a PDCA cycle here)
4. Understand what Resources you need for each process to ensure their availability - think broadly here so People, Equipment, Power, Space, Raw materials, Documentation, Training, support groups and so on
5. Assign the responsibilities and authorities for the processes, i.e.. who is going to do the process, who has control, can make decisions, what decisions can they make? These may well be defined within the Job Descriptions
6. Understand and address the risks & opportunities for the process
7. Evaluate the process and ensure that you are getting the outcomes you expect from it, if not implement the fix required (again Plan, Do, Check, Act)
8. Improve the Processes and the Quality management System - again that whole pesky continuous improvement thing. 

As part of the process mapping you should decide what the outputs from each area actually are and what resources are needed to fulfil items 1-7 above, item 8 you fulfil by setting up an audit / review cycle or a monthly management meeting which discusses the processes and reviews non conformances for example.

Deciding on Documentation

The business needs to decide to what extent it believes it's necessary to keep documentation to both support  the operation of it's processes and to have confidence that the processes are being carried out in line with your newly minted ISO9001:2015 certification. Go on, say it, "But you said we didn't have to document a QMS"... That's right you don't (again you are mad if you don't). What it's talking about here are the process documents that tell you have your organisation runs sales or manufacturing or finance. By having these in place and then auditing against these documents on a regular basis you have clause 4.4.2 sorted out.

In Summary

So in summary to meet ISO9001:2015 Clause 4.4 you need to 

1. Decide What the Quality management System will look like, how will you document it 
   
2. Understand the  processes in your organisation you are going to include, 
   
3. Make sure you have mapped the inputs / outputs & resources required, risks & opportunities per process
4. Document how you will carry out that process
5. audit against your documents on a regular basis 
6. Raise Improvement notices where there is an opportunity to improve or correct something within the process which would improve the output of that process.