QMS Guidance Pt. 13 – ISO 9001 Clause 10
So here we are, the final auditable clause and what a clause. This is the one where you as the Quality Manager or Quality Champion or even the consultant can choose to add value to the whole process. This is the ACT in the Plan, Do, Check, Act (PDCA) process advocated by ISO.
This is a completely new clause and requires you to not unsurprisingly have a focus on customer needs and customer satisfaction. Not only these two points but to actively find ways to make improvements to your products and services both now and in the future.
Like many other clauses in the standard there’s no requirement to document anything, and like many other times I as your consultant would hope that you would document what and how you are going to improve things and a process for review. This way you can take your time if necessary and make clear plans that all concerned can buy into and nobody is left in any doubt about what improvements are to be made, by who, when for and what the intention is.
The aims of the clause are that you improve products and service you presently provide and consider what future changes might be required (think Porters 5-Forces model and you probably wont go too far wrong). That you take some action at the overall business level to make sure the chance of things going wrong is reduced or even removed altogether. And to improve the performance of the QMS.
This clause is called Nonconformity and Corrective Action and deals with how to deal with things should they go wrong in some way.
Essentially its a two part clause 10.2.1 & 10.2.2 and both parts are in the, by now very familiar bullet list format. 10.2.1 gives you an overview of how you should react when things have gone wrong and 10.2.2 tells you what you need to document.
The handy bullet list in 10.2.1 provides a list of things to do and in what order. It also tells you, although not explicitly other than from customer complaints that nonconformity can be identified not just at the audit but by anyone at any time. It effectively tells you to;
1 – do something to control the situation
2 – do something to fix the problem
3 – deal with the impact (of the customer complaint)
4 – once the mess has been stopped and cleared up you now need to evaluate what went wrong, and do something to prevent it happening again. The other thing you’ll need to do is consider if there is anything else or similar issues that could occur and deal with that or them too.
5 – now you need to go back and reconsider the risk and opportunities in-light of what you’ve learnt.
10.2.2 tells you what to document which is a two part process. If you’ve crafted your non-conformance documentation well enough you can use that same document you use at the audit. Effectively you are required to record the nature of the nonconformity, and what actions were taken. It then requires you to look at the results of any action taken. The standard is silent on the process as such but it in effect means going back at a later date to review what was agreed and if it was effective.
Clause 10.3 is called Continual Improvement and this is where the QMS can have a real positive effect on how the organisation is run. This clause is where the Quality Manager or Consultant can reach into the Lean 6-Sigma playbook for data management processes to make justifiable adjustments to business processes.
Once again the standard is silent on documentation and once again if I were your consultant I’d be strongly recommending that the methods you’ve used, the results you’ve got from analysis and evaluation processes are documented. Once documented you can share them and effectively review the outputs to identify any opportunities for improvement.
The Key Take-Aways
Take-Away #1 – 10.1 provides one final handy reminder to focus on what your customers want both now and what they might want in the future meaning you should be as prepared as possible.
Take-Away # 2 – 10.2.1 provides a very useful aid to how to deal with non-conformity and in what order, follow it and you should find you have a repeatable system for dealing with a mess when it happens and how you can learn from the process.
Take-Away # 3 – 10.2.1 also reminds you to link everything back to risk and opportunity, completing the circle back to clause 4.
Take-Away # 4 – because the previously separate corrective action process is no-longer, the use of well crafted non-conformity documentation becomes all the more important and promotes more efficient ways of keeping all of the information in one handy place.
Take-Away # 5 – Continual Improvement of the QMS and overall organisational performance is made much clearer and given a greater degree of exposure. By adopting Lean 6-Sigma monitoring, measuring, analysis and evaluation processes, decisions for improvement will be made based on fact no matter how improbably it may have seemed previously and not on the ‘gut feeling’ approach.
Some closing words
This now completes the guidance notes on clauses 4 through 10, the auditable clauses. Clause 4 concerning itself with the context of the organisation Clause 5 is all about how the organisation is going to be led, Clause 6 is the high level planning processes involved, Clause’s 7 & 8 the support and doing process, Clause 9 is the big one for the auditors and is the checking part and finally clause 10 is the how and what actions are going to be taken to make improvements to the QMS.
When thinking about continuous improvement you wont go far wrong with beginning with the 7 basic questions; what, who, when, why, where, how, and cost. These question will underpin any enquiry into improvement of processes and the QMS as a whole.
In the next guidance note, the final of this series of notes I offer, I’ll be giving you some detail on required documentation and what other documentation I as a consultant think you should have in place to make your whole QMS work.
Philip Dawson MBA | Business Consultant | Leadership Coach
Lead Auditor | ISO 9001 | ISO 14001 | ISO 45001/OHSAS 18001 | ISO 27001 | Lean 6-Sigma Practitioner
Enjoyed this post or found it informative then: