If we’re not getting better, it feels like it’s getting worse…

ISO 9001:2015 Clause 10 – Improvement

This Clause is the ‘money maker’ for any organization – improvement = profits!

Since the 2015 version of ISO 9001 has removed specific requirements for a procedure for ‘Preventive Action’, Clause 10 places increased importance on an organization to be proactive and prevent non-conformances rather than waiting for a problem and correcting it. In fact, the authors might imagine the entire management system to be the ‘Preventive Action’ that was required in the last 4 versions of this Standard.

The section starts out with just what we’d expect: requirements to ‘… determine and select opportunities for improvement and implement necessary actions to meet customer requirements and enhance customer satisfaction…’. No surprises – we need to pay attention to improving processes, products and services and management system results.

These management system results will be measured against the Quality Objectives we set in clause 6.2 (Quality objectives and planning to achieve them) and analyzed in clause 9 – Performance Evaluation.

Clause 10.2 – Non-conformity and Corrective Action.

Non-conformity and Corrective action looks just like our current process, but adds a bit of ‘preventive action’ language with the phrase ‘… determining if similar nonconformities exist, or could potentially occur…’ (10.2.1 b) 3)

I think most of us are already doing this, and it’s a great way to get more value from our QMS. There are two very interesting ideas presented in the FDIS version in the Notes that did not make it into the final version:

1. “In some instances it can be impossible to eliminate the cause of a non-conformity; and,
2. Corrective action can reduce the likelihood of recurrence to an acceptable level. “

To me, this idea opens the door for ‘that’s the best we can do‘ . The result that may not be perfect, but will manage the risk associated with the situation. To me, this is a very logical approach, but will be somewhat ‘grey’ for auditors.

Naturally, there are requirements for ‘documented information’ about non-conformities, subsequent correction or corrective actions and the effectiveness of them. Nothing new – get it done and track the trail of evidence.

 

Finish off with 10.3 – Continual Improvement

The final paragraph adds a couple of polished concepts. We have to ‘…consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement…’ (10.3) Similar sounding to 2008, but adds a subtle nudge toward measuring QMS performance, not just process performance and output performance. Remember to focus on results when searching for opportunities – customer satisfaction, process results, system results and assessment of our capabilities. These are all fertile areas for finding ways to improve and get more value out of our systems.

All in all, these changes will help organizations find more value in their QMS. But it’s just like an exercise bike – if you hang dirty laundry on it, and don’t actually ride it, nothing will improve. And if we’re not improving, neither are our profits!