Clause 10:Demonstrate Continual Improvement

According to google,

continual (adjective) - forming a sequence in which the same action or event is repeated frequently.

There are few articles around the internet explaining the difference between continuous and continual improvement. Some of them are quite old but the spirit of the QMS has not changed since rev. 2000. You may not find it anything related to an organisation but still successfully implementing QMS. The standard is generic.

Any approach fulfilling PDCA cycle can be used but not "breakthrough change". I hope you understand why "breakthrough change" is not applicable. It is opposite to "controlled change". Are you allowed to improve efficiency of a process by decreasing the effectiveness of QMS?

 

I found this interesting article.

https://www.isixsigma.com/implement...gh-change-what-it-means-and-why-it-is-needed/

 

Arguable. The QMS is not a methodology like SixSigma. No matter how an organisation improves customer satisfaction, the effectiveness can not be impaired. This is the point where "improving the performance of organisation" diverges from "improving the performance of QMS".

 

I don't mean the SixSigma is not allowed. An organisation must improve efficiency of processes and effectiveness of the QMS in a frequently reccuring (consistent?) way. Any attempt to make a revolutionary shift should be avoided as this facilitates "uncontrolled change".

The comittee might well aware of the fact that many organisations (auditors as well) do not get the idea behind "continual improvement".

 

I don't think so. "breakthrough change" causes some degree of disruption. It does not fit the requirements in clause 10.3 and PDCA cycle is not applicable for "breakthrough change".

 

I think there is a confusion between the requirements for "continual improvement" in ISO9001:2008 and ISO9001:2015. Many auditors and organizations do not clearly understand what the standard actually expects in the Clause 10.3.

In the old ISO9001:2008, continual improvement was expected through the use of quality policy, quality objectives, audit results, analysis of data, corrective actions, preventive actions and management review. PDCA cycle was considered as an objective approach to continually improve the system. As such, there was no difference between continuous and continual improvements because any improvement action was considered a result of the these activities. Continual improvement required by the ISO9001:2008 was a project based improvement.

Things has changed in the ISO9001:2015. Now the standard asks us to consider the results of analysis and evaluation, and the outputs from management review to determine if there are needs that must be addressed as part of continual improvement. Quality policy, quality objectives, audit results, analysis of data, corrective actions, preventive actions and management review are used for only improvement. They are not tools for continual improvement any more although they provide basic information for evaluation. For continual improvement, we must review the results of analysis and evaluation, and the management review to detect new needs and opportunities that we have to pursue and consider in planning of the QMS. We must evaluate results of the management review to determine if we need to standardize certain decisions or adopt a SOP.

At the end of the day we must have:
- updated external and internal issues, and monitoring actions for these
- updated needs and expectations of interested parties, and monitoring actions for these
- updated planning of the QMS
- updated risks and opportunities, and actions for adressing these

If you take actions like this and update the QMS, your organization will meet the requirements in Clause 10.3. If you don't, the auditor may not detect it at all. Show the auditor few well-designed projects and she/he will be satisfied.

Although the new standard has nothing against project based improvement activities, it does not view them as continual improvement. The organization is free to improve the system in any way it likes to but continual improvement requires repeating events like I explained above.

 

I appreciate your point of view. I supposed the thread was about continual improvement. My explanation of continual improvement is too complicated.
My mistake, sorry.