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Tips To Improve Your QMS

24 November 2015
Dr Margaret Rooney explains how to meet the new Improvement requirements of ISO 9001:2015 and what happened to Preventive Action.


I never had a policy: I have just tried to do my best each and every day. – Abraham Lincoln

I have the simplest tastes. I am always satisfied with the best. – Oscar Wilde


Improvement – we all know what it is and what it means. However, how can we demonstrate it?

Moreover, how do we audit it?

The 2015 version of the international standard for Business Quality Management has three key requirements in clause 10 Improvement:

  • A general requirement to be proactive in seeking opportunities for improvement

  • To learn from non-conformity and deploy root cause analysis to achieve effective corrective action

  • To continually improve.

Proactive Improvement

Proactive improvement includes enhancing customer satisfaction, and a note in the standard reminds us that examples of improvement could include, “…breakthrough change, innovation and reorganisation.” Vocabulary such as “enhance, breakthrough, and innovation”, is not something we have hitherto associated with ISO 9001 and the certification process. This marks a gear change in the world of quality systems and their certification.

Root Cause Analysis

Root cause analysis, (which is inferred in clause 10.2, although this terminology is not used), is a critical and efficient approach, (if done properly). Although it does suggest a more passive approach to improvement – it supports businesses in identifying what went wrong and doing something to ensure that similar problems do not occur again.

Continual Improvement

Continual improvement could perhaps be construed as a halfway house between breakthrough and passive change – continual improvement of the system itself, based on analysis and evaluation of data and information relevant to the management system.

Interestingly, it is in the more passive section of the clause 10, (10.2 Nonconformity and corrective action), that there is a prescribed requirement for documented information as evidence of improvement – in effect, records.
So, what evidence might your assessor look for in the Clause 10 requirement? Here are some suggestions:
Passive improvement

  • Trends in data
  • Evaluation of trends
  • Root cause analysis of trends – keep asking why until the root cause is clear
  • Corrective action following root cause analysis
  • Effectiveness of the corrective action – did it work?
  • General discussion around implementation of improvements following non-conformance identification.

Proactive or breakthrough improvement

  • Brainstorming
  • SWOT or PEST analysis to identify:
    • Future expectations
    • Breakthrough change
    • Strategy change
    • Interested parties views.
  • Implementation plans and progress
  • General discussion around implementation of improvements following decision to implement breakthrough or strategic improvements.

Preventive action is dead – long live preventive action!
ISO 9001:2015, as a direct consequence of the requirements of Annex SL, has no prescriptive requirements for documented procedures. In relation to improvement, it is noteworthy that the 2008 explicit requirement for a documented procedure for preventive action is no longer in place. The removal of this tautology is to be welcomed.

Implementation of a management system is a preventive action. Risk-based thinking is a preventive tool, as is root cause analysis, (as required by the 2015 Improvement clause). Prevention is the ISO 9001 standard’s raison d’etre – so preventive action lives on.

Dr Margaret Rooney, November 23, 2015.