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The Changing Nature of Improvement

21 September 2016
Andrew Holt of CQI looks at the fine tuning of improvement that occurred in ISO 9001:2015.
In ISO 9001:2015 clause 10 recognizes that incremental (continuous) improvement is not the only improvement profile. Improvement can also arise as a result of periodic breakthroughs, reactive change or as a result of reorganization. 

Thus, the title of this clause is now “Improvement” (ISO 9001:2008 8.5.1 was “Continual improvement”). 

Also clause 10.1 is a new clause. 

It sets out the headline requirement for the organization actively to seek out and realize improvement opportunities that will better enable the organization to meet customer requirements and enhance their customers’ satisfaction. 

When looking to improve, the organization should be addressing unwanted effects by fixing them, stopping them happening or minimizing them. 

They should also seek to improve their products and services, as well as improving their QMS’ performance. 

The associated note reminds us that improvement can come in different ways: not just on an ongoing basis. 

Sometimes it occurs as a result of fixing a problem as well as corrective action, sometimes through innovation and sometimes as a result of reorganization. 

Vitally, preventive action no longer exists as a concept in ISO 9001:2015 – all references to it have been removed. Instead, it has been replaced by risk-based thinking. 

Moreover, the explicit requirement to improve the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data and corrective actions, and management review that appears in ISO 9001:2008 sub-clause 8.5.1 “Continual improvement” has been removed from ISO 9001:2015. 

Quality professionals should take note of the new requirements. 

The organization should review their products and services, as well as the effectiveness and performance of their QMS as a whole, with the goal of making improvements. 

A new requirement is to address unwanted effects, whatever they are and whatever the cause. The organization can do this by correction, prevention or reduction. 

An important note here is there are no longer any requirements to be fulfilled relating to preventive action (previously ISO 9001:2008 sub-clause 8.5.3). 

As a result, it is no longer necessary to have a documented procedure for preventive action. 
Pay attention to improving products and services not only to meet today’s but also tomorrow’s requirements. 

It is in clause 10.3 that requires the organization to work continually to improve its quality management system in terms of its suitability, adequacy and effectiveness. 

Suitability and adequacy are new. Effectiveness is ‘doing the job it’s meant to do’. 

Suitability means – is it right for the job? Adequacy means – is there too much, too little or is it just right? If there is too much, then it needs to be cut back, too little and it needs to be enhanced. 

As part of continual improvement, the organization is specifically required to use the outputs from analysis and evaluation (sub-clause 9.1.3) and from management review (clause 9.3.3) to determine areas of underperformance and to identify any opportunities for improvement. 

Tools and methodologies should be employed as appropriate by the organization to investigate the cause of underperformance and to support continual improvement. 

The ISO 9001:2008 sub-clause 8.5.1 requirement was prescriptive, but not helpful: improving through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. 

This has been dropped. 

The organization will now need to demonstrate that they are using the outputs from their analysis and evaluation processes to identify areas of underperformance and opportunities for improvement.