Organisations are required by ISO 9001:2015 to continually improve the suitability, adequacy and effectiveness of their management system.
They must also consider the results of analysis and evaluation and the outputs from management review, to determine if there are requirements or opportunities that need to be addressed as part of continual improvement.
Note that the requirement in this clause is for improvement of the effectiveness of the Management System. In other words, is the management system effectively doing what it is intended to do? EG: Consistently providing products and services that meet customer and applicable statutory and regulatory requirements, and enhancing customer satisfaction?
The reference to suitability and adequacy was new to the 2015 update of ISO 9001: IE: Is the Management System right for the job and if so, is it sufficiently detailed for the task? (If too basic it must be enhanced, if overcomplicated / disproportionate, then it needs to be simplified.)
Organisations must also be able to demonstrate that they are using the results of analysis & evaluation (see article 9.1.3) and management review (see article 9.3,) to identify any needs or opportunities that need to be addressed as part of continual improvement activities.
Note that as we discussed in article 10.1, continual improvement can be achieved by breakthrough projects as well as by small step by step ongoing improvement within existing processes (Kaizen.)
Opportunities to improve may be identified via sources such as:
Examples of Internal process Key Performance Indicators (KPI’s) which may be targeted for improvement might include:
OpEx (Lean) “8 Wastes” which may be targeted for reduction. IE:
As discussed in article 10.1, general requirements should be set by top management. In a typical business, auditors may look to determine if the following key areas have been reviewed and addressed appropriately:
In general, auditors will require evidence that organisations are using the outputs from analysis, evaluation and management review activities to identify improvement opportunities and quality management system underperformance and that appropriate actions have been taken to address any shortcomings.
EG: How data gathered and evaluated and strategic /corporate objectives, have been translated into specific Management System objectives. That subsequent monitoring and analysing of KPI’s is in place, and appropriate and proportionate actions have been implemented as a result.
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David Barker CQP MCQI