Organisations are required by ISO 9001:2015 to analyse and evaluate appropriate data and information arising from monitoring and measurement activities.
The results of the analysis must be used to evaluate the following:
It is also noted that methods used for the analyse of data could include statistical techniques.
Note the explicit requirements relating to how the data must be used. EG: If planning and actions taken to address risks and opportunities have been effectively implemented.
Note also there is a requirement to demonstrate evaluation as well as analysis. IE: Interpretation (and of course use) of the data analysed. We can also see that these requirements apply to data acquired both internally and externally. EG:
Note that now services also, not just products, are specifically referred to.
Statistical techniques are specifically referenced, but sophisticated techniques such as Statistical Process Control (SPC) are not mandated. Trend or Pareto analysis may be the most appropriate tools for many metrics to monitor progress and identify opportunities for further improvement. Internal audits is also useful of course, when gathering data on the effectiveness of the management system.
Analysis and Evaluation
Many organisations collect data but fail to follow the process through to conclusion with adequate analysis and evaluation to draw meaningful conclusions and appropriate action plans to address unfavourable results and trends, or to seize opportunities for improvement. Benchmarking (industry or competitor), is a useful tool to put results into perspective in order to determine if corrective action or improvement plans are required.
Management Review (See article 9.3) is the minimum requirement as far as the standard is concerned for reporting and acting on analysis and evaluation of key data. Whilst appropriate for strategic level process decisions, this forum may be too infrequent in many instances for appropriate and timely action to be taken on operational level information and data however. Many organisations carry out short but frequent and regular formal reviews of operational level metrics and implement the resultant action plans to great effect.
Auditors are being advised to ensure that organisations have used appropriate analysis and evaluation of data to ensure that effective use is made of the data. (Although there is no specific requirement that analysis and evaluation to be documented, the resultant output is a specified input into management reviews.)
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David Barker CQP MCQI