ISO 9001:2015 specifically requires the adoption by the organisation, of a process approach when developing, implementing, and improving the effectiveness of its management system.
There are several additional references throughout the standard to emphasise the point that improved performance (quality) is more likely when activities are understood and managed as interrelated processes.
Specifically, the organisation is required to:
Organisations are required to maintain and retain documented information to support the operation of its processes and to have confidence that the processes are being carried out as planned.
“Documented information” may include operational procedures and associated work instructions for example. The use of process diagrams/ flow charts or turtle diagrams can be used to great effect to map and improve processes.IE verify the interrelation of sub-process inputs and outputs and that monitoring and measuring in place is appropriate and effective. They can also then be used to document the process in the management system if required – much easier to follow when imparting organisational knowledge (See later article 7.1.6) during induction or training for example, rather than wordy process instructions.
Given the explicit emphasis placed on the process approach within the standard, we can expect auditors to specifically challenge organisations to demonstrate that they have considered and acted on the interaction of processes. Organisation will also need to retain documented evidence (records) that shows processes are performing in line with requirements. (IE: Key Performance Indicators to monitor the process in line with targets and expected process Inputs & Outputs can be demonstrated.)
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David Barker CQP MCQI