We now move into the ‘checking’ part of the PDCA cycle where your organisation should identify what needs monitoring and measuring to identify whether your quality management system is meeting all the requirements of interested parties.
Monitoring, measurement, analysis and evaluation
Your organisation should identify what needs monitoring and measuring and identify the relevant methods to collect this data.
Your organisation must monitor your customer’s satisfaction in relation to your products or services and analyse and evaluate data and information relevant to your business and management system operation.
New to this clause, is the requirement that you must effectively monitor the successful implementation of planning and actions to address risks and opportunities within your organisation.
Make sure you understand the speciﬁc requirements for analysis and evaluation when using results as inputs into your management review.
Internal audit requirements are largely similar. Planning for internal audits now has explicit considerations for quality objectives, customer feedback and changes impacting your organisation.
Your top management responsibility for action is now implicit whereas previously this was explicit, although there is a requirement for audit results to be reported to relevant management and for correction and corrective action to be taken without undue delay.
Auditors must be objective and impartial which is relatively unchanged from the previous standard. In fact, with the exception of there being now no requirement for a documented procedure, the internal audit clause remains mostly unchanged.
The potential impact on auditor competence is probably more signiﬁcant. In particular internal auditors should have the demonstrated knowledge and skills to audit Annex SL and the new structure and content in the standard especially if the quality management system does not include a quality manual and very few or even no documented procedures at all.
There are now additional requirements for the management review. Management review outputs have been enhanced to include many of the new areas of focus. These include:
- Changes in external and internal issues (such as strategic direction)
- Performance concerning external providers
- Adequacy of resources for effective quality management system and effectiveness of actions taken addressing risks and opportunities.
The basic requirement to conduct management reviews is much the same as in the existing clause 5.6 in ISO 9001:2008, but it now requires the organisation to take into account the business’ strategic direction and changing business environment.
What are currently labelled as inputs in ISO 9001:2008, are now called ‘considerations’ and whilst similar to the existing inputs, they are more clearly deﬁned and rely heavily on utilising the data generated from monitoring and measuring activities as deﬁned in earlier clauses.
Key change from ISO 9001:2008
Overall, the requirements within this clause remain largely unchanged although some have been enhanced. Monitoring perceptions of customer satisfaction are similar from previous requirements.
This clause has combined monitoring and measuring activities, added to them, made the requirements much more explicit and now requires the organisation to consider what they expect to achieve and how closely they have met those expectations.
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