Management Review - What’s changed in ISO 9001:201
This article particularly highlights the changes in the requirements for management review between ISO 9001:2008 and ISO 9001:2015 including how management review now links to the strategic objectives of an organization.
All in the review
When it comes to management review in ISO 9001:2015, this sits under sub-clause 9.3.1 which requires reviews of the quality management system to be undertaken by top management. These reviews are required to occur at planned intervals in order to ensure the quality management system’s continuing suitability, adequacy and effectiveness.
This, it should be noted, is essentially unchanged from the ISO 9001:2008 sub-clause 5.6.1.
ISO 9001:2015 requires management reviews to also consider the degree of alignment between the quality management system and the strategic direction of the organization.
Sub-clause 9.3.2 details the items that top management must, as a minimum, consider during a management review.
This has seen significant change. Previously, the requirement was simply for information on a list of items. This list has been modified and expanded.
There are 3 core requirements for the management review:
1. To revisit the status of any actions identified at previous reviews.
2. To consider any changes in the organization’s context.
3. To establish the performance and effectiveness of the Quality Management System.
In addition, sub-clause 9.3.2 c) requires information on trends in a list of items.
Here, specific reference is made to the need for trends relating to nonconformities and corrective action, monitoring and measurement results, audit results, customer satisfaction as well as relevant interested parties’ feedback, process performance, conformity of products and services, external providers’ performance and how well the quality objectives are being achieved.
Finally management reviews must consider information on opportunities for improvement, the adequacy of resources and if the actions to address risks and opportunities have been effective.
This sub-clause supersedes ISO 9008:2008 sub-clause 5.6.2 “Review input”.
While the overall purpose of management reviews remains unchanged, there are now new “strategic” items relating to context, risk and opportunities to be included on the agenda.
In addition, there is a requirement that “trends” be used to monitor specific elements of QMS performance and effectiveness.
This contrasts with ISO 9001:2008, where the requirement is simply to “include information” on these items. The implication for an organization is a more comprehensive review process.
It should be noted that a lot of the information listed will already be available in some organizations, but may not have been addressed under ‘quality management’ in the past.
Sub-clause 9.3.3 sets out specific requirements in respect of the outputs from management reviews.
The organization must retain documented information to provide evidence of the results of management reviews.
Quality professionals should note that this sub-clause supersedes ISO 9001:2008 sub-clause 5.6.3 “Review output”.
The requirements of both sub-clauses are, essentially the same. However, there is no longer an explicit need to address improvement of product related to customer requirements.
The organization is now, however, required to retain documented information as evidence of the results of the management reviews, rather than records of management review as stated in 9001:2008.