Preparing for ISO 9001:2015 Using Your 2008 QMS – Part 4: Management Review
A cornerstone of the transition process from ISO 9001:2008 to the ISO 9001:2015 requirements is the activity associated with an organisation’s “Management Review” of their Quality Management System.
It’s All About The Basics
If we consider Management Review as defined by ISO 9001:2008 as a process, despite not being referred to as such, we can see there are inputs, activities and outputs:
Management review – 5.6.1 General
“This review shall include assessing…the need for changes to the quality management system…”
Review input 5.6.2
“The input to management review shall include information on
- f) changes that could affect the quality management system”
Review output 5.6.3
“The output of from the management review shall include any decisions and actions relating to
- a) Improvement of the effectiveness of the quality management system and its processes…
- c) Resource needs”
In some manner, the organisation will discover that the ISO standard has changed (hopefully through an updating service or similar) and will be able to perform some type of “side by side” analysis of the changes. If we consider the current draft or “DIS” version available today, there’s such an analysis available from ISO, here:
From this type of information and perhaps a more detailed analysis done by the organization, an activity plan to incorporate the new, additional requirements into the QMS can be drawn up. The information, analysis and draft plan can be considered to be the input to the Management Review Process.
It follows that some activities are going to be needed based on a full understanding of the current implementation status of the Quality Management System and also the “deltas” created by the 2015 release. A list of changes may be discussed; for example the removal of the Quality Manual requirement, and the change to “documented information”.
The Review might consider whether the existing documents such as the Quality Manual and documented procedures are of importance to the organisation, its workers, customers and even regulatory bodies. Further still the proposed removal of the defined role of “Management Representative” will possibly cause a greater sharing of responsibility for various aspects of the implementation and maintenance of the QMS.
These review activities should result in a tangible output: “decisions and actions” as well as improvements to the QMS and resource needs.
Clearly then, it may be a management decision to plan a major re-write of the Quality Manual, to remove the heavily clause-based layout since it is difficult to “navigate”, is rarely referenced and isn’t worth simply re-aligning with the new “Annex SL” layout of the standard.
Similarly, the existing documented procedures will be maintained but in a simpler format, since these represent a good reference base for communicating to new employees. A resource will be assigned to work on the documentary changes and a budget will be allocated to provide some external expertise from a consultant.
If we consider that the “Plan, Do, Check, Act” Cycle has 4 phases and that the transition period is 3 years from the release date of ISO 9001:2015, if an organisation has selected their Management Review to be held annually, it can be seen that an alternate frequency will be needed to remain in control of the changes needed to be ready for a Certification Audit. Similarly, the program for the Internal Audits may have to change significantly, which will be the subject of the next edition in the NQA, USA Newsletter.
Author: Andy Nichols