ISO13485: The Importance of Management Review: ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the Quality Management System (QMS).
Section 5 of the standard requires management involvement and responsibility for the effectiveness of the QMS. Some consider this section’s mandate to be the most critical and important as it is the mechanism whereby those with strategic policy and financial decision-making authority come face to face, for better or worse, with the current state of their QMS.
The management review meeting represents the forum where process objectives, metrics and goals are reviewed and assessed. Couple that activity with section 5.4.2 of the standard that requires the QMS be continually improved. Fail to correct QMS deficiencies effectively and risk losing the ISO certification and, perhaps, the business opportunities that were a factor in the decision to pursue certification in the first place.
Suffice to say, management review requirements are serious business and must be conducted in earnest and without any superficiality. Correction of deficiencies must be tracked, monitored and documented. The frequency in which management reviews are conducted is an internal decision, however it is not uncommon for companies to conduct them quarterly or minimally semi-annually.
Let’s zero in on the factors and components that comprise an effective management review meeting:
For ISO auditing purposes and in addition to electronic copies, it is common to store all of the above in a Management Review binder. The binder serves as proof that management review meetings are being conducted and also creates a paper trail should an auditor wish to drill deeper into any particular component.
May 13, 2013
As discussed in part one and part two of this series, ISO13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the...
May 13, 2013
If you are like the majority of those who have worked in the biotechnology and pharmaceutical industry for at least the last five years, your company has been part of a merger, acquisition or some...