The management representative is responsible for ensuring the quality system is established and effective and must report on the performance of the quality system to management with executive responsibility.
Basic Requirements
This is typically done through a management review process, which requires management with executive responsibility to be a part of the review. Key metrics from the quality system are presented and the review must be documented including a list of attendees.
The management review must be held at least annually, although many organizations hold it biannually, or even quarterly. Typically the management review would contain a list of attendees (including the management representative and executive management), dates of the review and a statement that states the quality system is suitable and effective and involve signatures from the executive management and the management representative (both should also be listed as attendees).
Typical metrics at the management review would contain analysis of complaints, corrective and preventative actions, nonconformances, change control and other elements of the quality system including Pareto analyses and reviews of the quantities and sources of quality issues as well as metrics on the time that it takes for these processes to come to closure.
When these processes are not being adequately managed, this typically indicates additional resources are needed. A review of the resources should be included as well as a review of the audits that have occurred since the last meeting.
Additional Requirements
In addition, it’s required to cover product specific information, such as the number of units manufactured, process controls, changes in personnel (increases and decreases, turnover rates, etc.) and other factors that can impact product quality.
There should be a review of applicable regulatory requirements for the products and the geographies where they are marketed as well as a review of the customer requirements for each product. Each department will often be asked to prepare slides pertinent to their area. A formal review form or meeting minutes should be captured (it’s best to create an official form), to ensure action items and follow up items from the previous review have been documented and performed. The standard specifically calls for documentation of the inputs reviewed, and any decisions and actions related to the improvements needed to maintain the suitability, adequacy and effectiveness of the quality management system, improvements to product related customer requirements, changes needed to address applicable new or revised regulatory requirements and resource needs.