E.g. new sites, new management persons, new products and production machines should be mentioned because major changes were often planned in the last year (previous management report) or they are planned and budget is assigned for the next year (next management report).

Management review – general points

• Main achievements / changes of the year (sales & markets, innovations, products, infrastructure, personnel, risks)
• Decisions, initiatives, plans
• Quality objectives à KPIs

As in bookkeeping, types of costs are assigned specific accounts, content and group of process and product indicators (key performance indicators = KPIs) should be defined such that they remain stable over several years and trends become visible. The definition of KPIs should be generally useful for the company or the safety of the product and ideally correspond to the quality objectives. An example for a key performance indicator for a process could be the discarded components. A typical KPI for products (or service) could be the complaint rate. Generally, KPI and quality objectives have to be clearly defined such that be become measurable and countable.

The formal requirements for the management report for ISO 13485 and 9001 are similar. The focus here is on ISO 13485, where the requirements are generally higher, more formal and more specific to medical devices, but the concept is identical. Both standards differ in inputs and outputs. The input and outputs refer to the product (service) and the user, the processes and the planning of resources or actions due to defaults, inspections, growth, or changes in the environment.   

Management review – inputs (KPI)

• (market-) feedback
• (product / service) complaints
• reporting to regulatory authorities
• (internal/external) audits
• monitoring and measurement of processes
• monitoring and measurement of products
• corrective action
• preventive action
• follow up actions from previous management review
• changes that could affect the quality management system
• recommendations for improvement
• applicable new or revised regulatory requirements

Once the inputs are identified and summarized, it is recommended to discuss and agree on the interpretation of the results and to identify the next steps in the team. Did the internal audit identify process improvements? Is the quality management system effective and understandable for every one? Do complaints show trends and products or productions processes needs to improved? Does the company enter new markets with additional requirements? Does the company need additional space and machines?

The conclusions from these questions should be summarized in the management report output. Objectives and plans are evaluated in the management report of the following year.

Management review – outputs

• improvement to maintain effective QMS
• improvement of product (or services)
• changes due to regulatory requirements
• resource needs

The management review is a useful exercise done once a year, which helps to collect essential information and to lead the team.

Written by Dr. Thomas Hug, December 2023