Management Review Output in ISO 13485
The purpose of the review output is to document top management’s estimation of the quality management system regarding the efficiency of processes and the achievement of the quality objectives.
With review output, top management will demonstrate their satisfaction or dissatisfaction with the quality management system and its determination or expectations for the initiation of improvements, corrections, or changes.
Top management’s opinion of the quality management system is basically review output, expressed through decisions, both strategic and operative.
The review outputs of the management review process are decisions. The decisions are to be documented and communicated to all relevant parties in the medical device company:
- For the purpose of performing, executing, and controlling tasks and assignments
- For the purpose of information within the organization
A decision such as the management is satisfied with the current situation of the production and chooses to take no further action, is a legitimate decision that will be respected by all auditors. But it will need to be documented and justified with evidence that the results were satisfying.
In order to verify decisions accomplishment, decisions will be followed. Each operative decision will be described with the following:
- The decisions can be categorized according to the review issues: improvement on processes or products, preventive actions or changes or other issues mentioned during the review
- The description and content of the decision
- The implications of the decision for the quality management system will be evaluated: which system elements, processes, objects, and products are involved or will be influenced by the decision
- Objectives will be set in order to examine the effectiveness of the decision or action
- The required resources for the accomplishment will be addressed
- The relevant party in the organization that will be responsible for carrying out the decision will be submitted
- The decision will include the reference to the appropriate documentation in the QMS – if applicable
- Target dates will be scheduled in order to frame it
If a decision related to training of production employees was taken, the relevant functions or roles will be informed about the decision, and its objectives and target dates. In the next management review, the decisions will be followed up regarding performance and results.
Effectiveness of Processes
The review outputs are meant to assist the efficiency of the QMS and its processes. When suggestions are made, such as corrective actions, improvements, or a process change, their impact on the quality management system and the process will be evaluated.
Quality policy and objectives
When the quality objectives are added, updated or changed, relevant documents of the quality management system are updated:
- Quantitative change – the relevant objective control will be updated
- Strategic change – update of the quality policy will be considered
Customers and regulatory requirements
The decisions of the output review will increase the competence of the medical devices and promote the ability of the manufacturer to meet requirements, regulations and customers’.
The decision is oriented to the following matter safety, functionality, intended use, and performance of the medical device, for example:
- The short-term corrective action – annex was added to the user manual
- Top management decided in the review – a new and revised user manual will be designed, produced and distributed to all customers or distributors
Allocation of resources
Necessary resources to obtain the improvements or changes in processes, products and the achievement of quality objectives should be mentioned. Top management is obligated to distribute the required resources, but the numbers don’t have to be included in the review.
Another matter that should be considered is the distribution of resources needed to implement, perform, and complete effective Risk Management processes.
Standard ISO 14971 for risk management of medical devices, that ISO 13485:2016 refers to as guidance, requires management review as well, where the organization needs to discuss the policy regarding Risk Management and apportionment of suitable resources.
Documentation, approval, and distribution
The review outputs are intended to be documented. The documentation can appear on the designed form, meeting summary or special report, it depends on the organization, and how they decided to leave the trace. Form, designed for use, has to be submitted to the document control process. The outputs of the review are intended to be approved by top management. The approval may occur as a signature on the form or statement. The records of the review should be submitted to the process of records control, as required in the subclause of standard in Control of records.