All about Management Review in ISO 13485 – Lesson 7

The main goal to conduct a management review is to allow top management from time to time to examine the quality management system. That is done usually not less than once in a year.

Commonly, it’s done through the meetings. Various topics can be covered and Top management will check if there is any need for their improvement and changes or any other complex decision or intervention is needed.

Not to neglect the importance of quality objectives since it’s the main reason for management review.

ISO 13485 always emphasizes that you must document all decisions, records, and outputs according to standard. For easier document management and maintenance, you can create a form for the matter that will consist:

• Discussed issues
• The participants
• The date and the location where the review took place
• Evidence or reference to the evidence
• Results, agendas, and responsibilities for implementation

 

qmsWrapper comes with default processes made based on ISO 13485 requirements, including the “Management review meeting” that will make it easier to record all inputs and decisions.

 

Management Review Input

Accordingly, one of the first things is to compare the current performance with the quality objectives. A list of inputs is meant to be reviewed by top management. Inputs reflect on the aspects of performance, control, consulting, changes, improvements, and risks. ISO 13485 has a minimum list of 12 inputs that Top management needs to review to assess the health of the QMS. It includes feedback, complaint handling, audits, reporting to regulatory, process monitoring and measurement, corrective and preventive actions, follow-ups, any changes, or any other regulatory requirement.

The aim is to all processed inputs assist in a certain way in determining the achievement of planned results. The challenge here is to identify the sources of data, collect them in an orderly manner, and acceptably present them.

 

Management Review Output

The review outputs are meant to assist the efficiency of the QMS and its processes. Outputs can be seen as decisions and actions. They have to be carried out as a reaction to the data that were presented and discussed during the review. In practice, they are related to opportunities for the improvement and/or changes of the QMS.

Bear in mind, all 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. Including that in the next review, you are required to assess the success of those decisions. For example, instead of declaring “we must enhance our customers’ satisfaction” try “we should enhance customers’ satisfaction during installation activities”.

 

 

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