Management Review Input in ISO 13485

Management Review-Input in ISO13485

The management review is the key to check and estimate issues through the use of certain documents and information. The basis is clear, the management representative is intended to compare the performance with the objective and as a result.

It will show if and how the medical device company followed its defined processes. The list of inputs represents the quality management system and includes aspects of control, consulting, and taking decisions.

Medical device companies should be identified as the source of data and the responsible parties that are intended to provide the data, collect it in order, and present it. The information and data are intended to be presented as documented evidence to support top management in examine and considering decisions.

Result of Audits

Audit results will show how the organization’s activities and processes match to planned arrangements. It will show if they are successfully implemented and maintained.  This includes results from internal, external, supplier actions, and recommendations for improvements.

Customer feedback

Customer feedback results will be shows to top management. That will allow them to evaluate if customer requirements are met. Gotten information supposed to relate to different issues and aspects such as customer requirements and contract information, aspects of products, regulatory compliance, etc.  It may include passive feedback data that was received in the organization like customer complaints. But, also active feedback that the organization started such as customer feedback analysis of data collected through service activities.

Process performance and product conformance

Evidence that demonstrates the ability of realization processes to achieve planned results and the conformity of products to the acceptance criteria will be presented. Data from statistical analyses of product features and process performances will be included in the information. The process and product in comparison with the criteria should be allowed to top management to evaluate.

Status of Corrective and preventive actions

In the medical device, the company will be discussed the status of actions that will be taken to reduce the causes of potential nonconformities or nonconformities. Initiated through the organization, the corrective and preventive action will be analyzed.

Follow-up actions from previous management reviews

Decisions will be discussed for actions determined in previous reviews. The review will investigate whether they were implemented and applied, whether the actions were effective, and if they achieved their objectives.

Changes affecting the QMS

Changes that will be implemented in the quality management system that might affect it or the medical device is intended to be reviewed for their effectiveness and suitability to the QMS. The following are considered as a change:

·         Organizational changes

·         Changes in work procedures

·         Changes in the production installation

·         Changes in customer specifications

·         Changes concerning human resources

Improvements

Improvements that were initiated and implemented in the QMS and may affect the medical device will be reviewed. Top management must review the implementation and effectiveness of improvements in the organization. Improvements may occur as:

·         Decisions of previous reviews

·         Changes in processes for better efficiency

·         Improvements recommended by audits

Regulatory requirements

Top management will review changes in current applicable regulatory requirements and the demand for the implementation of new or revised regulatory requirements. The review shall relate to all activities of the manufacturer. By two parameters, the review is led:  

  • The location where the medical device is marketed
  • The location where the medical device is developed 

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