ISO 13485 Management Review [ISO 13485 Cl 5.6.1]
ISO 13485 is the standard for quality management systems in the medical device industry, encompassing detailed requirements for management reviews. These reviews are crucial for verifying the continuous suitability, adequacy, and effectiveness of the quality management system. The following is a summary of the requirements for management reviews as per ISO 13485:2016
The purpose of management reviews under ISO 13485 is to assess the performance of the quality management system, ensuring it meets regulatory and customer requirements and identifies opportunities for improvement.
Inputs for Management Review
The input to management review shall include, but is not limited to, information arising from:
- Customer Feedback
- Complaint handling
- Reporting to regulatory authorities
- Internal audits
- Monitoring and measurement of processes
- Monitoring and measurement of the product
- Corrective action
- Preventive action
- Follow-up actions from previous management reviews
- Changes that could affect the quality management system
- Recommendations for improvement
- Applicable new or revised regulatory requirements.
Output for Management Review
- Improvement is needed to maintain the suitability, adequacy, and effectiveness of the quality
management system and its processes - Improvement of product related to customer requirements
- Changes needed to respond to applicable new or revised regulatory requirements
- Resource needs.
Minutes of Management Review
The results of the management reviews must be documented each time. This documentation should include the review meeting minutes, a summary of the discussions, decisions made, and action items identified. The documentation serves as evidence of strong implementation and a record for future reference and audits.
Benefits OF Management Review Meetings
Conducting regular management reviews helps organizations:
- Ensure compliance with regulatory and customer requirements
- Identify and address issues proactively
- Continually improve the QMS
- Align the quality objectives with the strategic goals of the organization
- Demonstrate commitment to quality to stakeholders
By following these guidelines, organizations can uphold a strict quality management system that ensures the consistent provision of high-quality medical devices.
Frequently Asked Questions
An organization should conduct how many management reviews?
According to ISO 13485, an organization should conduct management review meetings at planned intervals, but the standard does not specify an exact number. It states, that management review meetings should be conducted at planned intervals to ensure the quality management system’s continuing suitability, adequacy, and effectiveness.
The frequency of MRM can depend on the organization’s size, complexity, and the specifics of its operations, but they are typically conducted at least once a year. The procedure must define the frequency in the procedure.
