How to Perform an ISO 13485 Management Review Within the Organization?

The ISO 13485 standard addresses the management review procedure in requirement 5.6. It entails assessing the applicability and efficacy of the quality management system, finding areas for development, and adjusting the system as necessary. Encouraging QMS improvement and preserving standard compliance depend heavily on the ISO 13485 management review procedure.

The goal of the ISO 13485 management review is to find areas for improvement while assessing the applicability and efficacy of an organization’s quality management system. In this phase, required inputs including audits, regulatory reporting, and customer feedback are reviewed, and the Quality Management System is adjusted as necessary. Organizations can use the supplied data to drive QMS improvement and increase customer satisfaction by appropriately completing an ISO 13485 management review.

A planned interval management review is necessary to guarantee the continued acceptability, sufficiency, and efficacy of a QMS built on ISO 13485. It must also comprise an evaluation of the QMS’s potential for modification and enhancement. Lastly, as proof of compliance, ISO 13485 documents of the management review must be preserved. So here are some of the ISO 13485 management review inputs:

Feedback and compliance management: This is typically a review of data and metrics that are closely tied to product performance, customer experience (e.g., metrics related to customer complaints, customer survey results), and ongoing, product-specific continuous improvement initiatives.

Reporting to regulatory authorities: The organization must examine both the reasons for reporting and the ISO 13485 procedure it uses to submit information to the regulatory bodies.

Audits: Does the management representative of the company go over the ISO 13485 audit reports and make sure they are incorporated into the annual audit plan? If so, a member of management is in charge of examining the audit findings and how they enhance the management system. If the audit reports contain the review data, they are records of the management review as well as the audits.

Monitoring and measurement of processes: Does your organization maintain metrics for its primary processes, also known as key performance indicators (KPIs), which are used to assess how adequate the procedures are? Management review is occurring if these KPIs are set up, examined by upper management, and utilized to decide how best to allocate resources for process enhancements.

Corrective and preventive action: Every corrective action does not need to be reviewed by the upper management. Instead, they should be aware of the patterns in nonconformity incidents and the efficacy of the actions done to specify improvements.

Follow-up from previous management review: If the previously listed steps are followed up on to make sure they were carried out, these criteria are fulfilled. To make sure of this, it is best to go over the minutes of the most recent ISO 13485 management review meeting. Making sure that the records reflect this follow-up examination is crucial.

Changes that could affect the QMS: The company must monitor external factors, such as the latest ISO 13485 standard version, that may have an impact on the system. Reviews of internal data will also cover modifications made within the company, like audits or suggestions for enhancement.

Recommendations for improvement: As mentioned above, some suggestions for enhancement, like those from the internal audit, can be handled as part of that system. Additional suggestions, such as those gleaned from an employee suggestion system, are often documented in a verifiable log.

Applicable new or revised regulatory requirements: Regulation changes that may affect the QMS and/or the business must be communicated to the higher levels of management.


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