| Regulatory Requirement | Document Section |
|---|---|
| ISO 13485:2016 Section 5.6 | Entire Document |
Overview
This SOP outlines the process for conducting surveillance of the quality management system (QMS) to confirm its ongoing appropriateness, effectiveness, and efficiency. Regular Management Reviews are conducted to document evaluations of QMS surveillance results and compliance with regulatory standards.
| Process Owner | \ |
| Key Performance Indicators | \ |
General Considerations
1.1. Inputs for Management Review
The organization uses various key performance indicators (KPIs) to monitor processes. At a minimum, the following data should be included as input for the Management Review:
- Status of Previous Management Review Measures
Input: Implementation status of previous measures.
Management evaluates the effectiveness of these measures. -
Audit Results
Input: Outcomes from internal audits, external audits by authorities and Notified Bodies, and supplier audits conducted by the organization. -
Status of Corrective and Preventive Actions (CAPA)
Input: Overview of nonconformities and actions taken to address them. -
Feedback and Complaint Management Status
Input: Summary of received feedback and complaints, and the corresponding responses. -
Risk Management Status
Input: Overview of actions taken related to risk management, such as risk mitigation, updates to risk reports, and findings from post-market surveillance. -
Incident Reporting Status
Input: Reported and assessed incidents, coordination with regulatory authorities, and follow-up actions taken. -
Compliance with Relevant Regulations
Input: Updates to regulations and their potential impacts on the QMS. -
Changes to the QMS
Input: Implemented or expected changes that affect the QMS, ideally assessed through the Change Evaluation List (e.g., changes in structure, processes, or customer needs). -
Other KPIs
Each process should have an assigned KPI to evaluate its effectiveness unless there is a valid reason for not using one (as outlined in ISO 13485:2016, para. 4.1.3). KPI results are part of the review input.
1.2. Outputs of Management Review
The Management Review Report must include an assessment of the QMS’s adequacy, suitability, and effectiveness in meeting regulatory requirements. Additionally, it should address the impact of processes on product safety.
The Management also reviews the organization’s quality policy, quality objectives, and KPI status. Based on the review’s findings, Management may decide on actions such as revising specific processes, implementing product changes, or reallocating resources.
1.3. Review Frequency
A Management Review must be conducted at least once per year. Ideally, it should take place before an external audit (e.g., by a Notified Body) and only after the results of internal audits are available.
Process Steps
2.1 Establishing Process KPIs
At the start of each review period, Management and the QMO define KPIs for the company’s QMS processes. Quality objectives are also assessed for continued relevance.
The results are shared with relevant personnel (e.g., process owners).
| Participants | Management, QMO |
| Input | Quality Policy, Quality Objectives |
| Output | Established Process KPIs |
2.2 Data Collection and Analysis
Process owners are responsible for tracking their process KPIs throughout the review period and maintaining records as needed.
At the end of the review period, the QMO compiles data from process owners and analyzes it according to predefined criteria to prepare for the Management Review. The QMO may perform further analysis to identify nonconformities and provide an initial evaluation of the QMS’s adequacy, suitability, and effectiveness.
| Participants | QMO, Process Owners |
| Input | KPI records |
| Output | Completed data analysis |
2.3 Preparation of the Management Review Report
Management and the QMO discuss the collected input and data analysis. Management evaluates the results against the predefined criteria and formulates an assessment of the QMS’s adequacy, suitability, and effectiveness. If needed, new improvement measures are defined. The findings are documented in the Management Review Report.
If necessary, Management sets up new or revised process KPIs and quality objectives for the upcoming review period. These updates are communicated to relevant members of the organization.
| Participants | Management, QMO |
| Input | Completed data analysis |
| Output | Management Review Report, new or revised KPIs and quality objectives, planned measures |