| Regulatory Requirement | Document Section |
|---|---|
| ISO 13485:2016 Section 5.6 | All |
Summary
This SOP describes how the surveillance of the quality management system shall be conducted to ensure ongoing
adequacy, suitability and efficacy of organizational processes. The organization regularly conducts a
Management Review to document the assessment of QMS surveillance outputs and overall compliance with
regulatory requirements.
| Process Owner | \ |
| Key Performance Indicators | \ |
General Considerations
1.1. Management Review Input
The organization can use varying key performance indicators (KPIs) to measure processes. At minimum, the
following data must be collected as input for the Management Review:
- Status of Measures of Previous Management Reviews\
Input: which measures have been implemented as planned.\
Management shall evaluate the effectiveness and efficacy of previous measures. - Audits Results\
Input: findings and measures from internal audits, audits by authorities and Notified Bodies, supplier
audits conducted by the organization. - Status of Corrective and Preventive Actions (CAPA)\
Input: summary of nonconformities found and respective actions taken. - Status of Feedback Management and Complaint Handling\
Input: summary of feedback and complaints received and actions taken in response. - Status of Risk Management\
Input: summary of actions taken as part of risk management, e.g. risk mitigation, updates of the risk
management report, results from post-market surveillance, etc. - Status of Incident Reporting\
Input: potential incidents that were assessed, incidents that were reported, summary of coordination with
supervisory authorities, actions taken as a result. - Status of Applicable Regulation\
Input: published and/or anticipated updates of relevant regulation, including expected implications for
the QM system. - Changes to the Quality Management System\
Input: implemented and/or anticipated changes that impact the QM system (and which, ideally, are assessed
as part of the Change Evaluation List – for instance, changes to the organizational structure,
infrastructure, processes or customer requirements). - Other Key Performance Indicators (KPIs)\
Typically, every processes should be assigned an indicator that allows the assessment of process
effectiveness, unless there is a valid explanation for why no KPI is reasonably applicable (see ISO
13485:2016, para. 4.1.3). KPI results become management review input.
1.2. Management Review Output
At minimum, the Management Review Report shall provide an assessment of the adequacy, suitability and efficacy
of the QM system to comply with regulatory requirements. Additionally, process impact on product safety shall
be critically reviewed.
As part of this process, the Management also reviews the organization’s quality policy, quality objectives and
the status of key performance indicators (KPIs).
Based on findings during the Management Review, the Management may define further measures such as the
revision of single processes, product changes or the (re-)allocation of resources.
1.3. Review Period
The organization shall conduct a Management Review (at least) once per year. Ideally, the review is conducted
before an external audit (e.g. by a Notified Body) and no sooner than audit reports from internal auditing are
available.
Process Steps
2.1 Setting Up Process Key Performance Indicators
At the beginning of every review period, Management together with the QMO defines key performance indicators
(KPIs) for the QMS processes of the company. The quality objectives are reviewed for continued adequacy.
The results of this process step are communicated to all relevant members of the organization (e.g. process
owners).
| Participants | Management, QMO |
| Input | Quality Policy, Quality Objectives |
| Output | Process KPIs |
2.2 Data Collection and Analysis
Every process owner is responsible to track the KPI of their process during the review period and to keep
records as required by the process.
At the end of a review period, the QMO collects data input from process owners and analyzes the KPI data
against pre-defined criteria in preparation for the Management Review. The QMO may undertake further
investigation to identify nonconformities and to provide a preliminary assessment of the adequacy, suitability
and efficacy of the QM system.
| Participants | QMO, Process Owners |
| Input | KPI records |
| Output | Completed data analysis |
2.3 Management Review Report
Management and QMO together discuss the reported input and completed data analysis. The Management is
responsible to evaluate the results against the pre-defined criteria and formulate an assessment of the
adequacy, suitability and efficacy of the QM system. Where necessary, the Management defines measures for
improvement. The results of the Management Review are documented in the Management Review Report.
Where necessary, the Management sets up new or revised process KPIs as well as quality objectives for the next
review period. This is communicated again to all relevant members of the organization.
| Participants | Management, QMO |
| Input | Completed data analysis |
| Output | Management Review Report, new or revised KPIs and strategic goals, planned measures |
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