1.1. Management Review Input

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 organiza-
tional processes. The organization regularly conducts a Management Review to
document the assessment of QMS surveillance outputs and overall compliance
with regulatory requirements.
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 mea-
sures.
• 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
result.
• Status of Applicable Regulation
Input: published and/or anticipated updates of relevant regulation, includ-
ing 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
1
List - for instance, changes to the organizational structure, infrastructure,
processes or customer requirements).
• Other Key Performance Indicators (KPIs)
While not every process of the QM system requires a KPI, most processes
should be assigned an indicator that allows the assessment of process effec-
tiveness, unless there is a valid explanation for why no KPI is reasonably
applicable.
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 previous strategic goals. It defines
new strategic goals for the next review period.
NOTE: this refers to the section of your quality manual where you
describe your organization’s process of managing company / team
objectives.
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 Definition of Strategic Goals and Process KPIs
At the beginning of every review period, Management together with the QMO
defines key performance indicators (KPIs) for QMS processes as well as strategic
goals for the company. The strategic goals are based on the organization’s quality
objectives as defined in the quality manual. 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 Strategic Goals, Process KPIs
2
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.
Finally, the Management sets strategic goals and, where necessary, new or revised
process KPIs 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

1.1. Management Review Input

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Regulatory Requirement Document Section

ISO 13485:2016 Section 5.6 All

1.2. Management Review Output

1.3. Review Period

Participants Management, QMO

Participants QMO, Process Owners

2.3 Management Review Report

Participants Management, QMO

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