OpenRegulatory Template

Regulatory Requirement Document Section
ISO 13485:2016 Section 5.6 All


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 <enter role of process owner>
Key Performance Indicators <enter KPIs to be tracked for the Management Review>

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:

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 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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