General Requirements

It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality system at defined intervals and with sufficient frequency. This is to ensure that the quality system satisfies all applicable requirements of Medical devices, which are mainly related to where the device is sold.

In this post, we discuss about one of the key process in the Quality System according to ISO 13485:2016 and 21 CFR 820 : the Management Review. Basically, it is a moment where the quality system of the company is fully reviewed in presence of the top management.

The dates and results of the management reviews must be documented and the procedure shall include these documentation requirements.

The Procedure

The procedure shall also contain the following requirements:

  • fixed agenda of topics to be discussed
  • the necessary attendees who are to participate in the review meeting
  • the interconnection between actions resulting from the management review and the Measurement, Analysis and Improvement process
  • The necessity to review quality policy and quality objectives.

Inputs

Firstly, the input are well defined by the ISO 13485:2016 and includes:

  • feedback complaint handling;
  • reporting to regulatory authorities;
  • audits;
  • monitoring and measurement of processes;
  • monitoring and measurement of product;
  • corrective actions;
  • preventive action;
  • follow-up actions from previous management reviews;
  • changes that could affect the quality management system;
  • recommendations for improvement;
  • applicable new or revised regulatory requirements (for example : here).
  • The review of risk management process.

Outputs

Secondly, the output are the following:

  • improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management system and its processes;
  • improvement of product related to customer requirements;
  • changes needed to respond to applicable new or revised regulatory requirements;
  • resource needs.

Management Responsibilities

There are different responsibilities which stay under the top management:

  • Establish a Quality Policy and a Quality Objectives
  • Establish and maintain organisational structure
  • Establish appropriare responsibilities and authorities
  • Provide adequate resources
  • Appoint a management representative
  • Conduct Management reviews
  • Establish a Quality Plan
  • Establish Quality System Procedure.

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