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Module 1 of 5 · ISO 13485 · Clause 4

Quality management system

Clause 4 lays the groundwork: what processes the system has, how they are documented, and how software involved in product quality gets validated.

Content reviewed on

Management system processes

Identify the QMS processes, their sequence and interaction, and the criteria to ensure they operate effectively, including outsourced processes.

Documentation requirements

A quality manual, documented procedures and a device master record for each type of medical device, with a complete change history.

Software validation for the system

When software is used in the QMS or in product monitoring, it must be validated before first use, following a risk-based approach.

What an auditor usually asks for

  • A QMS process map with sequence and interaction
  • An up-to-date quality manual and documented procedures
  • A device master record for each product family
  • A validation record for software used in the system

How to cover the management system in Kimobox

  1. 1Draw the QMS process map with Kimobox's process editor.
  2. 2Manage the device master record with document control and versions.
  3. 3Log software validation for the system as just another controlled document.

The device master record stays linked to its processes and its change history, no parallel folders.

See how the process map works in Kimobox

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

  1. ISO 13485:2016 — Medical devices. Quality management systems ISO · March 2016
  2. Regulation (EU) 2017/745 on medical devices EUR-Lex · 5 April 2017
  3. ISO 14971:2019 — Application of risk management to medical devices ISO · 2019 ed.
Next → Management responsibility