Approved Work Item
ISO/AWI TS 23485
Medical Devices — Quality management systems — Guideline for the application of ISO 13485:2016
Reference number
ISO/AWI TS 23485
Edition 1
© ISO 2025
Approved Work Item
Under development
A working group has prepared a draft.

Abstract

This document provides guidance on the intent of the requirements in ISO 13485:2016, with examples of possible steps an organization can take to meet the requirements. It does not add to, subtract from, or in any way modify those requirements. The document does not prescribe mandatory approaches to implementation or provide any preferred method of interpretation.

General information

  • Status
     : Under development
    Stage
    : New project registered in TC/SC work programme [20.00]
  • Edition
     : 1
  • Technical Committee :
    ISO/TC 210
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
4
Quality Education
9
Industry, Innovation and Infrastructure
10
Reduced Inequalities
12
Responsible Consumption and Production
16
Peace, Justice and Strong Institutions

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