Working draft
ISO/WD TS 23485.2
Medical Devices — Quality management systems — Guideline for the application of ISO 13485:2016
Reference number
ISO/WD TS 23485.2
ISO/WD TS 23485.2
Edition 1
© ISO 2026
Working 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 developmentStage: Close of comment period [20.60]
-
Edition: 1
-
Technical Committee :ISO/TC 210
- RSS updates
