ISO/NP TS 25502

Medical Devices — Quality management systems — Guideline for the application of ISO 13485:2016

General information

Current stage: 10.20 Effective date: 11 tet 2024

Originator: ISO

Owner: ISO/TC 210

Type: Technical Specification

Scope

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.

Life cycle

NOW

IN_DEVELOPMENT
ISO/NP TS 25502
10.20 New project ballot initiated
11 tet 2024

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