British Standards Institution

Source:: ISO
Committee:: CH/210/1 - Quality management systems for medical devices
Categories:: Information management | Standardization. General rules

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.

Purpose

User survey results identified the need for additional guidance on specific requirements and usage of ISO 13485:2016.

Comment on proposal

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

16/10/2024

Proposal end date:

22/12/2024

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

ISO/NP TS 25502 Medical Devices — Quality management systems — Guideline for the application of ISO 13485:2016

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