British Standards Institution

Source:: ISO
Committee:: CH/210/1 - Quality systems for medical devices
Categories:: Information management | Standardization. General rules
Comment period start date:: 16/10/2024
Comment period end date:: 22/12/2024

Comment by:

22nd Dec

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

Required form fields are indicated by an asterisk (*) character.

How important do you think standardization is in this area? *

Do you agree that a standard on this subject is feasible?: *

Please give reasons for your selections above: *

Would you or your organization use the standard? *

Would you or your organization be prepared to participate in the development of the standard or to comment on the draft when it is available? *

Are you aware of any regulation, existing standards and other good practice information in this area in the UK (e.g. Industry codes of practice; company specifications, international or European Standards)? *

Would the development of a standard(s) in this area have a particular impact/relevance to SME, consumer, environmental or societal interests? *

Are you aware of any other organizations to which this proposal may be relevant? If so please provide details below. *

Additional comments on the scope or proposal:

Although BSI will not usually enter into correspondence regarding individual comments or suggestions we may wish to contact you to seek further clarification. Please indicate whether this will be acceptable: *

Discard

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

Scope

Purpose

Comment on proposal

Discard changes?

Submit comment

Submit comment

Follow standard

Unfollow standard

Error