Templates ISO 13485 Templates

Updated December 2, 2022

Template: SOP Update of Regulations

Sven Piechottka

Template Download

This is a free template, provided by OpenRegulatory.

You can download it as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don't remove the copyright at the bottom).

Tired of copy-pasting? If you want to save time and edit these templates directly, you can use Formwork, our eQMS software. And if you're looking for step-by-step instructions for filling them out, check out our Wizard :)

This Template Has Been Audited!

This template or a slightly changed version of it has gone through the following audits successfully:

Berlin Competent Authority (LaGeSo), 06/2022

Don't Miss Updates to This Template

Subscribe to our newsletter and we'll keep you posted on which templates we've changed.

Questions? Still Lost in Regulation?

Good news! Our goal is to provide lots of stuff for free, but we also offer consulting if you need a more hands-on approach. We get stuff done really fast. Have a look!

Related Records

The following templates are records of this template. That means that this document mentions them somewhere and you need to fill them out to actually implement whatever this document proposes.

Template preview

Berlin Competent Authority (LaGeSo), 06/2022

Regulatory Requirement Document Section
ISO 13485:2016 Sections 5.6.2 and 7.3.3 All

Summary

This SOP describes how the organization identifies changes to regulation applicable either to the organization as a manufacturer or its products in the market. This process shall ensure that changes are identified early enough and required changes are implemented in a timely manner so that regulatory compliance is guaranteed at all times.

Process Steps

1. Regulatory Input / Review

The QMO is responsible to gather all available regulatory information that is potentially relevant for the organization and its medical device(s) based on respective documentation provided by the Product Manager(s). Input may entail statutory laws, regulations and guidance documents. The QMO analyzes the applicability of relevant regulations and documents his assessment in a List of Applicable Regulations.

Relevant input channels may include, but are not limited to:

Every relevant regulation is reviewed at least once per year, every time before a new medical device is placed on the market or as specified by the List of Applicable Regulations.

   
Participants QMO
Input Medical device specification (technical documentation), Available regulatory requirements
Output List of regulatory requirements

2. Actions Based on Applicable Regulation

If a new or revised applicable regulation is brought to their attention, the QMO updates the List of Applicable Regulations. Where necessary, updates to medical devices are implemented according to the change management process. Where updates to the organization’s quality management system processes are necessary, the QMO implements those directly or delegates implementation to the respective process owners.

The QMO communicates new or revised regulation to relevant members of the organization (e.g. process owners or product managers). Management is informed of new or revised regulation at least annually as part of the Management Review. As part of the relevant section of the Management Review Report, it is evaluated if updates to applicable regulations have been implemented effectively.

   
Participants QMO
Input New or revised regulation
Output List of regulatory requirements (updated), Communication to relevant members of the organization

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

Digital Health Jobs No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.