{domain:"www.qualitydigest.com",server:"169.47.211.87"} Skip to main content

User account menu
Main navigation
  • Topics
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Videos/Webinars
    • All videos
    • Product Demos
    • Webinars
  • Advertise
    • Advertise
    • Submit B2B Press Release
    • Write for us
  • Metrology Hub
  • Training
  • Subscribe
  • Log in
Mobile Menu
  • Home
  • Topics
    • 3D Metrology-CMSC
    • Customer Care
    • FDA Compliance
    • Healthcare
    • Innovation
    • Lean
    • Management
    • Metrology
    • Operations
    • Risk Management
    • Six Sigma
    • Standards
    • Statistics
    • Supply Chain
    • Sustainability
    • Training
  • Login / Subscribe
  • More...
    • All Features
    • All News
    • All Videos
    • Contact
    • Training

Understanding QMS Software Validation Requirements in ISO 13485:2016

Quality system software validation is nonnegotiable

Kyle Rose
Mon, 04/02/2018 - 12:02
  • Comment
  • RSS

Social Sharing block

  • Print
Body

As I’m sure many of you know, the ISO 13485 standard for medical devices was updated in 2016, which means the time to transition your quality management system (QMS) is now. Most auditing organizations have either cut off ISO 13485:2003 recertifications or will be doing so very soon.

ADVERTISEMENT

I was recently at a client’s location helping the company through its 2016 transition audit when an auditor from one of the largest notified bodies mentioned that less than 3 percent of its U.S. clients are ready to transition to ISO 13485:2016. As a leader in the quality consulting arena, we wanted to share some of our tips and best practices to make sure your organization is ready to ace its transition audit.

We’ll focus on the inclusion of a new requirements for quality system software validation in ISO 13485:2016. Section 4.1.6 outlines the process for validating computer software used in the quality system as follows:
“The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.

 …

Want to continue?
Log in or create a FREE account.
Enter your username or email address
Enter the password that accompanies your username.
By logging in you agree to receive communication from Quality Digest. Privacy Policy.
Create a FREE account
Forgot My Password

Add new comment

Image CAPTCHA
Enter the characters shown in the image.
Please login to comment.
      

© 2025 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute Inc.

footer
  • Home
  • Print QD: 1995-2008
  • Print QD: 2008-2009
  • Videos
  • Privacy Policy
  • Write for us
footer second menu
  • Subscribe to Quality Digest
  • About Us
  • Contact Us