ISO 13485:2016 Compliance: Resources to Help You Get Started

ISO 13485:2016 Compliance: Resources to Help You Get Started

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Transitioning to ISO 13485:2016 compliance is the top priority throughout the medical device industry right now. The industry is racing to absorb information on the latest version of the standard. Do you have a plan in place for getting your organization up-and-running with ISO 13485:2016? These resources will help you develop, fine tune, and implement your transition plan.

Put Your ISO 13485:2016 Compliance Plan in Place

There are a number of great resources on transition planning and gap analysis, including this post and white paper from the Emergo Group. You’ll learn some compelling reasons to begin the transition now, as well as significant areas of the standard that are affected. This will help you plan your transition timeline and resources accordingly.

Get a Handle on the Major Changes

Regulatory organizations such as RAPS can help you get a handle on the major changes to the ISO 13485 standard. Once you have a high-level overview of the affected processes, you’ll better understand the scope of the potential changes to your quality system.

Understand Where You Are

In this recent post, Pilgrim presented insights from our Regulatory Advisory Board that detailed specific challenge areas within the new version of the ISO standards. This post will help you think beyond section-level changes to specific processes and systems that will need your attention and continued focus. This includes quality processes such as supplier management, change management, employee training, complaint handling, and CAPA.

Connect with Your Peers

In fact, you can connect with thousands of them! The first phase of your ISO 13485:2016 transition will need to be a gap analysis. This phase is perfect opportunity to connect with your industry peers and learn where they foresee challenges. There are a number of ISO 13485 communities on LinkedIn that you can join to stay up to date on the standard.

Don’t Wait until the Last Minute

Medical device manufacturers need to transition to ISO 13485:2016 compliance by March 1, 2019. That is years away, but there are plenty of good reasons to start your transition now. ISO auditors will be incredibly strained over the next several years due to numerous standard changes within the medical device industry. Plus, companies that are up for recertification within the next three years will be strongly encouraged to comply with the 2016 version of the standards.

Register for Our Upcoming Webinar

Pilgrim also has a handle on the ISO 13485:2016 transition and we’re here to help you every step of the way. Download the first webinar in our four-part series on the ISO 13485:2016 transition. In this webinar, you’ll learn how to perform an ISO 13485 gap analysis and get up to speed on the new standard.


Roxane Napoli

Director of Marketing Communications, US Marketing, IQVIA