The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions, an IQVIA company

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Pilgrim is here to help you along the path to compliance. Are you ready to move forward?

Understanding the Gaps

The first step on the path to compliance is understanding the gaps between your current quality processes and the processes you need to have in place to comply with the new version of the standard. Have you performed your gap analysis yet? If not, these ISO 13485:2016 resources will help you get started.

Filling in the Compliance Gaps

Many affected medical device manufacturers and consultants have already begun or have even completed the gap analysis phase and are actively transitioning their processes to the new standard. These organizations are working through specific process areas and capabilities that will also need your attention as you plan and carry out your transition. It may be helpful for your organization to learn from what they’re experiencing as you move forward.

The Case for Quality System Transformation

On-Demand Webinar

Learn how compliance, quality system maturity, and a quality culture all feed into a successful global quality system.

quality system

Taking the Next Step

View our webinar to dig deeper into the changes and challenges being faced by industry leaders as they transition to ISO 13485:2016. During the presentation, Dan O’Leary, President of OMBU Enterprises, presents specific areas that need attention as you’re filling in the compliance gaps within your own organization. He also discusses which quality system areas will need fewer updates for this transition so you can focus on the processes that matter most.

This webinar will help you:

  • Understand the timing and overlap between ISO 13486:2016 requirements and other emerging global regulations.
  • Explore quality processes that need additional attention for a proper transition, especially supplier controls and customer complaints.
  • Review the many ways that risk and risk management will impact your quality system.
  • Define areas where QA personnel will need to increase regulatory focus in their day-to-day activities.

Support for Every Step of the ISO 13485:2016 Transition

Timely ISO 13485 compliance is becoming more critical than ever before, and Pilgrim is here to help you every step of the way. What challenges and successes are you encountering during your transition to ISO 13485:2016? Let us know in the comments below.

Justin Smith

Product Management Director, Pilgrim Quality Solutions