This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to apply risk management tools and techniques utilizing ISO 14971:2019 and ISO 24971:2020.
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8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
ISO 14971:2019 “Medical devices — Application of risk management to medical devices” defines a standard process for identifying risks associated with medical devices at all stages in a device’s life cycle, from product design to production and post-production use. The goal of ISO 14971 training is to develop a risk management plan that prioritizes that an effective quality system should systematically identify, analyze, evaluate, control, and monitor risk throughout the product life cycle to ensure that the devices are safe and effective.
To help understand ISO 14971:2019, the course will use ISO 24971:2020 “Medical devices— Guidance on the application of ISO 14971” which is a companion document. Tools and techniques described in ISO 24971:2020 will be used to demonstrate how risks can be assessed and evaluated.
Risk management is a key focus of the new QMSR regulation, with an emphasis on integrating risk management principles throughout the QMS. Manufacturers need to fully understand the relationship between ISO 13485 and ISO 14971, with a focus on life cycle risk management starting from design to post-market to ensure full compliance with the new regulation that goes live in 2026. In alignment with this regulatory advancement, FDA is proactively training pre-market and post-market CDRH personnel on both ISO 13485 and ISO 14971. If you work in medical devices, this is your call to action: get trained on ISO 13485:2016 and ISO 14971:2019.
What does this mean practically for industry? Compliance with every part of ISO 13485:2016 that explicitly discusses risk management is required and could be subject to regulatory inspection and consequences for noncompliance. The totality of the risk management system that wraps around and enhances all the risk-related clauses in ISO 13485 is highly suggested (by FDA) to be designed to comply with ISO 14971.
This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to apply risk management tools and techniques utilizing ISO 14971:2019 and ISO 24971:2020.
Through training, participants will learn:
Bob,
Thank you for all of your time and assistance with both; the Internal Audits and the Gap Analysis. I strongly feel that our QMS will have great improvements from these events.
Hi Bob,
Not sure if I ever told you, but the quality manual spreadsheets you provided have impressed every external auditor that’s come in.
We are grateful to you for sharing the template with us. We were certified to the 2015 version of the standard in December and the auditor said we saved him hours of auditing because we had all the information in one place.
More recently a customer asked if we might share the template with them. But I wanted to ask you if that would be alright before doing so.
Please let me know as soon as you can. Take care.
Hi Al,
I want to tell you how pleased everyone was with how far we have come. That is due in no small part to your efforts and coaching. Scott and I appreciate what you have done.
We had our ISO 9001:2015 certification audit this week and we passed with flying colors! No findings and only 3 OFI’s. We should be receiving our certificate in 4-6 weeks.
I wanted to say Thank You, to you and the QSG team for helping us with this transition. Your assistance certainly made it a much less daunting of a task for us to achieve. I’ll be sure to contact you when it’s time for our internal audit.
Thanks again for all your help!
Angelo,
It feels nice to put the successful audit behind us! We filed our corrective action report and sent it over last Friday. We should get our official re-certification in the coming days.
Al was a great resource in pulling us through this project. He fit well with the team. With Al and Don, you have some quality people working for your organization.
We’ll be getting back in touch with Al next month to begin scheduling out the training for ISO 9001:2015.
To Bob, Angelo, and Al,
As you have heard we successfully completed our ISO 9001, 2015 audit this past week with no findings and only 2 observations for improvements. I would like to thank you all for your efforts in helping us complete our journey. I’m confident this will make Vacuum Barrier a stronger organization going further. We will keep you in mind as additional demands surface that we may require your services again.
Thanks for letting us know!
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