Event Details

8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually

Description

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.

Who Should Attend

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.

Learning Objectives

Through training, participants will learn:

QMSR (Quality Management System Regulation) – Risk Management requirements
Describe the Risk Management Process as defined in ISO 14971:2019
Identify how ISO 14971:2019 relates to ISO 13485:2016 Risk Management Requirements
Leverage the relationship of ISO TIR 24971:2020 to ISO 14971:2019
Identify and Quantify Risks for their Organization
Apply Risk Management Tools and how they align with the Product Life Cycle and requirements in ISO 13485:2016

Course Outline

Applicability of ISO 14971:2019
Structural Changes of ISO 14971:2019
Changes and Additions to ISO 14971:2019
Changes and Additions to ISO 24971:2020
Detailed Analysis of ISO 14971:2019 with reference ISO 24971:2020 Tools and Techniques

- Clause 1 – Scope
- Clause 2 – Normative References
  - Clause 3 – Terms and Definitions
  - Exercise #1 – Terms & Definitions
- Clause 4 – General Requirements
  - Risk Management Plan – Example
- Clause 5 – Risk Analysis
- Clause 6 – Risk Evaluation
  - Tools during Product/Service Life Cycle
  - Exercise #2 – Supplier Risk Assessment (ISO 13485)
- Clause 7 – Risk Control
  - Control Options
  - Benefit-Risk Examples
- Clause 8 – Evaluation of Overall Risk
- Clause 9 – Risk Management Review
  - Overall/Total Residual Risk
  - Risk Management Review
- Clause 10 – Production and post production activities
- ISO 13485:2016 and Risk Management
  - Exercise #3 – Risk Application – Customer Complaints
  - Exercise #4 – Training Exercise – Risk
- ISO 14971:2019 Conclusions

Prerequisites

None

Instructors

Ken Campanale, Angelo Scangas, Alyce Nelson

Jeremy

★★★★★ 5/5

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.

George Belezos

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.

Mike Hughes

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.

Erik Sauve

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!

Rick Waszkiewicz

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.

David Tucker

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.

ISO 14971:2019 Risk Management Requirements Workshop

Course Summary

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