Are you up to date on the latest ISO 14971 developments?

ISO 14971 is the application of a risk management process for medical devices. The third edition of the standard differs from 14971:2007 — not only in chapter structure but also in its focus on the benefit-risk ratio. Under these updated guidelines, the concept of medical benefit is now clearly defined. Moreover, this latest version places a stronger focus on "information from the production and downstream phases," particularly in production and post-production activities.

However, the new standard does not stray from its original intent — to guide medical device manufacturers toward effective risk management compliance.

Unfortunately, clearing ISO 14971 can be difficult without the right processes and tools in place. With that in mind, many industry-leading medical device manufacturers have placed significant emphasis on ISO 14971 training programs.

5 Amazing ISO 14971 Training Programs

As an industry-leading enterprise quality management software (eQMS) provider, we've seen the value that ISO 14971 training programs can offer to medical device manufacturers. These programs give organizations the leverage needed to understand the regulation fully and rapidly institute compliance practices and procedures.

Which ISO 14971 training programs should your organization prioritize? Let's take a look at five of the more popular ones.

1. British Standards Institute

This course is designed to give participants a greater understanding of ISO 14971 and the impact that it has on the "decision-making processes at medical device manufacturing firms." The one-day training course helps medical device professionals improve risk management efforts in coordination with ISO 14971.

Learning Objectives:

  • Identify links between ISO 13485 and ISO 14971
  • Explain how risk management relates to the product lifecycle
  • Define risk management terminology
  • Outline stages of the risk management process
  • Define key deliverables within the risk management process

Prerequisites: Participants should have an understanding or experience with basic quality management systems for the medical device industry.

2. American Society for Quality

This course is designed for engineers, technicians, and professionals focusing on product and process risk. The course helps participants identify common risk management practices used in product design and manufacturing.

Learning Objectives:

  • Identify and analyze hazards of product, process or service
  • Create a process map
  • Perform a fault tree analysis
  • Perform failure mode and effects analysis
  • Understand the basics of human factors and their relationship to risk management

Prerequisites: None.

3. SGS

The one-day training course helps participants understand the importance of ISO 14971 and links between ISO 13485. SGS demonstrates how risk management applies to the entire product lifecycle and gives participants an opportunity to implement guardrails of the risk management process.

Learning Objectives:

  • Guided lessons through lecture and interactive workshops

Prerequisites: None.

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4. Association for the Advancement of Medical Instrumentation

This course helps participants understand risk management concepts used throughout the quality system to meet FDA, ANS/AAMI/ISO 14971, and ANSI/AAMI/ ISO 13485 requirements. Participants learn how to use risk management to make risk-based assessments during product development.

Learning Objectives:

  • Identify expectations for submissions and compliance
  • Apply risk management principles to the quality system

Prerequisites: None.

5. American National Standards Institute

This free course provides a brief overview of standards, defining types, and an introduction to key definitions and terms. This course describes ANSI's role within the standardization process. Additionally, ANSI's international standardization arena will be covered, along with an overview of regional/international programs.

Learning Objectives:

  • Introduction to standards
  • ANSI's role in U.S. standardization
  • ANSI's role in international standardization

Prerequisites: None.

Master ISO 14971 with Quality Management Software

The right ISO 14971 training program for your organization requires you to invest in the most up-to-date information. As a reminder, changes have been made to ISO 14971 over the last year. As such, it's always important to gap assess your processes when standards update.

Is your organization aligned with new ISO 14971 standards?

To maximize the effectiveness of the ISO 14971 training program, we recommend investing in a quality management system. The right system should fit seamlessly into your organization and provide a framework for consistent improvement.

To achieve the financial, collaborative, and quality benefits that a quality management system delivers, you need to select a tool that aligns with your organization's present state and future goals.

To improve your chances of making the right selection, we recommend downloading our QMS buyer's guide. In it, we reveal the top questions to ask any QMS vendor before making an investment.

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Published by Robert Fenton June 25, 2020
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