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Sep 14, 2021 Kelly Stanton

9 Best ISO 13485:2016 Training Programs in 2021

The caliber of your team’s ISO 13485:2016 training has a significant impact on the success and effectiveness of your quality programs. In fact, obtaining a quality management certification is crucial when it comes to achieving your quality goals and objectives. 

Without ISO 13485:2016 certification, some life sciences startups face severe regulatory fines and penalties, which may result in delayed product approval. It’s these kinds of unforeseen roadblocks that prevent even the most growth-oriented medical device and biopharmaceutical companies from achieving terminal velocity. 

In this article, we’ll review the best ISO 13485:2016 training programs. The courses listed below have helped teams dramatically improve their quality management system processes. Use the expert insights found in this article to identify the best course forward for your growing life sciences company. 

The Best ISO 13485:2016 Training Programs in 2021

In case you’re unfamiliar, ISO 13485:2016 is a global standard that details the unique requirements of a modern quality management system. 

From product design to production, ISO 13485:2016 outlines quality management system best practices during all phases of development. Additionally, ISO 13485 training helps teams master quality assurance and quality control in coordination with major quality laws and regulations. 

In your search for the best ISO 13485:2016 training programs, it’s important to prioritize the providers that cover the latest information related to ISO 13485. Unfortunately, many of the details covered in ISO 13485:2003 are no longer applicable.

Without further ado, here are a few best-in-class ISO 13485:2016 training programs.

ISO 13485:2016: General Training

The programs listed here are most appropriate for individuals interested in learning more about quality management system best practices. These courses provide a top-line overview of quality management system features, use cases, and more.

In general, these programs are suitable for novice quality management professionals. There are specific and advanced training courses related to implementation, corrective and preventive action (CAPA), and auditor training that we will discuss shortly.

Here are a few general training courses worth pursuing: 

  1. QMII ISO 13485 Executive Overview Training ($1,200)
  2. ASQ ISO 13485 Requirements from A to Z ($389)
  3. OMNEX Understanding and Documenting ISO 13485:2016 ($1,000)

RELATED READING: What is the Difference Between ISO 13485 and ISO 9001?

ISO 13485:2016: Implementation Training

The programs below are most suitable for quality professionals with an intimate understanding of ISO regulations and standards. These types of training programs focus intently on quality management system implementation, activation, administration, and performance optimization rather than ISO 13485:2016 guidelines.

Here are a few implementation training courses worth investigating:

  1. BSI Group ISO 13485:2016 Implementation ($1,050)
  2. ASQ ISO 13485:2016 Incorporating Key Requirements… ($899)

RELATED READING: The Best ISO 13485 Audit Checklist on the Web

ISO 13485:2016: CAPA Process Training  

By implementing CAPA processes into your quality management procedures, you’ll have an opportunity to better understand why product deviations occur and what remedies are needed to mitigate quality issues now and into the future.

ISO 13485:2016 Clause 8.5 understates the importance of CAPA as it relates to a life sciences quality management system. Qualio’s electronic quality management system (eQMS) comes equipped with a rich feature-set designed to help scaling startups and scale-ups identify the root cause of quality and compliance issues. As a result, teams can quickly and easily move through product development and onto rapid FDA approval.

Here are a few great CAPA process training programs: 

  1. Axeon ISO 13485 Root Cause and Corrective Action ($500)
  2. LearnAboutGMP CAPA Basics Course

RELATED READING: 7 ISO 13485:2016 Changes That Can Improve Your Company

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ISO 13485:2016: Auditor Training

Whether you’re an internal auditor or an external auditor contracted by a regulatory agency, there are a handful of ISO 13485:2016 auditor training programs to choose from. 

These programs equip auditors with the skills and knowledge needed to verify ISO 13485:2016 compliance, quality management system effectiveness, and more.

  1. BSI Internal Auditor Training ($1,050)
  2. BSI Lead Auditor Training ($3,150)

RELATED READING: The 7 Fastest Ways to Fail an ISO Audit

Accelerate ISO 13485:2016 Certification With Qualio

What does it take to accelerate your ISO 13485:2016 certification?

To start, we recommend committing to one (or more) of the ISO 13485:2016 training courses listed above. Next, we recommend analyzing the performance of your QMS. Does your system align with the latest industry standards? Is the system easy to use? Can the system scale with your business as it grows?

Finding the right QMS is half of the battle when it comes to medical device manufacturing. Prioritize vendors that cater to your specific industry, offer next-generation features, and provide helpful, hands-on support.

Qualio’s QMS is purpose-built for the medical device and biopharmaceutical industry. Additionally, we are suited to help teams comply with most international requirements, including ISO 13485:2016. 

To see precisely how our QMS works, check out our live demo.

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Published by Kelly Stanton September 14, 2021