Improving Quality Culture

97% Recommended

This course introduces the concept of Quality Culture in medical device organizations, using ISO 10010:2022 as a framework.

Auditors and regulators are increasingly probing “soft” factors like leadership commitment, behaviours, and culture because they directly affect compliance outcomes. ISO10010:2022 offers practical guidance for strengthening quality culture, giving employees and leaders a common language to build engagement, accountability, and continual improvement.

Participants will explore how leadership, behaviours, and engagement shape quality outcomes, and how organizations can evaluate and improve their culture to drive compliance, performance, and patient safety. Through real world examples and practical steps, learners will understand how to contribute to a positive quality culture within their teams and across the organization.

Our eLearning is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Trusted By Notified Bodies & Global Brands

Course Snapshot

Approved By

Comply Guru

Duration

60mins

Course Access

180-days

Teaching Format

eLearning

Certification on Completion

Yes

Language (s)

English

Have 5 or more that need training?

We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

FEATURED CUSTOMER

How Skeletal Dynamics switched to Online Learning & saved 50% on MedTech QARA Training

“Over the years, I have used many well-known U.S training providers, but I found Comply Guru had truly mastered ‘online’ training which has saved Skeletal Dynamics over 50% in training fees, associated expenses as well as 100% of the time lost spent travelling to training with other providers.”

Mario Arbesu

VP of Quality Assurance & Regulatory Affairs

FEATURED CUSTOMER

How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

“Comply Guru took the stress out of training. Their courses didn’t just tick a box—they added real value to our quality system.”

Bernard Wallace

Quality Affairs Manager

FEATURED CUSTOMER

How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

"Comply Guru’s trainers are not only experienced in their specific fields but are also experts in the art of training. By using a provider who integrates modern self-study e-learning methods with traditional in-person sessions, we can be confident that our learning outcomes are maximized."

Zoran Klaric

Manager Regional Training & Onboarding

Our Methodology

Not all eLearning is the same

Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. We deploy a multi-layered methodology that offers you a New Generation of eLearning.

Our Experts

Meet The People Behind The Course

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.

Our Training Specialist

Eoin Philip Kelly

Eoin has almost 20yrs of experience in internationally accredited training design & delivery. He founded Comply Guru to pursue his vision to bridge the major gap in the market for learning solutions that were more accessible, convenient & flexible in a fast-changing world of International Standards & Medical Device Regulations.

Course Overview

Improving Quality Culture

Key Features Covered

More Flexibility & More Savings vs Other Providers

Industry-leading eLearning Methodology

Scalable Learning for Teams

Course Access for 6 months

Quick Enrolment within 1hr

Manager Accounts for Groups of 10+

Learning Objectives

At the end of this short course, successful learners will be able to:

Define Quality Culture and explain why it matters
Understand the framework provided by ISO 10010:2022 for evaluating and improving quality culture
Identify leadership behaviours and organizational practices that strengthen (or weaken) culture
Apply practical tools for fostering engagement, accountability, and continual improvement
Recognize how roles contribute to a positive quality culture

Who Should Attend

This course is for individuals or organizations who want to understand how to improve Quality Culture.

Course Certificate

Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.

How Will You Be Assessed

In order to successfully complete this course, each Learner will need to:

Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)

What Are The Technology Requirements

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

Watch and Learn More

About our eLearning

Learn about how our eLearning is leading the industry for innovation through online learning

Why choose eLearning

Frequently Asked Questions

Can I buy just 1 license of this Essentials course?

Unfortunately not. The Essentials courses are only available for groups of 5 or more. If you would like a quote, please complete a Request Quote form and a member of our team will contact you to discuss this further.

Do we offer group discounts?

Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.

How long will I have access to the course?

The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.

What if I fail the eLearning assessment, what happens?

Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, you will not be eligible to continue to the live workshops.

What technology is used for this training?

When and where do I get my course certificate?

Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

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