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ISO 13485:2016 Certified Internal Auditor
This course is for those responsible for planning and scheduling an internal audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance professionals, ISO Project Managers, ISO Project Team Members or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.
Course Delivery: In-Person Training, Virtual Live Training, Training for Teams
This course has multiple delivery options to fit our customers’ individual needs. Click the tabs below for more information on each option.
In-Person Training
Virtual Live Training
Training for Teams
In-Person Training
In-Person Training consists of public classes conducted by one of our subject matter experts at one of our designated locations in one or more consecutive days.
Course Objectives
- Fully understand and successfully interpret the ISO 13485 requirements
- Identify medical device QMS terms
- Understand how to audit using the process approach
- Ask audit questions that get results
- Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
Benefits
Learn to plan and schedule an internal audit program for medical device quality management systems. Develop the skills you need to conduct a successful audit in this course devoted to the ISO 13485:2016 Medical Device Quality Management System standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situations—including managing the audit process and completing reporting—via hands-on workshops and two competency exams (MD & AU).
Prerequisites
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management System – Requirements For Regulatory Purposes. Copies will not be provided for you.
Target Audience
Anyone responsible for planning and scheduling an internal audit program for ISO 13485:2016, including quality assurance managers, ISO project managers, ISO project team members, compliance managers, and regulatory personnel.
Agenda
This is a three-day, instructor-led course available online or in-person. There are written tests on each of the competency units on days 2 and 3. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam.
Training Time: 24 hours
Continuing Education Credits (CEUs): 2.4 
Virtual Live Training
Our Virtual Live Training classes are conducted through an online platform by one of our subject matter experts in one or more sessions.
Course Objectives
- Fully understand and successfully interpret the ISO 13485 requirements
- Identify medical device QMS terms
- Understand how to audit using the process approach
- Ask audit questions that get results
- Describe the relationship between ISO 13485:2016 and applicable regulatory requirements
Benefits
Learn to plan and schedule an internal audit program for medical device quality management systems. Develop the skills you need to conduct a successful audit in this course devoted to the ISO 13485:2016 Medical Device Quality Management System standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situations—including managing the audit process and completing reporting—via hands-on workshops and two competency exams (MD & AU).
Prerequisites
All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management System – Requirements For Regulatory Purposes. Copies will not be provided for you.
Target Audience
Anyone responsible for planning and scheduling an internal audit program for ISO 13485:2016, including quality assurance managers, ISO project managers, ISO project team members, compliance managers, and regulatory personnel.
Agenda
This is a three-day, instructor-led course available online or in-person. There are written tests on each of the competency units on days 2 and 3. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam.
Training Time: 24 hours
Continuing Education Credits (CEUs): 2.4
Training for Teams
Training for Teams provides training for your group of employees in either a virtual live setting, or in-person at your facility. Connect with us to customize any of our standard courses to fit your specific need.
Currently scheduled classes are shown below. If no classes are displayed, please contact QCTS for other options.
