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ISO 13485:2016 Certified Lead 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.
Target Audience
Anyone responsible for leading an audit program for ISO 13485, including quality assurance managers, quality assurance professionals, ISO project managers, ISO project team members, compliance managers, or regulatory personnel.
Course Objectives
- Fully understand and interpret the requirements of ISO 13485
- Understand 21 CFR 820 requirements and be able to compare these to ISO 13485 requirements
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
- Understand how to apply ISO 9001 and ISO 13485 standards during in-class practical audit exercises
- Understand terminology of ISO 9001 and ISO 13485 and application in a medical device environment
- Develop an ISO 9001/ISO 13485 auditing system based on the ISO 19011 auditing requirements
- Learn how to ask audit questions that get results and to construct effective audit checklists
- Learn how to conduct opening and closing meetings that have impact
- Learn how to generate effective corrective actions
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.
Benefits
Learn how to lead an audit program for medical device quality management systems. Develop the skills you need to lead a successful medical device audit in this ISO 13485 lead auditor training course. Specifically designed to meet the needs of the medical device industry, this four-day class prepares medical device lead auditors for real-life situations via hands-on workshops. Participants will learn how to lead the audit process and to complete reporting. Three competency exams are included that can be submitted to Exemplar Global as part of your application for ISO 13485 Lead Auditor certification.
Agenda
This is a four-day, instructor-led course. There are written tests on each of the competency units on days 2, 3, and 4. 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. Day 4 will cover leading management systems audit teams (TL) along with a corresponding competency exam.
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. Day 4 will cover leading management systems audit teams (TL) along with a corresponding competency exam.
Training Time: 32 hours
Continuing Education Credits (CEUs): 3.2
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.
Target Audience
Anyone responsible for leading an audit program for ISO 13485, including quality assurance managers, quality assurance professionals, ISO project managers, ISO project team members, compliance managers, or regulatory personnel.
Course Objectives
- Fully understand and interpret the requirements of ISO 13485
- Understand 21 CFR 820 requirements and be able to compare these to ISO 13485 requirements
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
- Understand how to apply ISO 9001 and ISO 13485 standards during in-class practical audit exercises
- Understand terminology of ISO 9001 and ISO 13485 and application in a medical device environment
- Develop an ISO 9001/ISO 13485 auditing system based on the ISO 19011 auditing requirements
- Learn how to ask audit questions that get results and to construct effective audit checklists
- Learn how to conduct opening and closing meetings that have impact
- Learn how to generate effective corrective actions
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.
Benefits
Learn how to lead an audit program for medical device quality management systems. Develop the skills you need to lead a successful medical device audit in this ISO 13485 lead auditor training course. Specifically designed to meet the needs of the medical device industry, this four-day class prepares medical device lead auditors for real-life situations via hands-on workshops. Participants will learn how to lead the audit process and to complete reporting. Three competency exams are included that can be submitted to Exemplar Global as part of your application for ISO 13485 Lead Auditor certification.
Agenda
This is a four-day, instructor-led course. There are written tests on each of the competency units on days 2, 3, and 4. 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. Day 4 will cover leading management systems audit teams (TL) along with a corresponding competency exam.
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. Day 4 will cover leading management systems audit teams (TL) along with a corresponding competency exam.
Training Time: 32 hours
Continuing Education Credits (CEUs): 3.2
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.
