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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.
Course Objectives
- Fully understand and successfully interpret the ISO 13485 requirements
- Understand how to audit using the process approach
- Ask audit questions that get results
- Identify and document nonconformities
- Audit to the ISO 9001 Quality Management Systems
- Qualify additional staff to conduct internal audits
- Provide critical knowledge for your management staff
- Gain insight into the ISO 13485 audit requirements to augment/sustain your existing program
- Gain knowledge to help manage a successful ISO 13485 implementation project
- Provide professional credentials to your internal auditors
- Conduct an audit against the ISO 19011 Audit Standard
- Provide critical knowledge for your staff and management
Benefits
This course is certified in the Exemplar Global Certification Program, and meets the training portion of the requirements for certification of individual Quality Management System Internal Auditors.
Note: This course covers the ISO 13485:2016 revision as well as ISO 9001:2008, ISO 13485:2016 is not aligned with ISO 9001:2015. Therefore, ISO 9001:2015 is not covered as part of this course.
Agenda
Day One
- Terminology and Definitions
- Background, History and Rationale for Quality Assurance
- Introduction to the ISO Family of Documents
- Analysis of the Contents of ISO 13485
- Audit of the Active Medical (Audit #1)
- Quality System Requirements
- Analyzing Audit Findings
- Exemplar Global and U.S. Certification System
- Auditor Qualifications
- Roles and Responsibility of Auditors
Day Two
- Creation of Effective Audit Checklists
- Audit of Company Documents (Audit #2)
- Tips for the Internal Auditor
- Audit of Active Medical – Department Audit (Audit #3)
- Compiling Audit Findings
- Documentation in the Quality System
- Planning and Conducting Effective Audits
- Refining Interview and Note-Taking Skill
- Applicability of the Clauses to Company Situations
Day Three
- Audit of Active Medical – Dept and System Auditing (#4)
- Corrective Action Initiation and Closure
- Refining Audit Interview and Note-Taking Skills
- Creation of an Audit Report
- Preparation and Presentation of a Closing Meeting
- Review & EXAM
Training Time: 40 hours
Continuing Education Credits (CEUs): 4.0
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.
Understand the requirements of ISO 13485:2016 and the evidence to demonstrate conformance. Learn how it compares to 21 CFR 820 and ISO 9001:2015. Led by our experienced trainers, the courses include hands-on workshops in an engaging and collaborative learning environment.
The instructor-led, virtual course is delivered in 6 convenient, 4-hour sessions spread over 2 weeks. There is an online exam for each competency unit to be completed within 3 days of completing each unit to receive the documentation required for full certification.
- Fully understand and interpret the requirements of ISO 13485:2016
- Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
- Understand how to apply the requirements of the ISO 13485:2016 standard
- Conduct practical audit exercises to apply these requirements and manage the audit process in a collaborative and engaging environment.
This course has been specifically designed to meet the needs of the Medical Device Industry.
The instructor-led, virtual course is delivered in convenient full day sessions. Schedule a proctored, online exam within 3 days of completing each unit to receive the documentation required for full certification.
System Requirements
- Operating System: Windows 7 and up; or MAC OS X 10.13 and up;
- High-speed internet connection (2.5 Mbps download, 3.0 Mbps upload)
- Speakerphone or computer audio (VOIP). A telephone headset is recommended for optimal audio quality
- Webcam is required to take an online proctored exam.
- Fully understand and successfully interpret the ISO 13485 requirements
- Understand how to audit using the process approach
- Ask audit questions that get results
Training Time: 36 hours
Continuing Education Credits (CEUs): 3.6
The virtual classes are certified by Exemplar Global and qualify for early registration and multiple attendee discounts Early 30-day Registration Discount $100 applied when registration is processed.
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.
