Learn the specific differences between the ISO 13485:2003 and ISO 13485:2016 requirements.
Learn the specific differences between the ISO 13485:2003 requirements and ISO 13485:2016 requirements from an internal and external auditor’s perspective. Focus special attention on the concepts that will be difficult to audit.
Learn how to audit regulatory requirements, how changes impact an organization’s internal audit program and how to audit design traceability and design transfer. Cover auditing process and software validation and preparations for conducting your ISO 13485:2016 audits.
Please note that the ISO 13485:2016 Auditor Transition Training and ISO 13485:2016 The Path Forward courses deal with changes contained in the 2016 revision of the standard. There is some overlap in course content.
Students that successfully complete this course may claim to be a certificate holder for ISO 13485:2016 Auditor Transition Training. They may not claim to be a certified person.
- CEU Hours: 1.6
- Length: 16 Hours
- ASQ RU: 1.6
- Audience: Practitioner
- Provider: ASQ - ILT
- Understand the differences between ISO 13485:2003 and ISO 13485:2016 and how this will impact existing approaches to auditing
- Learn the alignment requirements between the new Quality Management System requirements contained in ISO 13485:2016 and Regulatory and Statutory requirements
- Understand the implications for organizations related to the increased emphasis on Regulatory requirements
- Learn to identify and write specific nonconformities
Who Should Attend:This course is intended for auditors who are auditing ISO 13485:2003 and will be auditing ISO 13485:2016. Additionally, others who will receive value from this course include managers and their representatives, quality and regulatory affairs personnel, internal auditors and suppliers, and audit program managers.
Important: All attendees are required to bring their own copy of both the ISO 13485:2003 and the ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes to this training. Copies will not be provided for you. The 2016 standard can be purchased here.
Student manual and handouts will be provided.
- If you need to cancel, we will refund your paid registration fee as noted below.
- Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
- Requests received within 5 business days of the course starting incur a $150 processing fee.
- After the course starts, there are no refunds or transfers.
- Registrants who fail to attend without advance notice are liable for the entire course fee.
- If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
- You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
An instructor-led traditional classroom experience. Classroom-based instruction involves the highest level of instructor/student interaction. We offer classroom style training in two formats. See public and on-site.
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ON-SITE TRAINING FOR YOUR ORGANIZATION.
ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.
5 Benefits of On-Site Training
- Expertise to your location: Saves time and travel expenses
- Convenient scheduling: Train groups of five or more
- Customizable courses: Training tailored to your groups’ needs
- Immediate results: Employees complete courses ready to apply what they’ve learned
- Value-add support: Instructors available to answer questions after session