Date(s) - May 12th, 2020 - May 13th, 2020
8:30 am - 4:30 pm
Manufacturers Resource Center
ISO 13485:2016 Internal Auditor Training
May 12-13, 2020
8:30 am – 4:30 pm
Manufacturers Resource Center
7200A Windsor Drive
Allentown, PA 18106
A sound auditing program is vital to the health and continual improvement of the QMS, and to comply with the requirements of ISO 13485:2016 for certification purposes.
MRC offers a two-day internal audit training class to teach internal auditors the requirements of ISO 13485:2016 and the fundamentals of the internal audit process. This class is designed to train personnel to become qualified and confident to conduct internal audits in a positive, constructive, friendly manner. Auditors will learn to:
• Plan and schedule the audits to be conducted.
• Prepare for the specific audits to be conducted using audit preparation tools (i.e., checklists, matrices, documentation, schedules, etc.)
• Conduct internal audits required for QMS system maintenance and compliance, and identify gaps.
• Obtain and review objective evidence of compliance including Management System procedures, work instructions, supporting records, personnel feedback, and implementation practices.
• Provide written reports that identify audit results; positive implementation aspects, nonconformities that require corrective action, as well as, observations and opportunities for improvement.
Auditors will be given several interactive exercises during the class. A certificate will be issued for each student who successfully completes the course.
This course is designed for company staff with audit responsibility for the organization’s ISO 13485 Quality System or will be undertaking Internal Quality Audits. It is suitable for all functions and levels tasked to carry out internal audits, organize the audit program for their ISO 13485 or integrated management system, to train or guide other internal auditors.
WCH Professional Services LLC
Wanda is a quality professional with over 20 years of experience in quality assurance, regulatory compliance, and continuous improvement. She has worked in different management roles in quality and operations of pharmaceutical and medical device manufacturing companies. Wanda is an MBA graduate from Devry University and has a bachelor’s degree in Science. During her career, she has implemented and guided certification efforts on ISO 9001, ISO 13485, FDA Quality System Regulation for medical devices, and cGMP’s for pharma businesses. Additionally, she has provided consulting services to other industries and supported efforts to obtain certifications in a variety of standards, including AS9100, ISO 14001, ISO 17025, ISO 27001, and ISO 45001. Wanda is a Certified Lean Six Sigma Green Belt, an ASQ Certified Quality Engineer, and Judge and trainer for the International Team Excellence Award competition at the ASQ World Conference.
Note: All registration fees must be received in advance of the date of your event. MRC must be notified of cancellations two weeks prior to the event, otherwise we can only grant a credit to another MRC event. Persons who do not show or notify us in advance will forfeit any credit. Remember, you can also send a substitute. Thank you.