Learn to develop and implement an internal quality system that meets the requirements of ISO 9001:2008 and ISO 13485. This course will help you prepare for an audit and effectively manage your resources. You’ll understand how to close out an audit and conduct follow-up surveillances.
This training course satisfies the requirement for Exemplar Global’s QMS Internal Auditor Registration Scheme. Learn the necessary background to develop, implement, and audit an internal quality system that meets the requirements of ISO 9001:2008 and ISO 13485:2016.
This version of our Exemplar Global-certified QMS Internal Auditor course includes workshops tailored to meet the medical device industry and discussions of ISO 13485 medical devices’ quality management systems requirements for regulatory purposes. Hands-on workshops reinforce the methods and techniques discussed.
There is a one-hour exam on the last day.
This course is offered in cooperation with AQS Management Systems, an Exemplar Global Certified course provider and meets the training requirements for individual auditor certification.
- CEU Hours: 2.3
- Length: 25 Hours
- ASQ RU: 2.3
- Provider: ASQ - ILT
- Become familiar with the elements of a sound quality system.
- Understand the audit evidence necessary to comply with ISO 13485:2016 requirements.
- Using ISO 19011 as a guide, learn pre-audit activities and conduct the audit, post-audit, and follow-up activities.
- Know how to prepare for an audit and effectively manage your resources.
- Know how to collect audit evidence and document observations, including techniques for effective questioning and listening.
- Understand how to verify effectiveness of corrective action, close out an audit, and conduct follow-up surveillances.
Prerequisites:All attendees are required to bring their own copy of the ISO 13485:2016 standard to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ.
Who Should Attend:Professionals who will conduct or participate in internal audits in the medical device industry, and those seeking to develop an ISO 13485 compliant quality management system should attend this training.
- The Internal Quality System and ISO 13485:2016
- Overview of the elements comprising a sound quality system, requirements of the governing documents, and the relationship of quality policy, the quality manual, procedures, and instructions. Included is a discussion of the audit evidence necessary to comply with ISO 13485:2016.
- The Audit Cycle
- Using ISO 19011 as a guide, pre audit activities, conducting the audit, and post-audit and follow-up activities are reviewed.
- Planning and Conducting the Audit
- How to prepare for an audit and effectively manage your resources
- How to collect audit evidence and document observations, including techniques for effective questioning and listening.
- Follow-Up Activities
- How to verify effectiveness of corrective action, close out an audit, and conduct follow-up surveillances
- Case Studies and Simulations
- Hands-on workshops reinforce the methods and techniques discussed.
Hands-on workshop activities, one-hour exam, face-to-face classroom instruction, and individualized assistance.
All attendees are required to bring their own copy of the ISO 13485:2016, ISO 9001: 2008, and ISO 19011S-2008 standards to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ from ASQ here. All attendees will receive a student course manual.
Due to stringent international standards guidelines, a maximum course enrollment is strictly enforced. If you are told you are on the waiting list or have registered and have not received a confirmation letter prior to the course, contact ASQ immediately to verify your status before you make travel arrangements.
- 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.
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