Thankfully we have 4 other ISO Classes for you to choose from. Check our top choices below or see all classes for more options.
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QPS is an Exemplar Global certified training provider for the following competency units contained in this class. Attendees successfully completing this course will receive a certificate of Attainment for these units.
AU- Management System Auditing
MD -Medical Devices
TL-- Leading Management Systems Audit Teams
Attendees will learn how to audit and lead an audit team including how to assess compliance to ISO 13485:2016. understanding how to plan, conduct, follow-up on, and work with audited
organizations to ensure efficient and effective audits. Students gain necessary auditing skills
through formal class work, role playing, group workshops and open forum discussions.
At the end of this course, attendees will be able to:
1. Understand the development and deployment of the Quality Management System for medical devices
2. Understand all levels of documents required including interpretation of each clause of ISO 13485:2016
3. Understand the differences among FDA QSR, ISO 13485:2003, ISO 13485:2016, and ISO 9001:2015
4. By performing 20+ case studies and dynamic simulated workshop, learn how to audit and demonstrate conformity to the requirements.
5. Learn how to evaluate the effectiveness of the entire QMS, including the process approach
6. Learn how planning, process, and supporting activities can be evaluated effectively.
7. Understand the importance of leadership, risk-based auditing, management review, internal auditing, and the monitoring and measurement of the QMS.
8. Understand the audit process and responsibilities.
9. How to plan, perform, report, and follow-up on audits.
10. Describe the role and responsibility of the auditor, lead auditor, and the auditee at all stages.
QMS auditing background.
Note: All attendees need to study ISO 13485:2016: before attending this class.
Who Should Attend
This course is designed for first, second, or third-party auditors and professionals who may be leading ISO 13485:2016 compliance activities in their organizations. This is also training for those involved with corporate internal auditing activities who wish to broaden their knowledge of a total audit process. This course is also recommended to anyone involved with supply chain management or supplier quality control or assurance.
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This class isn't on the schedule at the moment, but save it to your Wish List to find out when it comes back!
Quality & Productivity Solutions, Inc. is an international firm dedicated to providing practical and effective consulting and training to achieve client objectives. Whether it’s improvement in process, product, service, or overall performance, exceptional results are our business. We partner with...
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Developing Robust Integrated Management System (ISO 9001, ISO 14001, and Other Systems) This course has been designed to help you understand, implement and develop a globally integrated system to manage multiple global management systems. Course Benefits At the end of this course, attendees will be able to: Define quality management system framework...
Tuesday Jul 26th, 8:30am - 5:30pm Eastern Time(3 sessions)
ISO 13485:2016 MD Lead Auditor (Exemplar Global TL and MD) This is a 4-day course providing the certification of attainment for the following units: AU - Management System Auditing (3 days) for MD ISO 13485:2016 Management System Auditor Certificate (third day) TL - Leading Management Systems Audit Teams (4 days) for MD ISO 13485:2016 Lead Auditor...
Tuesday Aug 2nd, 8:30am - 5:30pm Eastern Time(4 sessions)
This course has been designed to help you understand and determine how to perform an internal or external audit for an AS 9100 system using the process approach, as well as show you how to effectively report and follow-up. Documentation and implementation details will also be covered. Course Benefits At the end of this course, participants will be...
Tuesday Aug 16th, 8:30am - 5:30pm Eastern Time(3 sessions)
Auditing to ISO 9001:2015 (Internal – Process and Risk-Based) This course is designed for two days. This is to understand changes from ISO 9001:2008 to ISO 9001:2015 requirements and how to audit your QMS. It covers how to plan and conduct process and risk-based audits, including corrective actions and follow-up system. Who Should Attend? Internal...
Tuesday Aug 23rd, 8:30am - 5:30pm Eastern Time(2 sessions)
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