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Changes in ISO 13485:2016

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Are you ready?

Days: Four • CTUs: 3.2• Price: $1695

Time: 8:00 am to 6:00 pm

Whether you need to understand the changes, learn how to implement the changes in your existing management system or train your existing auditors, AQS can help!

» ISO 13485:2016 The Path Forward

Days: 2 • CTUs: 1.6 • Price: $995
Time: 8:00 am to 5:00 pm

This course is intended for Management at all levels, Quality personnel, and others who need to understand the requirements of ISO 13485:2016; what the requirements mean for their organization, and the steps their organization must take to update their current QMS to meet the requirements of ISO 13485:2016.

  • At the end of this course, each participant will leave with a formal, documented and detailed plan that is specific to the needs of their organization. This plan will provide the details you will need to move your organization forward to accomplish two objectives:
    • Meet the requirements of ISO 13485:2016 and provide evidence that requirements have been met.
    • Achieve the embedded benefits contained in ISO 13485:2016. Benefits will focus on the organization and their customers.

Click here for more information about ISO 13485:2016 The Path Forward.

» ISO 13485:2016 Auditor Transition Training

Days: 2 • CTUs: 1.6 • Price: $995
Time: 8:00 am to 5:00 pm

This course is intended for auditors (external and internal auditors). It will cover the specific differences between the ISO 13485:2003 requirements and ISO 13485:2016 requirements from an auditor’s perspective. This course will emphasize the concepts that will be difficult to audit including new requirements that are less prescriptive, including for example; not requiring procedures and records, risk based thinking, knowledge management, and many others.

Click here for more information about ISO 13485:2016 Auditor Transition Training.

Because both ISO 13485:2016 The Path Forward and ISO 13485:2016 Auditor Transition Training deal with changes contained in the 2016 revision of the standard, there is inevitable overlap in course content. While many may choose to take both sessions, some choose one or the other making this overlapping content necessary.

 

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Schedule

 

See course schedule for ISO ISO 13485:2016 The Path Forward

See course schedule for ISO 13485:2016 Auditor Transition Training


 

 

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763-746-0505 • 800-633-2588 • Fax: 763-746-0504
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