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Internal Auditor Training for ISO 13485
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DescriptionLearn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485:2003 and ISO 9001:2000. Get your training from the industry leaders—STAT-A-MATRIX has been training auditors longer than any other training organization in the world. This version of our RABQSA-certified internal auditor course includes workshops tailored to the changing medical device industry and discussions of ISO 9001:2000 and ISO 13485:2003.
Topics for this course include:
- Analysis and interpretation of ISO 13485:2003
- The quality system
- The quality audit cycle
- Preaudit activities
- Internal audit case study
- On-site audit activities
- Report writing—nonconformity reports
- Corrective action—case study
- Final examination (1 hour)
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ObjectivesUnderstand how to prepare, conduct, and follow-up on internal audits for ISO 9001:2000 and ISO 13485:2003.
- Introduction to Internal Quality Systems Assessment—An introduction to the elements comprising a quality system, interpretation of the requirements of ISO 9001:2000 and ISO 13485:2003, and a discussion of what third-party assessment agencies look for.
- The Three Audit Phases—Planning, execution, and follow-up are examined closely using concepts detailed in ISO 19011.
- Planning and Auditing—How to prepare for an audit and manage your resources effectively.
- Conducting the Audit—How to collect objective evidence and document observations, including techniques for effective questioning and listening.
- Follow-On Activities—How to verify effectiveness and adequacy of corrective action, close out an audit, and conduct follow-on surveillances.
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Target AudienceThis is a perfect fit if you will be conducting, managing, or participating in internal (first-party) audits, or helping to develop an ISO 13485 quality system. Also great if you are involved in developing, implementing, and/or maintaining an internal audit system that meets the requirements of ISO 13485. |
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UL Knowledge Services workshops are designed for and intended to serve individuals using and relying upon UL services. UL Knowledge Services reserves the right to limit workshop attendance strictly to the foregoing. In addition, UL Knowledge Services reserves the right to change, reschedule or cancel any workshop at any time. UL shall not be responsible for any consequential or other losses resulting from the cancellation or postponement of this workshop such as airline and other travel/personal expenses.
UL Knowledge Services accepts the following forms of payment for registration: Visa, MasterCard, American Express and Invoice/PO. Please note that Invoice/PO is not accepted for online courses.
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Media
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Time Requirement
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Cost
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| Instructor-Led |
3 days |
$1,195.00 |
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Listed below are the dates and time(s) this course is offered. Select the class you would like to attend, and click the appropriate button below. Use the drop down box to restrict the list of classes to a specific venue (location, city or state). Otherwise, all class locations are listed.
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