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Click for public course registration details.
 Certified QMS Internal Auditor Training Course
Learn
the steps to develop, implement, and audit an internal quality system that efficiently
and effectively meets the requirements of ISO 13485:2003 and ISO 9001:2008.
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.
Objectives
Understand 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.
Topics
- 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)
Who Should Attend
This 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.
This training course is certified by RABQSA and
satisfies the training requirement for individuals seeking registration under
the RABQSA QMS Internal Auditor Registration Scheme.
See also ISO 9001 Internal Auditing for the Medical Device Industry* (ISO 13485) and aerospace*
(AS 9100) industries. On-site versions are available with emphasis on the telecommunications
industry (TL 9000) and ISO
14001 environmental management systems.
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CEUs: 2.5
Number of Days: 3
* This course offered in conjunction with ASQ.
Code: IAF
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