Learn the process-based concepts of the new ISO 13485:2003 - Medical Devices Quality Management Systems requirements for regulator purposes. Understand the relationships to the ISO 9001:2000 standard and the U.S. Quality System Regulation 21 CFR 820. Acquire the skills to conduct successful internal quality audits for ISO 13485:2003 and the related standards under the guidance of an experienced auditor/facilitator.
Learn the full range of internal auditing skills needed to lead your company's effort in developing a process-based auditing program leading to maximum value from your quality management system Review of the ISO 13485:2003 standard and comparison to requirements of ISO 9001:2000 and 21 CFR 820 Define and use basic quality system terminology Discuss the process approach and its impact upon auditing techniques and methodology Use innovative exercises to help you thoroughly understand the purpose and role of the internal quality auditor Learn and practice effective communication skills and techniques, including effective questioning and conflict management Learn how to plan, prepare and perform an internal quality audit. You will discuss how to participate in audit team meetings, collect audit evidence and report your findings.
Topics Covered Include:
The ISO 13485:2003 standard Basic system terminology Effective communication skills and techniques The internal quality audit.
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