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Transitioning to ISO 13485:2003 Overview

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This one-day course is aimed at medical-device manufacturers who are transitioning their ISO 13485:1996 quality management system to the 2003 revision.
ISO 13485:2003 joins medical-device regulatory issues (ISO 13485:1996) with specific segments of ISO 9001:2000. The worldwide medical-device community developed ISO 13485:2003 in an effort to standardize quality management systems across the supply base. Medical-device suppliers will discover that this new standard gives top management greater responsibility for the quality management system and adds some new regulatory industry guidelines.

This course is designed to review the basic requirements of ISO 13485:2003, the transition issues for existing users of the 1996 standard and the process approach to management. Participants will also gain an understanding of the importance of quality objectives, the relationship of processes to procedures and the major changes to internal auditing. (One-day course)

Who Should Attend
Top management, quality professionals, steering committee members and others responsible for transitioning the existing quality management system from ISO 13485 to ISO 13485:2003.

Learning Outcomes
-Review the requirements of ISO 13485:2003.
-Learn the new responsibilities of top management.
-Discover the importance of quality objectives and process approach to business.
-Examine regulatory industry changes.
-Learn transition steps.
-Understand audit program changes.

OUTLINE
Day One
I.Introduction
II.Learning objectives
III.Review ISO 13485:2000
IV.Philosophy
V.Eight quality management principles
VI.Major changes from ISO 13485:1996
VII.Details — New standard, regulatory and transition issues
VIII.Process approach
IX.Internal auditing program

Internal Auditor Training for ISO 13485:2003
Learn the necessary background to develop, implement and audit an internal quality system that meets the requirements of ISO 9001:2000 and ISO 13485. This version of our QMS internal auditor course includes workshops tailored to meet the medical device industry and discussions of ISO 13485 medical devices-quality management systems requirements for regulatory purposes. Hands-on workshops reinforce the methods and techniques discussed. There is a one-hour exam on the last day.

Who Should Attend
Professionals who will conduct, manage, or participate in internal (first-party) audits in the medical device industry. It is useful for those seeking to develop an ISO 13485-compliant quality management system.

Learning Outcomes
-Become familiar with the elements of a sound quality system.
-Understand the audit evidence necessary to comply with ISO 13485 requirements.
-Using ISO 19011 as a guide, learn preaudit activities, conducting the audit, and post-audit and follow-up activities.
-Know how to prepare for an audit and effectively manage your resources.
-Know how to collect audit evidence and document observations, including techniques for effective questioning and listening.
-Understand how to verify effectiveness of corrective action, close out an audit, and conduct follow-up surveillances.


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