D2 Associates, LLC.
12 West Water St
Chillicothe, Oh 45601
Ph: 740-772-2019
12 West Water St
Chillicothe, Oh 45601
Ph: 740-772-2019
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Quality Management Systems: ISO 13485 for Medical Device Industries
AUDIENCE: Recommended for medical device and diagnostics industry quality and
support professionals who need the latest information on ISO 13485:2003, and those
responsible for implementing or transitioning to the revised standards
COURSE LENGTH: 1 day
SCOPE: Understand the ISO 13485:2003 and ISO 9001:2000 standards and how they
impact your organization. Group discussions focus on compliance and registration
issues. How to design and document an effective Quality Management System
(QMS), what the revised requirements mean for the worldwide medical device
industry, and what third party auditors look for and find. What steps should the
organization take and what are the potential benefits of registration. Review of
benefits include: increased productivity, cost effectiveness, higher perceived
quality, enhanced internal and external communication and enhanced competitive
advantage.
TRAINING OBJECTIVES:
. Understand and describe the purpose, benefits and objectives of ISO 13485: 2003
. Explain the similarities and differences between ISO 9001:2000 and ISO 13485:
2003.
. Discuss the recent changes to ISO 13485: 2003
. Understand the implications of the medical device industry – changing standards
and
regulations
. How and when to implement your quality management system (QMS)
. Choose an implementation plan
. Prepare for a compliance or registration audit
. What are the common system deficiencies found by external auditors
TRAINING TOPICS
. Introduction to ISO 13485: 2003
. ISO 13485: 2003 each section – review and analysis
. Documentation requirements
. Quality system procedures
. Samples procedures for use
. Discussion on ISO TR 14969 revision
MAXIMUM CLASS SIZE: 20
SUITABLE: On-site or public offering
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