This is an ISO 13485 general orientation course
for personnel. The booklet is intended for distribution to each employee for
self-study or group training.
The course (see Table of Contents below)
- Explains the benefits of ISO 13485
- Explains how the quality system works
- Reviews the requirements of the standard
- Helps personnel to prepare for the
certification audit
- Provides a short multiple-choice test and
- Includes a certificate of completion
Now in its second edition (2003 standard), and
with over 20,000 copies sold, this course is established as the preferred choice
for company-wide ISO 13485 training
Table of Contents
Part 1: ISO 13485 Quality System
- The quality system helps us to achieve higher
customer satisfaction
- The quality policy and quality objectives
define our goals
- Your "customer" is the next person who uses the
output of your work
- How processes are controlled
- How the quality system works
- Our quality system is defined in three levels
of controlled documents
- You should use, maintain, and try to improve
the quality system
Part 2: ISO 13485 Standards
- ISO 13485 and national regulations
- ISO 13485 requirements
Part 3: ISO 13485 Audit
- ISO 13485 audit
- What happens during the registration audit
- Where auditors look
- How auditors examine documents and records
- What can you do to prepare for the audit
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