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Related Products:
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- Document Control
- ISO Management Modules
- Template Manual & Procedures
- Internal Audit Checklist
- Employee Training Booklets
- Tutorials and Guides (PDF)
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Also fully complies with
21 CRF 820 (FDA QSR)
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ISO 13485 IN OUR COMPANY
Self-study Course for Personnel
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24-page training booklet,
test, and certificate
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3 PDF files: booklet,
test, and certificate
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Purchase
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Free Samples
To download free samples/certificates, click on appropriate picture or link below.
Your browser will do the rest.
For Self-study or Group Training
Since 1996 this has been the most popular ISO 13485/FDA QSR general orientation
course on the market. The booklet is intended for distribution to all personnel
for self-study or group training. The course:
- Explains the benefits of ISO 13485 quality
system
- Explains how the quality system works
- Instructs personnel how to use the
system
- Reviews the requirements of the standard
- Helps personnel to prepare for the
ISO 13485 certification audits
- Provides a short multiple-choice test
- Includes a certificate of completion
Now in its fourth edition, and with over 20,000 copies sold, this course is established
as the preferred choice for company-wide ISO 13485 training.
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Quick FAQs
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- Are these booklets the same as those
offered in the Complete System Package?
Yes, these are the same booklets.
- Is there a discount when I buy the training
booklets together with other products in the Complete System Software Package?
Yes, you save nearly $600 when you purchase the Complete System Package, which includes
the employee training booklets, the ISOXpress software, ISO 13485 template manual
and procedures, and internal audit checklist.
- Who in the company needs to take this
training? Is it actually required in the ISO 13485 or 21 CFR 820 standard/regulation?
Everyone in the company must take a general orientation training about the ISO 13485/FDA
QSR quality system. This is explicitly required in the standard/regulation.
- How many questions are there on the
test? Is it difficult?
The test has 12 questions, and they are not difficult. The main purpose is to verify
that the trainee actually read the booklet.
- Can I reuse a booklet for more than
one person?
No, the booklet is intended to be used by one person only. It is a workbook, i.e.,
trainees need to write in it and check boxes. You must buy a license package that
covers all personnel who will use this booklet.
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