ISO 13485:2003 Essentials Course

WHO SHOULD ATTEND
Two Day Course – $795
Individuals who have limited
or no prior knowledge of the
ISO 13485:2003 standard and
want to gain an understanding
of the requirements of the
ISO 9000:2000 standards with
a focus on Medical Devices
Manufacturing Industry.
ISO 13485:2003
Essentials Course
PRE-REQUISITE
None.
TO REGISTER OR FOR
MORE INFORMATION
CALL : 1 800 463-6727
E-MAIL : [email protected]
This interactive course provides the basic knowledge and understanding of the key requirements of the new
ISO 13485:2003 Medical devices — Quality management Systems — Requirements for regulatory purposes.
The course will benefit anyone working in an ISO 13485:2003 environment, and will be especially useful for
individuals who may be required to develop, maintain or audit Quality Management System conforming to
ISO 13485 requirements. This course covers the new structure of the ISO 9000 family of standards, the
process approach, the 8 Quality Management Principles upon which the new standard is based, and
incorporates the concepts of ISO 14969:2003, “Quality management systems - Guidance on the application
of ISO 13485:2003”, ISO 14971, “Application of risk management to medical devices”.
Course Materials Include:
Comprehensive Student binder. This includes the new ISO 13485:2003 Medical devices — Quality
management systems — Requirements for regulatory purposes and various reference materials on regulations
and requirements.
An Introduction to ISO 27001. Provides an overview of
the Information Security Management System standard.
Business in Balance: An Introduction to ISO 14001:
2004. This training tool is designed to help you understand the basics by observing the standard in action.
CSA now offers a catalogue of on-line courses, tools,
and solutions. Learn and practice skills at your own pace,
wherever you are, in a cost-effective manner. Programs
available include:
Quality at Work: An Introduction to ISO 9001:2000.
Designed to help you understand the essentials and how
implementing this standard can help your organization.
Plus many more. Click here for more information:
https://learningcentre.csa.ca/lc_site/elearning.asp
On-Site Training Available
CSA also offers education and training delivered at your site. We will combine modules from different training
programs to give you exactly the information you need when you want it. Included with every in-house program
are comprehensive written materials for permanent reference.
Click here for more information: https://learningcentre.csa.ca/lc_site/onsite_sem.asp
Registration Form
Register on-line at https://learningcentre.csa.ca or mail/fax this form to:
CSA Education & Training
https://learningcentre.csa.ca
1-800-463-6727
[email protected]
5060 Spectrum Way, Suite 100, Mississauga, ON L4W 5N6, Toll Free 1-800-463-6727, Fax 416-747-2510
Name:
Title:
Company:
REGISTRATION FEE
Address:
Includes continental breakfast,
lunch and seminar materials.
• Canadian residents add 5% GST
• Quebec residents add 7.5% TVQ
• Maritime residents (NB, NS, NL) are
subject to a 13% HST in lieu of the
5% GST
City/Prov./State
Postal/Zip Code:
Telephone:
Fax:
DISCOUNTS
Course name:
CSA Sustaining Members will be
given a 10% discount.
Course Location:
CANCELLATION/
SUBSTITUTION AND
TRANSFER POLICIES
Cancellation requests received more
than 14 calendar days before the start
of the course will receive a full refund
minus a $100 administration fee.
Cancellation requests received within
the 14 days prior to the course will be
non-refundable.
Important Note
Confirmation and other correspondence are issued via email. Please include your email address on this form.
e-mail:
Course Date:
Method of payment (please add taxes as applicable)
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Date:
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Fee:
Substitutions will be permitted at any
time prior to the start of the course.
Please ensure that the substitute
student has met the pre-requisite
requirements, if any.
Minus
applicable discount
Plus
applicable taxes
Payments must be received before the
seminar. CSA reserves the right to
cancel any seminar and will, in such
event, fully refund all registration fees.
No liability is assumed by the
organizers for changes in seminar
dates, contents, speakers or venue.
Please review our Privacy Statement at www.csagroup.org/legal/. We will use the information provided to process your seminar registration and send
you additional information about our courses, products and services. You may remove your name from CSA Group promotional and newsletter
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TOTAL
U.S. Customers may pay the equivalent in U.S. funds
For more information on CSA Education & Training, or to register on-line, visit us at
https://learningcentre.csa.ca, call 1-800-463-6727 or email [email protected]
Toronto
T (416) 747-4017
F (416) 747-2510
[email protected]
Montreal
T (514) 428-2418
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Edmonton
T (780) 490-2007
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Vancouver
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www.csa.ca