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Online
"ISO
13485:2003 / ISO 19011 AUDITOR
TRAINING" |
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(Only
$249.95!)
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Who should
take this online training?
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You want to quickly and efficiently
learn how to audit to ISO 13485:2003.
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You want to upgrade your expertise
from auditing ISO 13485:1996 to ISO
13485:2003.
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You want to upgrade your expertise
from auditing with the guidance ISO
10011-1 to ISO 19011:2002.
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You do NOT have time to allocate 2
days to take an ISO auditor class.
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You want to train more of your staff
on auditing economically and without
having to immobilize them in a class
for a full day.
We also offer
ISO
13485 Training and
ISO 13485 Lead Auditor Training.
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ISO/TS 13485:2003 / ISO 19011
Auditor Training
is the solution:
-
It can be taken from anyone's
workplace or from home through the
Internet without any time limit to
complete the course.
-
It has "save and exit" features so
that you can do it at your own pace
(a couple of sections per day...).
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After registration, there are no
time limits on when you can start or
complete the course. You have
complete flexibility in taking the
course around your schedule.
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The cost ranges from $212.46 for
group training to $249.95 for
individual training. This is an
average 60% cost savings on
comparable class courses.
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It uses quizzes and case studies
that give very good exposure on
various types and classes of
medical devices.
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It provides excerpts of the
International Standard ANSI/ISO/ASQ
Q9001-2000 and uses ANSI/ISO/ASQ
ISO 19011 to give guidance on
auditing quality systems. Both
standards are reprinted with
permission of the American Society
for Quality and ANSI. All the
theoretical aspect of auditing is
covered according to the
guidelines of RAB (Registrar
Accreditation Board). Practical
training with trained auditors,
such as participation in an audit
is necessary before you can audit
effectively after taking this
class.
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It uses a continuous evaluation
method with on-going quizzes and
case studies to facilitate the
information retention.
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If your final average in the
ongoing evaluation is equal or
greater to 70% you will be issued
a training certificate that
you can print for 16 hours of
training on auditing 13485:2003
using ISO 19011.
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If your final average in the ongoing
evaluation is less than 70%, you
will have to take a final exam and
score above 70% to be issued the
training certificate.
Worldwide Course
Recognition:
Our online training courses are
recognized by all registrars and
hiring companies as objective evidence
of effective training on the
particular standard and regulation.
Since 1999, they have been the most
popular and most widely used training
courses in english, with over 15,000
trainees in the US and wordwide. The
standard and regulations are provided
online under licensing of the American
National Standard Institute (ANSI),
the American Society of Automative
Engineer (SAE), or courtesy of the
Federal Drug Administration (FDA).
Employees
of some of the following corporations are using this
online training:
Philips Medical andBaxter Healthcare .
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Testimonial
our auditor classes:
"I
just completed the Interactive online training for
the new ISO 9000:2000 Standard. I liked the fact
that I was able to take the class at my
convenience from my desk at work. I was able to
allocate a few hours over a 4-day period to take
the class. The layout of the on-line training was
easy to follow. All of the standard requirements
were in italics and an easy-to-understand
"translation" could be found directly
underneath. Also, since each section was followed
by a short quiz the entire process didn't feel
overwhelming."
Julie
C. Hagmann - ISO Coordinator of Baxter Healthcare
Corporation-Pleasanton Division |
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Signup
& Training Instruction |
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Step
1
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REGISTRATION
Upon
registration using Visa, America Express, or MasterCard (PO
purchases are available for
corporate accounts), you will
receive an invoice, an E-mail notification with the password to be
used to login to take the class. Fax the PO to (714) 484-3014.
THE
TRANSACTION IS SECURE:
The credit card registration
is done through a secure
socket, so there is no risk
for your credit card
information, which is
protected and cannot be
intercepted.

If you
register multiple users, you will receive a password for each one of
them. |
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Step
2
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Go
to the PRE-SIGNUP
SCREEN,
select a User ID that you can
remember easily, enter your
password and invoice #. |
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Step
3
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If
you are part of a group of
users, go to the SIGNUP
SCREEN,
and enter your personal
information that will be used
in the training certificate. |
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Step
4
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Go
to the LOGIN
SCREEN;
enter your User ID and
password.
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You
will be presented with
training slides followed by
quizzes, after taking a quiz,
click on the score button to
proceed.
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You
cannot retake quizzes again,
but you can go back and look
at previous slides by using
the "Previous"
button.
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You
have help buttons for each
quiz question, and
documentation examples for
each training slide.
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Unless
otherwise designated, all quiz
questions are within the
context of ISO/TS 16949:2002
and ISO
9004:2000.
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The
training is optimized for Microsoft
Internet Explorer 5.0+ and
Netscape
4.5+
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Suggestions
and Recommendations:
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Even if your
connection appears
to be slow, do not
click on buttons
such as "submit",
"Login" or "Score"
twice.
- Empty
your disk cache on a
regular basis to optimize
the performance of your
browser.
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For ease of
readability,
select "Verdana"
as your display
font.
- Do not disable
cookies.
- If
you are planning to leave
the training for more than
20 minutes, "Save and
Exit". The training
session times-out after 20
minutes of inactivity.
- If
you get an "Invalid
Amount" message
during registration, try a
different credit card
first. Some credit cards
do not allow certain
e-business transactions.
- Order
copies of the ISO/TS
16949:2002
standards from
ASQ
or
American
National Standards
Institute.
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Courtesy
of CALISO |
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Course
Outline for ISO
13485:2003/ ISO
19011 Auditor
Course objective
This course
has been
specifically
designed to meet the
needs of the Medical
Device Industry and
is for individuals
responsible for
planning and
scheduling an audit
program for ISO
13485 and those who
must perform audits
to ISO 13485 for
quality assurance.
It provides in-depth
understanding of the
ISO 13485 Audit
Process.
Course length
2 days are
required to complete
the ISO 13485
auditor course
Who should attend?
This is the
ideal course for
anyone who wants to
quickly and
efficiently learn
how to audit to ISO
13485:2003, upgrade
his/her expertise
from auditing ISO
13485:1996 to ISO
13485:2003, and
upgrade his/her
expertise from
auditing with the
guidance ISO 10011-1
to ISO 19011:2002.
The structure of the
training is as
follows:
1.
DEFINITIONS 2.
TYPES OF AUDITS
3. AUDIT OBJECTIVES
4. ROLES AND
RESPONSIBILITIES
5. AUDITOR
ACTIVITIES 6.
INITIATING THE AUDIT
7. PREPARING THE
AUDIT 8.
EXECUTING THE AUDIT
9. WHAT THE AUDITOR
IS LOOKING FOR
10. AUDIT DOCUMENTS
11. AUDIT
TECHNIQUES: TELL
ME/SHOW ME 12.
AUDIT TECHNIQUES:
AUDIT PATH 13.
AUDIT TECHNIQUES:
GRADUAL ELEVATION
14. AUDIT
TECHNIQUES: SAMPLING
18. AUDIT COMPLETION
AND CORRECTIVE
ACTION FOLLOW-UP
19. MEDICAL DEVICE
CASE STUDIES
Worldwide Course
Recognition:
Our online
training courses are
recognized by all
registrars and
hiring companies as
objective evidence
of effective
training on the
particular standard
and regulation.
Since 1999, they
have been the most
popular and most
widely used training
courses in English,
with over 15,000
trainees in the US
and worldwide. The
standard and
regulations are
provided online
under licensing of
the American
National Standard
Institute (ANSI),
the American Society
of Automotive
Engineer (SAE), or
courtesy of the
Federal Drug
Administration
(FDA).
Course requirements
• If you
are not familiar
with the ISO
13485:2003 standard,
it is recommended to
take the ISO
13485:2003 training
course first. •
The training is
optimized for
Microsoft Internet
explore 5.0 or
higher and Netscape
4.5 or higher.
Certificate
requirements
The course
uses a continuous
evaluation method
with on-going
quizzes to
facilitate the
information
retention. If your
final average is
equal or greater to
70% you will be
issued a training
certificate. If your
final averag
evaluation is less
than 70%, you will
have to take a final
exam and score above
70% to be issued the
training
certificate. |
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