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Online
"ISO 13485:2003 LEAD AUDITOR
TRAINING" |
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(Only
$359.95!)
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 Who should
take this online training?
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You want to quickly and efficiently
learn how to lead an ISO
13485:2003 audit,
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You want to quickly and efficiently be
trained on ISO 13485 (the standard), ISO
13485 (the vocabulary for the standard),
and ISO 9004 (the guideline to implement
the standard).
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You want to be a lead auditor to conduct
internal audits and supplier audits for
your company,
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You want to upgrade your expertise from
auditing ISO 13485:2000 to ISO
13485:2003,
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You want to upgrade your expertise from
auditing with ISO 10011-1 to ISO
19011:2002,
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You do NOT have time to allocate a 2-5
days to take an ISO auditor class,
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 Auditor Training.
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ISO/TS 13485:2003 Lead
Auditor Training
is the solution:
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It can be taken from anyone's
workplace or from home through the
Internet.
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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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The cost ranges from $305.96 for
group training of 10 or more
employes (each student receives
his own login and password) to
$359.95 for individual training.
This is an average 70% 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
ISO13485:2003 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 ISO
13485 Lead Auditor training certificate that
you can print for 22 hours of
training or 2.2 Continuing Education
Unit (CEU) on ISO 13485:2003 lead
auditor training on ISO
13485:2003.
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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 lead auditor classes:
"I just finished the
online ISO 13485 lead
auditor training and
wanted you know that two
weeks ago I attended a
5-day $1500.00 lead
auditor course. I actually
got a better understanding
of the new requirements
from your online course,
compared to some of the
areas that the 5-day
course left gray. I am
disappointed that I did
not know of the online
training prior to
investing the $1500.00,
your online training is
considerably less
expensive, more
comprehensive and I
received and
internationally recognized
training certificate. I
loved the convenience of
being to be able to take
it at my own pace and not
having to take time away
from work. I am going to
have members of all our
branches take this online
class, to strengthen our
audit team."
Mike Madewell - QA
Director of Taylor
Communications Inc. |
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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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Course Outline
for ISO 13485:2003
Lead Auditor Training
Course objective
This course
is based on the
quality management
system (QMS) standard
ISO9001:2008, the
guideline document for
implementing and
improving QMS's
ISO 9004:2000, and the
Fundamentals and
vocabulary for QMS's
ISO 9000:2005. It is
also based on ISO
19011, which is a
guideline document for
auditing quality
systems. The case
studies in the later
part of the course
will be presented
along with the
applicable sections of
ISO 13485:2003.
Course length
5-6 days
(doing a couple of
hours/day) are
required to complete
the ISO 13485:2003
lead auditor course.
Who should attend
Anyone who
wants to quickly and
efficiently understand
and learn how to audit
or lead an audit using
the QMS and EMS
auditing guideline to
ISO 19011:2002.
Course includes
The structure
of the training is as
follows
1. THE
STANDARD
2. THE
PROCESS APPROACH
3.
SCOPE
4. QUALITY
MANAGEMENT SYSTEM
5. MANAGEMENT
RESPONSIBILITY
6.
RESOURCE MANAGEMENT
7. PRODUCT REALIZATION
8. MEASUREMENT,
ANALYSIS AND
IMPROVEMENT
9.
DEFINITIONS
10.
TYPES OF AUDITS
11.
AUDIT OBJECTIVES
12. ROLES AND
RESPONSIBILITIES
13. AUDITOR ACTIVITIES
14. INITIATING THE
AUDIT
15. PREPARING
THE AUDIT
16.
EXECUTING THE AUDIT
17. WHAT THE AUDITOR
IS LOOKING FOR
18.
AUDIT DOCUMENTS
19.
AUDIT TECHNIQUES: TELL
ME/SHOW ME
20.
AUDIT TECHNIQUES:
AUDIT PATH
21.
AUDIT TECHNIQUES:
GRADUAL ELEVATION
22. AUDIT TECHNIQUES:
SAMPLING
23. AUDIT
COMPLETION AND
CORRECTIVE ACTION
FOLLOW-UP
24.
INDUSTRY 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
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 average
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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Courtesy
of CALISO |
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