ISO 13485 outlines quality management
system requirements for design, development, production and servicing of
medical devices and related services. Get to grips with the entire internal
auditing process, learn to plan audits, report on results and lead on follow up
action.
WHAT ARE THE
BENEFITS TO YOU?
This course will give you a
good understanding of how to perform an internal audit on your organisation's
processes. This will help you and your organisation to identify gaps in your
quality management system as a basis for improvement of regulatory compliance
and system effectiveness. Our experienced auditors will also guide you through
ISO 13485:2003 so that you have a good understanding of what your certification
body is looking for the next time they audit you.
APPLIED-
PRACTICAL TRAINING…
We have developed our training
courses to make them hands on and interactive. Simply put, it is our belief
that if we keep you involved in learning you will learn more and be able to use
more back at work.
SELF-POSSESSION
THAT YOUR QUALIFICATION IS VALID…
As an IRCA approved training course,
this course, our company and our trainers undergo an intensive inspection and
assessment every year with the International Register of Certificated Auditors
(IRCA) to give you the peace of mind that your qualification is valid and will
be recognised by your customers and certification body.
HOW TO BOOK…
Our course calendar can be viewed
below or just go to our BOOK NOW page if you know the course date you require.
Not too sure about which course to book? Just call us on 9566117567 to
discuss your training needs further
PRE-REQUIREMENTS
This course is intended for those
responsible for audit program for ISO 13485:2003, for those who perform the
audit, for Quality Assurance managers, ISO Project Managers, ISO Project Team
Members and for Managers & Supervisors interested in deeper understanding
of ISO 13485
Internal Auditor Training and its practical application.
ON THE
COURSE COMPLETION PARTICIPANTS WILL LEARN HOW TO
·
interpret & apply the requirements of ISO 13485
·
identify & implement the controls necessary for ensuring that QMS consistently
meets requirements.
·
conduct audit.
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