Quality Management System
Manufacturing or selling medical devices?
Plan to sell your products in the Europe or Canada?
Need to comply with the US FDA QSR?
Need to improve field action and customer complaint processes?
Wish you could do things right the first time?
We can help! Quality Works assisted dozens of
companies around the World in establishing and implementing
effective ISO 13485 2003 Quality Management Systems. ISO 13485
is a quality management system standard designed specifically for
medical device manufacturers. A Quality Management System compliant
with the standard is mandatory for a number of classes of medical
devices in Europe and Canada. The ISO 13485 2003 is based on ISO
9001 2000 standard, and has many of the same requirements. However,
there are additional requirements for process control, design
control, retention of records, traceability, compliance with
regulatory requirements and others.
Check our Products page to discover how
our documentation sets can help you in developing your Quality
Management System or call us for a complimentary, no obligation consultation.
We will be glad to assist you!
Call us today to discuss your specific ISO
13485 quality management system needs!
Discover techniques to build Lean ISO 13485 Management Systems.
Download a complimentary copy of our
The Prefect Manual - A Guide
to Lean Management Systems book