ISO 13485:2003
FDA
cGMP
ISO 9001:2008
Contract Manufacturing Solutions, Inc.,
better known as CMSI, proudly announced compliance to
the ISO 13485:2003 Standard on July 7, 2006. BSI
Management Systems, performed the audit in July and
recommended Contract Manufacturing Solutions, Inc. for
certification promptly thereafter. The ISO standards
provide a framework for an organization’s structure,
management and operational systems and procedures,
which combined will ensure consistency, efficiency, and
continuous improvement of services. ISO also helps pin
point weaknesses in processes and the root causes of
problems which lend to continuous improvement.
“Compliance represents a COMMITMENT on our behalf to
take our company far beyond the organizational
standards of our competitors and to surpass our
partner’s expectations for a quality organization,"
said Edwin Aguilera, President of Contract
manufacturing Solutions, Inc.
ISO 13485:2003
is an ISO standard, published in 2003, that indicates
the requirements for a comprehensive management system
for the design and manufacture of medical devices. This
standard places an emphasis on meeting regulatory as
well as customer requirements, risk management and
maintaining effective processes, mainly the processes
specific to the safe design, manufacture and
distribution of medical devices. ISO 13485 implies that
risk management must be intensively documented and
conducted throughout a product’s entire lifecycle, from
concept to both delivery and post-delivery.
ISO 13485:2003 ISO 13485:2003