ISO 13485:2003
FDA
cGMP
ISO 9001:2008
Contract Manufacturing Solutions,
Inc.,
better known as CMSI, proudly announced compliance to
the ISO 9001:2008 Standard issued through BSI
Management Systems. This significant achievement was
added to the already established ISO 13485:2003
Standard which CMSI puts great effort in throughout the
year to maintain through the highest Quality Systems in
the industry. The ISO 9001:2008 Certification
incorporates well with the ISO 13485:2003 registration,
while encompassing a focus on continuous improvement
and customer satisfaction.
ISO 9001:2008
indicates requirements for a quality management system
which are generic and intended to be applicable to all
organizations, regardless of type, size and product
produced. ISO 9000 is maintained by ISO, the
International Organization for Standardization, and is
administered by accreditation and certification bodies.
Some of the requirements in ISO 9001:2008 include but
are not limited to a set of procedures that cover all
key processes in the business, monitoring the processes
to ensure they are effective, keeping sufficient
records, evaluating output for defects and responding
with appropriate and corrective action where necessary
and overseeing continuous improvement.
ISO 13485:2003 ISO 13485:2003