• Length of establishment – A longer history
of surgical instrument manufacturing can indicate a level of
commitment to the industry and an accumulation of expertise in the
use, design and manufacturing processes of these highly innovative
instruments.
• Quality controls for manufacturing,
packing, storage, and installation should be in conformance with the
Quality System/Good Manufacturing Practice (QS/GMP) for Medical
Devices Regulations. Surgical OEMs are required to meet these
standards. Look for OEMs that go one step further with ISO 9001
certification, which underlines their commitment to quality control
and continuous improvement.
• Customer satisfaction – What systems does
the OEM have in place for handling faulty or otherwise unsatisfactory
products? Have they established a formal customer care unit? What sort
of product support do they have in place? What is their policy on
product returns, and how do they handle that process?
• Extended warranties – Help protect your
asset for a longer period. If an OEM offers an extended warranty, it
also demonstrates a level of confidence in their product and its
useful life.
• Quality control for supplied parts – What
percentage of the parts used in manufacturing the instrument are
provided by outside suppliers? What system does the OEM have in place
for quality control on these supplied parts and finished goods?
• Original manufacturer’s parts and
protocols should be used by service/repair vendors in the
repair process. To protect the integrity of your equipment, make sure
that broken and worn parts are replaced or repaired immediately using
only factory-certified parts and processes.
• Ongoing training – An organization’s
investment in ongoing training for their employees demonstrates its
commitment to quality. Formal training programs for employees can
contribute greatly to the product’s overall superiority.
• Waste handling – Environmental protection standards and
policies help to reduce consumption and control hazardous chemical
substances used in the product’s manufacturing process. They also
promote efficiency and recycling, resulting in better cost management.
