• Length of establishment – Manufacturers’ long history of designing surgical instrumentation can be an indication of the level of commitment to the industry and the accumulation of expertise in the use and manufacturing processes of these highly innovative instruments.

• Quality manufacturing conformance – It is imperative that quality controls for manufacturing, packing, storage, and installation 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 offer ISO 9001 certification, which underlines their commitment to quality control and continuous improvement. Olympus has gone one step further and recently received an independent evaluation of our entire quality system by the European Union. Our National Service Center qualified for and was granted ISO 13485 certification. For more details on what this certification means,
visit Olympus’ website and its Envision publication at: http://www.olympusamerica.com/msg_section/img/envision/08/
envision_Summer_2008.pdf.

• 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 type of product support exists? 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?

• Service Protocols – Original manufacturer parts and protocols protect the integrity of your equipment. It is important to understand how the manufacturer repairs your investment. Original manufacturer’s parts and protocols should be used by service/repair vendors in the repair process and protocols to ensure that your equipment is functioning properly. Make sure that broken and worn parts are replaced or repaired immediately using factory-certified parts and processes. At Olympus we know that our medical devices need to conform to the highest quality standards long after they are taken out of the box. Olympus repair processes are designed to return equipment to its original exacting factory specifications to preserve its superior quality and performance.

• Ongoing training – An organization’s investment in ongoing training for their employees and customers demonstrates its commitment to quality. Formal training programs for employees can contribute greatly to the product’s overall superiority. Additionally, ask your equipment manufacturer what type of training may be available for your organization. Olympus provides an extensive selection of educational programs through Olympus University; visit www.olympusuniversity.com for more information.

• 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. Be sure to understand which manufacturers are environmentally conscious in their business practices.