Pulse Systems Receives Dual Certification Under ISO 13485:2003 and ISO 9001:2008
the company has attained dual certification under the International
Organization for Standardization (ISO) quality systems standards, ISO
13485:2003 and ISO 9001:2008.
“Achievement of these highly-regarded quality certifications reinforces
our commitment to providing world-class contract manufacturing services to the
medical device industry, and communicates the significant progress we have
made toward that goal,” said
Systems, commenting on the importance of the announcement to the company’s
business strategy.
“Customers can now take advantage of our superior capabilities in laser
cutting and other precision fabrication services with the confidence of
knowing our manufacturing processes comply with the demanding requirements of
both ISO 13485 and the newest version of ISO 9001,” added
Manager at Pulse Systems, who led the certification program for the company.
The ISO 13485:2003 standard is specifically designed to certify medical
device manufacturers and their key suppliers. This standard defines
requirements for a quality management system where an organization needs to
demonstrate its ability to provide medical devices and related services that
consistently meet customer specifications and regulatory requirements.
ISO 9001:2008 is the most recent update of the widely-recognized ISO 9001
standard. While not specific to medical device manufacturing, ISO 9001 is
intended to enhance customer satisfaction through the effective application of
a quality management system, including processes for continual improvement of
the system and the assurance of conformity to customer and applicable
statutory and regulatory requirements. Pulse Systems had previously earned ISO
9001:2000 certification in
About Pulse Systems
Pulse Systems provides precision laser cutting of tubular metal components
for the medical device industry, including implantable devices such as
endovascular stents. The company also supplies value-added finishing processes
such as laser welding, electropolishing, Nitinol shape-setting, microblasting,
and Class 10,000 cleanroom assembly. Pulse Systems specializes in rapid
turnaround of prototype parts, and can support full production volumes through
its manufacturing operations. To learn more about Pulse Systems, visit
http://www.pulsesystems.com.
Pulse Systems will be exhibiting at the Medical Design and Manufacturing
West tradeshow in
SOURCE Pulse Systems