Pulse Systems Receives Dual Certification Under ISO 13485:2003 and ISO 9001:2008.
Medical device industry supplier gains recognition for the Quality Systems utilized to manufacture stents and other precision components
CONCORD, Calif., Feb. 4 /PRNewswire/ -- Pulse Systems announced today that the company has attained dual certification under the International Organization for Standardization International Organization for Standardization (ISO)
Organization for determining standards in most technical and nontechnical fields. Founded in Geneva in 1947, its membership includes more than 100 countries. (ISO (1) See ISO speed.
(2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. ) 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 Herb Bellucci, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Pulse 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 fabrication (fab´rikā´shn),
n the construction or making of a restoration. 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 Henry Maze, Quality 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 Continual Improvement (also called incremental improvement or staircase improvement) is a process or productivity improvement tool intended to have a stable and consistent growth and improvement of all the segments of a process or processes. 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 January 2006.
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 Laser welding
Welding with a laser beam. The primary apparatus is the continuous-wave, convectively cooled CO2 laser with either oscillator/amplifier (gaussian output beam) or unstable resonator (hollows output beam) optics. , 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 Anaheim, February 10-12, 2009 (Booth 3422).
CONTACT: Herbert J. Bellucci, President & CEO of Pulse Systems, +1-925-798-4080, firstname.lastname@example.org
Web site: http://www.pulsesystems.com/