Globe Newswire06.11.18
Pulse Systems has announced the company's ISO 13485 and ISO 9001 certifications have been successfully updated to the latest revisions of both standards. The company’s Quality Systems are now certified to the ISO 13485:2016 and ISO 9001:2015 standards, which represent the most recent revisions of these widely recognized manufacturing quality standards issued by the International Organization for Standardization (ISO).
"Our recent upgrade of these widely-recognized ISO quality certifications represents the culmination of significant effort by our entire quality, technical, and operations team,” said Herb Bellucci, president and CEO of Pulse Systems. “This latest company achievement highlights our on-going commitment to providing top-tier contract manufacturing services to the medical device industry."
Scott Nierotka, Pulse Systems’ director of engineering & quality, who led the successful upgrade project for the company, said, "We’re very proud of our many accomplishments at Pulse, from our pioneering work in developing and expanding our production-level laser machining capabilities for the medical device industry to the extension of our capabilities into laser welding, small part CNC machining, and Nitinol post-processing, all under our ISO certified Quality Systems. These latest revisions of the ISO standards incorporate the current thinking in risk management and adjust our focus from following internal processes toward meeting the complex needs of our external customers and regulatory agencies.”
The ISO 13485 standard is specifically designed to certify medical device manufacturers and their key suppliers. This International Standard specifies 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 and applicable regulatory requirements. Pulse Systems has been certified under ISO 13485 continuously since 2009.
While not specific to medical device manufacturing, the ISO 9001 standard specifies broadly-applicable requirements for a quality management system for organizations which need to demonstrate their ability to consistently provide products and services that meet both customer requirements, as well as applicable statutory and regulatory requirements. Pulse Systems first adopted the ISO 9001 standard in 2006.
Pulse Systems is exhibiting at the MD&M East tradeshow, at the Javits Convention Center in New York, June 12-14, 2018. Pulse Systems representatives will be available at Booth 439 to discuss the company’s manufacturing capabilities.
"Our recent upgrade of these widely-recognized ISO quality certifications represents the culmination of significant effort by our entire quality, technical, and operations team,” said Herb Bellucci, president and CEO of Pulse Systems. “This latest company achievement highlights our on-going commitment to providing top-tier contract manufacturing services to the medical device industry."
Scott Nierotka, Pulse Systems’ director of engineering & quality, who led the successful upgrade project for the company, said, "We’re very proud of our many accomplishments at Pulse, from our pioneering work in developing and expanding our production-level laser machining capabilities for the medical device industry to the extension of our capabilities into laser welding, small part CNC machining, and Nitinol post-processing, all under our ISO certified Quality Systems. These latest revisions of the ISO standards incorporate the current thinking in risk management and adjust our focus from following internal processes toward meeting the complex needs of our external customers and regulatory agencies.”
The ISO 13485 standard is specifically designed to certify medical device manufacturers and their key suppliers. This International Standard specifies 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 and applicable regulatory requirements. Pulse Systems has been certified under ISO 13485 continuously since 2009.
While not specific to medical device manufacturing, the ISO 9001 standard specifies broadly-applicable requirements for a quality management system for organizations which need to demonstrate their ability to consistently provide products and services that meet both customer requirements, as well as applicable statutory and regulatory requirements. Pulse Systems first adopted the ISO 9001 standard in 2006.
Pulse Systems is exhibiting at the MD&M East tradeshow, at the Javits Convention Center in New York, June 12-14, 2018. Pulse Systems representatives will be available at Booth 439 to discuss the company’s manufacturing capabilities.
