Pulse Systems upgrades ISO 13485:2016 and ISO 9001:2015 certifications


Medical industry supplier attains newest revisions for the quality systems utilised to manufacture precision device components

Pulse Systems has announced that its ISO 13485 and ISO 9001 certifications have been successfully updated to the latest revisions of both standards.

Pulse Systems, is wholly-owned subsidiary of United American Healthcare Corporation, it provides precision machining of metal components for the medical device industry. The company performs precision laser machining of tubular and flat metal components and ISO 7 (class 10,000) cleanroom assembly.

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 recognised manufacturing quality standards issued by the International Organization for Standardization (ISO).

"Our recent upgrade of these widely recognised 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 are 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."

He continued: "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 organisation 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.

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While not specific to medical device manufacturing, the ISO 9001 standard specifies broadly-applicable requirements for a quality management system for organisations that need to demonstrate their ability to consistently provide products and services that meet both customer requirements, as well as applicable statutory and regulatory requirements.