Quality
OakRiver Registrar: BSI
OakRiver's quality system was developed prior to the formal launch of the company. The founders of the company realized that the organization and operations of a successful engineering services firm had to be built on quality. This is especially true given OakRiver's participation in the medical device marketplace.
With over 10 years of history, OakRiver's quality system and processes have proven to be a differentiator in the engineering services we offer, helping us secure a marquee customer list in medical, semiconductor, and industrial markets.
Specifically in the medical device market, OakRiver's quality system has been leveraged to help customers develop their validation protocols and documentation. With growing regulatory requirements and increased demands on our customers' internal engineers, OakRiver has developed a suite of validation support services. These include IQ/OQ/PQ protocol development, test protocol development, test protocol execution, and calibration to name a few. We are both ISO9001 and 13485 certified. We are proud of our quality system and our customers have continuously told us that it is an integral part of the value we bring to their projects.
With over 10 years of history, OakRiver's quality system and processes have proven to be a differentiator in the engineering services we offer, helping us secure a marquee customer list in medical, semiconductor, and industrial markets.
Specifically in the medical device market, OakRiver's quality system has been leveraged to help customers develop their validation protocols and documentation. With growing regulatory requirements and increased demands on our customers' internal engineers, OakRiver has developed a suite of validation support services. These include IQ/OQ/PQ protocol development, test protocol development, test protocol execution, and calibration to name a few. We are both ISO9001 and 13485 certified. We are proud of our quality system and our customers have continuously told us that it is an integral part of the value we bring to their projects.
OakRiver's Quality System is certified to the following standards:
ISO 9001:2008 Design & Manufacturing, Registration #FM 98980
ISO 13485:2003 Medical Device Design & Manufacturing, Registration #FM 58109
