Biotech manufacturer recommended for continued certification to ISO 9001:2015 and ISO 13485:2016
Madison, WI USA. (April 17, 2020)
Promega Corporation announced today it successfully completed its first ever fully remote quality surveillance assessment and is recommended for continued certification to ISO 9001:2015 and ISO 13485:2016. Due to COVID-19 restrictions, the British Standards Institution (BSI) completed its six-day review of Promega manufacturing facilities in Madison, Wisconsin using video and voice calls from assessors’ home locations in Ohio and Georgia. Many on the Promega assessment facilitation team in Madison worked from home as well. Standard assessments usually entail on-site meetings and tours of multiple buildings.
Promega manufactures reagents used for COVID-19 testing. The company’s components currently support approximately 15 COVID-19 test kits around the world, and Promega provides RNA extraction reagents for more than 500 clinical labs globally.
“Being so customer focused, we have routinely needed to be nimble in our approaches while maintaining our quality standard, and manufacturing our COVID-19 related products is a real-time example of that,” says Ron Wheeler, Senior Director of Quality Assurance & Regulatory Affairs at Promega. “While a virtual assessment is a first for us, the team adjusted quickly because we were able to leverage our flexible quality system processes. This innovative approach enabled us to successfully complete this necessary assessment while also protecting both our business continuity and the health and safety of Promega and BSI staff.”
The Promega IT Department enabled the team to house large files for assessors to securely access and view, enabling full control of proprietary information. Discussions were conducted via video and audio conferencing. The team used www.promega.com, including the interactive Madison campus map on the website, to provide information about Promega products, facilities and operations. Assessors concluded with a recommendation of continued ISO certification and stated they were impressed with Promega capabilities, operations and knowledgeable staff.
ISO certification assures global customers that Promega is committed to quality and has established reliable and effective processes. Promega first certified to international standards for quality management systems in 1998, and the company’s commitment continues with 19 current global ISO certifications. The ISO series of quality management system standards are developed and maintained by the International Organization for Standardization. An organization achieving ISO certification has demonstrated to a third party that the organization meets all requirements of the standard and has implemented a quality system capable of developing, manufacturing, testing and delivering high quality products around the world.
To learn more about Promega ISO certification visit www.promega.com/quality
About Promega Corporation
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s 4,000 products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, drug discovery and human identification. Founded in 1978, the company is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. For more information about Promega, visit www.promega.com.