COLA recently passed its audit from the British Standards Institute (BSI), which extended COLA’s ISO 9001 certification to COLA’s newly launched FDA Third Party Review Services, according to a press release from COLA.
COLA’s ISO 9001 certificate covers the delivery and administration of the CLIA-equivalent accreditation program for medical laboratories, including on-site surveys, educational guidance throughout the post-survey process, and monitoring proficiency testing, in addition to laboratory education and FDA Third Party Review Services.
“The staff involved in the audit did a fantastic job sharing their work and commitment to internal and external customers. The auditor was particularly interested in the impact of the pandemic on our organizational goals, processes and metrics,” said Kathryn Connolly, Director of Quality Systems at COLA. “We shared the work of our COVID response team, and all the efforts by staff to keep moving forward, despite the uncertainty.”
The BSI auditor highlighted COLA’s organizational flexibility in response to the pandemic, formalization of project management leading to the completion of projects to meet strategic goals, and diversification opportunity in FDA Third Party Review as examples of best practices applicable in any industry.
COLA has been continually certified to ISO 9001 since initially receiving its ISO certification in April 2011 from the BSI. The ISO certificate is good for three years, after that time the company must complete a full-scale audit of its quality management system and business processes.
