Fluidigm receives ISO 13485 and ISO 9001 certification

Fluidigm, a pioneer in single-cell analysis, announced the company has received ISO 13485:2003 and ISO 9001:2008 certification for the design, development, manufacturing and distribution of single-cell genomics and high-throughput genomics systems.

The certified San Francisco facility designs and develops instrumentation, integrated fluidic circuits (IFCs), reagents, and software, and manufactures high-performance genomic reagents and conjugated antibodies. The certified Singapore facility manufactures Fluidigm instruments and IFCs for comprehensive analysis of single cells and nucleic acids from blood, tissues, and tumor samples.

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 13485:2003 includes requirements for the implementation of a quality management system for the design and manufacturing of medical devices. ISO 9001:2008 specifies requirements for a quality management system to demonstrate the companies’ ability to consistently provide products that meet customer and applicable statutory and regulatory requirements.

Our decision to invest in quality management systems, processes, and facilities was in response to our customer needs both today and in the future,” said Emi Zychlinsky, PhD, Senior Vice President of Quality and Regulatory at Fluidigm. “Simultaneous achievement of both ISO 13485 and ISO 9001 certifications through BSI reflects our commitment to provide high-quality products and customer service around the world.

These certifications are a significant milestone for Fluidigm, providing an important foundation to expand our business into clinical applications,” said Gajus Worthington, Chief Executive Officer of Fluidigm. “A commitment to quality is central to our mission. Providing our customers with reliable, high-performing products they can trust to answer life’s biggest questions, is our passion.”