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Pacific Biosciences Receives ISO 13485 and ISO 9001 Certification
Tuesday, December 15, 2015
MENLO PARK, Calif., Dec. 15, 2015 (GLOBE NEWSWIRE) — Pacific Biosciences of California, Inc., (Nasdaq:PACB) a pioneer and leader in long-read sequencing using its Single Molecule, Real-Time (SMRT®) Technology, today announced that the company has received ISO 13485 and ISO 9001 certifications for the design, development, manufacture, distribution, installation, and servicing of its nucleic acid sequencing platforms.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. The ISO 13485 Quality Management Standard for Medical Devices represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements.
“Achieving ISO certification demonstrates that PacBio has successfully implemented a quality management system that conforms to the world-wide standard for medical device and in vitro diagnostic (IVD) manufacturing,” said Jean Deslauriers, Director of Quality for Pacific Biosciences. “The ISO 13485 and ISO 9001 certifications represent an important milestone for our company and reflect our commitment to providing high quality products that meet customer expectations and comply with regulations.”
Michael Hunkapiller, Ph.D., Chairman and CEO of Pacific Biosciences commented: “These certifications are testament to the high level of performance and quality control we expect at PacBio during the development, manufacturing and support of our products. With an expanding global customer base, this level of rigor is important to ensuring our SMRT Sequencing products continue to provide accurate, reliable, and reproducible results.”
About Pacific Biosciences
Pacific Biosciences of California, Inc. (NASDAQ:PACB) offers sequencing systems to help scientists resolve genetically complex problems. Based on its novel Single Molecule, Real-Time (SMRT®) technology, Pacific Biosciences’ products enable: de novo genome assembly to finish genomes in order to more fully identify, annotate and decipher genomic structures; full-length transcript analysis to improve annotations in reference genomes, characterize alternatively spliced isoforms in important gene families, and find novel genes; targeted sequencing to more comprehensively characterize genetic variations; and DNA base modification identification to help characterize epigenetic regulation and DNA damage. Pacific Biosciences’ technology provides the industry’s highest consensus accuracy over the longest read lengths in combination with the ability to detect real-time kinetic information. PacBio sequencing systems, including consumables and software, provide a simple, fast, end-to-end workflow for SMRT Sequencing. More information is available at www.pacb.com.
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