Kemp Proteins’ Quality Management System receives ISO13485:2016 Certification
12th April 2022, Frederick, Maryland, — Kemp Proteins, a leading provider of gene-to-protein and monoclonal antibody development services to the pharmaceutical, diagnostics, and research industries, announced today that it has received ISO 13485:2016 certification for its Quality Management System (QMS). Achieving ISO 9001:2015 (certified since 2020) and now ISO 13485 certification demonstrates Kemp’s commitment to a company culture of continuous improvement and risk-based decision making, focused on providing our client partners with world-class protein development and manufacturing services.
“The conscious decision by our management team to implement a risk-based approach, together with the company philosophy of continual improvement, has enabled us to attain both ISO 9001:2015 and ISO 13485:2016 certification since purchasing the company in 2019,” said David Hicks, COO and Head of Quality for Kemp Proteins. “Achieving these ISO certifications affirms that we have successfully implemented a QMS that conforms to the ISO world-wide standards and represents important milestones for our company.”
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of QMS. ISO 13485:2016 is an internationally recognized quality standard to ensure a company’s QMS supports and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices and related services that meet their intended purpose.
“These important milestones are the best internationally recognized models to help demonstrate that Kemp Proteins’ Quality Management Systems reflects our commitment to providing our clients with a high-quality service – we are like an extension of their own laboratory.” Michael Keefe, CEO of Kemp Proteins commented, “In the last 3 years we have positioned ourselves as a world-class bioservices company, one that attracts high-achieving and driven personnel. This recent ISO 13485 Certification is testament to the hard work of the team and the high level of quality we expect throughout the development, manufacturing and support of our clients. Our Quality milestones together with our operational development provide a solid quality base for our company – one that we continue to build upon. We are committed to becoming a reliable partner to our varied client base.”
About Kemp Proteins (www.kempproteins.com)
Kemp Proteins LLC is a leading provider of gene-to-protein, hybridoma and cell line development services. Kemp’s team of experienced protein problem-solvers deliver best-in-class services that optimize productivity and mitigate risk for life sciences innovators developing protein-based products, including human and veterinary diagnostics, biopharmaceuticals, and vaccines. Kemp Proteins is a Six.02 Bioservices member company.
About Six.02 Bioservices (www.six02bio.com)
Six.02 Bioservices is a holding company focused on acquiring and managing a family of companies that will provide a continuum of best-in-class research services and products to protein-based innovators across the life sciences. The Six.02 Bioservices name reflects Avogadro’s number (6.023 x 1023), defined as the number of atoms or molecules per mole of any substance. The mole is a bridge between our world and the microscopic world—for example, a protein is 3×10-9 moles. Six.02 Bioservices was incorporated in 2018 on Mole Day (October 23), a date celebrated between 6:02 a.m. and 6:02 p.m. by scientists around the world.
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