ISO 9001 certification
Since 2008, Ella Biotech has maintained a Quality Management System (QMS) that is compliant and certified to ISO 9001. ISO 9001 is one of the most widely used management tools in the world today. It ensures that the company meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. Our Quality Management System is certified by DQS under certificate registration no. “345862 QM08”. The certification applies to following activities: “Development, Production and Distribution of Biopolymers”.
ISO 13485 certification
The International Organization for Standardization (ISO) is a voluntary, non-governmental organization that provides unified standards for many different areas of industrial activity. The ISO 13485 designation is the standard for manufacturers of medical diagnostics. While similar to GMP in many respects, holding an ISO 13485 certification is not a legal requirement, but is accepted as an international standard. Manufacturers are continually audited and must be recertified on a regular basis. The regular audits ensure that the reported standards of manufacturing are maintained and encourage continuous improvements.
As of 2010 we have observed an increasing demand for high quality oligos for use in In Vitro Diagnostics. Therefore, Ella Biotech determined to obtain the ISO 13485 certification to provide proof that we have a system in place to validate and provide traceability for oligonucleotide manufacturing history during the production process. In May 2011 we were successfully certified by DQS under certificate registration no. “345862 MP23SCC” for “Development, Production and Distribution of Biopolymers for the use in In-Vitro Diagnostics”.
Together with our customers in human diagnostics, we define the oligo characteristics that will work best for their diagnostic applications. We provide guidance on process scale-up for deliverable yields of a few nmoles up to multiple grams. We also boast supplementary services such as dedicated purification columns, aliquoting and other custom packaging, and oligo mixture formulation.
Please note: As we manufacture DNA oligonucleotides according to customer specifications, we do not claim any compliance to ISO with regards to design and development control as we are not involved in these steps.