GENEME quality standards are certified according to ISO 13485:2016, which formalizes recognition of our competence to produce, analyze and distribute nucleic acids, in-vitro diagnostic assays (IVD’s) and applications. The company participates in proficiency tests. Proficiency tests are an important part of ongoing qualification/validation.

Processes are described in Standard Operating Procedures. They are reviewed periodically. We maintain a clean and hygienic manufacturing area. The processes are clearly defined, validated and controlled. Instruments are qualified. The requalification period is defined. Instrument-related test documents are archived. Changes that affect the quality are validated if necessary. In cases where the quality cannot be covered by verification, the production process is validated. Records demonstrate that all the steps required by the defined procedures and instructions are in fact taken. Deviations are investigated and documented. Records of manufacture that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.

Audits are performed to confirm that activities within the different processes correspond to internal and external demands, as well as to investigate the efficiency and suitability of the quality management system. Internal audits verify that the Company’s policy is implemented throughout the entire organisation.

Products that fall under the scope of European Directive 98/79/EC on In Vitro Diagnostic Device have been specified as CE IVD on the website. This enables us to comply with the general requirements and safety regulations of CE. Find CE IVD logo on the product pages as shown here: