DAkkS accreditation certificate for medical devices – microbiological & hygienic testing, environmental monitoring (valid from 14.08.2020).
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Certificates & Accreditation Documents
DAkkS Accreditation – DIN EN ISO/IEC 17025
Detailed scope of accreditation – sterility testing, bioburden determination, detection of specified microorganisms, bacterial endotoxins (LAL), and airborne and surface germ counts in cleanrooms (valid from 07.07.2026).
DAkkS Umbrella & Sub-Accreditation Certificates
Umbrella DAkkS Accreditation Certificate covering all four partial accreditations D-PL-14013-01-01 through -04 (issued 24 August 2026; sub-accreditation -01 valid from 24.08.2026, -02 to -04 valid from 07.07.2026).
Appendix to the General Accreditation Certificate listing the four valid partial accreditation numbers (valid as of March 28, 2025).
Partial Accreditation Certificate for Food, Feed, and Cosmetics – Physical-Chemical and Microbiological Testing (Valid as of March 28, 2025).
Detailed scope of accreditation for consumer health protection – immunological, microbiological, molecular biological, physical, physicochemical, chemical, sensory and visual testing of food, feed, cosmetics, culture media, food contact materials and environmental samples at the Berlin and Ohrdruf sites (valid from 24.08.2026).
Partial Accreditation Certificate for Medicines and Active Ingredients – Analysis of Biopharmaceuticals, Active Ingredients, and Excipients (valid as of March 28, 2025).
Scope of pharmaceutical analysis – sterility testing, microbiological testing of non-sterile and herbal medicinal products, antimicrobial preservative efficacy testing, bacterial endotoxins and MALDI-TOF microbial identification for medicinal products, active ingredients and excipients (valid from 07.07.2026).
Partial Accreditation Certificate for Water Testing – Drinking Water, Swimming Pool Water, Mineral Water, Dental Water, Process Water (valid as of March 28, 2025).
Detailed scope of water testing – sampling and analysis of drinking water, mineral, spring and table water, swimming pool water, water from dental units, service water and food-industry process water in accordance with the Drinking Water Ordinance (TrinkwV), the Mineral Water Ordinance and the 42nd BImSchV, at the Berlin and Ohrdruf sites (valid from 07.07.2026).
GMP – Good Manufacturing Practice
Certificate of GMP Compliance issued by Landesamt für Gesundheit und Soziales Berlin following inspection on 10 October 2024 – covers human medicinal products and investigational medicinal products (phases I–III), sterility testing, microbiological testing of non-sterile products and bacterial endotoxin testing (LAL). Batch certification is not included.
Official letter of confirmation from LAGeSo Berlin regarding continued GMP compliance during the suspension of routine inspections due to the coronavirus pandemic (March 25, 2021).
Flexible Accreditation Scope – Lists of Accredited Test Methods
Current list of all accredited test methods under sub-certificate -01 (food, feed, cosmetics – Berlin site).
Current list of all accredited test methods under sub-certificate -01 (food, feed, cosmetics – Ohrdruf site).
Current list of all accredited test methods under sub-certificate -03 (pharmaceuticals & active substances – Berlin site).
Current list of all accredited test methods under sub-certificate -04 (water analysis – Berlin site).
Current list of all accredited test methods under sub-certificate -04 (water analysis – Ohrdruf site).
Regulatory Designation & Official Approval
Authorised to perform official controls within the EU Organic Regulation (Regulation (EU) 2018/848).
GMO screening, event-specific identification and quantification for Non-GMO Project compliance.