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 1702
Detailed scope of accreditation – test methods for sterility, bioburden, endotoxins, airborne germ & particle counts (valid from 14.08.2020).
DAkkS Umbrella & Sub-Accreditation Certificates (2025)
Umbrella DAkkS Accreditation Certificate for all four partial accreditations D-PL-14013-01-01 through -04 (valid as of March 28, 2025).
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 testing: physicochemical, chemical, and microbiological methods for food, feed, cosmetics, environmental samples, and plastics (42 pages, valid as of March 28, 2025).
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, microbiological testing of non-sterile products, endotoxins, MALDI-TOF microbial identification (valid as of March 28, 2025).
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, microbiological and chemical parameters in accordance with the Drinking Water Ordinance (TrinkwV), the Mineral Water Ordinance, and the 42nd Federal Immission Control Ordinance (BImSchV) (effective as of March 28, 2025).
GMP – Good Manufacturing Practice
Certificate of GMP Compliance issued by Landesamt für Gesundheit und Soziales Berlin following inspection on 18 June 2021 – covers human medicinal products, investigational medicinal products, sterility testing & endotoxin testing.
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.