Certificate D-PL-14013-01-02
DAkkS accreditation certificate for medical devices – microbiological & hygienic testing, environmental monitoring (valid from 14.08.2020).
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Certificates & Accreditation Documents
Selected certificates, accreditation scopes and designations. Certificates for other sites are available on request from our respective quality management team.
DAkkS Accreditation – Medical Devices
Annex to Certificate D-PL-14013-01-02 (available in German only)
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 Certificate & Annexes
Umbrella Certificate D-PL-14013-01-00 (available in German only)
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).
Annex to Sub-Certificate D-PL-14013-01-01 (available in German only)
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).
Annex to Sub-Certificate D-PL-14013-01-03 (available in German only)
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).
Annex to Sub-Certificate D-PL-14013-01-04 (available in German only)
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
GMP Certificate DE_BE_01_GMP_2024_0054
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.
Flexible Accreditation Scope – Lists of Accredited Test Methods
Flex List D-PL-14013-01-01 Berlin
Current list of all accredited test methods under sub-certificate -01 (food, feed, cosmetics – Berlin site).
Flex List D-PL-14013-01-01 Ohrdruf
Current list of all accredited test methods under sub-certificate -01 (food, feed, cosmetics – Ohrdruf site).
Flex List D-PL-14013-01-03 Berlin
Current list of all accredited test methods under sub-certificate -03 (pharmaceuticals & active substances – Berlin site).
Flex List D-PL-14013-01-04 Berlin
Current list of all accredited test methods under sub-certificate -04 (water analysis – Berlin site).
Flex List D-PL-14013-01-04 Ohrdruf
Current list of all accredited test methods under sub-certificate -04 (water analysis – Ohrdruf site).
Designations & Official Approval
Organic Farming Certificate LAGeSo (available in German only)
Authorised to perform official controls within the EU Organic Regulation (Regulation (EU) 2018/848).
Non-GMO Project (available in English only)
GMO screening, event-specific identification and quantification for Non-GMO Project compliance.
Forms & Shipping Documents
Explore a curated selection of documents to support your processes and requirements.
