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Document Library

Find and download the documents you need – from accreditation certificates and submission forms to technical guidelines and product information.

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Certificates & Accreditation Documents

All certificates, accreditation scopes and regulatory designation in one place. Download what you need – or request a specific document from our quality management team.

DAkkS Accreditation – DIN EN ISO/IEC 17025

Certificate D-PL-14013-01-02

DAkkS accreditation certificate for medical devices – microbiological & hygienic testing, environmental monitoring (valid from 14.08.2020).

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 & Sub-Accreditation Certificates

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 Umbrella Certificate D-PL-14013-01-00 (available in German only)

Appendix to the General Accreditation Certificate listing the four valid partial accreditation numbers (valid as of March 28, 2025).

Sub-Certificate D-PL-14013-01-01 (available in German only)

Partial Accreditation Certificate for Food, Feed, and Cosmetics – Physical-Chemical and Microbiological Testing (Valid as of March 28, 2025).

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).

Sub-Certificate D-PL-14013-01-03 (available in German only)

Partial Accreditation Certificate for Medicines and Active Ingredients – Analysis of Biopharmaceuticals, Active Ingredients, and Excipients (valid as of March 28, 2025).

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).

Sub-Certificate D-PL-14013-01-04 (available in German only)

Partial Accreditation Certificate for Water Testing – Drinking Water, Swimming Pool Water, Mineral Water, Dental Water, Process Water (valid as of March 28, 2025).

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.

GMP Conformity Confirmation LAGeSo (available in German only)

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

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).

Regulatory Designation & 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.

Download Section

Explore a curated selection of documents to support your processes and requirements.
Customer Shipping Label for Samples

Shipping label and sample submission form including client details, sample information and requested parameters.

Sample Submission Form

GMO sample submission form for documenting sample identification, origin, and raw material source.