ISO/IEC 17021-1:2015 describes the "General requirements for accreditation bodies accrediting conformity assessment bodies". One such accreditation body is the German DAkkS (Deutsche Akkreditierungsstelle GmbH). It confirms the impartiality and objectivity of conformity assessment bodies within the scope of an accreditation procedure.

With the approval, the conformity assessment body is entitled to use the accreditation logo, e.g. of DAkkS, on the certificates they issue.
DQS Medizinprodukte GmbH assesses management systems and products on the basis of nationally and internationally recognized regulations and standards. The accreditations and notifications available for this purpose are:

ANAB Accreditation Body

ISO 9001 and ISO 13485

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DAkkS German Accreditation Body

ISO 9001 and ISO 15378 (in German)

PDF

DAkkS German Accreditation Body

ISO 13485 (in German)

PDF

DAkkS German Accreditation Body

Annex to the accreditation certificate ISO 9001 and ISO 15378 (in German)

PDF

SCC Standards Council of Canada

ISO 13485

PDF

MDSAP Regulatory Authorities Council

(TGA Australia, ANVISA Brazil, Health Canada, MHLW/PMDA Japan, US FDA)

PDF

ZLG Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices

Regulation (EU) 2017/745 - MDR (in German)

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