DQS Accreditations and Notifications in the Medical Sector
DQS MED Auditing and Certification Rules
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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:
DAkkS German Accreditation Body
ISO 9001 and ISO 15378 (in German)
DAkkS German Accreditation Body
ISO 13485 (in German)
DAKKS accreditation decision: application for change of accreditation
ISO 13485
DAKKS Annex to the accreditation certificate
ISO 13485
DAkkS German Accreditation Body
Annex to the accreditation certificate ISO 9001 and ISO 15378 (in German)
SCC Standards Council of Canada
ISO 13485
MDSAP Regulatory Authorities Council
(TGA Australia, ANVISA Brazil, Health Canada, MHLW/PMDA Japan, US FDA)
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)