.svg)
DQS Medizinprodukte GmbH
Accredited by: DAkkS
DQS Medizinprodukte GmbH is accredited by the German accreditation body DAkkS for certification in accordance with DIN EN ISO/IEC 17021-1:2015, covering a comprehensive scope for medical devices, including both non-active and active devices, sterilization methods, and products with specific substances or technologies. The certification encompasses various services related to the lifecycle of medical products, such as maintenance, distribution, and transportation, and applies to health facilities and manufacturers of custom-made products. It also adheres to DIN EN ISO 9001 principles for management systems and complies with additional legal and normative requirements, including sector-specific programs. The certification is valid from November 7, 2023, and must be verified alongside the official accreditation certificate, with current status available in the DAkkS accredited organizations database.
August-Schanz-Straße 21, 60433 Frankfurt am Main, Germany
Certification Scopes (5)
ISO 13485
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope outlines the certification scope of the German accreditation body DAkkS for medical devices according to DIN EN ISO/IEC 17021-1:2015. The certification covers various technical areas including non-active and active medical devices, sterilization methods, and products containing specific substances or technologies. It also includes services such as maintenance, distribution, and transportation related to medical devices. The certification applies to organizations involved in the lifecycle of medical products, health facilities, and manufacturers of custom-made products. The document specifies the standards, regulations, and additional requirements that must be met by the certified entities. The certification is valid from 09.10.2023, with an issuance date of 31.07.2024.
ISO/IEC 17021-1
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope outlines the certification scope of DQS Medizinprodukte GmbH accredited by DAkkS according to DIN EN ISO/IEC 17021-1:2015. The certification allows them to conduct conformity assessment activities listed in the document. Additional legal and normative requirements, including sector-specific programs, are met as confirmed in the attached sub-accreditation certificates. The management system requirements align with DIN EN ISO 9001 principles. The certification is valid from 07.11.2023 and must be viewed alongside the official accreditation certificate. Current accreditation status can be verified on the German Accreditation Body's accredited organizations database.
ISO 9001
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope outlines a certification scope by DAkkS, the German accreditation body, for DQS Medizinprodukte GmbH. The certification is in accordance with DIN EN ISO/IEC 17021-1:2015 for conformity assessment activities. The certification covers management systems in industries such as chemicals, pharmaceuticals, rubber and plastic products, non-metallic mineral products, metal production, machinery, electrical equipment, retail, IT, healthcare, and other services. The certification is specifically for ISO 9001 Quality Management Systems. The scope is valid from 10.03.2025 and must be verified through the DAkkS database. This scope also provides abbreviations for organizations and standards used in the certification process.
ISO 15378
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope pertains to the certification scope of DQS Medizinprodukte GmbH by DAkkS, the German accreditation body. The certification is in accordance with DIN EN ISO/IEC 17021-1:2015 and DIN EN ISO 15378:2018 standards for medical devices and primary packaging materials for pharmaceuticals. The certification allows the company to conduct conformity assessment activities as listed in the document. The certification also includes compliance with additional legal and normative requirements, including sector-specific programs. The management system requirements align with the principles of DIN EN ISO 9001. The certification is valid from 07.11.2023 and should be considered alongside the official certificate. More information can be found on the DAkkS website.
ISO 13485
Management Systems
Standards Council of Canada
Germany
The accreditation includes activities related to laboratory testing, inspection, and certification services across various sectors and products. It also covers quality management systems and compliance verification to ensure adherence to industry standards. Additionally, the scope extends to the accreditation of organizations providing training and competence assessment services.
%201.svg)
.svg){kind=small}
.svg)
