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TÜV Rheinland LGA Products GmbH
Accredited by: DAkkS
TÜV Rheinland LGA Products GmbH certifies products and management systems to international standards.
Am Grauen Stein 29, 51105 Köln, Germany
Certification Scopes (3)
ISO/IEC 17021-1
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope is an attachment to an accreditation certificate issued to TÜV Rheinland LGA Products GmbH by the German Accreditation Body. It is valid from November 15, 2022, and complies with the standards of DIN EN ISO/IEC 17021-1:2015. The certification covers conformity assessment activities listed in the sub-accreditation certificates D-ZM-14169-01-01 and D-ZM-14169-01-02. The certification body meets the minimum requirements of the standard and any additional legal or normative requirements, including sector-specific programs. The management system requirements outlined in DIN EN ISO/IEC 17021-1 align with the principles of DIN EN ISO 9001. For the most up-to-date accreditation status, refer to the German Accreditation Body's accredited bodies database at www.dakks.de.
ISO 13485
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
The German accreditation body DAkkS certifies organizations according to DIN EN ISO/IEC 17021-1:2015, covering industries such as medical devices, including non-active and active devices, implants, in-vitro diagnostics, and sterilization methods. The certification also includes services like calibration, maintenance, and transportation, as well as organizations involved in the medical device lifecycle. Specific technologies covered are nanomaterials, software-controlled devices, and products containing certain substances. The certification specifies detailed categories within each industry segment, listing the types of medical devices and services covered. It also covers infection prevention in medical product processing based on hygiene requirements set by the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM). Activities and services covered include raw materials, components, maintenance services, medical product trading, transportation, and custom manufacturing in health-related fields like optometry, dental technology, audiology, orthopedics, and rehabilitation technology. The certification is valid from 15.11.2022 and includes abbreviations for standards organizations like DIN, EG, EN, EU, and ISO.
ISO/IEC 17021-1
Certification Body for Management Systems
Deutsche Akkreditierungsstelle GmbH
Germany
This scope is an annex to a partial accreditation certificate issued according to DIN EN ISO/IEC 17021-1:2015, valid from 15.11.2022. It is part of the accreditation certificate D-ZM-14169-01-00 held by TÜV Rheinland LGA Products GmbH. The certification body meets the requirements of DIN EN ISO/IEC 17021-1:2015 and additional legal and normative requirements to conduct conformity assessment activities. Specifically, it certifies management systems related to outdoor equipment noise emissions under Directive 2000/14/EG, including various types of machinery. The certification body complies with the Product Safety Act and Directive 2000/14/EG, Annex IX. The certification covers a range of equipment and machinery specified in the Directive.
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