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syszert GmbH

Accredited by: DAkkS

syszert GmbH is a certification body accredited by DAkkS, providing ISO certification services.

https://www.syszert.de/index.html

Ringstraße 32, 71364 Winnenden, Germany

Certification Scopes (4)

ISO/IEC 17021-1

Certification Body for Management Systems

Deutsche Akkreditierungsstelle GmbH

Germany

This scope is an attachment to an accreditation certificate issued by the German Accreditation Body, valid from November 19, 2024. It is granted to syszert GmbH in Winnenden, allowing them to conduct conformity assessment activities in accordance with DIN EN ISO/IEC 17021-1:2015. The certification body complies with additional legal and normative requirements, including sector-specific programs as confirmed in the accompanying sub-accreditation certificates D-ZM-16019-01-01 and D-ZM-16019-01-02. The management system requirements outlined in DIN EN ISO/IEC 17021-1 align with the principles of DIN EN ISO 9001.

Human health activities
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ISO 9001

Certification Body for Management Systems

Deutsche Akkreditierungsstelle GmbH

Germany

This scope is an annex to a partial accreditation certificate issued to syszert GmbH, indicating compliance with DIN EN ISO/IEC 17021-1:2015 standards for conducting conformity assessment activities. The certification covers management systems in the areas of quality (ISO 9001:2015) and environmental (ISO 14001:2015) management. The accredited scope includes industries such as pharmaceuticals, rubber and plastic products, metal production, machinery, electrical equipment, retail, and other services. The certification is valid from 19.11.2024 and aligns with relevant national and international standards. The certification is subject to ongoing monitoring by the German Accreditation Body.

Manufacture of rubber and plastic products
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ISO 14001

Certification Body for Management Systems

Deutsche Akkreditierungsstelle GmbH

Germany

This scope is an annex to a partial accreditation certificate issued to syszert GmbH, indicating compliance with DIN EN ISO/IEC 17021-1:2015 standards for conducting conformity assessment activities. The certification covers management systems in the areas of quality (ISO 9001:2015) and environmental (ISO 14001:2015) management. The accredited scope includes industries such as pharmaceuticals, rubber and plastic products, metal production, machinery, electrical equipment, retail, and other services. The certification is valid from 19.11.2024 and aligns with relevant national and international standards. The certification is subject to ongoing monitoring by the German Accreditation Body.

Manufacture of rubber and plastic products
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ISO 13485

Certification Body for Management Systems

Deutsche Akkreditierungsstelle GmbH

Germany

This scope outlines the certification scope of the German accreditation body DAkkS for syszert GmbH, valid from 19.11.2024. The certification covers conformity assessment activities according to DIN EN ISO/IEC 17021-1:2015, with additional requirements for quality management systems for medical devices under ISO 13485:2016. The certification program focuses on management systems for medical devices, excluding specific categories like anesthesia devices and in-vitro fertilization equipment. Calibration services are not certified but require accreditation under ISO/IEC 17025. The certification is applicable to organizations involved in the lifecycle of medical products, healthcare facilities, and custom manufacturers. This scope also provides explanations of abbreviations and references to relevant standards and organizations.

Human health activities
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