Extension of ISO 17021-1 accreditation for the certification of Quality Management Systems

24 November 2021

ECM extends its accreditation as certification body for quality management systems to technical area 1.1.A of ISO 13485 standard.

Ente Certificazione Macchine, accredited body by Accredia for the certification of Quality Management Systems for the international standards EN ISO 9001:2015 and EN ISO 13485:2016, extends its certification scope within the ISO 13485 standard.

Following the successful outcome of the accreditation extension process provided by Accredia, ECM extends its ISO 17021-1 accreditation to technical area 1.1.A of ISO 13485 standard.

ECM therefore expands its accreditation scope to the QMS certification of “General non-active, non-implantable medical devices”, which fall within Technical Area 1.1.A. Regarding the activities and devices included in the technical area 1.1.A of ISO 13485, please refer to the following Accredia document > https://www.accredia.it/app/uploads/2021/03/AreeTecnicheACCREDIA_gennaio2021.pdf


For information: Sales Manager ECM Medical Devices Division – Eng. Diego Stevanella diego.s@entecerma.it | (+39) 393 2471040

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