Quality & Certifications – Elbatech Group

Elbatech Group Certifications

Aerospace Certification

Elbatech Group certify to the High level of standard for the Aerospace devision – AS9100D:2016

AS9100 is an international quality management standard for the aerospace industry. It places an emphasis on consistent verification methods, bringing together requirements outlined in the SAE’s AS9000 and Europe’s prEN9000-1 standards. It specifies extensions of the ISO9001 (currently ISO9001-2015) quality management system to ensure safety and quality in aerospace products. AS9100 mandates actions to ensure traceability of components, ensuring that correct revision of engineering documentation is used and documented, and details how verification and validation testing should be documented, among other things. Elbatech’s compliance with AS9100 guarantees quality using standardized methods of assurance and makes it easier for aerospace customers to verify the quality of the products.

Medical device Certification

Elbatech Group certify to the Medical device standard – ISO13485:2016

Many years of quality manufacturing to the medical devices market according the strict medical standart quality management system, giving our customers the strong assurance of strict manufacturing and long product life due to the quality prosess being used.
This standard adopted by CEN as EN ISO 13485:2016/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.;

Quality management system

Elbatech Group certify to the QMS standard – ISO9001:2015

Elbatech is fully certified to ISO 9001-2015. The company implements the ‘process approach’, laid down by the most widely accepted quality management standard in the world. Elbatech has developed processes for electromechanical engineering and assembly and adapts them to suit the product being produced. Coordinated management of interconnected production activities ensures optimal flow of output from one stage as input to the next and involves monitoring of processes against objectives as a clearly defined policy. The result is fast and efficient production, on-time delivery and minimal faults.