Quality Assurance and Accreditation

iso-smallQuality Management System ISO 9001

Certification No. FM89418

ISO 9001, established by the International Organization for Standardisations (ISO), is the international standard that aims to build a quality management system trusted by customers. Organisations worldwide, big and small, use the standard to prevent quality disputes and provide products and services that meet their customers’ needs.

Macrogen obtained ISO 9001 certification from BSI (British Standards Institution) in xxxx. We manage and operate the certification to provide services that earn our customers’ satisfaction and trust. This has led to cost reductions, improved profits and enhanced competitiveness, as well as increased management effectiveness from company-wide quality policies and goals and detailed regulations on work processes.

ISO-90012Medical Device Sector Quality Management System ISO 13485

ISO 13485 is an internationally recognised quality standard that states the requirements of the Quality Management System (QMS) for the design and manufacture of medical devices and it certifies the safety of medical devices. ISO 13485 is based on ISO 9001 with some additional clauses related to the design, development, production, installation and additional services of medical devices.

Macrogen obtained ISO 13485 certification for its Medical Device Sector Quality Management System from TUV SUD of Germany in 2011 for the development and production of microarray products and services that meet the expectations of customers.

Along with this certification, Macrogen is continuously measuring key indexes and implementing improvements, and it maintains a strict quality management system related to medical devices to maximise customer satisfaction.

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