Certifications

Encaplast: quality certifications for medical devices

EN ISO 13485:2012 / AC:2012

Since 2012 Encaplast S.p.A. is certified according to ISO 13485:
The ISO 13485 standard “Medical devices — Quality management systems — Requirements for regulatory purposes” identifies a standard for the quality management system specific to medical companies, which includes aspects of the ISO 9001 standard and specific requirements for the medical devices sector.

UNI EN ISO 9001:2008

Encaplast S.p.A. is certified according to ISO 9001:
Obtaining the ISO 9001 certification means creating a qualitative/organizational system within the company that complies with the requirements of the standard. The requirements of this standard apply to all business processes, from sales to purchases, production, etc. Appropriate documentation of the processes (quality manual, procedures, instructions) with recorded results must be supplied.

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