Our certifications.

We are a company specialised in medical packaging and pharmaceutical packaging, located in the prestigious biomedical district in Mirandola.
The compliance to industry regulations and also our quality system are the core of our daily activities, to ensure safe, reliable and efficient products according with the high standards required by the industry.
Encaplast® continues to invest in cutting-edge technology, lean production and ongoing training for our team, with the goal of maintaining a high level of performance and consistently exceeding customer expectations.
The certifications are an acknowledgement of our quality management system and they demonstrate the attention we pay to each stage of the production process, from design to the final packaging.

EN ISO 13485:2016.

Encaplast® S.p.A. has been certified according to ISO 13485 since 2012, a highly prestigious recognition in the medical and pharmaceutical packaging industry.
ISO 13485, entitled “Medical devices – Quality management systems – Requirements for regulatory purposes,” in Italian “Dispositivi medici – Sistemi di gestione per la qualità – Requisiti per scopi regolamentari”, is a specific standard for companies operating in the medical field.
This certification includes the key aspects of ISO 9001 and it introduces specific requirements to the medical device industry.
Obtaining ISO 13485 certification demonstrates Encaplast® S.p.A.’s commitment to quality and compliance with applicable regulations.
Thanks to a well-defined management system, we are able to guarantee safe, reliable products that meet the highest industry standards.
This certification is a tangible sign of our ongoing commitment to providing outstanding medical and pharmaceutical packaging solutions.

CERTIFICATE

UNI EN ISO 9001:2015.

Encaplast ® S.p.A. is also certified according to ISO 9001, one of the most important international quality management standards. ISO 9001 certification represents a systemic approach to ensure effectiveness and efficiency in internal processes and the organisation of activities, as well as the achievement of company objectives.

CERTIFICATE

ISO 15378:2018.

Encaplast® S.p.A. holds ISO 15378:2018 certification, a standard that defines specific requirements for primary packaging materials utilised in the medical products field.
This certification is an extension of ISO 9001 and places special emphasis on Good Manufacturing Practices (GMP) applicable to the primary packaging materials industrial sector.
ISO 15378:2018 ensures that our quality management system can provide primary packaging materials for medicinal products which meet customers requirements, including regulatory requirements and international standards.
ISO 15378:2018 certification acknowledges Encaplast® S.p.A.’s ongoing commitment to providing packaging solutions that are safe and efficient.
We are proud to contribute to the safety and quality of medical products through our quality management system, in compliance with GMP and with acknowledged international standards.

CERTIFICATE

Our certifications.

EN ISO 13485:2016.

UNI EN ISO 9001:2015.

ISO 15378:2018.

ENCAPLAST® SPA

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