Quality assurance throughout the product life cycle
We ensure high standards of quality and safety in accordance with strict regulatory and legal requirements. Production operates in controlled ISO 7 and ISO 8 environments and our entire business is governed by ISO 9001, ISO 13485, ISO 14001 and ISO 15378.
Current certifications
External surveillance audit carried out in June 2026 and closed with zero non-conformities. Read more →
Company certification
Management systems certified by an accredited body. Certificates available on request.
ISO 9001
Quality management system.
ISO 13485
Quality management system for medical devices — CE-marked dosage cups, spoons and applicators.
ISO 14001
Environmental management system, certified with zero non-conformities.
ISO 15378
Good manufacturing practices (GMP) for primary packaging materials for medicinal products.
Clean-room classification
The class of the controlled environment where products are made — distinct from company certification.
ISO 7 / ISO 8 clean rooms
Production in a controlled environment (ISO 14644) across all technologies: injection, injection-blow and blow moulding.
Product and material compliance
Requirements that products and materials meet. Declarations available on request.
Materials compliant with FDA requirements
The materials used in our products meet the applicable FDA requirements. Declaration of conformity available on request.
CE marking on medical devices
Dosage cups, spoons and applicators are CE-marked medical devices, produced under ISO 13485.
Pharmaceutical and food grade
Pharmaceutical- and food-grade HDPE and PP in bottles, caps and devices.
ESG rating
Independent assessment of environmental, social and governance performance.
EcoVadis Silver 2026
Silver Medal in the 2026 EcoVadis sustainability rating — top 15% of rated companies.
Quality documents
Documents available for consultation and download. Certificates and specific declarations of conformity are available on request.
ESG commitments
The Environment, Social, Governance approach is already part of our DNA. We make a difference one step at a time — and continuously monitor every action.
Environment
- ISO 14001 certification with zero non-conformities
- Around 20% of energy consumption powered by our own photovoltaic panels
- Progressive reduction of energy per tonne of raw material processed and of drinking-water consumption
- Only 0.17% of raw materials not incorporated into finished product, recovered through waste managers
- PCR, BIOPE and RHDPE materials and circular economy projects (SeaRubbish2Cap, RREDUCE, Sustainable Plastics)
Social
- Regular presence on Exame magazine's list of Best Companies to Work For
- Comprehensive health insurance for employees
- Continuous training and skills development
- Gender diversity in leadership positions
- Procedures aimed at zero accidents at work and involvement in community initiatives
Governance
- Code of Ethics and Code of Good Conduct to prevent and combat harassment
- Whistleblowing Channel (Decree-Law 109-E/2021)
- Sustainable Purchasing Policy and responsible supply chain
- Transparency and integrity in stakeholder relations
Proof
- EcoVadis Silver Medal 2026
- 2026 external audit with zero non-conformities
- Digital Product Passport in preparation (PPWR)
- Policies and documents available for download
Ethics & Compliance
Neutroplast's positioning stems from a responsible view of the role companies play in the community in which they operate. In each pillar of intervention we act with a robust ethical conscience, reflected throughout the value chain and in communication with our stakeholders.
With the entry into force of Decree-Law 109-E/2021 of 9 December, introducing measures to prevent and combat corruption and related offences, Neutroplast's Whistleblowing Channel was created — aimed at anyone wishing to report offences or violations of rights relating to the company.
Access the Whistleblowing Channel
Secure and confidential external platform (Workky).
Frequently asked questions
Is Neutroplast ISO 15378 certified?
Yes. ISO 15378 defines good manufacturing practices for primary packaging materials for medicinal products and is one of four current certifications, together with ISO 9001, ISO 13485 and ISO 14001.
Are the medical devices CE-marked?
Yes. Dosage cups and spoons and the vaginal applicator are CE-marked by a notified body and produced under ISO 13485.
Where can I obtain certificates and declarations?
ISO certificates, the QMS scope and policies are available on this page. Product-specific declarations of conformity and batch certificates are provided by the Quality team on request.
Do you have a packaging project?
Talk to our sales team. We reply within 48 hours, in English or Portuguese.