At ACTO® Pharma, our commitment to safety, reliability, and superior quality is anchored by a robust framework of international certifications. These documents serve as global validation of our internal processes, manufacturing integrity, and the high-performance standards of our final products.

International Management System Certifications

To ensure operational excellence and continuous improvement across all organizational levels, we rigorously adhere to the following internationally recognized management standards:

 

• ISO 9001: Quality Management System – Ensuring consistent quality and operational efficiency.

 

• ISO 13485: Medical Devices Quality Management System – Demonstrating our expertise and competence in the medical device industry.

 

• ISO 45001: Occupational Health and Safety Management System – Prioritizing a safe and healthy working environment for our workforce.

 

• ISO 10002: Customer Satisfaction Management System – Emphasizing our dedication to customer focus and effective feedback management.

 

• HACCP: Hazard Analysis and Critical Control Points – Approved by the Ministry of Agriculture and Forestry; guaranteeing biological, chemical, and physical safety in our relevant production lines.

Regulatory and Manufacturing Compliance

We operate in full compliance with national and international health authorities to deliver safe and effective products:

 

• Good Manufacturing Practices (GMP): Our facility proudly holds the GMP certificate issued by the Ministry of Health. This certification is definitive proof of our commitment to the highest standards of production hygiene, safety, and traceability.

 

• CE Certification (93/42/EEC MDD): Our medical device disinfectants, wound care solutions, and other medical consumables are CE certified in accordance with the Medical Device Directive. We proactively monitor evolving regulations, such as the Medical Device Regulation (MDR), and adapt our processes to ensure seamless compliance and safety.

 

• Biocidal Product Licensing: Every product in our biocidal range is manufactured and licensed under the strict framework of Biocidal Product Regulations, ensuring legal and safe market supply.

By integrating these world-class criteria into our daily operations, ACTO® offers the highest level of trust and quality assurance to its global partners and end-users.