GOOD MANUFACTURING PRACTICES CERTIFICATION
The Good Manufacturing Practices (GMP) Certification, also known in Portuguese as Boas Práticas de Fabricação (BPF), is recognized for its strategic importance in the business environment, enabling companies in the medical-hospital sector to market their products both domestically and internationally.
Since 2004, the registration of new products or the revalidation of existing medical devices has been contingent upon the company’s certification in GMP.
ISO 9001
ISO 9001 aims to ensure that the organization can consistently and repeatedly provide goods and services that meet established specifications, thereby fulfilling applicable requirements.
NBR ISO 13485
The NBR ISO 13485 standard defines the requirements for a comprehensive quality management system focused on the design, production, and distribution of medical devices. It has been specifically developed for organizations that manufacture or supply medical devices or provide related services, with the objective of ensuring continuous compliance with regulatory and customer requirements.
While it is a standalone document, ISO 13485 is often implemented in conjunction with ISO 9001. However, unlike ISO 9001, ISO 13485 places less emphasis on continuous improvement and customer satisfaction, and instead prioritizes compliance with regulatory requirements, risk management, and the maintenance of effective processes to ensure safety in the design, manufacturing, and distribution of medical devices.
GOOD CITIZEN COMPANY – ABRAIDI
Vicca has been certified with the Good Citizen Company seal, granted by the Brazilian Association of Importers and Distributors of Implants (ABRAIDI). This seal serves as a Code of Conduct and recognizes member companies that base their operations on four fundamental pillars: ethics, quality, good practices, and patient safety, always ensuring transparency in relationships between companies, entities, and the end consumer.