Quality Management Systems (QMS)
- ISO 9001: Quality management standard focused on customer satisfaction and continuous improvement.
- ISO 14001: Environmental management standard that improves environmental performance and reduces the impact of organizational activities.
- ISO 13485: Standard specific to medical devices that establishes requirements for the quality management system in their design and production.
- GxP (Good Practices): Generic term that includes:
– GMP (Good Manufacturing Practices)
– GLP (Good Laboratory Practices)
– GCP (Good Clinical Practices)
– GSP (Good Storage Practices)
– GPhP (Good Pharmacovigilance Practices)
- OEA (Authorized Economic Operator): Certification that recognizes companies that meet security standards in the international supply chain, facilitating international trade.
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Pharmacovigilance: Monitoring and evaluation of the safety of medications once they are on the market, aimed at identifying and preventing adverse effects
international trade.