ISO 9001 seeks customer satisfaction through the effectiveness and efficiency of processes, proposing a management model based on processes and a systematic approach to risk.

Among others, we highlight the following advantages in implementing this model:

• Advanced and recognized management model.
• Standardization of internal procedures.
• Improved communication with Customers and Suppliers by using common concepts and terminology.
• Promotion of change and continuous improvement.
• Greater fluidity in internal communication.
• Increased technical and regulatory knowledge.

If you are a medical device manufacturer, you must implement the ISO 13485 standard as it includes a focus on compliance with legal requirements applied to medical devices, however if  are “only” a part of the supply chain, you can (should) implement a management system in accordance with the requirements of ISO 9001.