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.