20 november, 2015


Beneli as of today has taken a new step in its development through activities certified under ISO 13485. ISO 13485 is the world’s most widely used standard for medical devices. Successful design and manufacturing is based on quality management system based on ISO 9001. ISO 13485 is the ISO 9001 with additional requirements.
The standard is designed to be a tool for the manufacturers to create conditions that make it possible to comply with applicable regulatory requirements and performance requirements as well as customer’s different requirements throughout the product lifecycle.
The standard does not provide a direct solution to the design quality but it can make it easier to create a framework that allows the use of different solution models. Both standards are based on the manufacturer’s size, product complexity and potential risks as well as the manufacturer’s quality, for its own operation and for the product.
Customer benefits of certification

  • Improves risk management and reduce the risks
  • Is a tool for management to maintain quality assurance
  • Is a tool to ensure business continuity
  •  Is a tool to involve staff through risk management
  •  Signals reliability to your stakeholders
  •  Improves efficiency
  •  Certification has continuity over time through annual audits


For more information, please contact Head of Quality Heather Hagvik at heather.hagvik@beneli.se alt +46 0738 18 60 16.