ISO 13485 – Quality Management System for Medical Devices

The international standard ISO 13485 serves as the basis for certifying quality management systems in companies that manufacture or distribute medical devices, or are involved in their manufacturing as part of the supply chain.

A quality management system forms the backbone of operations and tasks for manufacturers of medical devices. It ensures that both internal and external regulations are reliably followed.

By appropriately certifying their system, manufacturers can build trust in their processes and products and demonstrate their commitment to safety and quality.

The standard addresses the requirements that manufacturers and suppliers of medical devices must meet when developing, implementing, and maintaining management systems for the medical technology industry.

Advantages: 

• Process security through documented procedures 
• Evidence of compliance with legal requirements 
• Increased product safety for patients and users 
• Enhanced satisfaction among customers and employees 
• Highlighting the company’s competence

What is ISO 13485? 

ISO 13485 is a standalone standard for quality management systems for manufacturers of medical devices or in vitro diagnostics. It originates from the internationally recognized and accepted standard series EN ISO 9000. ISO 13485 continues the process-oriented approach of ISO 9001 and complements it with specific aspects that are particularly important for manufacturers of medical devices or in vitro diagnostics.

What does ISO 13485 contain?

 ISO 13485 supports manufacturers in developing a quality management system that enables safe and effective processes. These processes are designed to ensure consistent design, development, production, installation, delivery, monitoring, tracking, and disposal of medical devices, covering their entire product lifecycle. This is to ensure that medical devices and in vitro diagnostics can be used safely for their intended purpose.

What is the legal significance of ISO 13485? 

Regulatory approval programs for medical devices or in vitro diagnostics often rely on the requirements of ISO 13485. The general requirements in ISO 13485 are expanded and adapted to specific legal market requirements through concretizations and additions.

What is the difference between ISO 13485 and EN ISO 13485? 

ISO 13485 is the internationally recognized basic version of the standard, but it has been harmonized into a European standard by the European standardization organization to be considered in European regulatory approval procedures. By following a harmonized standard, a manufacturer can prove that its products or services meet the technical requirements of the relevant EU legislation and, if necessary, also assert the so-called presumption of conformity.