ISO 13485:2016 Medical Devices (Quality Management Systems)

Requirements for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device. ISO 13485 is based on ISO 9001 but the requirements are specific to design and manufacturing in medical device industry. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment.

 

ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.

 

An ISO 13485 Certification for Your Business
Could Provide the Following Benefits:

• Improve your company’s credibility and image.
• Improve customer satisfaction.
• Improve your processes.
• Improve decision-making
• ISO 13485 is a commitment to continual improvement and customer satisfaction. It is a commitment to creating safe medical devices.
• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations
• Outline how to review and improve processes across your organization

 

ISO 13485 Specific Industries:

ISO 13485:2016 is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices. Organizations that use this standard include:

 

• Manufacturers of medical devices
• Organizations that supply products or raw materials to medical device manufacturers
• Quality management organizations that contract to medical device manufacturers
• Organizations that provide services to medical device manufacturers
• Makers of sterile medical devices
• Manufacturers of surgical medical devices
• sales organizations and logistics companies
• specialists such as dental technicians, hearing aid manufacturers, orthopedic technicians, orthopedic shoe manufacturers, opticians,
pharmacists, dentists and dental laboratories

 

According to the International Organization for Standardization, ISO 13485 applies to companies in one or more stages of medical device production. This includes the sourcing of materials, distribution, design, and sterilization, among other functions in the manufacturing life cycle.