What Are the ISO Standards for Medical Devices

What Are the ISO Standards for Medical Devices?

If you are a medical practitioner, a health professional, or just simply reading out of curiosity, then this article will provide you with information concerning the ISO standards related to medical devices!

No industry or organization places more importance on the strict compliance of quality assurances and standards compared with the design and production of medical devices and implements. These standards ensure that potential hazards are being identified, managed, and prevented. Sanitation is also another important issue.

If you want to learn more about these standards, then proceed with reading the paragraphs below!

ISO Standards Applicable to Medical Devices

ISO 9001

This standard is the best-known ISO standard for a reason. Although this standard is not industry-specific, it still applies to organizations that produce medical devices as it generally tackles quality management systems in any business organization.

This quality management system ensures that the structure and processes being operated by an organization apply a well-structured and rigorous system that continually strives on improving the overall effectiveness and efficiency of the organization.

This applies to medical device manufacturers because ISO 9001 will help identify the processes that need to be improved, pinpoint bottlenecks in the manufacturing process, facilitate quality control in the overall system, and recognize the accountability of the different units of the organization.

ISO 13485

If ISO 9001 is the best-known ISO standard across different organizations, ISO 13485 is its counterpart for the medical device industry. This standard is best-known in the medical device industry because it focuses on the quality management system specifically for medical device manufacturers.

This standard provides a framework that expands ISO 9001 for the specific needs of the industry. Compliance with this standard streamlines the possibility of selling the products to different parts of the world because consumers are more assured that medical devices meet quality.

Here are some requirements that ISO 13485 provides:

  • Reporting requirements for various regulatory agencies and authorities
  • Sanitation requirements for medical device manufacturers
  • Ensuring that medical devices are sterile when delivered to its end-users
  • Hazard controls and contamination control procedures
  • Safe and secure work environment requirement
  • Provision of documentation for the support of medical device files

Reading the statements above, it can be concluded that such requirements are medical device industry-specific.

ISO 14001

This standard complements the medical device industry because it focuses on environmental management systems.

This system is composed of rules that define how the organization manages its surrounding environment by providing guidelines, practices, procedures, records, and plans. Such environmental management system is, of course, tailored to the specification of the medical device industry.

Since the medical device industry has its own set of regulations and legal requirements, the system should match the industry’s environmental interaction of its internal and external processes.

Creating a sustainable environment is the primary concern of different industries in the world. Thus, reducing the environmental footprint is a key component in the implementation of ISO 14001.

This will also provide benefits such as improved costs by trimming down wastage and consumption of energy. The development of a sustainable, healthy, sanitary, and safe work environment would also ensue from this standard.