What is ISO 13485


ISO 13485 is the international quality standard for medical devices which is published by the International Organization for Standardization (ISO). This standard is based on ISO 9001:2015 which incorporates the requirements of quality management systems specifically to the medical device industry.

However, ISO 13485 and ISO 9001 are not exactly the same. The quality management system employed by ISO 13485 provides for additional requirements, procedures, and policies which are specific only for the medical devices processes. Another difference between the two is that ISO 9001 does not require any approval from different regulatory bodies for medical device processes.

However, ISO 13485 does require such approval in some countries despite the fact that ISO 13485 has no exact definition of what a medical device quality should constitute. The primary goal and objective of this international quality standard are to ensure that all medical device manufacturers are using best practices by incorporating quality management systems in the installation, facilitation, design, production, development, research, and disposal of medical devices. This also includes the provision of technical support in the organization.

Currently, ISO 13485 is also referred to as ISO 13485:2016.

What Does a Quality Management System Mean Under ISO 13485?

The quality management system under ISO 13485 works the same way as the quality management system under ISO 9001 in the sense that the approach to the steps of quality management is the same.

Hence, QMS is a set of standards, policies, procedures, documentation, rules, roles, responsibilities, framework, instruction, and forms that guide an organization in delivering trusted quality services and products that should also address the concern of its customer and other regulatory requirements.

Here is a list of manufacturers or organizations that would need an ISO 13485 certification:

  • Manufacturers of Medical Devices
  • Software Developers of Medical Devices
  • Contract manufacturers for medical devices
  • Manufacturers of the component needed for medical devices
  • Service providers who are responsible for the maintenance and installation of medical devices

However, the difference between ISO 13485 from ISO 9001 is that its implemented quality management system provides for the specific need of the manufacturing medical device industry. Compliance with this system involves an evidence-based documentation process that is based on the principle that if there is no documented evidence, then there is no proof of compliance.

Once there is proof that an organization has complied with the requirements set forth by ISO 13485, then business credibility will arise for medical device manufacturers which will achieve the goals and objectives of medical device organizations.

To name a few, we have listed the requirements set forth by ISO 13485:

  • Control procedures related to hazard threats and contamination problems
  • Sanitary, safe, and secure workplace environment procedure
  • Strict documentation process on the provision and support of medical device files and forms
  • Ensuring the sanitation, hygiene, and appropriate protocol for the manufacturers of medical devices
  • Reporting requirements for the statutory requirements as well as the rules and regulations where the medical device manufacturer is located.

It can therefore be concluded that the quality management system of ISO 13495 must be continuously monitored, maintained, implemented, and updated to ensure that the medical device manufacturer complies with all applicable standards and relevant rules and regulations where the organization operates.