Medical devices — Quality management systems
ISO 13485:2016 is an international standard that details the requirements of a quality management system for medical device companies, and it specifies the experiences necessary to ensure that these organizations are capable of providing products and services that consistently meet customer, regulatory and market needs. Medical device companies can greatly benefit from adhering to the ISO 13485 standard. It’s designed for organizations that plan on having their devices used by human beings. It’s important that all parties involved in its creation or sale are dedicated to securing the highest quality for the patients who will be using it.
Processes that are relevant to ISO 13485:2016 that are not performed by the organization but are relevant to quality must be assessed. Any problems or changes in these processes must be monitored, maintained, and controlled by the organization.
Requirements of ISO 13485:2016 are applicable to medical device companies no matter their size or type. If there is a requirement that applies to medical devices, the same requirements also apply to any associated service supplied by the organization. Specific requirements apply especially when it comes to validation activities, where the parts will be tested after certain stages of production and then need to be documented properly.
ISO 13485 is organized into the following eight sections
Benefits of ISO 13485:2016 Certification