Some medical devices require higher-tech than a remoteor personal heart failure sensor. Some are however as simple as a tongue-depressor. All medical devices share one thing: They benefit greatly from being manufactured and designed to conform to ISO 13485. The ISO 13485 international norm is the most popular method of testing the effectiveness of a medical device manufacturer’s quality assurance system (QMS).
ISO 13485 Overview
This article addresses frequently asked questions about ISO 13485 manufacturing as well as the regulations that apply to QMS's use by medical device manufacturers. See this Medical devices - Quality management systems - Requirements for regulatory purposes for more answers.
What is ISO 13485 exactly?
ISO 13485 regulates medical device QMS systems across the globe. It is focused on maintaining QMS effectiveness in ensuring that it meets regulatory and customer requirements and guaranteeing QMS conformance. ISO 13485, which is a global standard for QMS requirements on international markets, was designed to bring different standards into line across nations.
ISO 13485 provides guidelines for quality management that are geared toward the safe design, manufacturing and distribution of medical devices. This is not just an obligation under ISO 13485, but also because it allows device manufacturers to limit variation. This results in economic benefits, such as lower scrap and a higher efficiency of the process.
Which Regions Is ISO 13485 Valid?
All European Union countries, Canada Japan Australia, Australia and many more must comply with ISO 13485. The standard applies to all 165 members of the International Organization for Standardization. (1) Check iso 45001 for more.
How does ISO 13485 differ from ISO 9001
ISO 13485 can be used as a standalone document but was developed based on ISO 9001, which is the most widely-respected quality management standard around the world. Both documents fall under QMS guidelines. However, ISO 9001 is a standard that sets general requirements that demand a greater focus on continuous improvement and customer satisfaction. These are essential for all manufacturers. However they present unique challenges for medical device producers since they are subjective and can be difficult to measure.
ISO 13485 is not about making medical device manufacturers adhere to the ISO 9001 requirements. It is about setting up measures that will better gauge quality performance. They include measures that relate to meeting customer requirements and maintaining the efficiency of the QMS. See General requirements for the competence of testing and calibration laboratories for info.
Two other significant differences separate ISO 13485 from ISO 9001:
It focuses more on risk management.
It also provides additional requirements for documented procedures.
While device manufacturers can receive certificates to both standards, they can choose not to due to differences in their intent. Furthermore, even though the two standards were more harmonized, variations in their formats have occurred since ISO 9001 was restructured in 2015. The company must develop strategies to comply with both sets of requirements , if the requirement for conformity is needed.