ISO 13485 45001 17025 Medical Devices Quality Management Systems

Certain medical devices can be as intricate as a remoteand a customized heart failure sensor. Some medical devices are as easy and straightforward like a tongue depressor. All medical devices benefit tremendously by conforming to ISO 13485. The ISO 13485 international standards is the most reliable method to assess the effectiveness of medical device manufacturers' QMS. (QMS)
ISO 13485 Overview
This article answers frequently asked questions about ISO 13485 manufacturing as well as the requirements of the FDA applicable to QMS use by medical device manufacturers. See this Medical devices - Quality management systems - Requirements for regulatory purposes for more answers.

What exactly is ISO 13485 exactly?
ISO 13485 regulates medical device QMS systems across the globe. It is focused on maintaining QMS effectiveness, meeting customer and regulatory specifications and making sure QMS compliance. ISO 13485, which is an international standard that governs QMS requirements in international markets, was created to align different standards across different countries.

ISO 13485 provides guidelines for quality management that are geared towards the safe design, manufacturing and distribution of medical devices. This is not just required under ISO 13485, but also because it permits device makers to reduce variations. This provides economic benefits through decreased scrap and improved efficiency of the process.

Which regions are ISO 13485 Valid?
All European Union member countries, Canada and Japan, as well as Australia, must comply with ISO 13485 in order to utilize the majority of medical devices. The 165 members of the International Organization for Standardization are required to comply with this standard. (1) Check Occupational health and safety management systems - Requirements with guidance for use for more.

What makes ISO 13485 different from ISO 9001?
ISO 13485 stands alone, but it has a direct link to ISO 9001. Both of them are part of the QMS family, however ISO 9001 has a more general set of requirements which demands a greater emphasis on customer satisfaction and continuous improvement. While these are crucial issues for all manufacturers, they pose unique challenges for medical device manufacturers because they tend to be subjective and therefore difficult to measure.

ISO 13485 focuses on metrics that are more precise in evaluating quality performance, rather instead of requiring medical device businesses to adhere to ISO 9001 requirements. These include metrics related to customer requirements and maintaining QMS efficiency. See General requirements for the competence of testing and calibration laboratories for info.

ISO 13485 is different from ISO 9001 in two important ways:
It places greater emphasis on risk management.
It also outlines additional requirements for documented procedures.
Manufacturers of devices can be certified according to both standards, but they are not required to do so in accordance with the purpose of the standards. While both standards are at peace, differences in their formats have developed since ISO 9001 was restructured. The company must develop strategies to meet both sets of requirements if conformance is required.