Rather than requiring medical device companies to meet the potentially subjective aspects of the ISO 9001 requirements, ISO 13485 is targeted toward meeting metrics that more accurately gauge quality performance. Although these are critical concerns for all manufacturers, they pose unique challenges for medical device makers because they tend to be too subjective and are therefore difficult to measure. Although both are in the same QMS family of standards, ISO 9001 is a general set of requirements that necessitates greater focus on continual improvement and customer satisfaction. ISO 13485 is a stand-alone document, but it was based on and is directly related to ISO 9001, the world’s leading quality management standard. The standard applies to all 165 member countries of the International Organization for Standardization (ISO).(1) How is ISO 13485 Different From ISO 9001? In Which Regions is ISO 13485 Applicable?įor most medical devices, compliance to ISO 13485 is required by all European Union members, Canada, Japan, Australia and many other nations. This in turn provides economic benefits in the form of reduced scrap and general process efficiencies.

In addition to being a regulatory requirement, an ISO 13485-compliant QMS makes good business sense because it helps device manufacturers minimize variation.

The guidelines for maintaining effective quality management processes outlined in ISO 13485 are all geared toward the safe design, manufacture and distribution of effective medical devices.

Since different countries often have different standards, ISO 13485 is intended to provide a globally harmonized model of QMS requirements for international markets. It is focused on maintaining QMS effectiveness and meeting regulatory and customer requirements. ISO 13485 is the most common medical device QMS regulatory standard in the world. The aim of this article is to answer frequently asked questions about ISO 13485 manufacturing and the related regulatory requirements that apply to medical device companies’ use of QMS. The ISO 13485 international standard is the world’s most widely used means of measuring the effectiveness of a medical device manufacturer’s quality management system (QMS). But all medical devices have one thing in common: they benefit immensely from being designed and manufactured in alignment with ISO 13485. Others are as simple as a tongue depressor. Some medical devices are as complex as a remote, personalized heart failure sensor.

En iso 13485 2016