ISO 13485 45001 17025 Medical Devices Quality Management Systems

Some medical devices can be as intricate as a remote, personalized heart failure sensor. Others, however, are similar to a tongue depressor. All medical devices have one feature in common: they benefit immensely by being developed and manufactured in accordance with ISO 13485. The ISO 13485 international standards is the most reliable method to assess the efficiency of medical device manufacturers' quality management systems (QMS)
ISO 13485 Overview
This article answers frequently asked questions about ISO 13485 manufacturing. It also addresses regulatory requirements that relate to the use of QMS by medical device companies. See this Medical devices - Quality management systems - Requirements for regulatory purposes for more answers.

What is ISO 13485?
ISO 13485 is the most widely used medical device QMS regulatory standard in the world. It is focused on ensuring QMS effectiveness while satisfying the requirements of customers and regulatory agencies. ISO 13485 is designed to be a global standard model of international requirements for QMS, since different countries have different standards.

ISO 13485 outlines the guidelines for quality management. They are designed to make sure that medical devices can be safely designed, manufactured and distributed. Apart from being a regulatory requirement having a QMS that is ISO 13485 compliant is good for business because it assists device makers in reducing variation. This can result in economic benefits in the form of less scrap and general efficiency in the process.

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

What is the difference between ISO 13485 and ISO 9001? ISO 13485 differ from ISO 9001
ISO 13485 can be used as a stand-alone document, but was developed based on ISO 9001, which is the most well-known quality management standard in the world. ISO 9001, although both are part of the QMS family of standards is a set of common requirements. This demands a greater attention to customer satisfaction and continuous improvement. These aspects are vital for every manufacturer. However medical device makers have unique challenges because they are subjective and therefore difficult to measure.

Instead of making medical device companies comply with the subjective aspects of the ISO 9001 requirements, ISO 13485 is targeted toward meeting metrics that more accurately gauge the performance of quality. These include metrics that help to satisfy the needs of customers and ensure that the QMS is effective. See ISO 17025 for info.

ISO 13485 differs from ISO 9001 in two important ways:
It is more important to focus on managing risk.
It also contains additional conditions that must be fulfilled in order to document procedures.
Although device manufacturers can get certificates for both standards however, they may not be able to due to the differing requirements in the intent of both standards. In addition, the format of both standards have changed since ISO 9001 was restructured. If both standards are required it is recommended that the business develop strategies to be in compliance with each set.

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