ISO 13485 Medical Devices

Featured Content: ISO 13485 Overview with Susan Mecca

Read about the new ISO 13485:2016 medical devices quality management system, its impact on your business, and how your organisation can benefit from the new standard.

Read more by downloading the interview series below.

What is ISO 13485 Medical Devices?

ISO 13485 Medical Devices is the internationally recognised quality management system (QMS) for manufacturers of medical devices and related services. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector.

ISO 13485 Medical Devices is only applicable to manufacturers of medical devices and related services.

What does ISO 13485 Medical Devices do?

We provide ISO 13485 certification, an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector.

It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.

Last revised in 2003, this standard is based on the ISO 9001:2000 process model approach. However, it includes particular requirements for medical devices and excludes some of the requirements for ISO 9001. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes..

ISO 13485 Medical Devices Benefits

ISO 13485 certification promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale.

A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance. It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.

We provide accredited assessment and certification to ISO 13485.

ISO 13485 Medical Devices Downloadable Content

LRQA's datasheet and FAQ document discuss the fundamentals of ISO 13485 and the changes in the medical regulatory landscape as well as how it affects your organisation. Discover more information on ISO 13485 by downloading the documents below:

ISO 13485 Datasheet


ISO 13485 FAQ

LRQA ISO 13485 Datasheet
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LRQA ISO 13485 FAQ
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How LRQA Can Help

Management systems are becoming increasingly linked to the success and survival of organisations. In parallel, CEOs and MDs worldwide are placing greater emphasis on the independent assessment that helps ensure management systems are 'fit for purpose'. Our unique methodology helps organisations manage their systems and risks to improve and protect their current and future performance. We provide certification and training across all of the major QMS standards.

For organisations with other standards, we can often offer integrated assessments, thus delivering savings on both time and money. Speak with us today!