What You Need to Know About the ISO 13485:2016 Update

ISO 13485:2016: An Introduction

The international standard ISO 13485 governs the manufacture of medical devices. The first edition was published by the International Organization for Standardization (ISO) in 1996. The ISO currently reviews standards at least every five years to determine whether they need to be updated. The first update to ISO 13485 was released in 2003. This has now been superseded by ISO 13485:2016, which came out on March 1, 2016. According to the ISO, this set of standards was updated “to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations.” The standard is used by medical device manufacturers to ensure the quality of their products and by third-party entities to certify companies that manufacture such devices.

When a new edition of the standard is published, it does not immediately invalidate certifications issued in accordance with previous versions. A transition period retains certifications to the previous standard while the transition is made to the new edition. For the first two years, certifications can still be issued in accordance with the 2003 version. As of March 1, 2018, that period has concluded and all new certifications and certification renewals must be done according to ISO 13485:2016. Prior certifications under ISO 13485:2003 remain valid until March 1, 2019. Within the European Union, recent certifications have been done according to EN ISO 13485:2012, which comprises ISO 13485:2003 with the addition of a forward and annexes. Companies certified under the 2003 standard are expected to schedule an audit prior to the expiration of current certification.

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