Understanding ISO 13485: 2016
History, Importance and Implementation Commentary by Kim Trautman

There are many compounding factors in the timeline that affect a medical device manufacturer’s decision as to when and how to transition to the new standard ISO 13485:2016. One thing is certain, if you have not started your gap analysis, the time to start that transition is now.

Under the new standard, global device companies are required to conform to country specific regulatory requirements for each jurisdiction where the product is sold. Additionally, the regulation includes a provision for “strengthening of supplier controls” which requires device manufacturers to ensure all supplier quality-related processes fully comply with the requirement. ISO 13485 will ultimately act as a tool for companies to effectively plan, monitor and improve overall quality management and must be a top priority for manufacturers looking to maintain compliant certifications.

Q1 Productions was lucky enough to host Kim Trautman, and to discuss the history, importance and implementation of ISO 13485:2016. Kim is the EVP of Medical Device International Services at NSF International. She most recently held the position of Associate Director for International Affairs at the FDA’s office of the center director where she also served as the FDA’s Medical Device International Quality systems expert. Kim’s webinar presentation highlighted the historical background, why ISO 13485 was revised, key changes for ISO 13485:2016 revisions to assist in gap assessments and implementation of changes, Understanding the ISO 13485:2016 transition timeline, and where to go to gain additional understanding. These are some of my takeaways from her presentation:


Historical background

The International Organization Standardization (ISO) 13485 was first published in 1996. In the mid 1990’s there was a large harmonization effort with the US FDA revising its GNP which is now called the Quality System Regulation. ISO 13485 was completed around the same time as many other regulatory agency changes were occurring in Japan and the EU. There are only three true versions of ISO 13485. The 1996 original, the revision in 2003, and now the revision in 2016. Some people have a 2012 version which is a European version that includes an annex.

ISO 13485 is a sector specific standard based off of ISO 9001. There are many sectors that build off of 9001, including the automotive, telecommunication, and aerospace industry. The standard represents the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices and in vitro diagnostic devices, as well as their related processes and services.


Why ISO 13485 Was Revised

Since 2003, new medical device regulatory activities emerged in South American nations, Asian Pacific nations, and more recently in African nations. Leading to the Global Harmonization Task Force (GHTF) in 2011 to request TC210 to consider revisions in light of the ISO Technical Management Board’s decision on the QMS High Level Structure and requirements.

Kim Trautman explained the intended benefit of ISO 13485: 2016 was “to serve as a harmonized model to be used by national and regulatory bodies in charge of QMS regulatory requirements.”

In 2011, ISO/TC 210 Working Group 1 conducted a web-based user survey to determine need for revision of the 13485 standard. There were responses from every global region, organization size, and regulatory classifications. This helped define the changes that needed to be made.


Key changes for ISO 13485:2016 revisions

The survey, previously mentioned, highlighted main areas that would be addressed in the 2016 version. The revisions include: management responsibilities, corrective and preventive actions, software validation, supply chain, outsourcing, risk management, postmarket information gathering, adverse event reporting, design verification & validation, complaint handling, handling of returned product, environment controls, process validation, records management, process approach, annex z to en iso13485:2012, alignment with ISO 9001:2008, product lifecycle management, and emerging markets

ISO 13485: 2016 revisions improve clarity of the requirements and increase confidence that the requirements are consistent with cGMPs or current Quality System regulatory requirements/objectives. They also increase harmonization of QMS regulatory requirements, and increase medical device manufacturers’ ability to meet customer requirements.


ISO 13485:2016 transition timeline

The standard was published on March 1, 2016 with a three-year transition period. However, starting March 1, 2017- March 1, 2018 it is highly discouraged that any certifying body issue new certifications or re-certifications to ISO 13485: 2003. And starting March 1, 2018 no new certification or recertification to the 2003 version will be allowed.


Where to go to gain additional understanding

Q1 Productions is hosting the 5th and 6th Semi-Annual Supplier Quality Conference on April 20-21 in Alexandria, VA, or on June 5-6 in San Jose, CA. With over 25 distinguished presenters, open dialogue and group share, and unparalleled networking and perspectives, these conferences are the best way for Quality Teams to exchange progressive ideas. Kim Trautman will be presenting at both conferences. Kim Trautman and NSF International Medical Devices Education also provides multiple in depth workshops.