SafetyCulture Summit 2021
Learn more about the international standard for the QMS of medical device life cycles
Published 22 Jul 2021
ISO 13485:2016 is an international standard for the Quality Management System (QMS) of organizations and providers of activities involved in the design, manufacture, distribution, servicing, and disposal of medical devices.
As an internationally accepted standard set by the International Organization for Standardization (ISO), companies with ISO 13485:2016 certification are recognized to produce medical devices that consistently perform according to specifications, meet the high expectations of the healthcare industry, and operate in compliance with regulations.
In this article featuring ISO 13485, we will discuss:
It cannot be stressed enough how the quality of medical devices impact the quality of services that the healthcare industry provides. Having a benchmark for the standardization of medical devices’ production, distribution, servicing, and disposal gives the assurance that medical devices are of high quality, will do no harm to the patient and medical professional when used correctly, and will perform as expected.
During the first quarter of 2020, there were individuals and groups that initiated the use of 3D printers to supplement the urgent need of valves for ventilators when the COVID-19 pandemic began. It was a quick and creative solution that helped save lives when hospitals ran out of ventilator valves during a COVID-19 surge and patients were pouring in.
The unorthodox method of producing ventilator valves, however, raised concerns over the safety of materials used to produce the 3D-printed ventilator valves, risk of contamination, and other possible legal issues. There are authorized bodies that have since provided guidelines to facilitate the safe and legal production of 3D-printed medical devices and recognized ISO 13485:2016 as a benchmark for validating production processes.
ISO 9001 is the foundation for a variety of QMS-based ISO standards aimed to ensure the best quality of products and services, among which is ISO 13485:2016 intended for medical devices. That said, ISO 9001:2015 and ISO 13485:2016 have essential differences:
If a company is involved in the life-cycle of medical devices, they may find that ISO 13485 is more appropriate for their QMS needs.
The first iteration of ISO 13485 was published in 1996 and it was created based on two standards: ISO 9001:1994 and EN 46001. Together with ISO 13488 intended for suppliers, ISO 13485 provided a framework for the QMS of medical device manufacturers. ISO 13485:2003 was later published as an updated standard and it replaced both 1996 versions ISO 13485 and ISO 13488.
ISO 13485:2016 is the current version of the standard and it was based on ISO 9001:2008.
As a side note, ISO 13485:2016 was already being worked on for years before ISO 9001:2015 came out and both were ready for release with 6 months in between them. This is why ISO 13485:2016 was based on an older version of ISO 9001.
Here is a summary of the requirements for compliance with the ISO 13485:2016 standard:
Organizations that wish to get third-party certification for the ISO 13485:2016 standard can utilize gap analysis tools or internal auditing forms like this audit template to identify areas for improvement in implementing processes that are intended to conform with the standard. Review this ISO 13485 audit checklist for internal audits and download for free as PDF or as a digital checklist on the iAuditor mobile app so you can begin your internal audits right away.
ISO 13485:2016 internal audit template (you can also download as PDF)
It takes time, resources, and a concerted effort to get third-party certification. See these tips to get an idea on how to prepare for ISO 13485:2016 certification.
Help in implementing QMS that is aligned with ISO 13485:2016 with the use of a powerful auditing software used around the world for quality and safety. iAuditor by SafetyCulture can help capture and correct gaps in quality and efficiently utilize resources as your organization prepare for ISO 13485:2016 certification. With iAuditor, you can:
Available on Android, iOS, and the web, iAuditor is a customizable mobile quality and safety inspection app mainly used to maintain and improve quality and safety in numerous industries. iAuditor offers a number of ready-to-use quality and safety templates, as well as tools that can be used by organizations where stringent QMS is crucial in maintaining quality and compliance with regulations and industry standards.
Erick Brent Francisco is a content writer and researcher for SafetyCulture since 2018. As a content specialist, he is interested in learning and sharing how technology can improve work processes and workplace safety. His experience in logistics, banking and financial services, and retail helps enrich the quality of information in his articles.
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