New Revisions to the ISO 13485 Standard

We recently attended a presentation about the new revisions to the ISO 13485 standard. This is the first major upgrade since 2003 and the requirements go into effect in 2019. The event was held at Massachusetts Medical Device Development Center (M2D2) on the campus of UMass in Lowell. M2D2 serves as an incubator for smaller medical device companies and provides affordable access to lab space and engineering and research facilities. The biggest change is a shift to a more “risk based approach” to your Quality Management System (QMS). Even though risk has always been an implicit consideration for previous ISO standards, it was mainly focused in Section 7 for product realization. Now, you’re expected to apply risk management methods and techniques to all QMS processes, including outsourcing. As stated in Section 4 of the new ISO document, companies are new required to apply a risk-based approach to: • Control of QMS processes • Control of external party processes • Validation of QMS software Other changes include: • Alignment of global regulatory requirements • Additional requirements and clarity with regard to validation, verification and design activities • Strengthening of supplier control processes • Increased focus regarding feedback mechanisms • More explicit requirements for software validation for different applications The new software validation requirements cover software used in your QMS process as well as software used in production and service provision. In addition, you will need to validate the software before use, and as appropriate, after changes to the software or application. Section 7.5.6 specifically states, “Ensure that validation and revalidation are proportionate to the risk of using the software, including the effect on the ability of the product to conform to specifications.” The good news is that there is a section of the new requirements document that highlights the changes from ISO 13485:2003 to ISO 13485:2016. If you’ve been good about maintaining your compliance procedures you should be in good shape.

Appstem is exhibiting at the following healthcare conferences. If you’ll be attending please stop by and say hello. HIMSS Connected Health http://www.himss.org/event/connected-health-conference December 11-14, 2016 Washington DC Booth 417 Health 2.0 WinterTech http://www.health2con.com/ticket/wintertech2017/ January 11, 2017 San Francisco, CA HIMSS Annual Conference http://www.eventsinamerica.com/events/himss-annual-conference-exhibition-2017-healthcare-information-management-systems-society/ev53c97d7da3135/#.WEg-0KIrL_8 February 19-23, 2017 Orlando, FL