ISO 13485:2016 What You Need to Know Robert M. Wolfarth, C.Q.A.

What’s Changing: Major Themes Many “clean up” of definitions Revision ties sections together into themes Requires incorporation of risk management into all main quality system (QS) processes within your organization Requires consideration of all relevant local and international requirements Requires monitor, measurement of QS performance during production AND post-market (risk based) Note emphasis on risk management. Reflects new EU approach.

Other Exciting Gifts QS supporting software validation is now a requirement Tech File now a requirement (not just in the MDD) Employee training/skills requirements will need more sharp definition Training effectiveness checks – new requirement Increased focus on clean rooms and sterile medical devices

Other Exciting Gifts UDI requirements Need a procedure for communicating with regulating authorities Increased requirements for supplier approval and evaluation Corrective and preventive actions must be risk-based Must have plans in place and documented evidence for V&V, design transfer to new location Risk-based process outsourcing and supplier controls

The Status Final DIS (FDIS.2) of ISO 13485 likely to be approved during the ISO/TC 210 WG1 meeting (November 14-20 in Denver. Publication of ISO 13485 likely in early 2016.

What to Tell Your Boss Standard will be published in 2016. Contains a heavy emphasis on risk management. Your company will have 3 years to update its quality system to comply. Recommendation: get started now, at least with planning.