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

2. 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.

3. 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

4. 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

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

6. 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.