It’s here: the long awaited 2016 update to ISO 13485 was published at the end of February. This revision is a big shake up of the venerable devices quality standard. It’s going to need time, effort and planning for transition to the 2016 edition.
In conjunction with AusMedtech 2016 conference in Adelaide in May and leading Notified Body TUV Sud, we are hosting a full day workshop on Transition to ISO 13485:2016. It’s on 9 May, immediately before AusMedtech and there are discount rates for attendance at both events. So what’s changing? Lots, including:
- Much more emphasis on risk management throughout the standard. (afficionados of IEC 60601 may find this familiar)
- More flexibility to omit compliance to specific clauses if they are truly not applicable to your operations
- Closer alignment to GHTF and IMDRF definitions and classifications and inclusion of more concepts and requirements from the US FDA Quality Systems Regulations (21 CFR 820)
- Moving away from ISO 9001 (which has a new and different clause structure) and with regulatory compliance taking centre stage in ISO 13485. Those running combined 13485/9001 systems are going to find thing more complicated and onerous.
- More explicit links to regulatory requirements and compliance, including things like postmarket reporting.
- New and Strengthened Technical Content in areas of verification and validation, design processes, sterilization, software validation and more.
Registration is at the bargain rate of $500/$550 for AusBiotech Member/Non Member or only $300/$350 if registered in conjunction with AusMedtech conference.
Need a new quality system or has your old system gotten too cumbersome? We specialise in setting up or refreshing quality systems. We believe in systems that reflect practice and not the other way round. You will find no cookie cutter systems here. Instead we prefer management systems that are light touch, appropriate to the operation and easy to manage. Talk to us today to learn how we can help you achieve a compliant quality system that’s easy to use and adds real value to your business. Call +61 2 9906 2984 or email firstname.lastname@example.org.