Changes in ISO13485:2016?

av Peter Mattesson

After a long and winding road it seems like the new international standard ISO 13485 will finally be a reality.

Voting will take place at the end of this year and, if accepted, likely be published during 2016. European harmonization is expected at the same time.

What about the changes? Are they big? Well, it depends. If you are already on the US market, you are familiar with many of the new requirements; validation of administrative software, more thorough purchasing controls, more records to keep, more requirements on process validation. Maybe the biggest change is that the new standard expect you to take a risk based approach on all processes, not just product realization. It is worth pointing out that when the standard talks about risk it is in relation to product safety, performance and fulfillment of regulatory requirements.

The transition period for the new standard is three years, starting from the publishing date. So there is no need for a rush. But it might be a good idea to start preparation already now, contact us if you want to learn more or need support with a gap analysis.