ISO 14001 transition and ISO 13485

Answer:

Since both ISO 14001 and ISO 13485 have new versions, it is best to conduct the transition for both standards at the same time. The problem is that the ISO 14001:2015 has adopted High Level Structure (with ten clauses) and ISO 13485:2016 is created according to ISO 9001:2008 so it kept the old clause numbering and this will make the transition and the integration more difficult that it should be.

The best toolkit for you is ISO 14001:2015 Documentation Toolkit (https://advisera.com/14001academy/de/iso-14001-2015-gap-analyse-tool/ 001-documentation-toolkit/) that contains all necessary documents together with some most frequently used ones. You can use your old Quality Manual and combine it with our new Environmental Manual that is a part of above mentioned toolkit. Practically you will need to identify common requirements of ISO 13485 and ISO 14001:2015 and merge them into joint sections and for different requirements you will have separate sections in the manual. We will also publish ISO 13485:2016 Documentation Toolkit soon so if you decide to purchase it later, you will get a big discount as our previous customer.