CORVID-19 related lockdowns & restrictions, has created
a novel situation. However Certification-related Audits are still required to
be conducted in-spite of current restrictions. To enable Certification audits
to continue, most Certification Bodies worldwide have or are moving to Remote
Auditing. This means that the Auditing is carried out remotely as the default.
In the past, they were the exceptions.
ISO 13485 Standards was updated on 1st March 2016.
With the ongoing reviewing and updating of all the Management Standards, it is interesting to note that ISO 13485 is the exception. In particular
ISO 13485 follows the previous Standard (and ISO 9001: 2008) Index layout. This is in-spite of ISO specifying that all new or revised Management Standards in 2013 will comply to the new Annex SL format...