AAMI/IEC TIR80001-2-7:2014

The purpose of this technical report is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1. The purpose of this Technical Report is to: 1) Provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1 2) Provide an exemple assessment method which can be used by HDOs in varying contexts to assess themselves against IEC 80001-1 3) Define a PRM comprising a set of processes, described in terms of process purpose and outcomes that demonstrate coverage of the requirements of IEC 80001-1 4) Define a PAM that meets the requirements of ISO/IEC 15504-2 and that supports the performance of an assessment by providing indicators for guidance on the interpretation of the process purposes and outcomes as defined in IEC 80001-1 (PRM) and the process attributes as defined in ISO/IEC 15504-2 This technical report does not introduce any requirements in addition to those expressed in IEC 80001-1. Annex 3