PD ISO/TR 80001-2-7:2015 - Page 2

Application of risk management for IT-networks incorporating medical devices. Application guidance. Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 | Status: Current, Proposed for withdrawal

1 Scope The purpose of this part of ISO/TR 80001 is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1. The purpose of this part of ISO/TR 80001 is to

1. a) provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1,
2. b) provide an exemplar assessment method which can be used by HDOs in varying contexts to assess themselves against IEC 80001-1,
3. c) 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, and
4. d) 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 part of ISO/TR 80001 does not introduce any requirements in addition to those expressed in IEC 80001-1.