DSF/ISO 80001-2-7 TR Ed. 1 - 62A/945/CDTR
Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
| Organization: | DS |
| Status: | pending |
| Page Count: | 143 |
scope:
The purpose of this technical report is to provide guidance to HDOs on self-assessment of their 205 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 exemplar 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.
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