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AAMI TIR80001-2-7
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AAMI TIR80001-2-7 2014 Edition, January 1, 2014 Application of risk management for ITnetworks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to selfassess their conformance with IEC 80001-1
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Description / Abstract:
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 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.
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.