VDI 5702 BLATT 1
Medical device software - Medical SPICE Process assessment model
|Publication Date:||1 April 2017|
|ICS Code (IT applications in health care technology):||35.240.80|
|ICS Code (Software):||35.080|
|ICS Code (Medical equipment in general):||11.040.01|
This standard is structured as follows:
• Section 5 provides a detailed description of the structure and key components of the process assessment model, which includes two dimensions: a process dimension and a capability dimension; assessment indicators are introduced in this section.
• Section 6 addresses the process dimension. It uses process definitions from the standards referenced in Section 2 to identify a process reference model. The processes of the process reference model are described in the process assessment model in terms of purpose and outcomes. The process assessment model expands the process reference model process definitions by including a set of process performance indicators called base practices for each process. The process assessment model also defines a second set of indicators of process performance by associating work products with each process. Annex B is also linked directly to Section 6 as it defines the work product characteristics.
• Section 7 addresses the capability dimension. It duplicates the definitions of the capability levels and process attributes from ISO/ IEC 15504-2, and expands each of the nine attributes through the inclusion of a set of generic practices. These generic practices belong to a set of indicators of process capability, in association with generic resource indicators, and generic work product indicators.
• Annex A provides a statement of conformance of the process assessment model to the requirements defined in ISO/IEC 15504-2.
• Annex B provides selected characteristics for typical work products to assist the assessor in evaluating the capability level of processes.