VDI 5702 Blatt 1:2017-04
Current
The latest, up-to-date edition.
Medical device software - Medical SPICE Process assessment model
Hardcopy , PDF
German - English
01-04-2017
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Preliminary note
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Overview of the process
assessment model
6 The process dimension and
process performance indicators
(level 1)
7 Process capability indicators
(level 1 to 5)
Annex A - Conformity of the
process assessment model
Annex B - Work product characteristics
Annex C - Reference mappings
Annex D - Relation with IEC/TR 80002-3
Annex E - References to terms and definitions
Bibliography
Gives 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.
| DocumentType |
Standard
|
| Pages |
180
|
| PublisherName |
Verlag des Vereins Deutscher Ingenieure
|
| Status |
Current
|
| Supersedes |
| ISO/IEC 33020:2015 | Information technology Process assessment Process measurement framework for assessment of process capability |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO/IEC 15504-4:2004 | Information technology Process assessment Part 4: Guidance on use for process improvement and process capability determination |
| IEC TR 80002-3:2014 | Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/IEC 33001:2015 | Information technology Process assessment Concepts and terminology |
| DIN EN 62366 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| VDE 0750-101 : 2016 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
| ISO/IEC 33003:2015 | Information technology Process assessment Requirements for process measurement frameworks |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO/IEC 15504-2:2003 | Information technology Process assessment Part 2: Performing an assessment |
| VDE 0750-241 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| VDI 1000:2017-02 | VDI Standardisation Work - Principles and procedures |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/IEC 33002:2015 | Information technology Process assessment Requirements for performing process assessment |
| ISO/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| DIN EN 62304 : 2016 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO/IEC 15504-1:2004 | Information technology Process assessment Part 1: Concepts and vocabulary |
| VDE 0750-1 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| ISO/IEC 33004:2015 | Information technology Process assessment Requirements for process reference, process assessment and maturity models |
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