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WorksheetsQMS Overview
Total questions: 10
Worksheet time: 12mins
Reorder the following processes in correct chain order
SW - Software Development
CE - Product Approval
BA - Business Analysis
SM - Software Maintanance
What document contains an overview of qm documentation?
SW-SOP-01 - Software Development
QM-QMH-01-QM-Manual
QM-QMH-02-Quality-Policy
HR-SOP-04-QM-Overview
What does QM want to achieve?
Traceability
Low manufacturing costs
reproducable quality
happy investors
Systemtest cases are traceable to (a) requirements and (b) tests are traceable to (c) requirements.
Match the following documents to the corresponding V-Model SOPs
System Architecture
PR-SOP-01 Project Realisation
Software Requirements
BA-SOP-01 Business Analysis
Source Code
SW-SOP-01 Software Development
Approval Checklist
CE-SOP-01 Product Approval
Processes, that are in charge of product manufacturing are grouped as (a) processes. The (b) processes are mainly for qm control and all the processes are supported by (c) processes.
An overview of a project is found in...
project plan
software development plan
usability evaluation plan
test plan
(a) is done before the (b) .
The Validation consists of (c) evaluation for the technical part and (d) evaluation for the medical content.
Which of the following are direct interfaces to the SW-Process?
PR - Project Realisation
BA - Business Analysis
SA - Sales
SU - Support and Feedback
Which of the following processes are dicteated by their own specific ISO norm?
BA-SOP-02-Usability-Engineering
RM-SOP-01-Risk-Management
PS-SOP-01-Supplier-Rating
ME-SOP-01-Medical-Content
