QMS Overview

Reorder the following processes in correct chain order

• CE - Product Approval

• SW - Software Development

• 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.

• software
• usability
• stakeholder

Match the following documents to the corresponding V-Model SOPs

• CE-SOP-01 Product Approval

• Software Requirements

• SW-SOP-01 Software Development

• Approval Checklist

• PR-SOP-01 Project Realisation

• Source Code

• BA-SOP-01 Business Analysis

• System Architecture

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.

• core
• management
• assisting
• redundant
• funny

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.

• Verification
• Validation
• usability
• clinical
• technical
• approved

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