Project Outline Include a brief description of the project. Describe the overall project deliverables. Material can be taken from the approved proposal that you submitted to the instructor. This ma

Running head: QUALITY MANAGEMENT INTEGRATION PLAN 0

Medical Needs

Quality Management Integration Plan

Connie Farris

Colorado Technical University

Project Performance and Quality Assurance

(MPM357-1902A-02)

Jason Lewis

Abstract

Medical Needs is in the process of setting up business in Nashville and Memphis Tennessee. This company will provide any medical device the doctor prescribes for the patients, with an extensive line of medical products available. They are hoping to be securely established by the fall of next year. A risk analysis has been performed and the stakeholders requested a quality analysis to ensure all the materials used will meet FDA QS regulations and ISO 14971 device quality system requirements This will include all vendor materials and the equipment used to manufacture the devices in both locations. In the next few weeks we will cover all aspects needed to complete this step of the preparations to open these businesses.

Quality Management Integration Plan

Table of Contents

Abstract 1

Plan Quality Management Week 1 4

Perform Quality Management Week 2 TBD 5

Perform Quality Assurance Week 3 TBD 6

Control Quality Week 4 TBD 7

Control Quality Week 5 TBD 8

Plan Quality Management Week 1















Perform Quality Management Week 2 TBD
Perform Quality Assurance Week 3 TBD Control Quality Week 4 TBD Control Quality Week 5 TBD

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