Qualit system

OPTIMIZING THE QUALITY MANAGEMENT SYSTEM
TO BE IN COMPLIANCE
By: Diana Rodríguez Cruz
UNIVERSIDAD DEL TURABO
Business Administration School

OPTIMIZING THE QUALITY MANAGEMENT SYSTEM TO BE IN COMPLIANCE

The Quality Management System (QMS) is a set of requirements to direct and control quality of the product or service in an organization. These requirements are defined in theFederal Drug Administration guidance (FDA), International Standard Organization (ISO) standards and also in the International Conference on Harmonization of technical requirement for registration of pharmaceuticals for human use guidance currently known as ICH guidelines that are optional. The general purpose of this study is to demonstrate that an optimal quality management system is thebase for a long period regulatory compliance and therefore, for enduring market success. This study examines the importance of the organization in regulatory compliance through simplifyingied and streamlining Quality System process.
An organized and purposeful quality management structure viewed as a whole, consisting of interrelated and independent elements is the successfundamentals to continue in the specific market. The high cost of non compliance could result be since in economic penalties until to close the organization.REVISE SENTENCE However, the QMS is a key factor in gaining competitive advantage. The investigation examines the elements of the Quality Management System strategy, factors that promote or inhibit the implementation of QMS in anorganization and the relationship of QMS and organizational performance. Individual improved process and incorporated, linked ones with the other create a strong structure to manage the day to day activity and the future of the organization.
Jointly the Quality performance and the manufacturing capability improve the organization achieves and sustains a competitive advantage. INCLUDE INABSTRACT KEY FINDINGS

TABLE OF CONTENTS

Page
|ABSTRACT…………………………………………………………………… |2 |
|TABLE OF CONTENT……………………………………………………….. |3 |
|PROBLEMSTATEMENT……………………………………………………. |4 |
|Purpose and objectives………………………………………………… |5 |
|Study Justification……………………………………………………... |6 |
|Delimitations andLimitations…………………………………………. |7 |
|THEORETICAL FRAMEWORK…………………………………………….. |8 |
|2.1 To verify what posit the Quality management System strategy………………………………………………………………...| |
|2.2 To assess the factors that promote or inhibit the implementation of QMS in an organization……………………………………………….. |8 |
|2.3 To examine the relationship of QMS and organizational performance……………………………………………………………. | |
|FINDINGS……………………………………………………………………..|11 |
|CONCLUTIONS AND IMPLICATIONS…………………………………….. | |
|REFERENCES………………………………………………………………… |17 |
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