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INTRODUCTION TO QUALITY &
ISO
JPTF
-QUALITY
OFFICER
TRAIN
ING
MODULE2013
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Quality System and Quality
Relationships
Quality Management SystemISO 9000/14000
Management & Employees
Quality Assurance
QualityOfficers
GMP/ HACCPManagement
& Employees
Production and Quality
Control on the floor / in field
- Workers
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What is ISO 9001?
ISO 9000 was revised in 2000. ISO
9001:2008, is the latest ISO 9000standard. Its called the approval
standard. It has 5 main sections:
Quality Management System
Management Responsibility
Resource Management
Product Realization
Measurement Analysis and
Improvement
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Why Do I Need ISO 9001?
Approval is often a pre-requisite whenbidding for major contracts and
government work ISO 9001:2000 represents the accepted
minimum management standards for awell managed organization.
Whether you wish to operate
internationally or to expand locally ISO9001:2000 approval will helpdemonstrate to your customers thatyou have a commitment to quality.
The approval and assessment processfor ISO 9001 can help you improveoverall performance and widenbusiness opportunities.
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What is Quality?Quality
The totality of all the characteristics of aGood, or Service that bears on its ability tosatisfy its stated or implied needs.
What is Quality Management?
The aspect of management function that
determines and implements the qualitypolicy
What is the Quality Policy?The overall intention and directionregarding quality, as formally expressedand authorized by top management
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What is Inspection?
Activities such as measuring,examining, testing, gauging one or
more characteristics of a product
or service and comparing these
with specific requirements
(standards) to determine
conformity. (These activities are
directed towards defectdetection).
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Quality Assurance & GMP both callfor the same basic requirementsBasic Requirements for GMP &
Quality:-Clear, written instructions andprocedures.Trained operators.Records of actions, deviations andinvestigations.Records for manufacture anddistribution.Proper storage and distribution.Systems for complaints and recalls.Sanitation & Hygiene system.
