INTRODUCTION TO QUALITY & ISO

JPTF - QUALITY OFFICER TRAINING MODULE 2013

Quality System and Quality Relationships Quality Management System ISO 9000/14000 Management & Employees

Quality Assurance Quality Officers

GMP/ HACCP Management & Employees Production and Quality Control on the floor / in field - Workers

Quality Assurance Procedures for self-inspection and/or quality audits sanitation inspection, gmp inspections, in-process quality, incoming raw material inspections. Reporting, investigation and recording of findings of audits. Reporting, investigation and recording of deviations from quality standards. Regular evaluation of product quality to verify consistency and continued improvement

What is ISO 9001? ISO 9000 was revised in 2000. ISO 9001:2008, is the latest ISO 9000 standard. Its called the approval standard. It has 5 main sections: Quality Management System Management Responsibility Resource Management Product Realization Measurement Analysis and Improvement

 Why Do I Need ISO 9001? Approval is often a pre-requisite when bidding for major contracts and government work ISO 9001:2000 represents the accepted minimum management standards for a well managed organization. Whether you wish to operate internationally or to expand locally ISO 9001:2000 approval will help demonstrate to your customers that you have a commitment to quality. The approval and assessment process for ISO 9001 can help you improve overall performance and widen business opportunities.

What is Quality? Quality The totality of all the characteristics of a Good, or Service that bears on its ability to satisfy its stated or implied needs. What is Quality Management?

The aspect of management function that determines and implements the quality policy What is the Quality Policy? The overall intention and direction regarding quality, as formally expressed and authorized by top management

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 defect detection).

Quality Assurance & GMP both call for the same basic requirements Basic Requirements for GMP & Quality:Clear, written instructions and procedures. Trained operators. Records of actions, deviations and investigations. Records for manufacture and distribution. Proper storage and distribution. Systems for complaints and recalls. Sanitation & Hygiene system.