Quality Management System.ppt

IE673 Session 10 - ISO 9000 Quality Management System ISO 9000 What is ISO 9000? A series of standards that outline the requirements for a quality management system. The ISO 9000 Series ISO 9000 - Quality Management and Quality Assurance Standards - Guidelines for selection and use ISO 9001 - Quality Systems - Model for Quality Assurance in Design/Development, Production, Installation, and Servicing ISO 9002 - Quality Systems - Model for Quality Assurance in Production and Installation ISO 9003 - Quality Systems - Models for Quality Assurance in Final Inspection and Test Certification Time Line Certification Maintenance Benefits of ISO 9000 Certification and Registration Elements of ISO 9001 - 4.1 Management Responsibilities * ISO 9000 Versus cGMP Management Responsibility Design Manufacture Inspection/Test Installation Service Manufacture Inspection/Test Installation ISO 9000 cGMP A 0 5 10 15 20 Avg Time Months Determine Readiness Preparation Service Apply for Certification Documentation Review Pass Certification Fail Corrective Action On Site Assessment A B C D E G Initial Certification Semi-Annual Audits 3 -Year Recertification Use of Recognized Certification Label in Marketing and Promotions Registered in dept of Trade and Industry Directory Accessibility to EC Market Visibility Overall Improved Competitiveness Are there established quality policies are they communicated to all employees? Who has the responsibility authority for quality? Are people trained to perform their function? Are people responsible for implementing maintaining standards? Is management involved with quality issues? Elements of ISO 9001 - 4.2 Quality System Quality System The procedures instructions must be written constantly updated Quality Assurance is to be maintained documented Instructions in the QA Manual and Procedural instructions efficiently implemented Elements of ISO 9001 - 4.3 Contract Review Are contracts reviewed for intent and capability? Are there records mainta