ISO 9001 Quality Management System

What is ISO? INTERNATIONAL ORGANIZATION FOR STANDARDIZATION Established in 1947 Head Office is based in Geneva - Switzerland Greek Word “isos” which means equal

Current ISO Standards ISO 9001:2008 Quality Management System Environmental Management System ISO 22000 Food Safety Management System ISO 27001 Information Security Management System

History of ISO 9000 Second world war US military standards NATO British Standards Institute BS5750 ISO 9000:1987 Vocabulary Standard Revised in ISO 9000:1994 & ISO 9001:2000 QMS ISO 9001:2008 Current

Hierarchy / Chain of Monitoring (ISO) International Organization for Standardization Worldwide Accreditation Bodies (Every Country) Certification Bodies

World-wide Accreditation Bodies UKAS United Kingdom TGA DAR German PNAC Pakistan RvA Netherlands ANSI RAB America JAB Japan COFRAC France

ISO 9001 CERTIFICATION BODIES UKAS BVC LRQA ACS Registrars Moody International

Introduction to ISO 9001 QMS ISO 9001 is the quality management system standard. Which addresses the basic requirements for a quality system. It is equally applicable to manufacturing, servicing & inspection / testing organizations.

Continual improvement of the quality management system About ISO 9001:2008 Process Model Continual improvement of the quality management system 5 Management C R Responsibility u e C q u s u s t i 6 8 o r t ISO9001/2008 e Resource Measurement, Analysis o m m Management Process e e Model m Improvement n r e t s r s 7 s Product/ Service Product Realization & Service Input Output

ISO 9001:2008 QMS Process requirements Five Key Activities (Paragraphs) 4. Quality Management System 5. Management Responsibility 6 Resource Management Please refer process model approach diagram. Slide no 12. 7. Product Realization. 8. Measurement, Analysis, Improvement

ISO 9001:2008 4.0 Quality Management System 4.1 Requirements shall Establish, Document, Implement, Maintain Continually improve its effectiveness Note the continuos improvement is a requirement.

ISO 9001:2008 5. Management responsibility 5.1 Management Commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Planning It is no longer say what you do and do what you say, it is more about keeping customer satisfied. Finally recognition that QMS has to be administered. 5.5 Responsibility, authority and communication 5.6 Management review

ISO 9001:2008 6. Resource Management 6.1 Provision of Resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment

ISO 9001:2008 7. Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring & measuring devices.

ISO 9001:2008 8.0 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of Non conformity product 8.4 Analysis of data 8.5 Improvement

Integrated Management System

Training courses we can offer during system development & implementation ISO 9001 QMS Introduction ISO 9001 QMS Internal Auditing ISO 14001 EMS Introduction ISO 14001 EMS Internal Auditing Occupational Health & Safety Basic Introduction Integration of ISO 9001, ISO 14001 & OHSAS 18001 ISO 22000 Food Safety

Benefits of ISO Standardization Globally Recognized Improvement in Quality System Efficiency Controlled Wastages Better Motivation World-wide Acceptance Customer Satisfaction

Trained Work Force Better Working Environment Defined Roles & Responsibilities Better Coordination Environment Friendly Better Future Increased Competence & Commitment of Employees as well as Vendors

STEPS TO GET YOUR COMPANY ISO CERTIFIED (Summary) GAP Analysis Training Session Defining Quality Policy Developing & implementing Operating Procedures, Job Descriptions and Work Instructions Setting Quality Objectives Training of Internal Auditors Pre-evaluation of QMS System Certification Audit Never Ending Improvement