ISO 9000 Quality Systems

Course Contents, Concepts and Issues

• Why Quality Standards Matter
• What Is the International Organisation for Standardization (ISO)?
• ISO Structure
• ISO Code of Ethics
• What 'International Standardization' Means
• How ISO Standards Benefit Society
• The Hallmarks of the ISO Brand
• ISO and World Trade
• ISO and Developing Countries
• How to Recognize ISO Standards
• The ISO Standards: An Introduction
• ISO Standards – ISO 9000 and ISO 1400: An Overview
• The ISO 9000 Family
• Objectives of ISO 9000
• The Clients or Customers’ Quality Requirements
• General Regulatory Quality Requirements
• Enhancing Client and Customer Satisfaction,
• Towards Continuous Quality Improvement
• ISO Quality Principles
• Principle 1 Client or Customer Focus
• Principle 2 Leadership
• Principle 3 Involvement of People
• Principle 4 Process Approach
• Principle 5 Systems Approach
• Principle 6 Continuous Improvement
• Principle 7 Factual Approach to Decision Making
• Principle 8 Mutually Beneficial Supplier Relationships
• The ISO 9000:2000 Series
• ISO 9000:2005 Quality Systems - Fundamentals and Vocabulary
• ISO 9001:2000 Quality Systems – Requirements
• ISO 9004:2000 Quality Systems - Guidelines for Performance Improvements
• ISO 19011:2002 Guidelines for Quality and/or Environmental Systems Auditing
• The ISO 9000 Quality Standards
• IWA 1:2001 to IWA 1:2005 (International Workshop Agreement) -
• Guidelines for Process Improvements in Health Service Organizations
• IWA 2:2003-Quality Systems - Guidelines for the Application of ISO 9001:2000 in Education
  IWA 4:2005-Quality Systems -- Guidelines for the Application of
• ISO 9001:2000 in Local Government
• ISO Guide 34:2000-General Requirements For The Competence Of Reference Material Producers
• ISO Guide 34:2000/Cor 1:2003-
• ISO 9000:2005-Quality Management Systems -- Fundamentals and Vocabulary
• ISO 9001:2000-Quality Management Systems -- Requirements
• ISO 9004:2000-Quality Management Systems -- Guidelines for Performance Improvements
• ISO 10002:2004-Quality Management -- Customer Satisfaction -- Guidelines for Complaints Handling In Organizations
• ISO 10005:2005-Quality Management Systems -- Guidelines for Quality Plans
• ISO 10006:2003-Quality Management Systems -- Guidelines for Quality Management In Projects
• ISO 10007:2003-Quality Management Systems -- Guidelines for Configuration Management
• ISO 10012:2003-Measurement Management Systems -- Requirements for Measurement Processes and Measuring Equipment
• ISO/TR 10013:2001-Guidelines for Quality Management System Documentation
• ISO/TR 10014:1998-Guidelines for Managing the Economics of Quality
• ISO 10015:1999-Quality Management -- Guidelines for Training
• ISO/TR 10017:2003-Guidance on Statistical Techniques for ISO 9001:2000
• ISO 10019:2005-Guidelines for the Selection of Quality Management System Consultants and Use of Their Services
• ISO/TR 13352:1997-Guidelines for Interpretation of ISO 9000 Series for Application within the Iron Ore Industry
• ISO 13485:1996-Quality Systems -- Medical Devices -- Particular Requirements for the Application of ISO 9001
• ISO 13485:2003-Medical Devices -- Quality Management Systems -- Requirements for Regulatory Purposes
• ISO 13488:1996-Quality Systems -- Medical Devices -- Particular Requirements for the Application of ISO 9002
• ISO 14964:2000-Mechanical Vibration and Shock -- Vibration of Stationary Structures -- Specific Requirements for Quality Management in Measurement and Evaluation of Vibration
• ISO/TR 14969:2004-Medical Devices -- Quality Management Systems -- Guidance on the Application Of ISO 13485: 2003
• ISO 15161:2001-Guidelines on the Application of ISO 9001:2000 for the Food and Drink Industry
• ISO 15189:2003-Medical Laboratories -- Particular Requirements for Quality and Competence
• ISO/TS 16949:2002-Quality Management Systems -- Particular Requirements for the Application of ISO 9001:2000 for Automotive Production and Relevant Service Part Organizations
• ISO 19011:2002-Guidelines for Quality and/or Environmental Management Systems Auditing
• ISO/TS 19218:2005-Medical Devices -- Coding Structure for Adverse Event Type and Cause
• ISO 22870:2006-Point-Of-Care Testing (POCT) -- Requirements for Quality and Competence
• ISO/TS 29001:2003-Petroleum, Petrochemical and Natural Gas Industries -- Sector-Specific Quality Management Systems -- Requirements for Product and Service Supply Organizations
• ISO/IEC 90003:2004-Software Engineering -- Guidelines for the Application of ISO 9001:2000 to Computer Software
• ISO 9001:2000 Goals
• Identifying Goals
• Identifying Role Expectations
• Applying the ISO 9000 Family of Standards in Your Organisation
• Establish Your Current Status; Determine the Gaps between Your Quality Management System and the Requirements of ISO 9001:2000
• Determine the Processes That Are Needed To Supply Products to Your Customers or Clients
• Developing a Plan to Close the Gaps in the Processes
• Carrying Out Your Plan
• Undergoing Periodic Internal Assessment
• Demonstrating Organisational or Departmental Conformity to Quality Standards
• Importance of Conformity Assessment
• Undergoing Independent Audit
• Continuous Organisational or Business Improvement
• Maintaining the Benefits and Continuous Improvement
• ISO Certification
• Publicising ISO Certification
• Preparing For the ISO Certification Assessment
• Maintaining Certification
• Performance Management as a Quality Instrument
• ISO’s 2005-2010 Action Plans for Developing Countries