ISO 9000 and ISO 1400 standard

By the conclusion of the specific learning and development activities, the delegates swill be able to:
Demonstrate an understanding of the importance of quality standards
Explain what the International Organization of Standardizations (ISO) represents
Exhibit an understanding of the structure of ISO, as an organisation
Explain ISO code of ethics
Explain the benefits of ISO to organisations
Identify the hallmarks of the ISO as a brand
Explain ISO’s contribution to world trade
Exhibit an understanding of the benefits that ISO represents to developing countries
Recognise ISO standards
Distinguish between ISO 9000 and ISO 1400
Determine the elements that constitute the ISO 9000 family
Explain clients or customers’ quality requirements
Demonstrate an understanding of the general regulatory quality requirements
Exhibit an understanding of how to enhance client and customer satisfaction
Exhibit an understanding of the processes involved in continuous quality improvements
Explain at least five of the eight ISO quality principles
Name the constituents of ISO 9000:2000 series
Demonstrate a significant grasp of the ISO 9000 quality standards, as it pertains to different
industry sectors
Explain the background to the international working group agreement – IWA 1:2001 and IWA
1:2005, as it pertains to health service organisations
Explain the ISO/TS 29001:2003 as it pertains to petroleum petrochemical and natural gas industrial
sectors
Explain at least 10 ISO 9000 standards, linking them to their specific standards parameter
Determine the relationship between performance management and quality improvement in public sector organisations
Explain how ISO certification might be achieved
Exhibit an understanding of the marketing opportunity that ISO certification represents
Suggest the steps that should be taken in preparation for ISO certification assessment
Explain the progress that the ISO’s 2005 to 2010 action plan for developing countries has made, suggesting effort towards its enhancement

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 an 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 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
39. 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 applicationof 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 9001:2000f or the competence of reference material producers ISO Guide 34:2000/Cor 1:2003
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 Plan for Developing Countries

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