“ISO 9000: A Quality Management System(QMS) is required to achieve Total Quality Management”

1. “ISO 9000: A Quality Management System(QMS) is required to achieve Total Quality Management” • System • Tools & techniques • People Latest Version of ISO 9001:2015

2. For more than half a century, the International Standard for Organizations (ISO) has been developing standards to protect society from potential errors. http://www.praxiom.com/iso-tutorial.htm

3. ISO is the International Organization for Standardization. It was set up in 1947 and is located in Geneva, Switzerland. Its purpose is to facilitate and support international trade by developing standards that people everywhere would recognize and respect. ISO achieves this purpose through the participation and support of its members. These members come from 158 national standards organizations. http://www.praxiom.com/iso-tutorial.htm

4. ISO standards are developed by technical committees. The people who serve on these technical committees come from many national standards organizations. Consequently, ISO standards have worldwide support. • The International Organization for Standardization chose the acronym ISO (and not IOS) because the word ISO also means “equal” or “equivalent” in Greek, and because ISO works better when translated into other languages. • Currently, ISO has 193 technical committees, 540 subcommittees, and 2244 working groups. Since 1947, ISO has developed 16,455 international standards. http://www.praxiom.com/iso-tutorial.htm

5. Members of the ISO 9000 family • ISO 9000: 2000 - Quality management systems – Fundamentals and vocabulary • ISO 9001: 2000 Quality management systems - Requirements • ISO 9004: 2000 Quality management systems – Guidance for performance improvement • ISO 19011: - Guidelines on quality and/or environmental management systems auditing Latest Version of ISO 9001:2015

6. Features • Why go for ISO 9000? – benefits • For manufacturing & service companies • Generic in nature • Represents the minimum level of quality system

7. Who is responsible for development and revision? • International Organization for Standardization ( ISO ) - Geneva based federation of national standards bodies • Revision undertaken by ISO/ TC 176, which is a technical committee on quality management and quality assurance

8. History of Quality Standards • 1979 BS 5750 • 1987 ISO 9000 series (1st Edition ) (ISO 9001/ ISO 9002/ ISO 9003) • 1994 ISO 9000 2nd Edition (ISO 9001/ ISO 9002/ ISO 9003) • 2000 ISO 9001 3rd Edition (ISO 9001:2000)

9. Audit – first party, second party, third party • Audit – desk, compliance, surveillance • Compliance, non-compliance • Non-compliance – major, minor, (observation) • Revision – every 5 years • Process, not product • ‘Process approach’

10. Members of the ISO 9000 family • ISO 9000: 2000 - Quality management systems – Fundamentals and vocabulary • ISO 9001: 2000 Quality management systems - Requirements • ISO 9004: 2000 Quality management systems – Guidance for performance improvement • ISO 19011: - Guidelines on quality and/or environmental management systems auditing

11. ISO 9000:2000 - defines quality management principles terms and definitions fundamentals - systems approach, process approach, continual improvement ISO 9001:2000 - specifies quality system requirements for achieving customer satisfaction, applicable to entire enterprise. (“permissible exclusions” (like design) are limited to requirements within Clause 7 - Product Realization, and your registrar must verify they are not part of your business) ISO 9004:2000 - provides guidelines for performance improvement, based on quality management principles and approaches defined in ISO 9000, and continual improvement of the quality management system itself. (However, ISO 9004 is NOT intended as a guideline for implementing or assessing implementation of ISO 9001 requirements)

12. ISO 9000:2000 is the foundation for performance excellence Business Vision Performance Excellence Malcolm Baldrige Criteria Performance Improvement ISO 9004:2000 Baseline Performance: ISO 9001:2000 Competitive Advantage Efficient Quality Management System Effective Quality Management System

13. 8 quality principles underlying ISO 9000:2000 • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships

14. the 8 Principles of Quality Management They’ve been the guiding principles for the most popular quality standard; ISO 9001.But they’re also useful resources for any management professionals who want to implement or improve their existing quality management programme.

15. Principle 1 CUSTOMER-FOCUSED ORGANISATION Organisations depend on their customers and therefore should understand current and future customers’ needs, meet customer requirements and strive to exceed customer expectation

16. Principle 2 LEADERSHIP Leaders establish unity of purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives.

17. Principle 3 INVOLVEMENT OF PEOPLE People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit. An organisation is nothing without its staff whether part-time, full-time in house or out-sourced. It’s their abilities that maximised to achieve business success.

18. Principle 4 PROCESS APPROACH A desired result is achieved more efficiently when related resources and activities are managed as a process. The process approach is all about efficiency and effectiveness. It’s also about consistency and understanding that good processes also speeds up activities. Great processes reduce costs, improve consistency, eliminate waste and promotes continuous improvement.

19. What is a process? Activities that transform input into output Activity Input Output Resources: People Facilities/Equipment Material Methods Results: Products Services Performance

20. How is a process managed? Monitor & Measure the Process make sure the inputs are right, the transformation activities consistently work, and the desired results are achieved, then - improve the process as needed Activity Input Output Right Resources: Qualified People Right Facilities/Equipment Correct Materials Proven Methods Desired Results: Quality Products Quality Services Customer Satisfaction

21. Process approach • Process = a group of activities using resources, and managed in order to enable the transformation of inputs into outputs. • The output from one process usually directly becomes the input to the next process • ‘Process approach’ is the control & management of a system of processes within an organisation, and the identification & interactions of these processes. It provides linkage between individual processes within the system, as well as their combination & interaction • Organisations must control all process inputs, (people, facilities/equipment, material and methods) and must establish appropriate controls over the transformation activities

22. Principle 5 SYSTEM APPROACH TO MANAGEMENT Identifying, understanding and managing a system of interrelated processes for a given objective improves the organisation’s effectiveness and efficiency. This means that multiple processes are managed together as a system which should lead to greater efficiency.

23. System Approach Organisations must understand a system is a set of interrelated processes the output of one process is the input to one or more subsequent processes, so ... It is critical to manage the interface between processes to ensure that the overall system is effective

24. Principle 6 CONTINUAL IMPROVEMENT This principle is very straight forward: Continual improvement should be a permanent objective of the organisation.

25. Continual Improvement Continual improvement of the organisation’s overall performance should be a permanent objective: It must be a planned activity if the organization desires to improve overall performance and capabilities.

26. Principle 7 FACTUAL APPROACH TO DECISION MAKING Effective decisions are based on the analysis of data /information. A logical approach, based on data and analysis, is good business sense. Unfortunately, in a fast paced workplace, decisions can often be made rashly, without proper thought. The efficiency that will have been imbued in the organisation after the implementation of prior principles will allow decisions to be made with clarity. Informed decisions lead to improved understanding of the marketplace as data is collated and analysed, and the ability to defend past decisions.

27. Principle 8 MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS This principle deals with supply chains. It promotes the relationship between the company and its suppliers; recognising it is interdependent. A strong relationship enhances productivity and encourages seamless working practices. The result is optimisation of costs and resources, fostering long term relationships and the ‘flexibility of joint responses to changing market or customer needs and expectations’.

28. Putting it all into Practice Like the eight quality principles, an automated enterprise quality management system (quality management software) built on the ISO standard has very effective impact on the total operation of an organization.

29. 5 main sections in ISO 9001 • Quality management system • Management responsibility • Resource management • Product realisation • Measurement, analysis and improvement TAMAT

30. Assignment • Why is it important to become ISO 9001 certified? TAMAT