ISO 9000

These standards are guidelines on how to document the processes in specific industries. The goal is consistency and a set of complete, easy to follow instructions. ISO 9000 is a set of five guideline standards that define the requirements for an effective quality management system.

1. ISO 9000

2. A function of a cost, profit margin and markets forces A function of the organization’s efficiency and effectiveness Determined by the extent to which a product or a service successfully serves the purposes of the user during usage Fundamental parameters of the saleability of a product

3. Definition of Quality

4. Definition of Quality In the context of ISO 9000, quality is concerned with the totality of the characteristics that satisfy needs. Quality is defined as the degree to which a set of inherent characteristics fulfill the requirements.

5. Evolution of Quality Thinking Quality Control Quality Assurance Quality Management

6. Verification and Validation This is the process of checking that a product, service, or system meets specifications and that it fulfils its intended purpose. Validation can be expressed by the query, “Are you building the right thing?” Verification, on the other hand, by “Are you building it right?”

7. Verification Verification is a quality control process that is used to evaluate whether or not a product, service, or system complies with regulations, specifications or conditions imposed at the start of a development, scale-up or production. Often an internal process

8. Validation Validation is a quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.

9. Stakeholders Interested Party Success Criteria Owner Financial return Employees Job satisfaction, pay and conditions and quality of leadership Customers Quality of products and services Community Contribution to the community – jobs, support for othe r traders in the community - care for the local environment Suppliers Satisfactory mutual trading Investors Value of shares Government Compliance with legislation

10. Historical Antecedent of ISO *Based on trust and confidence

11. What is ISO ? International Organization for Standardization (ISO) ISO is Greek root meaning equal These standards are guidelines on how to document the processes in specific industries. The goal is consistency and a set of complete, easy to follow instructions. ISO guidelines is where the TQM process can become a bit overwhelming.

12. ISO and TQM * ISO is the process that typically shifts an organization's culture to allow successful TQM implementation

13. Understanding ISO standards ISO standards are just a Quality Management System (QMS) with specific guidelines on how to document the processes.  ISO is not, however, a way to get around Total Quality Management.    Since ISO is focused on consistency and record-keeping, while TQM is focused on employee involvement and product improvement, they go hand in hand. Both are customer requirements focused, but Total Quality Management is really the driving factor. 

14. ISO 9000

15. ISO 9000 ISO 9000 is a set of five guideline standards that define the requirements for an effective quality management system. Of the five, only three are certification standards (ISO 9001, 9002 and 9003); both ISO 9000 and 9004 are guidelines for the other three.

16. Quality Management Organizations and Awards ISO 9001:2008 ISO 9001:2000 ISO 9000:2005 ISO 9004:2000 Malcolm Baldrige National Quality Award European foundation for Quality Management’s EFQM Excellence Model Canada Awards for Excellence Alliance for Performance Excellence

17. Quality Management Organizations and Awards CAPA Quality Systems ISO 14001 ISO 27001 and Information Security ISO 17025 Testing and Calibration AS 9100

18. 1. ISO 9001:2008 International Organization for Standardization’s ISO 9001:2008 series describes standards for a QMS addressing the principles and processes surrounding the design, development and delivery of a general product or service.

19. 2. ISO 9001:2000 Organizations can participate in a continuing certification process to ISO 9001:2000 to demonstrate their compliance with the standard, which includes a requirement for continual improvement of the QMS.

20. 3 – 4. ISO 9000:2005 and ISO 9004:2000 ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2000 provides guidance for improvement methods However, neither of these standards can be used for certification purposes as they only provide the standards and not requirements.

21. 5. Malcolm Baldrige National Quality Award It is a competition to identify and recognize top-quality U.S. companies. This model addresses a broadly-based range of quality criteria, including commercial success and corporate leadership. Once an organization has won the award it has to wait several years before being eligible to apply again.

22. 6. EFQM Excellence Model European foundation for Quality Management’s EFQM Excellence Model supports an award scheme similar to the Malcolm Baldrige Award for European companies

23. 7. Canada Awards for Excellence National Quality Institute presents the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of Quality and Workplace Wellness, and have met the institute’s criteria with documented overall achievements and results

24. 8. Alliance for Performance Excellence Alliance for Performance Excellence is a network of state, local, and international organizations that use the Malcolm Baldrige National Quality Award criteria and model at the grassroots level to improve the performance of local organizations and economies.

25. 9. CAPA Quality Systems A CAPA Quality System is absolutely essential in some format for a complete quality management program.  What it is called is not as important as the fact that it absolutely must exist within the quality program.  A CAPA quality system is a required part of ISO compliance, and is a vital part of TQM practices. The corrective action, preventive action program is the means by which unforeseen issues are addressed, remedied, and eliminated.  

26. 10. ISO 14001 ISO 14001 is the most well-known standard in the ISO 1400 family. Unlike many other quality control standards, the ISO 14001 standard does not have any exact measures. Achieving certification is based upon meeting all three of the components of the ISO 14001 Environmental Management Standards; minimizing how business operations negatively impact the environment, complying with the regulations and laws outlined in the EMS and continual improvement.

27. 11. ISO 27001 and Information Security Information security is part of the world of information technology and that is where ISO 27001 comes in. ISO 27001 plays an integral part in the information security management process. An information security management process is a set of policies that focuses on the need for information security within the information technology area.

28. 12. ISO 17025 Testing and Calibration ISO 17025 provides a roadmap of the general requirements needed by testing and calibration laboratories to prove competency.  ISO17025 is not the only method of accreditation, but it does provide a level of visibility that few other programs offer because it is an internationally-recognized standard.  Companies who are looking to contract out testing services very often look for ISO17025 accreditation for this very reason.

29. 13. AS 9100 AS9100, the Aerospace Quality Management System standard provides guidance for suppliers, designers, and manufacturers alike, and is now a several-part-series of standards that cover inspection, maintenance, and the requirements for aerospace suppliers and distributors.

30. Certification ISO Certify organizations ISO does not certify organizations. Many countries have formed accreditation bodies to authorize certification bodies, which audit organizations applying for ISO 9000 compliance certification.

31. *commonly preferred and known; actual standards to which an organization’s quality management can be certified with an ISO 9001:2000 certification

32. Applying organizations is assessed based on an extensive sample of its sites, functions, products, services, and processes An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years.

33. Auditing Two types of auditing are required to become registered to the standard.

34. The aim is a continual process of review and assessment, to verify that the system is working as it’s supposed t, find out where it can improve and to correct or prevent problems identified.

35. Advantages of ISO 1 2 3 4 5 6 7 8

36. Eight descriptions of the principle Principle 1: Customer Focus Principle 2: Leadership Principle 3: Involvement of People Principle 4: Process Approach Principle 5: System approach to management Principle 6: Continual Improvement Principle 7: Factual approach to decision making Principle 8: Mutually beneficial supplier relationship

37. Principle 1: Customer Focus Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

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

39. Principle 3: Involvement of People People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.

40. Principle 4: Process Approach A desired result is achieved more efficiently when activities and related resources are managed as a process

41. Principle 5: System approach to management Identifying, understanding, and managing interrelate processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives

42. Principle 6: Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective of the organization.

43. Principle 7: Factual approach to decision making Effective decisions are based on the analysis of data and information.

44. Principle 8: Mutually beneficial supplier relationship An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

45. THANK YOU AND GOD BLESS!