Iso ppt.pptx

ISO

1. ISO Certifications

2. Origin of ISO Standards • Published from the International Organization for Standardization. About International Organization for Standardization Worldwide federation of national standards bodies Presently comprising of 170 member countries Promotes development of standardization and related activities across the world Objective is to facilitate exchange of goods and services and development of cooperation in intellectual, scientific, technological and economic activities. • 2

3. About ISO • ISO develops standards and guides to encourage good practice in accréditation and certification. • ISO does not issue certificates. • ISO does not accredit, approve or control the certification bodies. • ISO does not carry out ISO 9001 or ISO 14001 certification . 3

4. 4 ISO 9000 Series of Standards • Initial standards based on BS 5750: 1979 that was developed by British Standards Institution (BSI) • ISO 9000 series was first published in 1987 • About ISO 9000 family of standards Relate to Quality Management Systems Designed to help organizations as guidelines Ensures that the customers & stakeholders needs are met

5. 5 Evolution of ISO 9000 Series • ISO 9000: 1987 came up with 3 models for quality management systems – ISO 9001: 1987 Model for quality assurance in design, development, production, installation and servicing – ISO 9002: 1987 • • Model for quality assurance in production, installation and servicing Similar to the ISO 9001: 1987 version except covering the creation of new products. – ISO 9003: 1987 • • Model for quality assurance in final inspection and test Not concerned with how the product was made and was only concerned about the final inspection and testing of quality.

6. 6 Evolution of ISO 9000 Series • ISO 9000 series was first amended in 1994 which had the following details. ISO 9000: 1994 emphasized on: Preventive action instead of checking just the final product Need for evidence of compliance along with the documented procedures ISO 9001: 2000 version: Amendment resulted in combination of the 9001, 9002 and 9003 standards into one called the 9001. Design & development procedures were required only if the company was engaged in creation of new products Process Management, monitoring and optimizing company’s task instead of just inspection, was included Involvement of top management Expectation of continual process improvement and tracking customer satisfaction • •

7. 7 About ISO 9000 Standards • The family of ISO 9000 standards developed by International Organization for Standardization and is made of the following core standards – ISO 9000: 2000 Fundamentals & Vocabulary – ISO 9001: 2000 • • Quality Management Systems – Requirements Deals with the requirements that have to be met by the organizations which want to adopt the ISO standards. – ISO 9004: 2000 • Quality Management Systems – Guidelines for performance improvements Relates to organizations who wish to improve beyond the scope of ISO 9001:2000. Has an element of self evaluation and this standard does not stand for certification.

8. Evolution of ISO 9000 Series 9

9. Evolution of ISO 9000 Series • ISO 9001: 2008 version Introduced clarifications to the requirements of ISO 9001: 2000 version Also introduced certain changes to make is consistent with ISO 14000: 2004 certification ISO 9001 and ISO 14001 are among ISO's most well known standards ever ISO 9001 helps organizations to implement quality management ISO 14001 helps organizations to implement environmental management . • 10

10. About ISO 14000 Standards • ISO 14000 family of Standards pertain to Environmental Management These standards help organizations Minimize the negative affect on the environment in their operations Comply with applicable laws, regulations and other environmentally oriented requirements Continually improve the above ISO 19011 audit standard applies when auditing for both 9000 and 14000 compliance. • • 11

11. Evolution of ISO 14000 Series • BSI Group publishes the first Environmental Management System Standards BS 7750: 1992 • ISO 14000 series first published in 1996. ISO 14001: 1996 relates to standards used by organizations for designing and implementing an effective environmental management system ISO 14004: 1996 relates to general guidelines on principles, systems and support techniques • The latest amended standard among ISO 14000 series is ISO 14001: 2004, which is a generic standard. 13

12. Generic Standards ISO 9001 and ISO 14001 are generic standards. Generic means that the same standards can be applied: • • • • • to any organization , large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. no matter what the organization's scope of activity if it wants to establish a quality management system , ISO 9001 gives the essential features or if it wants to establish an environmental management system , ISO 14001 gives the essential features. 14

13. Quality Management • • ISO 9001 is for quality management . Quality refers to all those features of a product (or service) which are required by the customer. Quality management means what the organization does to ensure that its products or services satisfy the customer's quality requirements comply with any regulations applicable to those products or services enhance customer satisfaction , and achieve continual improvement of its performance • 15

14. Environmental Management ISO 14001 is for environmental management . This relates to what the organization does to: minimize harmful effects on the environment caused by its activities, to conform to applicable regulatory requirements , and to achieve continual improvement of its environmental performance . 16

15. 17 Management System • Management system means what the organization does to manage its processes, or activities in order that its products or services meet the organization’s objectives , such as satisfying the customer's quality requirements , complying to regulations , or meeting environmental objectives

16. 18 Management System • Management system means To be really efficient and effective the organization can manage its way of doing things by systemizing it. Nothing important is left out. Everyone is clear about who is responsible for doing what, when, how, why and where. Management system standards provide the organization with an international, state-of-the-art model to follow. •

17. 19 ISO Standards & Management Systems Large organizations, or ones with complicated processes, could not function well without management systems. Companies in such fields as aerospace, automobiles, defence, or health care devices have perfected management systems over the years. The ISO 9001 and ISO 14001 management system standards make these successful practices available for all organizations .

18. 20 Benefits of ISO 9001 & ISO 14001 • International, expert consensus on state-of-the-art practices for quality and environmental management • Common language for dealing with customers and suppliers worldwide in B2B. • Increase efficiency and effectiveness. • Model for continual improvement.

19. 21 Benefits of ISO 9001 & ISO 14001 • Model for satisfying customers and other stakeholders. Build quality into products and services from design onwards. Address environmental concerns of customers and public, and comply with government regulations. Integrate with global economy Sustainable business Unifying base for industry sectors • • • • •

20. 22 Benefits of ISO 9001 & ISO 14001 Qualify suppliers for global supply chains Technical support for regulations Transfer of good practice to developing countries Tools for new economic players Regional integration Facilitate rise of services

21. 23 Our Take from ISO Standards • Organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified Certification is not a requirement of ISO 9001 or ISO 14001 Certification is a decision to be taken for business reasons : if it is a contractual, regulatory, or market requirement, If it meets customer preferences it is part of a risk management programme, or if it will motivate staff by setting a clear goal • •

22. Our Take from ISO Standards • Both ISO 9001 and ISO 14001 concern the way an organization goes about its work Processes affect final products or services and they are process standards. ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services through Setting Processes Documentation & Document Control Customer Focus Production Processes & Monitoring Processes Reviews , Controls and Improvement • • 24

23. ISO 9001 on Setting Processes • Through the implementation of ISO 9001 Standards, an organization determines the processes needed for the quality management system and their application, determines the sequence and interaction of these processes, determines criteria and methods needed to ensure that both the operation and control of these processes are effective, ensures the availability of resources and information necessary to support the operation and monitoring of these processes, monitors, measures where applicable and analyzes these processes, implements actions necessary to achieve planned results and continual improvement of these processes. Back 25

24. ISO 9001 Process: Documentation For the implementation, an organization, needs to document Quality policy and quality objectives Quality manual Procedures and records Records necessary to ensure Effective Planning Operation of processes Control of processes Back 26

25. ISO 9001 Process: Document Control • ISO 9001 requires organizations to control various documents to approve documents for adequacy prior to issue, to review and update as necessary and re-approve documents, to ensure that changes and the current revision status of documents are identified, to ensure that relevant versions of applicable documents are available at points of use, to ensure that documents remain legible and readily identifiable, to ensure that documents of external origin determined by the organization are identified and their distribution controlled, and to prevent the unintended use of obsolete documents, and to apply suitable identification to obsolete documents if they are retained for any purpose. Back

26. ISO 9001 Process: Customer Focus • For the implementation of ISO 9001 an organization needs to determine and document: requirements specified by the customer, including the requirements for delivery and post-delivery activities, requirements not stated by the customer but necessary for specified or intended use, where known, statutory and regulatory requirements applicable to the product, and any additional requirements considered necessary by the organization. Back 28

27. ISO 9001 Process on Production & Service • ISO 9001 requires all production and service to happen under controlled conditions while ensuring: the availability of information that describes the characteristics of the product, the availability of work instructions, as necessary, the use of suitable equipment, the availability and use of monitoring and measuring equipment, the implementation of monitoring and measurement activities, and the implementation of product release, delivery and post-delivery activities Back 29

28. ISO 9001 Process: Monitoring & Measuring Equipment Control • ISO 9001 requires processes to ensure that monitoring and measurement can be carried out, and is carried out in a manner that is consistent with the monitoring and measurement requirements – – – – – calibrated, verified or both at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded, adjusted or re-adjusted as necessary, have identification in order to determine it’s calibration status, safeguarded from adjustments that would invalidate the measurement result, and protected from damage and deterioration during handling, maintenance and s t o r a ge. B ack 30

29. ISO 9001 Process: Provision of Reviews • ISO 9001 recommends provision of timely management reviews. The input to management review includes information on below: results of audits, customer feedback, process performance and product conformity, status of preventive and corrective actions, follow-up actions from previous management reviews, changes that could affect the quality management system, and – recommendations for improvement. Back 31

30. ISO 9001 Process on Controls • Provisions are made to ensure control over various non- conformities while also advising on the course of action on the same by taking action to eliminate the detected nonconformity, by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer, and by taking action to preclude its original intended use or application. by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started . Back 32

31. ISO 9001 Process on Improvements It recommends actions for Corrective and Preventive Actions to be taken for improvements through • reviewing nonconformities, including customer complaints, determining the causes of nonconformities, evaluating the need for action to ensure that non-conformities do not recur, determining and implementing action needed, records of the results of action taken, and reviewing the effectiveness of the corrective action taken Back 33

32. 34 ISO Certifications: Conclusions • ISO develops standards and guides to encourage good practice in accréditation and certification. Processes affect final products or services and ISO 9001 or ISO 14001 are process standards. Certification is a decision to be taken for business reasons : if it is a contractual, regulatory, or market requirement, If it meets customer preferences it is part of a risk management program, or if it will motivate staff by setting a clear goal Certification is not a requirement of ISO 9001 or ISO 14001 • • •