Training programme

1. Training programme "ISO 9001:2008"

2. INTRODUCTION TO ISO 9000: 2008 Every top management always maintains that their business organization mission is to provide top quality products/service to meet the needs of their customer. The reality is that the organization has many other goals also to peruses, such as maximizing customers, profits, declaring more benefits to the dependents, enhancing employee’s job satisfaction and ultimately serving the community and society at large.

3. INTRODUCTION TO ISO 9000: 2008 “The ultimate goal of a company is to make profit. This can be fulfilled only if we have such cross-functional goals as quality, cost and delivery. Without achieving these goals, the company will be left behind by the competition. Out of these goals, which need to be fulfilled by the company, quality is the most important as inferior quality will lead to its profits eroded by higher costs and it will be enable to deliver the product in time for the customer.

4. INTRODUCTION TO ISO 9000: 2008 If these cross-functional goals are realized, profit will fallow. Therefore we should regard all other management functions as existing to serve the super ordinate goal of quality” . To survive in a competitive market, it is imperative for the organization not only to maintain the high levels of quality but keep on enhancing these levels continuously to keep pace with the ever increasing expectations of the customer. To achieve this the organization need to have a world class Quality Management Systems (QMS) One model of such a QMS, described in ISO 9000:2008series of standard, has been designed by top experts and specialists of the world in the field of quality after a great deal of deliberation and discussions in the ISO Technical Committee TC 176

5. The first steps 1950’s and 1960’s Dominance of Military – based “Quality Programs” (MIL-Q-9858, AQAP, Def Std etc.) 1970’s “QA” Standards BS 5750 first published (1979)

6. The birth of ISO 9000 ISO 9000 series developed by ISO/TC 176 (early 80’s) and published (1987) ISO 9000 Concepts, selection and use ISO 9001/2/3 Certification ISO 9004 Guidelines Internationally developed, but not truly accepted worldwide.

7. Growth of QMS Standards 1990’s Widespread acceptance of ISO 9000 around the world (now over 9,00,000 cert. issued) Revision work done on ISO 9000 from 1997-2000; worldwide participation and strong consensus. Aim to simplify, consolidate and improve.

8. Key Elements of ISO 9001:2008 Process approach and PDCA Comparison (may be a little unfair on ISO 9001:1994!) ISO 9001:1998 “Documented procedures evidenced by records” ISO 9001:2008“Defined and managed processes evidenced by results”.

9. Deming's Formula PLAN DO CHECK ACT

10. Deming's Formula Plan : What do we want to achieve? Vision, Mission, Objectives How can we achieve it? Business plan, Strategies,Resources Dr. Deming – “It’s pointless to establish an objective without defining a method to achieve it”

11. Deming's Formula Do : Get everyone involved, committed and motivated (“Leadership”!) Carry out “the plan” Deploy throughout the organization Break down the objectives to the appropriate functions and levels.

12. Deming's Formula Check : Is this want we expected? Are the results OK? Look for trends

13. Deming's Formula Act :Correct what went wrong (Correction) Plan to do it right next time (Corrective action) Learn to make things “error-proof” (Preventive action) Think – how can we do this…….. Faster?, Cheaper? Better? Safer?

14. WHAT IS ISO 9000 CERTIFICATION ALL ABOUT? CONFIDENCE Providing CONFIDENCE to the customer that requirements for the product will be met. ISO 9001: 2008 Philosophy ISO 9000 lays down what requirements your quality management system must meet. But it does not dictate how they should be met. Allows great flexibility for implementation in different business sectors and business cultures.

15. Do we need Certification? Some options : Internal audits I want to use ISO 9001:2008 as a management tool, but my customers don’t require me to be ‘certified’. 2nd party audits I provide my products to a very limited number of customers, and they audit me to ISO 9001:2008as part of their supplier evaluation programme. 3rd Party Certification I want to be able to demonstrate to a number of customers that my QMS meets ISO 9001:2008 requirements. Avoid multiple audits by the organization’s clients or reduce the frequency or duration of client audits.

16. QUALITY Confirmation to specification Fitness for purpose Meeting the agreed requirements

17. Customers expect quality because – They want product or service that is reliable They want it to meet their requirements They want value for their money

18. QUALITY MATTERS TO YOU You want job satisfaction You want to be respected You want to enjoy work You want to do a good job You want to secure job You want to be proud to work for your organization.

19. CUSTOMER DISSATISFACTION Failure to meet delivery Failure to meet specification Not fit for the purpose Failure in service Results for which is – They complain They change the supplier They inspect

20. WE SHOULD ALWAYS REMEMBER Our customers are the only judge of whether we are a Quality Organization Never assume you know what your customer wants

21. Customer Assurance (Confidence) Quality will be achieved Quality will be maintained Problems will be minimized Confidence can be obtained by effective quality management.

22. QUALITY MEASUREMENT AND IMPROVEMENTS Identify product characteristics Define levels of achievement Adopt statistics Measure achievement Innovate to improve Publicize improvement

23. 6 aspects of ISO – 9000 (Cuboid) 1. Commitment 2. People 3. Processes 4. Procedures 5. Implement 6. Maintain

24. BENEFITS OF ISO Customer confidence International recognition Acceptance in Global Markets Identification of specified & implied needs of quality Consistency in quality Understanding customer’s requirement throughout the organization Reduction in product liability Better Management of safety, Risk and Hazard Reduction in waste and rework Employee participation in company activity Improvement in profits Doing right work at the first time Increase in the prestige or level of the organization

25. “A Customer is the mostimportant visitor on our premises.He is not dependent on us.We are dependent on him.He is not an interruption on our work.He is the purpose of it.He is not an outsider on our business.He is a part of it.We are not doing him a favourby serving him.He is doing us a favour by giving us anopportunity to do so.” - Mahatma Gandhi

26. “A Customer is the mostimportant visitor on our premises.He is not dependent on us.We are dependent on him.He is not an interruption on our work.He is the purpose of it.He is not an outsider on our business.He is a part of it.We are not doing him a favourby serving him.He is doing us a favour by giving us anopportunity to do so.” - Mahatma Gandhi

27. 4.0 Quality Management System 5.0 Management Responsibility 6.0 Resource Management 7.0 Product realization 8.0 Measurement, Analysis and Improvement

28. 1.0 SCOPE This International Standard specifies requirements for a quality management system where an organization • needs to demonstrate its ability to consistency provide product that meets customer and applicable regulatory requirements, and • Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

29. 2.0 APPLICATION • All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. • Where any requirements (s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. • Where exclusion are made, claims of conformity to this International Standard are not applicable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

30. 4. Quality Management system 4.1 General Requirement The organization shall establish, document, implement, maintain and continually improve the QMS effectiveness in accordance with the requirements of this International Standard. The organization shall: • Identify the process needed for the QMS and its application thru out the organization (see 1.2 Application); • Determine the sequence and interaction of these processes; • Determine criteria and methods needed to ensure the effectiveness of processes operations and control; • Ensure the resources and information necessary are available to support the process operation and monitoring; • Measure, monitor and analyze these processes; and • Implement necessary actions to achieve planned results and continual improvement of these processes • Define outsourced process if any and its control (2008)

31. 4.2.1 The quality management system documentation shall include: • Documented Quality Policy and Objectives • Quality Manual: • Documented procedures required by the Standard. • Documents required by the organization to ensure the effective planning, operation and control of its processes. • Records required by the Standard The extent of documentation is dependent on the organization size, type of activities, processes complexity, their interactions as well as personnel competence. Procedures required by the standard can be individual or combined. A single document can address one or more procedures. Documentation can be any form, type of medium. (2008)

32. Discussion: • Define documentation including records to support an effective and efficient operation of the organization of processes. • Extent of documentation to consider contractual requirements, regulatory requirements and interested parties and organization competency, • Evaluation of documentation from functionality, user friendliness, resources needed, policy and objectives, current and future requirements, benchmarking and interface with interested parties.

33. 4.2.2 Quality Manual The Quality Manual shall include: • The Scope of the QMS, including any exclusion details & Justification. • Documented procedures established for the QMS, or make reference to them. • A description of the QMS processes interaction Discussion: • What should be covered in Quality Manual?

34. 4.2.3 Control of Documents A documented procedure shall be established. The controls needed are: • Approval for adequacy prior to issue • Review and update and re-approve • Ensure identification of document changes and current revision status • At points of uses, relevant versions of applicable documents are available • Ensure documents are readily identifiable and remain legible • To identify and control distribution of externally originated documents relevant to QMS (2008) • To prevent unintended use of obsolete documents and suitably identify them if they are retained for any purpose.

35. 4.2.4 Control of Records Quality records provide evidence of conformity and of the effective operation of the QMS. These shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls for identification, legibility, storage, protection, retrieval, retention time and disposition.

36. 5.Management Responsibility 5.1 Management Commitment Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness by: • Communication to the organization the importance of meeting customer as well as statutory & regulatory requirements; • Establishing the quality policy: • Ensuring that the Quality Objectives are established • Conducting management reviews; • Ensuring resources are available

37. Discussion: Involvement of top management is essential for developing and maintaining an effective and efficient quality management system by • Establishing vision, policies and strategic objectives • Leading by example • Improvement projects • Identifying product realization process • Creating an environment that influences development and involvement of people. • To determine achievement of set objectives • Defining method for measurement of organizational performance.

38. 5.2 Customer focus Top management shall ensure that customer requirements are determined, and met with the aim of customer satisfaction enhancement. Discussion: Understanding and meet the needs and expectations of interested parties by: • Identifying interested parties needs & expectations • Translate needs into requirements • Communicate the requirement throughout the organization • Focus on process improvement to ensure value for the identified interested parties.

39. End user needs and expectations may include • Conformity • Dependability • Availability • Delivery • Post realization activities • Price and life cycle cost • Safety • Liability • Environmental impact

40. 5.3Quality policy Top management shall ensure that the quality policy: • Is appropriate to the purpose of the organization; • Includes a commitment to meeting requirements and continual improvement of the QMS effectiveness; • Provides a framework for establishing and reviewing quality objectives; • Is communicated and understood in the organization; • Is reviewed for continuing suitability

41. 5.4 Planning 5.4.1 Quality Objectives • Top management ensures that quality objectives are established at relevant functions and levels within the organization, including those needed to meet requirements of product. • Objectives shall be consistent with the quality policy shall bemeasurable.

42. Discussion: • Quality Policy provides a framework for the setting of quality objective, leading to improved performance. • Communication of objectives to enable people to contribute.

43. 5.4.2 Quality Management System Planning • Top management shall ensure that: • QMS planning is carried out in order to meet requirements in 4.1 and quality objectives. • Plans & implementation of changes to QMS shall not affect the integrity of the QMS.

44. Discussion: • Responsibility of management for quality planning of the organization. • Focusing on defining the processes needed to meet effectively and efficiently organization quality objectives and requirements consistently.

45. 5.5. Responsibility, Authority & Communication 5.5.1 Responsibility and authority Top management ensures responsibilities and authorities are defined & communicated. • Discussion • Responsibility and authority of personnel throughout the organization defined to enable them to achieve the quality objectives and to enable their involvement, motivation and commitment.

46. 5.5.2 Management representative Top management shall appoint a member of the organisation’s management (2008) as MR. Irrespective of other responsibilities, MR is responsible and has authority to: • Ensure establishment, implementation & maintenance of the processes needed for the QMS • Reporting to top management on the QMS performance and any improvement need • Ensure awareness of customer requirements throughout the organization is promoted.

47. Discussion • Reporting to top management and communicate with customers and other interrelated parties on matters pertaining to the quality management.

48. 5.5.3 Internal communication • Top management shall ensure that appropriate processes for communication within the organization are established. • Top management shall ensure that communication regarding the effectiveness of the QMS takes place.

49. Discussion • Effective and efficient processes for communicating the quality policy, requirements, objectives and accomplishments. • Encouragement for providing feedback and communication from people reflecting their involvements including: • Employee survey and suggestion scheme • Team briefing and other meetings

50. 5.6 Management review 5.6.1 General Top management shall review QMS at planned intervals to ensure suitability, adequacy and effectiveness. Include assessing improvement opportunities and the need for QMS, quality policy & quality objectives changes. Maintain records of review.