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ISO-9001: 2000 Awareness Training

ISO-9001: 2000 Awareness Training. Presentation By : Shashikant Gupta. ISO – 9001:2000. CONTENTS…. Course Objectives What is ISO? What is Quality? Terms and definitions Stake holders and their expectations Quality Management principles The software process

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ISO-9001: 2000 Awareness Training

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  1. ISO-9001: 2000 Awareness Training Presentation By : Shashikant Gupta

  2. ISO – 9001:2000

  3. CONTENTS… • Course Objectives • What is ISO? • What is Quality? • Terms and definitions • Stake holders and their expectations • Quality Management principles • The software process • ISO 9000:2000 Family of Standards • ISO-9001:2000 Clauses • Guidelines for Self Assessment

  4. COURSE OBJECTIVES • To provide an overview of ISO 9001: 2000 standards • To understand the elements that support the implementation of an ISO 9001:2000 Quality Management System

  5. What is ISO? The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 130 countries, one from each country. ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity

  6. More about ISO… • Worldwide Federation of National Standards Bodies (ISO Member Countries) • Preparation of International Standards carried out through: - ISO Technical Committees (TCs) - Subcommittees (SCs) - Working Groups (WGs).

  7. More about ISO… • ISO Collaborates closely with the International Electro-technical Commission (IEC) on all matters of Electro-technical Standardisation. • Committee Draft (CD) prepared by Technical Committees. • Draft International Standards (DIS) adopted by the Technical Committees are circulated to the Member Bodies for voting. • Publication as an International Standard requires approval by at least 75% of the Member Bodies casting a vote. • ISO 9000 Standards prepared by Technical Committee ISO / TC 176, Quality Management and Quality Assurance. • ISO 9001 prepared by Subcommittee SC2, Quality Systems.

  8. Objectives of ISO 9000 A successful organisation should offer products that : - Meet a well defined need, use or purpose. - Comply with applicable standards and specifications. - Comply with requirements of society. - Address environmental considerations. - Are available at competitive prices. - Satisfy customers’ expectations. - Are provided at a cost which will yield a profit.

  9. WHAT IS QUALITY? The formal definition of quality as stated in ISO 9000 : 2000 is - Ability of a set of inherent characteristics of a product, system or process to fulfill requirements of customers and other interested parties. Note : The term “ quality ” may be used with adjectives such as poor, good or excellent.

  10. TERMS AND DEFINITIONS • ORGANIZATIONGroup of people and facilities with an arrangement of responsibilities, authorities and relationships.

  11. TERMS AND DEFINITIONS • REQUIREMENT Need or expectation that is stated, generally implied or obligatory. Notes : 1.Generally implied means it is custom or common practice for the organization, its customers, and other interested parties, that the need or expectation under consideration is implied. 2.A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality system requirement, customer requirement. 3.A specified requirement is one which is stated, for example, in a document. 4.Requirements can be generated by different interested parties.

  12. TERMS AND DEFINITIONS • PROCESSSet of interrelated or interacting activities which transforms inputs into outputs. • PRODUCTResult of activities or process. Notes : • A product may include service, hardware, processed materials, software or a combination thereof. • A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g., knowledge or concepts) or a combination thereof.

  13. TERMS AND DEFINITIONS • TRACEABILITYAbility to trace the history, application or location of that which is under consideration. Note: When considering PRODUCT, traceabilitycan relate to - origin of the material and parts- processing history- distribution and location of the product after delivery.

  14. TERMS AND DEFINITIONS • PROCEDURESpecified way to carry out an activity or process. Note: A procedure when documented, becomes a ‘documented procedure’. • PROJECTUnique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources.

  15. TERMS AND DEFINITIONS • AUDITSystematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. • REVIEWActivity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objective.

  16. TERMS AND DEFINITIONS • CONFORMITY Fulfillment of a requirement • NON-CONFORMITYNon-fulfillment of a requirement • DEFECTNon-fulfillment of a requirement related to an intended or specified use • CORRECTIONAction to eliminate a detected non-conformity.

  17. TERMS AND DEFINITIONS • CORRECTIVE ACTIONAction to eliminate the cause of a detected non-conformity or other undesirable situation. • PREVENTIVE ACTIONAction to eliminate the cause of a potential non-conformity or other undesirable potential situation.(Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.)

  18. TERMS AND DEFINITIONS • CUSTOMER SATISFACTION Customer’s opinion of the degree to which a transaction has met the customer’s needs and expectations. • QUALITY MANAGEMENT SYSTEM System to establish a quality policy and quality objectives and to achieve those objectives.

  19. TERMS AND DEFINITIONS • QUALITY POLICY Overall intentions and direction of an organization related to quality as formally expressed by Top Management. Note 1: The quality policy should be consistent with the overall policy of the organization and should provide a framework for the settings of quality objectives. Note 2: Quality Management principles of this International Standard may form a basis for the establishment of a quality policy.

  20. TERMS AND DEFINITIONS • QUALITY OBJECTIVE Something sought or aimed for, related to quality. Note 1: Quality objectives should be based on organization’s quality policy. Note 2: Quality objectives are specified at different levels in the organization. At an operational level, quality objectives should be quantitative. Note 3: Different terms are sometimes used for quality objectives, such as quality targets, quality aims or quality goals.

  21. TERMS AND DEFINITIONS • TOP MANAGEMENT Person or group of people who direct and control an organization at the highest level.

  22. TERMS AND DEFINITIONS • QUALITY PLANNING Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives. • QUALITY IMPROVEMENT Part of quality management, focused on increasing effectiveness and efficiency .

  23. TERMS AND DEFINITIONS • QUALITY CONTROLOperational techniques and activities that are used to fulfil requirements for quality. • QUALITY ASSURANCEPlanned and systematic activities implemented within the quality system and demonstrated as needed to provide adequate confidence that an entity will fulfil given requirements for quality.

  24. TERMS AND DEFINITIONS • EFFECTIVENESS Measure of the extent to which planned activities are realized and planned results achieved. • EFFICIENCY Relationship between the result achieved and the resources used.

  25. TERMS AND DEFINITIONS • SUPPLIEROrganisation that provides a product to the customer. • CUSTOMERRecipient of a product provided by the supplier. Notes: • Example: Consumer, client, end-user, retailer, beneficiary or purchaser. • The customer can be either external or internal to the organisation.

  26. TERMS AND DEFINITIONS SUPPLIER CHAIN AS PER ISO 9001:2000 SUPPLIER ORGANIZATION CUSTOMER

  27. STAKE HOLDERS AND THEIR EXPECTATIONS

  28. QUALITY MANAGEMENT PRINCIPLES • Customer Focus • Leadership • Involvement of people • Process Approach • System Approach to Management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships

  29. QUALITY MANAGEMENT PRINCIPLES • Customer Focus -Understand current and future customer needs -Meet customer requirements and strive to exceed customer expectations

  30. QUALITY MANAGEMENT PRINCIPLES • Leadership -Establish unity of purpose, direction, and the internal environment of the organization. -Create the environment in which people can become fully involved in achieving the organization’s objectives.

  31. QUALITY MANAGEMENT PRINCIPLES • 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.

  32. QUALITY MANAGEMENT PRINCIPLES • Process approach -A desired result is achieved more efficiently when related resources and activities are managed as a process. • System approach to management -Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization.

  33. QUALITY MANAGEMENT PRINCIPLES • Continual improvement -A permanent objective of the organization is continual improvement. • Factual approach to decision making -Effective decisions are based on the logical or intuitive analysis of data and information.

  34. QUALITY MANAGEMENT PRINCIPLES • Mutually beneficial supplier relationships -The ability of the organization and its suppliers to create value enhanced by mutually beneficial relationships.

  35. THE SOFTWARE PROCESS REQUESTS SOFTWARE PROCESS SOFTWARE PRODUCTS OR SERVICES RESOURCES PEOPLE HARDWARE SOFTWARE TIME EFFORT MONEY QUALITY VALUES FEEDBACK CONTROL Version 2.0 Date: 01/03/2003

  36. TO ACHIEVE PROCESS CONTROL • Measurement is effected. • Comparison against a pre-set goal is made. • Any deviations are corrected by a feedback mechanism.

  37. C U S T O M E R C U S T O M E R CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM SAT I S FACT ION MANAGEMENT RESPONSIBILITY R E Q U I R E M E N T S RESOURCE MANAGEMENT MEASUREMENT, ANALYSIS, IMPROVEMENT PRODUCT REALISATION INPUT OUTPUT PRODUCT MODEL OF THE PROCESS APPROACH

  38. ISO 9000:2000 FAMILY OF STANDARDS

  39. MODEL FOR QUALITY ISO 9001 : 2000 QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS

  40. STANDARDS / GUIDELINES FORCERTIFICATION • ISO 9000 : 2000 - QMS Fundamentals & Vocabulary • ISO 9001 : 2000 - QMS Requirements • ISO 9004 : 2000 - QMS Guidelines for PerformanceImprovement • ISO 9000 - 3 : 1997 - Guidelines for application of ISO to the development, supply, installation and maintenance of Computer Software • ISO 10005 : 1995 QM – Guidelines for Quality Plans • ISO 10006 : 1997 QM – Guidelines for Quality in Project Management

  41. STANDARDS / GUIDELINES FORCERTIFICATION • ISO 10007 : 1995 QM – Guidelines for Configuration Management • ISO 10013 : 1995 – Guidelines for developing Quality Manuals / Documentation • ISO / IEC 12207 : 1995 – Information Technology – Software life cycle process • ISO / IEC 9126-1 : 2001 – Software Engineering Product Quality (non-functional attributes) • ISO 19011 : 2000 Guidelines for Quality Systems Auditing

  42. ISO 9001 : 2000QUALITY MANAGEMENT SYSTEMS - CLAUSES 4. Quality Management System 4.1 General Requirements (For Software Development and Services) 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control Of Documents 4.2.4 Control Of Records

  43. 5. Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system

  44. 5. Management Responsibility 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output

  45. 6.Resource Management 6.1 Provision Of Resources 6.2 Human Resources 6.2.1 General 6.2.2 Competence, Awareness and training 6.3 Infrastructure 6.4 Work Environment

  46. 7. Product Realization 7.1 Planning the Product Realization 7.2 Customer Related Process 7.2.1 Determination of Requirements related to the Product 7.2.2 Review of Requirements related to the product 7.2.3 Customer Communication

  47. 7. Product Realization 7.3 Design And Development 7.3.1 Design And Development planning 7.3.2 Design And Development inputs 7.3.3 Design And Development outputs 7.3.4 Design And Development review 7.3.5 Design And Development verification 7.3.6 Design And Development validation 7.3.7 Control of Design And Development changes

  48. 7. Product Realization 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product

  49. 7. Product Realization 7.5 Product and Service Provision 7.5.1 Control of Service Provision 7.5.2 Validation of Processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of monitoring and measuring devices

  50. 8. Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring and measurement of process 8.2.4 Monitoring and measurement of product

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