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ISO 9001:2000

ISO 9001:2000. Objectives: To provide quality management system To ensure customer satisfaction To improve from inspection to prevention To define responsibilities for quality. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO in Greek refers to equal, homogeneous or uniform.

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ISO 9001:2000

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  1. ISO 9001:2000 • Objectives: • To provide quality management system • To ensure customer satisfaction • To improve from inspection to prevention • To define responsibilities for quality INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

  2. ISO in Greek refers to equal, homogeneous or uniform. • ISO is the acronym for the International Organization for Standardization. • ISO 9000 began with the launch of Technical Committee 176 in 1979 to deal with generic quality principles – the need for an international minimum standards for how manufacturing companies establish quality control methods, not only to control product quality, but to maintain its uniformity and predictability. • The system was issued in 1987 largely based on the 1979 British quality standard. • ISO 9000 standards originally designed to cover manufacturing, later to the service industries and now is extended in training and education. • Of the 20 standards in ISO 9000, 12 have direct application. ISO 9000

  3. ISO 9001:2008 standards, to higher education • institutions. The International Organization for Standardization (ISO) • ISO has been described as requiring organizations “to say what they do, do what they say, then prove it to a third party” (Seddon, 2000). • A criticism of the ISO approach has been of its perceived focus on process rather than on outcomes. ISO 9000

  4. http://www.iso.org/iso/home.html ISO 9000

  5. Design control Management responsibility Quality System Purchasing Contract review Flowchart of ISO 9000 Training students ISO 9000 Quality System for Higher Education Purchaser supplied product Training management & administration Control of non-performing products Process control Training instructors & staff Internal quality audits Corrective action Quality records Monitoring

  6. ISO 9001:2000 • ISO 9001:2000 promotes a process approach in developing, implementing and improving the effectiveness of a quality management system to enhance customer satisfaction by meeting customer requirements. • Process approach is referred to as the application of system of processes within an organization, together with the identification, interactions and management of the processes. PROCESS APPROACH

  7. ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes and focuses on effectiveness of the quality management system in meeting customer requirements. • ISO 9004 gives guidance on a wider range of objectives of a quality management system than ISO 9001, especially for the continual improvement on overall performance, efficiency and effectiveness. ISO 9001 & ISO 9004

  8. ISO 9001:2000 Process approach emphasizes on four components: • Understanding and meeting requirements. • Considering processes in terms of added value. • Obtaining results of process performance and effectiveness. • Continual improvement of processes based on objective measurement. PROCESS APPROACH

  9. Continual improvement of the quality management system Management responsibility Resource management Measurement, analysis and improvement Customers requirements Customers satisfaction Product realization Product Input output MODEL OF A PROCESS APPROACH Value added activities Information flow

  10. Plan-Do-Check-Act (PDCA) methodology can be applied: • Plan – establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies. • Do – implement the processes. • Check – monitor and measure processes and product against policies, objectives and requirements for the product and report the results. • Act – take actions to continually improve process performance. PROCESS APPROACH & PDCA

  11. Vision: • Is a broad intentions of an organization, all inclusive and forward thinking. • Describes aspirations for the future without specifying the means that will be used to achieve the desired ends. • Inspires employees for the best, the most or the greatest. Vision, Mission, Goals, Objectives and Plans

  12. To become a world class university, an internationally reputable community of intellectuals who will make the nation proud for their contributions to scholarly writing and discoveries and continue to give new meaning to the progress, growth and development of the nation and the world. • Untuk menjadi Universiti bertaraf dunia iaitu sebuah komuniti cendekiawan dan intelek bereputasi antarabangsa yang menjadi kebanggaan negara kerana sumbangannya dalam penulisan kesarjanaan dan penemuan yang sentiasa memberi pengertian baru kepada kemajuan, perkembangan dan pembangunan negara dan dunia. UPM Vision

  13. Mission is a statement that verbalizes the beliefs and the directions of the organization. Key elements of a mission statement include: • Obligation to stakeholders – emphasis is placed on meeting the needs of various stakeholders. • Scope of the business – defines the customers served, the functions provided and the technology employed. • Sources of competitive advantage – the skills that will be developed to achieve the vision and describes how the organization intends to succeed in creating value and competitive advantage. • View of the future – the anticipated regulatory, competitive and economic environment in which the organization must compete. Mission

  14. To be a leading Center of Learning and Research, contributing not only towards human advancement and discovery of knowledge but also to the creation of wealth and nation building. • Menjadi Pusat Pembelajaran dan Penyelidikan yang unggul, yang menyumbangkan bukan sahaja kepada kemajuan manusia dan penerokaan ilmu tetapi juga kepada pembentukan kekayaan dan pembangunan negara. UPM Mission

  15. Goals: • Attempts to improve an organization’s performance by making mission statement more concrete. • Address both financial and non-financial issues. • Reachable – can be reached with a stretch. • Cut across financial areas. Objectives: • Represents the operational definition of goals, can be measured and have time dimension. Plans: • Describe specific tactics, assign responsibilities, identify how resources can be allocated, schedule activities and specify vision targets. Goals, Objectives and Plans

  16. We, the staff of Universiti Putra Malaysia, are committed towards excellence through the inculcation of quality culture in teaching, research and professional service, and to fulfill the expectations of our clients. Kami, staff Universiti Putra Malaysia beriltizam ke arah kecemerlangan melalui penerapan budaya kualiti dalam pengajaran, penyelidikan, dan perkhidmatan profesional untuk memenuhi ekspekstasi pelanggan. Quality Policy for UPM

  17. ISO 9001:2000 • 4.0 Quality management system • 5.0 Management responsibility • 6.0 Resource management • 7.0 Product realization • 8.0 Measurement, analysis, improvement REQUIREMENTS

  18. 4.1 General requirements • The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements. • The organization shall – • Identify the processes needed for the quality management system • Determine the sequence and interaction of these processes • Determine criteria and methods needed • Ensure availability of resources and information necessary • Monitor, measure and analyze these processes • Implement actions necessary to achieve planned results and continual improvement of these processes. 4. Quality management system

  19. 4.2 Documentation requirements 4.2.1 The QMS documentation shall include - Documented statements of a quality policy and quality objectives A quality manual Documented procedures required by this standard Documents needed by the organization to ensure the effective planning, operation and control of its processes Quality records required by the International Standard. 4. Quality management system

  20. 4.2 Documentation requirements 4.2.2 Quality Manual The organization shall establish and maintain a quality manual that includes - The scope, details of and justification for any exclusions The documented procedures or reference to them A description of the interaction between the processes of QMS 4.2.3 Control of documents Documents shall be controlled. The documented procedure must define the controls needed - 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 4. Quality management system

  21. To ensure that relevant versions of applicable documents are available at points of use • To ensure that documents remain legible and readily identifiable • To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 4.2.4 Control of records • Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. • Records shall remain legible, readily identifiable and retrievable. • A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 4. Quality management system

  22. 5.1 Management commitment Top Management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by - Communicating the importance of meeting customer, statutory and regulatory requirements Establishing the quality policy Ensuring the quality objectives are established Conducting management reviews Ensuring the availability of resources 5. Management responsibility

  23. 5.2 Customer focus Top Management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. 5.3 Quality policy Top Management shall ensure that the quality policy - Is appropriate to the purpose of the organization Includes a commitment to comply with requirements and continually improve the effectiveness of the QMS Provides a framework for establishing and reviewing quality objectives Is communicated and understood within the organization Is reviewed for continuing suitability. 5. Management responsibility

  24. Example of quality policy for the scope of research and commercial development of the TNC (R&I) UPM: Visi: Menjadi pusat penyelidikan dan pembangunan komersil yang unggul dalam memberikan sumbangan kepada penerokaan ilmu, kemajuan manusia, pembentukan kekayaan dan pembangunan negara. Misi: Berusaha untuk menjadi pusat penyelidikan dan pembangunan komersil yang efisien dan profesional. 5. Management responsibility

  25. Example of quality policy for the scope of research and commercial development of the TNC (R&I) UPM: Dasar Kualiti: Staf UPM beriltizam ke arah kecemerlangan dalam pengurusan penyelidikan, pelaksanaan penyelidikan dan pengurusan pengkomersialan melalui penerapan budaya kerja berkualiti secara berterusan untuk memenuhi ekspektasi pelanggan dan selaras dengan MS ISO 9001:2000. Seterusnya seluruh entiti penyelidikan dan pembangunan komersil akan melaksanakan tanggungjawab dalam mencapai objektif kualiti yang ditetapkan, serta memastikan objektif tersebut dikaji dari semasa ke semasa supaya selaras dengan visi, misi dan dasar kualiti penyelidikan dan pembangunan komersil UPM. 5. Management responsibility

  26. 5.4 Planning 5.4.1 Quality objectives Top Management shall ensure that the quality objectives are established at relevant functions and levels within the organization. 5.4.2 QMS planning Top Management shall ensure that - The planning of QMS is carried out in order to meet the requirements Integrity of the QMS is maintained when changes to the QMS are planned and implemented. 5. Management responsibility

  27. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are defined and communicated within the organization 5.5.2 Management representative (MR) Top Management shall appoint a member of management who, irrespective of other responsibilities have the responsibility and authority that includes - Ensuring processes needed for the QMS are established, implemented and maintained Reporting to top management on the performance of the QMS and any need for improvement Ensuring the promotion of awareness of customer requirements throughout the organization. 5. Management responsibility

  28. 5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QMS. 5.6 Management review 5.6.1 General Top Management shall review the organization QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. Records from management review shall be maintained (see 4.2.4). 5. Management responsibility

  29. 5.6.2 Review input Inputs include current performance and improvement opportunities related to – Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous management reviews Planned changes that could affect the QMS Recommendations for improvement. 5. Management responsibility

  30. 5.6.3 Review output Output from management review shall include any decisions and actions related to – Improvement of the effectiveness of the QMS and its processes Improvement of product related to customer requirements Resource needs. 5. Management responsibility

  31. 6.1 Provision of resources The organization shall determine and provide the resources needed – To implement and maintain the QMS and continually improve its effectiveness To enhance customer satisfaction by meeting customer requirements. 6. Resource management

  32. 6.2 Human resources 6.2.1 General Personnel shall be competent on the basis of appropriate education, training, skills and experience. 6.2.2 Competence, awareness and training The organization shall Determine the necessary competence for personnel Provide training or take other actions to satisfy needs Evaluate the effectiveness of the actions taken Ensure that personnel are aware of the relevance and importance of their activities Maintain appropriate records of education, training, skills and experience. 6. Resource management

  33. 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes - Buildings, workspace and associated utilities Process equipment (hardware and software) Supporting services (transport and communication) 6.4 Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. Human factors include such as creative work methods, safety rules, special facilities for staff. Physical factors include such as cleanliness, ventilation, noise, hygiene. 6. Resource management

  34. 7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization. The organization shall determine - Quality objectives and requirements for the product The need to establish processes, documents and provide resources Required verification, validation, monitoring, inspection and test activities to the product and the criteria for product acceptance. Records needed to provide evidence that realization processes and resulting product meet requirements. 7. Product realization

  35. 7.2 Customer related processes 7.2.1 Determination of requirements related to the product The organization shall determine - Requirements specified by the customer Requirements not stated by customers but necessary for specified use and intended use Statutory and regulatory requirements related to product Any additional requirements determined by the organization. 7.2.2 Review of requirements related to product The organization shall ensure that - Product requirements are defined Differences are resolved The organization has the ability to meet the defined requirements. 7. Product realization

  36. 7.2.2 Review of requirements related to product / service • Records of the results of the review and actions arising from the review shall be maintained. • Where the customer provides no documented statement of requirement, the customer requirement shall be confirmed by the organization before acceptance. • Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. 7. Product realization

  37. 7.2.3 Customer communication The organization shall determine and implement arrangements for communicating with customers in relation to - • Product / service information • Enquiries, contracts or order handling, including amendments • Customer feedback including customer complaints. 7.4.1 Purchasing process • The organization shall ensure that purchased product / service confirms to specified purchase requirements. • The type and extent of control applied to the supplier and the purchased product / service shall be dependent upon the effect of the product on subsequent product realization or the final product. 7. Product realization

  38. 7.4.1 Purchasing process • Shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. • Criteria for selection, evaluation and re-evaluation shall be established. • Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained. 7.4.2 Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate - • Requirements for approval of product, procedures, processes and equipment • Requirements for qualification of personnel • Quality management system requirements. 7. Product realization

  39. 7.4.3 Verification of purchased product • Shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. • Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information. 7. Product realization

  40. 7.5 Production and service provision 7.5.1 Control of production and service provision • The organization shall plan and carry out production and service provision under controlled conditions which includes - • The availability of information that describes the characteristics of the product • The availability of work instructions • The use of suitable equipment • The availability and use of monitoring and measurement • The implementation of release, delivery and post-delivery activities. 7. Product realization

  41. 7.5.2 Validation of processes for production and service provision • The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. • This includes any processes where deficiencies become apparent only after the product or service is in use or the service has been delivered. • Validation shall demonstrate the ability of these processes to achieve planned results. 7. Product realization

  42. 7.5.3 Identification and traceability • Where appropriate, the organization shall identify the product by suitable means throughout product realization. • The organization shall identify the product status with respect to monitoring and measurement requirements. • Where traceability is a requirement, the organization shall control and record the unique identification of the product. 7.5.4 Customer property • The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization. • The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. • If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained. 7. Product realization

  43. 7.5.5 Preservation of product • The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. • This preservation shall include identification, handling, packaging, storage and protection. • Preservation shall also apply to the constituent parts of a product. 7.5.6 Control of monitoring and measuring devices • The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements. • The organization shall establish processes to ensure that monitoring and measurement can be carried out. 7. Product realization

  44. 7.5.6 Control of monitoring and measuring devices • Where necessary to ensure valid results, measuring equipment shall – • Be calibrated and verified at specified intervals, or prior to use • Be adjusted or re-adjusted as necessary • Be identified to enable the calibration status to be determined • Be safeguarded from adjustments that would invalidate the measurement result • Be protected from damage and deterioration during handling, maintenance and storage. Shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements and take appropriate action on the equipment and any product affected. Records shall be maintained. 7. Product realization

  45. 8.1 General • Plan and implement the monitoring, measurement, analysis and improvement process needed. 8. Measurement, Analysis and Improvement Man Material CAUSE EFFECT Method Module

  46. 8.2 Monitoring and measurement 8.2.1 Customer satisfaction • Monitor information relating to customer perception as to whether the organization has fulfilled customer requirements. • The methods for obtaining and using this information shall be determined. 8.2.2 Internal audit • Conduct periodic internal audits at planned intervals to determine whether the QMS: • conforms to planned arrangements • Has been effectively implemented and maintained. Auditors shall not audit their own work. • Responsibilities, requirements for planning and conducting audits, reporting results and maintaining records shall be defined in a documented procedure. 8. Measurement, Analysis and Improvement

  47. 8.2.3 Monitoring and measurement of processes • Apply suitable methods for monitoring and measurement of QMS processes that will demonstrate the ability of the processes to achieve planned results. • When planned results are not achieved, correction and corrective actions shall be taken, as appropriate, to ensure conformity of the product. 8.2.4 Monitoring and measurement of product • Monitor and measure the characteristics of the product to verify that product requirements are fulfilled that shall be carried out at appropriate stages of the product realization process. • Evidence of conformity with the acceptance criteria shall be maintained. • Records shall indicate the person(s) authorizing release of product. 8. Measurement, Analysis and Improvement

  48. 8.3 Control of nonconforming product • Ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. These shall be defined in documented procedure. • Shall deal with nonconforming product by one or more of the followings: • 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 by taking action to preclude its original intended use or application. • Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained. • When nonconforming product is corrected it shall be subject to re-verification. • When detected after delivery, shall take action appropriate to the effects or potential effects of the nonconformity. 8. Measurement, Analysis and Improvement

  49. 8.4 Analysis of data • Determine, collect and analyze data to demonstrate the suitability and effectiveness of the QMS and to evaluate continual improvement. • The analysis of the data shall provide information relating to - • Customer satisfaction • Conformance to product / service requirements • Characteristics and trends of processes and products including opportunities for preventive action • Supplier performance. 8. Measurement, Analysis and Improvement

  50. 8.5 Improvement 8.5.1 Continual improvement • Continuously improve the effectiveness of the QMS through the use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. 8.5.2 Corrective action • A documented procedure shall be established to define requirements for - • Reviewing nonconformities including customer complaints • Determining the causes of nonconformities • Evaluating the need for action to ensure that nonconformities do not recur • Determining and implementing action needed • Recording of the results of action taken and reviewing corrective action taken. 8. Measurement, Analysis and Improvement

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