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Quality Management System Introduction in Small and Medium-sized Enterprises By Franz Ertl

PHARE Business Support Programme of the European Union UEAPME - SME FIT II. Quality Management System Introduction in Small and Medium-sized Enterprises By Franz Ertl.

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Quality Management System Introduction in Small and Medium-sized Enterprises By Franz Ertl

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  1. PHARE Business Support Programme of the European UnionUEAPME - SME FIT II Quality Management SystemIntroduction in Small and Medium-sized EnterprisesBy Franz Ertl This project is funded by the European Union under the PHARE Business Support Programme and implemented by UEAPME and its partners. The content of this document does not necessarily reflect the opinion of the European Commission.

  2. Quality Management System ISO 9000:2000 History of ISO 9000 Definition „Quality“ Benefits of Quality Mangement Four Core Standards Major focus points Eight Quality Mangement Principles Related Management Systems Content of ISO 9001:2000 Summary Quality Management System 15. Juli 2014 2

  3. 1. History of ISO 9000 1987 Version 1994 Version 2000 Version Neue Version: 9001:2008 since September 5, 2008 The Headquarter of ISO Organisation is located in Geneva (Switzerland) Quality Management System 15. Juli 2014 3

  4. 2. Definition of ‚Quality‘ (ISO 9000:2000) „The degreetowhich a setofinherentcharactersticsfulfilsrequirements.“ Customers areinterestedthattheproduct/servicetheybuymeetsthequalitytheyareoffered. Quality Management System 15. Juli 2014 4

  5. 3. Benefits of Quality Management International practices for quality management. Common language for dealingwithcustomers and suppliersworldwide in B2B (Business to Business). Increaseefficiency and effectiveness by earlyrecognisingproblems. Model for continualimprovement. Model for satisfyingcustomers and otherstakeholders. Buildqualityintoproducts and services from design onwards. Addressenvironmentalconcerns of customers and public, and complywithgovernmentregulations. Integratewith global economy. Optimizingprocessesforproductionandinformation Quality Management System 15. Juli 2014 5

  6. 4. Four Core Standards 1.Definitions, vocabulary, fundamentals of ISO 9000 2. Requirements of the quality management system 3.ISO 9004: 2000: Guidelines for performance improvements 4.ISO 19011: guidelines for quality and/or environmental management systems audit http://www.iso.org/iso/iso_catalogue/management_standards.htm Of these, only ISO 9001 is a certifiable standard (i.e. ISO9001 is the only standard that you can be assessed against), with the others being for guidance and information purposes only. Quality Management System 15. Juli 2014 6

  7. 5. Major focus points 1. Customer focus 2. Contiunual improvement http://www.tqmc.org/iso9000.php Quality Management System 15. Juli 2014 7

  8. 6. Eight Quality Management Principles 1: Customer focus 2. Leadership 3. Involvementofpeople 4. Processapproach 5. System approachtomanagement 6. Continualimprovement 7. Factualapproachtodecisionmaking 8. Mutuallybeneficialsupplierrelationships Quality Management System 15. Juli 2014 8

  9. 7. Related Management Systems ISO 13485 : 2003-2007 – For medical devices: ISO 9001:2000 certification is mandatory ISO TS 16949:2001 – Quality management systems - Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations EN ISO 14001:2005 - 2004 Environmental management systems Quality Management System 15. Juli 2014 9

  10. 8. Contents ISO 9001:2000 Section 1: Scope Section 2: Fundamentals of quality management systems Section 3: Terms and definitions Section 4: General requirements Section 5: Management responsibility Section 6: Resource management Section 7: Product realization Section 8: Measurement, analysis and improvement In effect, users need to address all sections 1 to 8, but only 4 to 8 needs implementing within a QMS. Quality Management System 15. Juli 2014 10

  11. 8. Quality System Requirements ISO 9001 is a quality assurance model made up of 20 sets of quality system requirements. This model applies to organizations that design, develop, produce, install, and service products. ISO expects organizations to apply this model, and to meet these requirements, by developing a quality system. Quality Management System 15. Juli 2014 11

  12. Clause 4: Quality Management: 4.1General requirements • Define a quality policy. Your policy should describe your organization's attitude towards quality. • Define the organizational structure that you will need in order to manage your quality system. • Define a procedure that your senior managers can use to review the effectiveness of your quality system. Quality Management System 15. Juli 2014 12

  13. 4.2 Documentrequirements • Develop a quality system and a manual that describes it. • Develop and implement quality system procedures that are consistent with your quality policy. • Develop quality plans which show how you intend to fulfill quality system requirements. You are expected to develop quality plans for products, processes, projects, and customer contracts. Quality Management System 15. Juli 2014 13

  14. 4.2 Quality Manual It includes the policies and targets, process description, process instructions and process responsibility. ‘Not quantity is the key! ‘, but adequacy, functionality and continuity create transparency and acceptance of staff and executives. Quality Management System 15. Juli 2014 14

  15. 4.2 Documentcontrol • The procedure of Control of Notes comprises, • the creation, the determination of marking, storage, protection /data security, retrievability, safekeeping periods and responsibilities of who possesses the notes or has access. • For example: • Where and how long are the documents stored? • Which documents are useful? • Howareoutdateddocumentsmarked? Quality Management System

  16. A QM system is a matter for the Management It is no longer possible to delegate the responsibility Communicate the requirement to your stuff Make Quality policy and quality targets Create key figures for performance / benchmarking Clause 5: Management Responsibilities 5.1 Management Commitment Quality Management System

  17. Quality is what the customer requires. The topmost aim must be to meet your customers’ requirements and win, retain and further increase their confidence and satisfaction. Identify your customers’ desires and expectations Clarify product-related obligations e.g. legal requirements 5.2 Customer focus Quality Management System

  18. The quality policies should be written down in your QM manual Aims: Customer satisfaction, development of stuff, future improvement Which Ressources do you provide Customer requirements should be at the centre of attention. Mandatory: The commitment to continuous improvement On-going review of the quality policies and its adequacy for the company Formulate the guidelines concerning the planned business position and development very clearly, and underpin them with quantifiable aims, so that they can be put into practice. 5.3 Quality policy Quality Management System

  19. Quality policies are the orientation frame for the formulation of measurable quality targets and the registration of activities and means that are necessary to achieve these targets. Identify the procedures that have a direct impact on company success and customer satisfaction. Determine measurable targets that concretely state what you intend to achieve in a defined period, e.g. with regard to customer expectations, procedures, your market and the current product requirements. Define the activities necessary for achieving the targets. Communicate these targets and measures and provide the necessary resources. Moreover, you have to plan changes in your QM system in such a way that the system can seamlessly continue to function. 5.4 Quality objectives and planning Quality Management System

  20. Delegate responsibilities and authorization to employees in the whole company, you will achieve that quality becomes the concern of employees of all levels and the QM system will be implemented in practice. By systematically promoting internal communication and targeted information transfer you can make sure that quality policies become well-known, your staff feels included and is able to contribute to the company’s success and its further improvement. Define responsibilities and authorization of those employees who will have to take decisions that are relevant for quality. Name a QM representative as member of the topmost management in larger companies, or in smaller companies you can take on the responsibility yourself. 5.5 Responsibility, authority and communications Quality Management System

  21. A QM system is never perfect and final! It is a highly vital system and has to be adapted to the ever changing customer requirements and desires, market requirements, internal quality requirements, necessary product improvements, manufacturing processes and other given facts. The management has to assess if the QM system is well-suited, adequate, and efficient or needs to be changed, and enhance the quality policies and quality targets. Assess the efficiency of your QM system and its processes on a regular basis. The results of internal audits and previous assessments, customer feedback, process efficiency, faults and customer complaints as well as considering changes that affect your QM system provide the basis for this assessment. You should write down these results and announce them in your company. 5.6 Management review Quality Management System

  22. 6.1 Provision of resourcesYou strive for customer satisfaction and business success. You can only achieve and secure this if you have qualified staff and sufficient tangible resources. 6.2 Human resourcesYour employees have to be qualified, motivated and willing to work hard. 6.3 InfrastructureBuilding, work place, equipment and the corresponding service and disposal facilities have to be in compliance with the state of the technology and thus also with the legal requirements, e.g. occupational health and safety. 6.4 Work environmentWorking environment positively influences the motivation of the persons involved in the production and service process. Clause 6: Resource Management Quality Management System

  23. 7.1 Planning of product or service realisation Customers will not accept that you break promises concerning deadline, number of units, and product requirements and quality.Monitor and enhance the quality targets 7.2 Customer related processesIdentify whether the quality characteristics of the product or service are completely determined and whether you are able to fulfil the quality requirements before you place an offer or accept an order. See to a clear communication with the customer. 7.3 Design and developmentCan the product be produced easily or with a huge effort? You have to fulfil this QM requirement only if you develop products/services in your company. Clause 7: Product Realisation Quality Management System

  24. 7.4 PurchasingMake a clearly defined order which contains quantities, price and date of delivery, clear quality statements with technical details. Make a list of suitable suppliers. Assess your suppliers. Document the assessment. Is your supplier certified? Make goods inward test to ensure that requirements are met. 7.5 Production and service provisionYou have to provide the adequate manufacturing facilities, auxiliary means, documents, staff and their qualification. The requirements have to be stated in e.g. QM process instructions, work instructions, process descriptions, workflows, hiring plans and shop floor papers. Clause 7: Product Realisation Quality Management System

  25. 7.5.1 Control of product and service provision Appropriate production facilities have to be selected. Measurement equipment is available. The staff needs to be qualified by training and instructions and has to document the measurement. Selection and extent of the applicable methods depend e.g. on type and number of units of the product, on the product features that have to be controlled, on process capabilities and customer requirements. 7.5.2 Validation of processes of production and service provision Staffs need to be qualified. The criteria for a continuous monitoring and control have to be determined in a process instruction und notes have to be made on these issues. You have to provide for regular checks (anew validation) in order to detect deviations in good time. Clause 7: Product Realisation Quality Management System

  26. 7.5.3 Identification and traceability Document changes of product. In case of non-conformity the product could be traceable all over product lifetime. For example for security installations like airbags in cars which contain explosive capsules. Clause 7: Product Realisation Quality Management System

  27. 7.5.4 Customer propertyHas to be carefully handledMake a goods inward inspection (completeness, identity and transport damages) and ensure correct storage. 7.5.5 Preservation of productIn-house treatment of productsAttention when shipping the product: Needed time for transport, sensitivity to shock and vibration, other environmental conditions and the means of travel and transportation required by the customer. Consistency with the shipping documents and legal requirements (for example military goods). Clause 7: Product Realisation Quality Management System

  28. 7.6 Control of monitoring and measuring devicesTesting equipment has to show the required accuracy. You have to determine the required accuracy and the adequate test equipment. Tests and testing devices have to be monitored, calibrated and serviced after use or at regular intervals. You have to calibrate and register all test equipment used in your company in an inventory list and label it with a distinctive mark (e.g. identification number). The calibration certificates have to be stored. Clause 7: Product Realisation Quality Management System

  29. 8.1 GeneralDefinitions of procedures to ensure product conformity. 8.2 Measurement and MonitoringContinually adaption to new requirements of market and customers. Adapt also effectiveness and efficiency of the processes and the QM system.On the basis of data, facts and information analyses have to be made and the foundation for making decisions has to be prepared. 8.2.1 Customer SatisfactionCustomer feedback, complaints and surveys, sales information, field studies, etc.The information should be selected and analyzed systematically in order to obtain statements on developments, e.g. by means of a defined process of complaints. 8: Measurement, Analysis and improvement Quality Management System

  30. 8.2.2 Internal Audits Plan internal quality audits systematically. Define responsibilities and frequency as well as the areas to be audited.Make sure in a system audit that your QM system is effective and complete. Carry out process audits by checking the effectiveness of your instructions and processes. Define the time frame for the internal audits.You can commission a customer of yours or an external auditor.Make sure that the results summarized in an audit report are discussed with the persons concerned, and that the required corrections will be carried out and their effectiveness will be examined. Results of quality audits are an integral part of the management assessment. 8: Measurement, Analysis and improvement Quality Management System

  31. 8.2.3 Monitoring and measurement of processesThe basis of improvement of processes is controlling and measuring them.With regard to serial production, fulfil the requirements by examining machine capabilities. 8: Measurement, Analysis and improvement Quality Management System

  32. 8.2.4 Monitoring and measurement of productIt is possible to conclude whether the customers’ requirements are met by means of testing the product. Documented tests serve as a proof that your product has left your factory flawlessly. This can also play an important role with regard to product liabilities. The instructions with regard to tests and documentation have to be documented in QM process instructions and QM plans. 8: Measurement, Analysis and improvement Quality Management System

  33. 8.3 Control of nonconforming productUse the opportunity to learn from mistakes and implement measures of optimization. Defective products must not be processed further or delivered. Mark defective parts and products, write down defects which were discovered and report them to the persons concerned so that evaluations of defects can be carried out and further measures can be discussed, e.g. the handling of defective products and measures of correction. It must be taken care that the parts which were reworked will be tested once again with regard to the concerned characteristics before releasing them. 8: Measurement, Analysis and improvement Quality Management System

  34. 8.3 Control of nonconforming productUse the opportunity to learn from mistakes and implement measures of optimization. Defective products must not be processed further or delivered. Mark defective parts and products, write down defects which were discovered and report them to the persons concerned so that evaluations of defects can be carried out and further measures can be discussed, e.g. the handling of defective products and measures of correction. It must be taken care that the parts which were reworked will be tested once again with regard to the concerned characteristics before releasing them. 8: Measurement, Analysis and improvement Quality Management System

  35. 8.4 Analysis of dataDecisions should be made based on data, analysis and information. In your company, suitable data has to be determined which will support you in assessing the effectiveness of the QM system. This data has to be collected, recorded and analysed. The data analysis has to present evidence on Customer Satisfaction: meeting the product requirements, process and product characteristics and their further development – including the possibility to take pre-emptive measures, Suppliers. 8: Measurement, Analysis and improvement Quality Management System

  36. 8.5 ImprovementAnalysis of the results of internal audits, data analyses, preventive and corrective measures as well as management assessments help you to improve your system. Measures to stop these problems and avoid repeating them have to be determined.Customer complaints: Show your customers that you take their complaints seriously. Use complaints as a help for improving your processes and procedures. In order to achieve a constantimprovement an entrepreneurial culture is needed which is marked by openness and dialogue. Being open towards mistakes and giving and receiving constructive criticism, not only with regard to the employees, but also the management and direction are essential. The employees’ motivation to take part in the process of constant improvement will be destroyed if no measures are following the proposals. 8: Measurement, Analysis and improvement Quality Management System

  37. If you have an existing quality management system you find non conform products earlier than without systematically looking for them. You want your customer to come back and not the product you will provide it by conform products. If you hear the complaints from your customer you will react. Registration to DIN EN ISO 9000:2000 Standards provides an objective testimony that the company has implemented an effective quality management system. Is certification itself important to the marketing plans of the company? Even without certification, companies should utilize the ISO 9000 model as a benchmark and a guideline to assess the adequacy of its quality programs in the European market. 9: Summary Quality Management System

  38. Thank you Quality Management System 15. Juli 2014 38

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