1. 1 Quality Management Z SUZSANNA E SZTER T ÓTH R ITA D ÉNES Department of Management and Corporate Economics 1 March 2016

2. 2 Agenda for today „Memo”: ISO 9000, quality management principles Logic of ISO 2

3. 3 Military standards Additional standards to ISO 9000 ISO 14000 Self-evaluation criteria of Quality Awards Conformance to requirements Industry specific systems ISO 9000 HACCP (ISO 22000) QS 9000 VDA 6.1 A system without quality GMP AS9000 TL9000 Comenius 2000 ISO TS 16949 ISO/IEC 17025 ISO 27000 Six Sigma CAF ISO 9000:2000 CMMI World class QMS ENQA ISO 28001 OHSAS 18001 ISO 18001 ISO 13485 ISO 50001 Quality Management Systems

4. 4 ISO with membership of 162 national standards institutes more than 19 000 standards and related documents covering almost every industry… International Organization for Standardization This system involves requirements and not product standard. It consist of general requirements. The system must be implemented according to the special features of the applying organization. http://youtu.be/mf43myt6Dr8

5. 5 8 quality management principles ISO 9000

6. 6 8 quality management principles ISO 9000

7. 7 ISO 9001 requirements ISO9001:2000 revision – focus is on the processes rather than on the structure. Aim of requirements: achieving customer satisfaction by meeting customer needs and requirements based on the implementation of a QMS. ISO 9001 requirements link organizational activities Generality – answers should be given by the organization During implementation the organization seeking ITS OWN answers to the necessary requirements.

8. 8 ISO 9001 requirements – General requirements of establishing a QMS The basic requirement for establishing and managing a QMS is the all-inclusive mapping of processes. Identification of those processes which have a direct impact on the quality of a product. Determine process sequence and interaction. Determines the procedures, the processes. Monitoring and measuring of processes affecting product conformity to requirements. Ensure and allocate the necessary resources and make the necessary information available Determine the criteria and methods for process operation and control

9. „Vicious” circle of ISO 9001

10. 10 Clause 5 – Management responsibility Important conditions: Active participating of top management in order to establish, manage and develop an effective and efficient QMS Setting good example in their work Motivating employees to take part in making decisions, improvements and operation of the QMS Establishing a motivating working environment Recognizing and acknowledging individual and team achievements

11. 11 Clause 5 – Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, Authority and Communication 5.6 Management review

12. 12 5.1 Management commitment: Provide evidence of commitment in the everyday operation of the organization 5.2 Customer focus: Ensure customer requirements are determined and met in order to improve customer satisfaction. 5.3 Quality policy and quality objectives 5.4 Planning: the QMS in order to reach quality objectives. 5.5 Responsibility, Authority and Communication 5.6 Management review: Regular revision of the QMS in order to validate its suitability, conformance, efficiency and effectiveness. Clause 5 – Management responsibility

13. ISO 9001 requirements

14. 14 Clause 6 – Resource management To the operation of a QMS several kinds of resources are needed. It is the responsibility of the management to identify the resources necessary to achieve strategic goals and implement the strategy. 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment

15. 15 6.2 Human resources It is the management’s responsibility to provide the organization with employees who possess the skills, abilities and experience needed to establish, manage and improve the QMS effectively and efficiently. –!–! –selection, education on entry, integration task, identify the style of the organisation or department –differences training/education, develop their knowledge, skills and abilities Clause 6 – Resource management

16. 16 6.3 Infrastructure –Buildings; –Workspace; –Associated utilities; –Process equipment (both hardware and software); –Supporting services (such as transport, communication, or information systems) Clause 6 – Resource management

17. 17 6.4 Work environment Determine and manage the work environment needed to achieve product conformity. 6.5 Other resurces Information, Supplier and partners, Natural resources, Financial resources Clause 6 – Resource management

18. ISO 9001 requirements

19. 19 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of measuring and monitoring equipment Clause 7 – Product realization

20. 20 7.1 Planning of product realization –Need for resources, processes, documents based on the requirements of the different stakeholders Clause 7 – Product realization

21. 21 7.2 Customer-related processes –Determination of requirements related to the product –Review of requirements related to the product –Customer communication Clause 7 – Product realization How to determine the requirements of the customers? What do the customers want?

22. 22 7.3 Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes Clause 7 – Product realization

23. 23 7.3 Design and development Design and development inputs –functional and performance requirements –statutory and regulatory requirement, –legislation, –previous information. Design and development outputs Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. –information for purchasing, production, and service –essential characteristics for safe and proper use Clause 7 – Product realization

24. 24 7.3 Design and development Design and development verification Perform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions. Design and development validation Perform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. Clause 7 – Product realization

25. 25 7.4 Purchasing Purchasing process: Ensure that purchased product conforms to its specified purchase requirements. Evaluate and select suppliers: Establish the criteria for selection, evaluation, and re-evaluation. Purchasing information Verification of a purchased product: Establish and implement the inspection or other necessary activities for ensuring the purchased products meet the specified purchase requirements. Clause 7 – Product realization How to choose/select the suppliers? How to measure their performance?

26. 26 7.5 Production and service provision Availability of work instructions, as necessary; use of suitable equipment; availability and use of monitoring and measuring equipment; implementation of product release, delivery, and post-delivery activities Clause 7 – Product realization Validation of processes for production and service provision Identification and traceability Customer property Preservation of a product

27. 27 7.6 Control of measuring and monitoring equipment Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. use and control the monitoring measuring devices Clause 7 – Product realization Treatment, test, device implementing verification authorities, list, check list, calibration, laboratory In your opinion, why is this important?

28. ISO 9001 requirements

29. 29 Clause 8 – Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement

30. 30 8.1 General Plan and implement the monitoring, measurement, analysis, and improvement processes needed to: –Demonstrate conformity to product requirements –Ensure conformity of the system –Continually improve effectiveness Determine through planning the need for, and use of, applicable methods, including statistical techniques, as well as, the extent of their use. Clause 8 – Measurement, analysis and improvement

31. 31 8.2 Monitoring and measurement –Customer satisfaction –Internal audit: to reveal shortcomings both in the operation and in the controlling of the system. Improvement actions are to be taken to eliminate weaknesses. It is the most important tool for improving the QMS. –Monitoring and measurement of QMS process –Monitoring and measurement of product Clause 8 – Measurement, analysis and improvement Examples for measurements: autodetection, random sampling, laboratory measurements, measurement of the output

32. 32 8.3 Control of nonconforming product Clause 8 – Measurement, analysis and improvement Ensure any nonconforming product is identified and controlled to prevent its unintended use or delivery. Establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product. What should we do in case of a nonconforming product?

33. 33 8.4 Analysis of data Determine, collect, and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system. –Customer satisfaction –Conformity to product requirements –Characteristics and trends of processes and products, including opportunities for preventive action –Suppliers 8.5 Improvement –Continual improvement –Corrective action –Preventive action Clause 8 – Measurement, analysis and improvement

34. 34 Documentation requirements Provides the organization with guidelines to fulfill ISO 9001. Ensure the overall control of processes. Serve as the basis of fulfilling, completing a given task, activity. They prove the effective operation of the QMS and the fulfilment of requirements. Quality manual Quality procedures Job instructions Quality records, reports, forms Level 2: defines who, what, when Level 3: answers how Level 4: shows that the system is operating Documents which are essential to plan, operate, manage and control processes.

35. T HANK YOU FOR YOUR KIND ATTENTION ! Rita Dénes D EPT. OF M ANAGEMENT AND C ORPORATE E CONOMICS F ACULTY OF E CONOMIC AND S OCIAL S CIENCES B UDAPEST U NIVERSITY OF T ECHNOLOGY AND E CONOMICS tothzs@mvt.bme.hu https://www.youtube.com/watch?v=OMmaMypolZE