1. Quality Management Quality management systems 6th March 2014

2. ISO 9001 requirements

3. Clause 7 – Product realization 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

4. 7.1 Planning of product realization Plan and develop the processes needed for product realization. Keep the planning consistent with other requirements of the quality management system and document it in a suitable form for the organization. Determine through the planning, as appropriate, the: Quality objectives and product requirements Need for processes, documents, and resources Verification, validation, monitoring, measurement, inspection, and test activities Criteria for product acceptance Records as evidence the processes and resulting product meet requirements Verification and Validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose Validation. The assurance that a product, service, or system meets the needs of the customer and other identified stakeholders. It often involves acceptance and suitability with external customers. Verification. The evaluation of whether or not a product, service, or system complies with a regulation, requirement, specification, or imposed condition. It is often an internal process.

5. 7.2 Customer related processes Determination of requirements related to the product Determine customer requirements: Specified for the product (including delivery and post-delivery activities) Not specified for the product (but needed for specified or intended use, where known) Determine: Statutory and regulatory requirements applicable to the product Any additional requirements considered necessary by the organization Review of requirements related to the product Review the product requirements before committing to supply the product to the customer. Ensure the product requirements are defined Resolve any requirements differing from those previously expressed Ensure its ability to meet the requirements If product requirements are changed, ensure relevant documents are amended and relevant personnel are made aware of the changed requirements

6. 7.2 Customer related processes Customer communication Determine and implement effective arrangements for communicating with customers on: Product information Inquiries, contracts, or order handling (including amendments) Customer feedback (including customer complaints)

7. 7.3 Design and development Design and development planning (can be eliminated) Plan and control the product design and development. This planning must determine the: Stages of design and development Appropriate review, verification, and validation activities for each stage (Clear assignment of) responsibility and authority for design and development Design and development inputs Determine product requirement inputs and maintain records. The inputs must include: Functional and performance requirements Applicable statutory and regulatory requirements Applicable information derived from similar designs Requirements essential for design and development Review these inputs for adequacy and resolve any incomplete, ambiguous or conflicting requirements.

8. 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. The outputs must: Meet design and development input requirements Provide information for purchasing, production, and service Contain or reference product acceptance criteria Define essential characteristics for safe and proper use Be approved before their release Design and development review Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to: Evaluate the ability of the results to meet requirements Identify problems and propose any necessary actions 7.3 Design and development

9. 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. Control of design and development changes Identify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions. 7.3 Design and development

10. 7.4 Purchasing Purchasing process Ensure that purchased product conforms to its specified purchase requirements. The type and extent of control applied to the supplier and purchased product depends upon the effect of the product on the subsequent realization processes or the final product. Evaluate and select suppliers based on their ability to supply product in accordance with the requirements. Establish the criteria for selection, evaluation, and re-evaluation. Maintain the results of evaluations and follow- up actions. Purchasing information Ensure the purchasing information contains information describing the product to be purchased, including the requirements for: Approval of product, procedures, processes, and equipment Qualification of personnel Verification of a purchased product Establish and implement the inspection or other necessary activities for ensuring the purchased products meet the specified purchase requirements.

11. 7.5 Production and service provision Control of production and service provision Plan and carry out production and service provision under controlled conditions to include, as applicable: Availability of product characteristics information Availability of work instructions, as necessary Use of suitable equipment Availability and use of monitoring and measuring equipment Implementation of monitoring and measurement activities Implementation of product release, delivery, and post-delivery activities

12. 7.5 Production and service provision Validation of processes for production and service provision Validate any production or service provision where subsequent monitoring or measurement cannot verify the output. This validation include processes where deficiencies may become apparent only after product use or service delivery. Establish validation arrangements including: Criteria for process review and approval Approval of equipment Qualification of personnel Use of defined methods and procedures Requirements for records Re-validation

13. 7.5 Production and service provision Identification and traceability Identify the product by suitable means during product realization. Identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, control the unique identification of the product and maintain records. Traceability is the ability to verify the history, location, or application of an item by means of documented recorded identification Customer property Exercise care with any customer property while it is under the control of, or being used by, the organization. (raw material, unfinished product, documentation, area etc.) Preservation of a product Preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation includes: Identification Handling Packaging Storage Protection

14. 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 and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements. Where necessary to ensure valid results: Calibrate and/or verify the measuring equipment at specified intervals or prior to use Calibrate the equipment to national or international standards (or record other basis) Adjust or re-adjust as necessary Identify the measuring equipment in order to determine its calibration status Safeguard them from improper adjustments Protect them from damage and deterioration (proper maintenance)

15. ISO 9001 requirements

16. 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

17. Clause 8 – Measurement, Analysis and Improvement Factual approach to decision making, continuous improvement, mutually beneficial customer-supplier relationship, customer-oriented organization – ISO 9000 principles cannot be achieved if the organization does not measure processes. Effective and efficient decisions cannot be made if there are missing, false or unreliable data No need to talk about continuous improvement if we do not know which areas, processes need to be developed Relationships with suppliers cannot be managed if we cannot measure the performance of suppliers Customer focus is based on the measurement of customer needs and requirements and on the knowledge of specific and latent needs The identification and implementation of process for measuring, controlling, monitoring, analyzing and improving is needed as they ensure that the processes and products continuously fulfil requirements. The analysis of data and results of corrective actions are the inputs of management review.

18. 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. The management has to consider and identify the process suitable for monitoring, measuring, analysing and improving the performance of a QMS.

19. 8.2 Monitoring and measurement Customer satisfaction Monitor information on customer perception whether the organization is meeting requirements. Define the methods for obtaining and using this information. Customer satisfaction can be considered as a measure of the output of the QMS. The collection of CS data can be either active or passive, several sources of information. 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.

20. 8.2 Monitoring and measurement Internal audit Conduct internal audits at planned intervals to determine if the quality management system: Conforms to planned arrangements Conforms to requirements of ISO 9001 Is effectively implemented and maintained The organization must: Plan the audit program, Consider the status and importance of the audited areas, Consider the results of prior audits, Define the audit criteria, scope, frequency, and methods, Select and use impartial and objective auditors (not audit their own work) Ensure management of the audited areas takes actions without undue delay to eliminate detected nonconformities and their causes. Verify through follow-up actions the implementation of the action and report the results. Maintain the records of audits and their results.

21. 8.2 Monitoring and measurement Monitoring and measurement of process Apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. Confirm through these methods the continuing ability of each process to satisfy its intended purpose. When the planned results are not achieved, take correction and corrective action, as appropriate. Monitoring and measurement of product Monitor and measure product characteristics to verify product requirements are being met. Carry out the monitoring and measuring at the appropriate stages of product realization in accordance with planned arrangements. The methods used for measuring and monitoring processes should reflect the fulfilment of customer requirements. The monitoring and measuring of processes and products cannot be separated. Measurements: autodetection, random sampling, laboratory measurements, measurement of the output

22. 8.3 Control of nonconforming product 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. Take action to eliminate the detected nonconformity Authorize its use, release, or acceptance by concession Take action to preclude its original intended use or application Take action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started Maintain records. When nonconformity is corrected, reverify it to show conformity. Nonconformities can take several forms: It can be repaired / mended  repair process The product can be sold at a discount price, can be sold through other channels If the product is useless, it can be recycled or rolled out.

23. 8.4 Analysis of data Determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system, as well as, evaluate where continual improvement of the effectiveness of the quality management system can be made. Include in the analysis the data generated by monitoring and measuring activities and from other relevant sources. Analyze this data to provide information on: Customer satisfaction Conformity to product requirements Characteristics and trends of processes and products, including opportunities for preventive action Suppliers Focus on measurements and on documents which highlight the processes that need improvement.

24. 8.5 Improvement Continual improvement Continually improve the effectiveness of the quality management system through: Quality policy Quality objectives Audit results Analysis of data Corrective and preventive action Management review The organization should have an overall strategy for the improvement of the QMS.

25. 8.5 Improvement Corrective action Take corrective action to eliminate the causes of nonconformities and prevent recurrence. Corrective action must be appropriate to effects of the problem. Establish a documented procedure for corrective action that defines requirements to: Review nonconformities (including customer complaints) Determine the causes of nonconformities Evaluate the need for actions to prevent recurrence Determine and implementing the needed action Maintain records of the results of the action taken Review the effectiveness of corrective action taken

26. 8.5 Improvement Preventive action Determine the action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Ensure preventive actions are appropriate to the anticipated effects of the potential problem. Establish a documented procedure for preventive action to define requirements to: Determine potential nonconformities and their causes Evaluate the need for actions to prevent occurrence Determine and implementing the needed action Maintain records of the results of the action taken Review the effectiveness of preventive action taken

27. Process of implementing and maintaining a QMS based on ISO 9001 1.Fully engage top management to Define why an organization want to implement ISO 9001 Define the organization’s mission, vision, and values Define the organization’s stakeholders: customers, suppliers, stockholders, employees, society, etc. Define quality policy, and Define and align organizational objectives and related product/service quality objectives. 2.Identify key processes and the interactions needed to meet quality objectives 3.Implement and manage the QMS and its processes (using process management techniques)

28. 4.Build the ISO 9001-based QMS Identify ISO 9001 requirements Map these requirements with the implemented QMS, where applicable Make a gap analysis : identify where in the existing system the requirements are fulfilled, and where they are not Include in the QMS processes the activities, procedures and controls needed. 5.Implement the system, train company staff and verify effective operation of the processes 6.Manage the QMS Focus on customer satisfaction Monitor and measure the operation of the QMS Strive for continual improvement Consider implementing business excellence models in the company operations 7.If necessary, seek third party certification/registration of the QMS or alternatively, issue a self-declaration of conformity Process of implementing and maintaining a QMS based on ISO 9001

29. Certification Certification is not a requirement In specific industries and markets certification serves as an entry barrier be a contractual or regulatory requirement be necessary to meet customer preferences fall within the context of a risk management programme, and help motivate staff by setting a clear goal for the development of its management system. National accreditation board Independent registar – third party who controls the fulfilment of ISO requirements Periodic audits

30. Total Quality Management Principles

31. FeatureQuality inspection Statistical quality control Quality management (assurance) systems Total quality management Primary goaldetection of defectscontrolharmonizationstrategic pressure Way of reaching quality Solving quality problems Assuring stable competitive position The aim of activities Homogeneous products Homogeneous products with less control Focusing on preventing defects and on the production process in a wider sense Market and customer needs and expectations Methods Standardization and measurement Statistical tools and techniques Quality projects and systems Strategic planning, subsuming goals, mobilization of the total system The tasks of quality professionals and quality function control, sorting, calculuses, qualification trouble shooting, applying statistical methods quality planning, quality programs, valuation of quality system education, trainings, supporting other departments, planning quality projects, setting quality goals and objectives Responsible for quality quality inspection production and other engineering functions all departments Every employee with the contribution and total commitment of management The approach of quality, orientation InspectionControlEstablish and manage a quality system Prime management system

32. Antecedents of TQM After World War II USA: Increasing demands for consumer goods focus on quantity and not on quality War production capability was converted to the mass production of consumer goods Other countries (Japan, Korea, Taiwan and Germany): Little infrastructure left, smaller markets to serve New flexibility, capability, understanding what customers desired  economic revolution Also captured large segments of the US market producers in Europe and Asia continued to gain market share in the US 1980s: US lost its domination as supplier foreign competitors were more innovative, more cost effective, and more capable of meeting the consumer’s requirements

33. Antecendents of TQM American managers must change the way if they are to survive MIT: Made in America report  signs of systematic and pervasive ills that cannot be corrected by working harder to do the same things that failed in the past New consumer-oriented economy  brings quality closer to the value based approach Quality: A basic business strategy that provides goods and services that completely satisfy both internal and external customers by meeting their explicit and implicit expectations.

34. What is a TQM system? Quality is determined by the senior managers of an organization Customer focus: concept of internal customer, external customer thorough collection and analysis of customer requirements These requirements must be understood and met Process improvement work is the result of a series of interrelated steps and activities that result in an output Continuous attention to each of these steps to reduce the variability of the output and improve the reliability of the process reliable processes redesign processes Total involvement Active leadership of senior management Utilizing the talents of all employees New and flexible work structures to solve problems, improve processes and satisfy customers

35. Supporting elements I. Leadership: role of senior managers as advocates, teachers, and leaders by applying the tools and language, by requiring the use of data and by recognizing those who successfully apply the concepts of TQM Education and training: quality is based on the skills of every employee and his or her understanding of what is required Core trainings and additional trainings Supportive structure: senior managers may require support to bring about the change necessary to implement a quality strategy Consultants, small support staff help the senior management team understand the concepts of quality, assist by networking with other quality managers serve as a resource on the topic of quality for the senior management team.

36. Supporting elements II. Communications: communications in a quality environment may need to be addressed differently in order to communicate to all employees a sincere commitment to change Reward and recognition: teams and individuals who successfully apply the quality process must be recognized and possibly rewarded Recognizing successful quality practitioners provides role models for the rest of the organization Measurement: the use of data becomes paramount in installing a quality management process. The collection of customer data provides an objective, realistic assessment of performance and is useful in motivating everyone to address real problems