Understanding Quality and Quality Management PDF
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This document provides a foundational overview of quality management, exploring different perspectives on quality and its dimensions, including product-based, transcendent, user-based, manufacturing-based and value-based definitions. It details quality dimensions like performance, features, reliability and durability. The document also delves into service quality, highlighting its unique characteristics.
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Lesson 1 TOPIC: Understanding Quality By the end of this lesson, Concepts & Quality Management you will: What is Quality? Explain the concepts and Differing Functional Perspectives on fundamentals of...
Lesson 1 TOPIC: Understanding Quality By the end of this lesson, Concepts & Quality Management you will: What is Quality? Explain the concepts and Differing Functional Perspectives on fundamentals of quality Quality management. The Three Spheres of Quality Other Perspectives on Quality International Quality Standards Why This Lesson During this session, you will initially become familiar with the concept of quality. Afterwards, you will explore how various functional areas may have distinct perspectives on quality and its management. You will then delve into the three spheres of quality, which are quality control, quality assurance, and quality management. Lastly, you will discover how cultural factors can affect the implementation of quality management practices by comparing different approaches utilised around the world. What is Quality? Quality is a multifaceted concept with varying definitions and dimensions depending on the context in which it is used. At its core, quality refers to the inherent goodness or excellence of a product or service. However, what constitutes "goodness" or "excellence" may differ depending on who is defining it and what their priorities are. It is also viewed differently depending on the function or perspective from which it is being examined. For example, a marketing team may prioritise the perceived quality of a product's branding and packaging, while a manufacturing team may focus on the reliability and consistency of the product's performance. In order to effectively communicate about quality, it is important to recognise that differences in perceptions of quality exist. This means that we need to take into account the different perspectives and priorities of various stakeholders when discussing and evaluating quality. Another important distinction to make is between quality in the context of service and manufacturing. While some aspects of quality may be similar across these two domains, there are also important differences to consider, such as the role of customer interactions in service quality. Product Quality Dimensions David Garvin, a Harvard Business School professor, conducted research on the different ways in which quality can be defined. He identified five main definitions of quality: 1) Transcendent: Quality is something that is difficult to define but is intuitively understood, such as beauty or love. 2) Product-based: Quality is defined by the attributes and components of the product itself. 3) User-based: Quality is determined by whether the customer is satisfied with the product or service. 4) Manufacturing-based: Quality is defined by whether the product conforms to its design specifications. 5) Value-based: Quality is determined by whether the product provides good value for its price. Based on these definitions, Garvin developed eight quality dimensions, which are as follows: Performance Features Reliability Conformance Durability Serviceability Aesthetics Perceived Quality 1) Performance: This refers to how efficiently a product achieves its intended purpose. For example, in the case of an automobile, it may refer to fuel efficiency or acceleration. 2) Features: This refers to the additional attributes of a product that supplement its basic performance. For example, in the case of a television, it may refer to features such as surround sound, HDTV capability, and the like. 3) Reliability: This refers to the consistency with which a product performs over its useful life. For example, if a product has a 2% failure rate over a useful life of 10 years, it can be considered 98% reliable. 4) Conformance: This refers to the degree to which a product adheres to quantifiable or numeric specifications. It is allowed to vary by a small amount, known as "tolerance." For example, it may refer to the size or electrical characteristics of a product. 5) Durability: This refers to the degree to which a product can withstand stress or trauma without failing. 6) Serviceability: This refers to the ease and cost-effectiveness with which a product can be repaired. 7) Aesthetics: This refers to the subjective sensory characteristics of a product, such as its taste, feel, sound, look, and smell. Quality always refers to the degree to which these attributes are matched to consumer preferences. 8) Perceived Quality: This refers to the quality of a product as perceived by the customer. It may be influenced by factors such as brand image, brand recognition, and word-of- mouth recommendations. It is ultimately based on the customer's opinion of the product. Service Quality Dimensions Service quality is challenging to define compared to product quality because of the unique characteristics of services. These characteristics include customer participation in the service process, intangibility, simultaneity, perishability, and heterogeneity. 1) Customer Participation in the Service Process: Unlike products, services often require the active involvement of customers in the service process. For example, when you visit a restaurant, you participate in the service process by choosing your meal, communicating with the server, and paying for the service. 2) Intangibility: Services are intangible and cannot be physically possessed or touched. For example, you cannot touch a haircut, financial advice, or a healthcare service. This characteristic makes it challenging to measure and evaluate the quality of services. 3) Simultaneity: Services are often produced and consumed simultaneously. For example, when you receive a live performance or visit a dentist, the production and consumption of the service occur at the same time. This characteristic makes it challenging to control the quality of services. 4) Perishability: Services cannot be stored or inventoried like products. If a service is not used or consumed, it is lost. For example, an empty seat on an airplane cannot be saved for future use, and a missed appointment with a consultant cannot be resold. 5) Heterogeneity: Services are often variable and inconsistent because they are delivered by people who have different skills, attitudes, and behaviours. For example, two massages from different therapists may differ in quality even if they are from the same spa. This characteristic makes it challenging to standardise and replicate the quality of services. A set of service quality dimensions was published by marketing professors Parasuraman, Zeithamel, and Berry (PZ&B) from Texas A & M University. These dimensions are widely recognised and defined as: 1) Tangibles: This dimension refers to the physical facilities, equipment, personnel, and communication materials associated with the service. An example of this dimension is cleanliness in a hotel room. 2) Reliability: This dimension refers to the ability to perform the promised service dependably and accurately. Reliable service performance is a customer expectation, and it means that the service is accomplished on time, in the same manner, and without error every time. An example of this dimension is receiving mail at the same time each day. 3) Responsiveness: This dimension refers to the willingness to help customers and to provide service promptly. An example of this dimension is avoiding keeping customers waiting for no apparent reason. 4) Assurance: This dimension refers to the ability of employees, in terms of knowledge and courtesy, to convey trust and confidence to customers. The assurance dimension includes competence, politeness and respect, effective communication, and a general attitude to serve customers. An example of this dimension is being polite and showing respect for the customer. 5) Empathy: This dimension refers to the provision of caring, individualised attention to customers. The empathy feature includes approachability, sensitivity, and effort to understand the customer's needs. An example of this dimension is being a good listener. Differing Functional Perspectives on Quality Each functional area in an organisation has a unique perspective on quality. For example, the accountant's perspective on quality is mainly focused on the information required for accounting and tax purposes. The operations department is concerned with information related to process control and scheduling to ensure that products are produced efficiently and delivered on time. Finance, on the other hand, is interested in managing cash effectively to maintain financial stability. Functional perspectives on quality can also be divided into various areas, such as engineering, supply chain, operations, strategic management, marketing, financial, and human resources. 1) Engineering Idea Generation Preliminary Design Prototype Development Prototype Iterations Final Definition Product Design and Evaluation Implementation Figure 1.1: Design Life Cycle Engineering plays a crucial role in ensuring that products and processes meet the desired level of quality. The discipline of engineering applies mathematical problem-solving skills and modeling techniques to develop and optimise products and processes. Within engineering, there are several sub-disciplines that contribute to quality: Operations Research: This involves using mathematical and statistical techniques to solve problems related to variations experienced in the production area. Operations Research helps to identify and eliminate the root causes of quality issues in the production process. Product Design Engineering: This involves the activities associated with developing a product from concept development to final design and implementation. Quality is assured at the design stage by considering factors such as the product's reliability, durability, and ease of manufacture. Concurrent Engineering: This approach involves combining product and process design efforts and forming cross-functional teams to improve quality and reduce the time to market for new products. Activities such as life testing and reliability testing are conducted during the design process to ensure that the product meets the desired level of quality. Statistical Process Control (SPC): This involves monitoring the process capability and stability of a manufacturing process using statistical techniques. SPC helps to detect and prevent quality issues before they occur by monitoring key process parameters and taking corrective actions when necessary. 2) Operations Perspective The operations perspective is a functional perspective that focuses on how the organisation's systems and processes are designed and managed to achieve quality outcomes. This perspective is grounded in the systems view, which is a key aspect of modern quality management thinking. The system’s view emphasises that an organisation is made up of interdependent parts that work together to achieve a common goal. In the operations perspective, these parts include processes, people, equipment, materials, and information. Quality is achieved when all these parts work together seamlessly to produce products or services that meet or exceed customer expectations. Organising Planning Inputs Conversion Customer Outputs Process Controlling Process Customer Control Feedback Figure 1.2: Conversion system model of operations management To manage quality from an operations perspective, organisations use various tools and techniques such as process mapping, value stream mapping, flow charts, and statistical process control. These tools help to identify and eliminate waste, improve efficiency, reduce errors and defects, and ensure consistency in the delivery of products or services. Continuous improvement is also a key aspect of the operations perspective. Organisations strive to continuously improve their systems and processes by setting goals, measuring performance, and identifying opportunities for improvement. The goal is to achieve a culture of continuous improvement where quality becomes an ingrained part of the organisation's DNA. 3) Strategic Management Strategic management is a perspective that emphasises the importance of planning processes to achieve long-term goals in an organisation. This perspective highlights the connection between strategic planning and quality management. For quality management to be successful and effective in an organisation, it needs to be integrated into all business processes, including strategic planning. This means that quality-related goals, tactics, and strategies should be considered an essential part of the overall strategic planning process, rather than a separate entity or unit. By integrating quality management into strategic planning, organisations can ensure that quality is a top priority and that all business decisions are made with quality in mind. This approach also helps to create a culture of quality within the organisation, where everyone is focused on achieving high-quality results. Firm Mission, Vision and Goals External Analysis Internal Analysis Strategic Operations Business-Level Strategy Corporate-Level Strategy Operational Subplans Organisational Change Organisational Design Management Reward Systems Strategic Alignment between Structure and Goals Figure 1.3: Generic strategic planning process 4) Marketing In marketing, the focus is on the perceived quality of a product or service, which refers to how the customer views the quality. Marketers are responsible for managing the quality perceptions of the customer, which means they must take into account the customer's needs, preferences, and expectations when developing and promoting the product or service. One way marketers can improve quality is by listening to the voice of the customer (VOC), which refers to the customer's feedback and preferences regarding a product or service. By gathering and analysing VOC data, marketers can identify areas where improvements are needed and implement changes to meet customer expectations. Marketing also plays a crucial role in promoting the quality of a product or service to potential customers. Through advertising, sales promotions, and other marketing efforts, marketers can create a perception of high quality that can attract customers and generate sales. However, it's important to ensure that the actual quality of the product or service matches the perceived quality, as failing to meet customer expectations can lead to negative reviews and damage the brand's reputation. 5) Financial The financial perspective on quality management looks at the impact of quality on the financial performance of an organisation. Two prominent quality experts, Deming and Juran, had different views on the financial aspect of quality. Deming believed that improving quality can lead to improved organisational performance and a reduction in defects. By reducing defects, organisations can save costs associated with scrap, rework, and warranty claims. This can lead to increased profitability and better financial performance. Improve Cost Productivity Quality Reduction Improved Provide Stay in Capture More Jobs Business the Market Figure 1.4: Deming value change Juran emphasised the impact of quality on customer satisfaction and reputation. He believed that quality-related costs can result in lost sales due to a poor reputation for reliability. For example, if customers experience frequent product failures or defects, they may choose to switch to a competitor with a better reputation for quality, resulting in lost sales and lower revenue. 6) Human Resources The human resources perspective in quality management focuses on involving the workforce in order to develop and utilise their full potential to meet the company's objectives. It is believed that it is impossible to implement quality without the commitment and action of the employees, therefore, it is important to align the workers' and the company's needs. This involves conducting job analysis to ensure that employees are properly trained and equipped with the necessary skills to perform their roles effectively. Human resources also play a critical role in fostering a culture of quality within the organisation. This involves implementing training programmes to develop the necessary quality-related skills, establishing clear job expectations and performance metrics, and incentivising employees to meet quality goals. Additionally, human resources can create a positive work environment that supports quality through employee engagement, recognition programmes, and open communication channels. Ultimately, the human resources perspective recognizes that employees are the driving force behind quality management and that their involvement and commitment are essential to the success of any quality initiative. By investing in their development, engagement, and alignment with the company's objectives, organisations can create a sustainable culture of quality that drives continuous improvement and business success. The Three Spheres of Quality The Three Spheres of Quality, also known as the Three Dimensions of Quality, are a framework used to understand and improve quality in an organisation. Quality Management Quality Quality Assurance Control Figure 1.5: Three spheres of quality 1) Quality Control (QC) Quality Control (QC) is a set of activities designed to ensure that a product or service meets specified quality requirements. It involves monitoring and evaluating the production process to identify any defects or issues that could affect the quality of the final product or service. QC is based on the scientific method, which involves breaking down the production process into its fundamental components, understanding the relationship between those components, and then generalising how those interrelationships apply to the larger phenomenon of quality being studied. The activities involved in QC include monitoring process capability and stability, measuring process performance, reducing process variability, optimising processes to nominal measure, performing acceptance sampling, and developing and maintaining control charts. By doing so, QC helps organisations identify and correct problems in their processes, improve product and service quality, and reduce waste and rework. QC is an essential part of any quality management system and is often used in conjunction with other quality tools and techniques, such as statistical process control (SPC) and Six Sigma. 2) Quality Assurance (QA) Quality assurance (QA) is a set of activities that focus on ensuring that a product or service meets the established quality requirements and standards. QA is a proactive approach to quality management that aims to prevent defects from occurring, rather than simply detecting and correcting them after they have already happened. This helps to reduce the cost of quality, improve customer satisfaction, and increase overall organisational efficiency. Some common QA activities include: Failure mode and effect analysis (FMEA): FMEA is a risk assessment technique used to identify and prioritise potential failures in a product or process and determine their effects on the system. Concurrent engineering: Concurrent engineering involves the collaboration of cross- functional teams to design and develop products and processes concurrently. This can help to identify and address potential quality issues early in the design process. Experimental design (DOE): DOE is a statistical method used to design experiments that can help to identify the factors that affect a product or process and optimise it for better quality and efficiency. Process improvement: Process improvement involves identifying and addressing process inefficiencies and bottlenecks to improve overall performance and quality. Design team formation and management: Effective management of design teams is critical to ensuring the quality of a product. This involves selecting the right team members, providing them with the necessary resources and support, and ensuring effective communication and collaboration among team members. Quality audit: A quality audit is a systematic review of an organisation's quality management system to ensure that it meets the established standards and requirements. Reliability/durability product testing: This involves testing products under various conditions to ensure that they can withstand the intended usage and meet the established quality requirements. 3) Quality Management (QM) Quality Management (QM) is a process that integrates Quality Control (QC) and Quality Assurance (QA) activities to ensure that quality is consistently met or exceeded in all aspects of an organisation's operations. The focus of QM is to create an organisational culture that places a high value on quality and ensures that quality is the responsibility of everyone in the organisation, not just the quality manager or team. The main activities of QM include planning for quality, creating a quality organisational culture, providing leadership and support for quality initiatives, providing training and retraining, designing an organisational system that reinforces quality ideals, providing employee recognition, and facilitating organisational communication. Planning for quality involves defining quality goals, identifying processes that need improvement, and developing a plan for achieving those goals. Creating a quality organizational culture involves instilling a sense of pride and ownership in quality among employees and integrating quality into the organisation's values and vision. Providing leadership and support involves ensuring that leaders at all levels of the organisation are committed to quality and actively promote quality initiatives. Providing training and retraining involves ensuring that employees have the skills and knowledge needed to meet quality standards and identifying areas where additional training is needed. Designing an organisational system that reinforces quality ideals involves creating processes and systems that support quality, such as performance metrics, reward systems, and quality feedback mechanisms. Providing employee recognition involves recognising and rewarding employees who demonstrate excellence in quality. Finally, facilitating organisational communication involves ensuring that information related to quality is communicated effectively throughout the organisation, so that everyone is aware of quality goals, progress, and results. The overall goal of QM is to create a culture of continuous improvement and ensure that quality is an integral part of an organisation's operations. Other Perspectives on Quality The Value-Added Perspective (VAP) on Quality refers to a way of looking at quality that involves a subjective assessment of the efficiency of every step of the process for the customer. In other words, the VAP focuses on whether each activity in the production process adds value to the customer. This can be determined by asking the question, "Would this activity matter to the customer?" If the answer is no, then the activity may not be necessary and can be eliminated. The VAP emphasises the importance of streamlining processes and eliminating waste, which can lead to improved efficiency and cost savings. The Cultural Perspective on Quality recognises that quality improvement may differ according to culture. For example, Japanese companies tend to stress conformity and uniformity in producing quality, while American firms are more likely to favour empowerment approaches that reward creativity and individualism. Cultural factors such as values, beliefs, and attitudes can influence how quality is defined and how it is pursued. Therefore, it is important to take cultural differences into account when implementing quality improvement initiatives. International Quality Standards Managing quality for a multinational firm involves implementing quality management practices that are effective in different countries and cultures where the organisation operates. This requires an understanding of local regulations, cultural norms, and customer expectations. The American approach to quality improvement is primarily focused on statistical process control and quality tools such as Six Sigma and Lean. These approaches emphasise reducing defects and variation in processes to improve quality and efficiency. The Japanese approach to quality improvement, on the other hand, emphasises teamwork and continuous improvement. It includes tools such as Total Quality Management (TQM), Kaizen, and Quality Circles, which involve the active participation of employees in identifying and solving problems to improve quality. The European approach to quality improvement involves a more regulatory approach, with an emphasis on standardisation, quality control, and compliance with regulations. It includes standards such as the ISO 9000 family of standards and the EFQM Excellence Model. ISO 9000:2000 is a set of international standards that define the requirements for a quality management system. It covers areas such as customer focus, leadership, involvement of people, process approach, continuous improvement, and evidence-based decision-making. The Chinese approach to quality improvement has evolved over time, with an increasing focus on quality management and quality control. It includes approaches such as Six Sigma and Lean, as well as the use of quality tools and methodologies in manufacturing and service industries. Culture can have a significant impact on quality approaches, as different cultures may have different values, beliefs, and attitudes toward quality. For example, Japanese culture places a high value on teamwork and continuous improvement, while American culture may value individualism and competition. It is important for organisations to understand the cultural context in which they operate to effectively implement quality management practices. International Quality Standards (American) The Baldrige Performance Excellence Programme is a quality management programme developed by the US government that is focused on improving business results. This programme provides a framework that is non-prescriptive and adaptable to various industries and organisations. It helps companies to align their goals and processes, and it allows for goal- based diagnosis. The programme is based on the Malcolm Baldrige National Quality Award, which was created in 1987 to recognise and promote quality excellence in American companies. The Baldrige criteria are based on seven categories: leadership, strategy, customers, measurement, analysis and knowledge management, workforce, and operations. The programme provides guidelines for each of these categories, which organisations can use to assess their performance and identify areas for improvement. The Baldrige Programme is designed to be adaptable to different types of organisations, including small businesses, non-profits, and government agencies. It focuses on achieving results, rather than on specific quality tools or techniques. This makes it a flexible programme that can be customised to meet the needs of any organisation. One of the benefits of the Baldrige Programme is that it encourages companies to align their goals and processes. This means that everyone in the organisation is working towards the same objectives, which helps to improve efficiency and effectiveness. The programme also emphasises the importance of measurement and analysis, which helps organisations to track their progress and identify areas for improvement. Organisational Profile: Environment, Relationships, and Strategic Situation 2 5 Strategic Workforce planning focus 1 7 Leadership Results 3 6 Customer Operations focus focus 4 Measurement, analysis, and knowledge management Figure 1.6: Baldrige Performance Excellence Programme Evaluation Process Receive applications Stage 1 Independent review No Select for consensus review? Feedback report to Judges applicant Yes Stage 2 Independent review No Select for site visit? Feedback report to Judges applicant Yes Stage 3 Site visit review No Review and recommend winners Feedback report to Judges applicant Yes Feedback Report Figure 1.7: Baldrige process International Quality Standards (Japanese) The Japanese Total Quality Control (TQC) is a comprehensive approach to quality management that focuses on the involvement of all employees in improving the quality of products and processes. It was developed in Japan in the 1950s and 1960s, and it became an integral part of the country's economic success. The TQC approach includes several key elements, including visibility, in-process inspection, the N=2 technique, total involvement of the workforce, the five S's, and preventive maintenance. Visibility refers to the use of visual aids, such as charts and graphs, to make quality problems more visible and easier to identify. In-process inspection involves checking products at each stage of the production process to detect and correct defects early. The N=2 technique involves pairing workers to check each other's work, to ensure that quality standards are being met. Total involvement of the workforce means that every employee is responsible for the quality of the products and services they produce. This requires training, empowerment, and a culture of continuous improvement. The five S's refer to a set of practices aimed at improving workplace organisation and efficiency. These practices are Seiri (sorting), Seiton (systematic arrangement), Seiso (cleaning), Seiketsu (standardisation), and Shitsuke (sustaining). Preventive maintenance involves anticipating and addressing potential problems before they occur. This includes regular maintenance of equipment and tools, and ongoing training for employees to ensure that they are using the tools and equipment correctly. Overall, the TQC approach emphasises continuous improvement and the involvement of all employees in the pursuit of quality. This approach has been influential in the development of other quality management systems, such as Lean Production and Six Sigma. International Quality Standards (European) The European Quality Award is a framework for evaluating and recognising the achievements of organisations that have implemented a comprehensive approach to quality management. It was developed by the European Foundation for Quality Management (EFQM) and is awarded to organisations that demonstrate excellence in their approach to quality management. The award assesses organisations in the following categories: leadership, strategy, people, partnerships and resources, processes, products and services, customer results, people result, society results, and key results. The categories are further broken down into criteria, which are evaluated on a scale of 0 to 1,000 points. To be eligible for the award, an organisation must score a minimum of 400 points in each of the nine categories. The European Quality Award emphasises the importance of leadership and people in achieving quality excellence. It recognises that quality management is a team effort, and that all employees have a role to play in achieving quality goals. The award also recognises the importance of partnerships and resources, and the need for organisations to work collaboratively with suppliers and other stakeholders to achieve quality excellence. One of the key features of the European Quality Award is its focus on results. The award recognises that quality management is not just about implementing processes and systems, but about achieving tangible results for customers, employees, and society as a whole. It encourages organisations to set measurable goals and track their progress towards achieving them. The European Quality Award is a prestigious award that is highly regarded in Europe and around the world. It has been awarded to a wide range of organisations, including businesses, government agencies, and non-profit organisations. International Quality Standards (Chinese) In recent years, China has been rapidly developing its manufacturing industry and exporting a wide range of products to various countries worldwide. However, there have been concerns about the quality of Chinese products. To address this issue, the Chinese government has taken several initiatives to improve the quality of products and services. One of the initiatives is the adoption of international quality standards such as ISO 9001:2000. This standard specifies the requirements for a quality management system and helps organisations to improve their overall performance by focusing on customer satisfaction, continuous improvement, and process efficiency. Another initiative is the implementation of various quality control measures such as product testing and inspection, quality certification, and quality monitoring. The government has also set up quality control agencies to ensure that products meet the required quality standards before they are exported. Despite these initiatives, there is still a perception that Chinese products are of low quality. This could be due to various factors such as lack of awareness among manufacturers and consumers, inadequate quality control measures, and the use of low-quality materials and components. Therefore, there is a need for Chinese manufacturers to improve their understanding of quality management and adopt best practices to enhance the quality of their products. Additionally, the government needs to enforce stricter quality regulations and ensure that quality control measures are properly implemented and monitored. By doing so, China can enhance its reputation as a reliable supplier of high-quality products and services. ISO 9000: 2008 ISO 9000:2008 is an international standard that outlines the requirements for a quality management system (QMS). It focuses on ensuring that a company's products and services meet customer and regulatory requirements while continually improving their quality. The standard is based on a series of manuals that companies can use to document their quality systems, and it can be adapted to many different industries and cultures. ISO 9000:2008 has three standards: ISO 9000:2008 - Quality management systems: Fundamentals and vocabulary, ISO 9001:2008 - Quality management systems: Requirements, and ISO 9004:2008 - Quality management: Guidelines for performance improvement. ISO 9001:2008 is the most widely recognised standard in the ISO 9000 series. It outlines the requirements for a company to have a QMS that meets customer and regulatory requirements and continually improves its effectiveness. The standard is structured into five clauses: 1) Quality management system: This clause outlines the requirements for establishing and maintaining an effective QMS. It includes requirements for documentation, process control, and continuous improvement. 2) Management responsibility: This clause outlines the responsibilities of top management in establishing and maintaining an effective QMS. It includes requirements for leadership, customer focus, and communication. 3) Resource management: This clause outlines the requirements for managing the resources needed for an effective QMS. It includes requirements for human resources, infrastructure, and work environment. 4) Product realisation: This clause outlines the requirements for planning and executing the processes needed to produce products and services that meet customer requirements. It includes requirements for design, purchasing, production, and service provision. 5) Measurement, analysis, and improvement: This clause outlines the requirements for monitoring and measuring processes and products to ensure they meet customer requirements and continually improve their effectiveness. It includes requirements for data analysis, corrective and preventive actions, and continual improvement. - end of content –