SO9004:2000E) Top management should also define methods for measurement of the organization's performance in order to determine whether planned objectives have been achieved Methods include measurement of process performance throughout the organization, external measurement, such as benchmarking and third-party evaluation assessment of the satisfaction of customers, people in the organization and other interested parties assessment of the perceptions o customers and other interested parties of performance of products provided, and measurement of other success factors identified by management derived from such measurements and assessments should also be management review in order to ensure that continual improvement of the quality management system is the driver for performance improvement of the organization 5.1.2 Issues to be considered When developing, implementing and managing the organizations quality management sy stem management should consider the quality management principles outlined in 4.3 On the basis of these principles, top management should demonstrate leadership in, and commitment to the following activities understanding current and future customer needs ad expectations, in addition to requirements promoting policies and objectives to increase awareness, motivation and involvement of people in the organization establishing continual improvement as an objective for processes of the organization planning for the future of the organization and managing change setting and communicating a framework for achieving the satisfaction of interested parties In addition to small-step or ongoing continual improvement, top management should also consider breakthrough changes to processes as a way to improve the organizations performance. During such changes, management should take steps to ensure that the resources and communication needed to maintain the functions of the quality management system are provided Top management should identify the organizations product realization processes, as these are directly related to the success of the organization. Top management should also identify those support processes that affect either the effectiveness and efficiency of the realization processes or the needs and expectations of interested parties Management should ensure that processes operate as an effective and efficient network. Management nould analyse and optimize the interaction of processes, including both realization processes and support Consideration should be given to nsuring that the sequence and interaction of processes are designed to achieve the desired results effectively and efficiently ensuring process inputs, activities and outputs are clearly defined and controlled, monitoring inputs ad outputs to verify that individual processes are linked and operate effectively ad efficiently. dentifying and managing risks, and exploiting performance improvement opportunities, conducting data analysis to facilitate continual improvement of processes identifying process owners and giving them full responsibility and authority
ISO 9004:2000(E) 6 Top management should also define methods for measurement of the organization’s performance in order to determine whether planned objectives have been achieved. Methods include - financial measurement, - measurement of process performance throughout the organization, - external measurement, such as benchmarking and third-party evaluation, - assessment of the satisfaction of customers, people in the organization and other interested parties, - assessment of the perceptions o customers and other interested parties of performance of products provided, and - measurement of other success factors identified by management. Information derived from such measurements and assessments should also be considered as input to management review in order to ensure that continual improvement of the quality management system is the driver for performance improvement of the organization. 5.1.2 Issues to be considered When developing, implementing and managing the organization’s quality management system, management should consider the quality management principles outlined in 4.3. On the basis of these principles, top management should demonstrate leadership in, and commitment to, the following activities: - understanding current and future customer needs ad expectations, in addition to requirements; - promoting policies and objectives to increase awareness, motivation and involvement of people in the organization; - establishing continual improvement as an objective for processes of the organization; - planning for the future of the organization and managing change; - setting and communicating a framework for achieving the satisfaction of interested parties. In addition to small-step or ongoing continual improvement, top management should also consider breakthrough changes to processes as a way to improve the organization’s performance. During such changes, management should take steps to ensure that the resources and communication needed to maintain the functions of the quality management system are provided. Top management should identify the organization’s product realization processes, as these are directly related to the success of the organization. Top management should also identify those support processes that affect either the effectiveness and efficiency of the realization processes or the needs and expectations of interested parties. Management should ensure that processes operate as an effective and efficient network. Management should analyse and optimize the interaction of processes, including both realization processes and support processes. Consideration should be given to - ensuring that the sequence and interaction of processes are designed to achieve the desired results effectively and efficiently, - ensuring process inputs, activities and outputs are clearly defined and controlled, - monitoring inputs ad outputs to verify that individual processes are linked and operate effectively ad efficiently, - identifying and managing risks, and exploiting performance improvement opportunities, - conducting data analysis to facilitate continual improvement of processes, - identifying process owners and giving them full responsibility and authority
SO9004:2000E) managing each process to achieve the process objectives, and the needs and expectations of interested parties Iso 9001: 2000, Quality management systems-Requirements 5 Management responsibility 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 a)communicating to the organization the importance of meeting customer as well as statutory and requirements, b)establishing the quality policy, c)ensuring that quality objectives are established d)conducting management reviews, and e)ensuring the availability of resources 5.2 Needs and expectations of interested parties 5.2.1 General Every organization has interested parties, each party having needs and expectations. Interested parties of organizations include customers and end-users people in the organization, owners/investors(such as shareholders, individuals or groups, including the public sector, that have a specific interest in the organization) society in terms of the community and the public affected by the organization or its products 5.2. 2 Needs and expectations The success of the organization depends on understanding and satisfying the current and future needs and expectations of present and potential customers and end-users, as well as understanding and considering those of other interested parties In order to understand and meet the needs and expectations of interested parties, an organization should identify its interested parties and maintain a balanced response to their needs and expectations, translate identified needs and expectations into requirements communicate the requirements throughout the organization, and focus on process improvement to ensure value for the identified interested parties. To satisfy customer and end-user needs and expectations, the management of an organization should understand the needs and expectations of its customers, including those of potential customers, determine key product characteristics for its customers and end-users
ISO 9004:2000(E) 7 - managing each process to achieve the process objectives, and - the needs and expectations of interested parties. 5.2 Needs and expectations of interested parties 5.2.1 General Every organization has interested parties, each party having needs and expectations. Interested parties of organizations include - customers and end-users, - people in the organization, - owners/investors (such as shareholders, individuals or groups, including the public sector, that have a specific interest in the organization), - suppliers and partners, and - society in terms of the community and the public affected by the organization or its products. 5.2.2 Needs and expectations The success of the organization depends on understanding and satisfying the current and future needs and expectations of present and potential customers and end-users, as well as understanding and considering those of other interested parties.. In order to understand and meet the needs and expectations of interested parties, an organization should - identify its interested parties and maintain a balanced response to their needs and expectations, - translate identified needs and expectations into requirements, - communicate the requirements throughout the organization, and - focus on process improvement to ensure value for the identified interested parties. To satisfy customer and end-user needs and expectations, the management of an organization should - understand the needs and expectations of its customers, including those of potential customers, - determine key product characteristics for its customers and end-users, ISO 9001:2000, Quality management systems – Requirements 5 Management responsibility 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 a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources
SO9004:2000E) identify and assess competition in its market, and dentify market opportunities, weaknesses and future competitive advantage Examples of customer and end-user needs and expectations, as related to the organizations products, include conformity dependability availability delivery post-realization activities rice and life-cycle costs, product safety. product liability, and environmental impact The organization should identify its people's needs and expectations for recognition, work satisfaction, and personal development. Such attention helps to ensure that the involvement and motivation of people are as The organization should define financial and other results that satisfy the identified needs and expectations of owners and investors Management should consider the potential benefits of establishing partnerships with suppliers to the organization,in order to create value for both parties. a partnership should be based on a join strategy sharing knowledge as well as gains and losses. When establishing partnerships, an organization should dentify key suppliers, and other organizations, as potential partners jointly establish a clear understanding of customers'needs and expectations, jointly establish a clear understanding of the partners' needs and expectations, and set goals to secure opportunities for continuing partnerships In considering its relationships with society, the organization should demonstrate responsibility for health and safety consider environmental impact, including conservation of energy and natural resources dentify the current and potential impacts on society in general, and the local community in particular of its products, processes and activities ISO9001: 2000, Quality management systems- Requirements 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction 8
ISO 9004:2000(E) 8 - identify and assess competition in its market, and - identify market opportunities, weaknesses and future competitive advantage. Examples of customer and end-user needs and expectations, as related to the organization’s products, include - conformity, - dependability, - availability, - delivery, - post-realization activities, - price and life-cycle costs, - product safety, - product liability, and - environmental impact. The organization should identify its people’s needs and expectations for recognition, work satisfaction, and personal development. Such attention helps to ensure that the involvement and motivation of people are as strong as possible. The organization should define financial and other results that satisfy the identified needs and expectations of owners and investors. Management should consider the potential benefits of establishing partnerships with suppliers to the organization, in order to create value for both parties. A partnership should be based on a join strategy, sharing knowledge as well as gains and losses. When establishing partnerships, an organization should - identify key suppliers, and other organizations, as potential partners, - jointly establish a clear understanding of customers’ needs and expectations, - jointly establish a clear understanding of the partners’ needs and expectations, and - set goals to secure opportunities for continuing partnerships. In considering its relationships with society, the organization should - demonstrate responsibility for health and safety, - consider environmental impact, including conservation of energy and natural resources, - identify applicable statutory and regulatory requirements, and - identify the current and potential impacts on society in general, and the local community in particular, of its products, processes and activities. ISO9001:2000, Quality management systems – Requirements 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction
SO9004:2000E) 5.2.3 Statutory and regulatory requirement anagement should ensure that the organization has knowledge e of the statutory and regulator equirements that apply to its products, processes and activities and should include such requirements as part of the quality management system. Consideration should also be given to he promotion of ethical, effective and efficient compliance with current and prospective requirements, the benefits to interested parties from exceeding compliance, and the role of the organization in the protection of community interests 5.3 Quality policy Top management should use the quality policy as a means of leading the organization toward improvement of its performance An organization's quality policy should be an equal and consistent part of the organizations overall In establishing the quality policy, top management should consider the level and type of future improvement needed for the organization to be successful the expected or desired degree of customer satisfaction, the development of people in the organization, the needs and expectations of other interested parties, the resources needed to go beyond ISo 9001 requirements, and he potential contributions of suppliers and partners The quality policy ca be used for improvement provided that it is consistent with top managements vision and strategy for the organizations future it permits quality objectives to be understood and pursued throughout the organization, it demonstrates top managements commitment to quality and the provision of adequate resources for achievement of objectives, it aids in promoting a commitment to quality throughout the organization, with clear leadership by to it includes continual improvement as related to satisfaction of the needs and expectations of customers and other interested parties, an it is effectively formulated ad efficiently communicated As with other business policies, the quality policy should be periodically reviewed Iso9001: 2000, Quality management systems-Requirements 5.3 Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system c) provides a framework for establishing and reviewing qual ity objectives, d) is communicated and understood within the organization, and e)is reviewed for continuing suitability
ISO 9004:2000(E) 9 5.2.3 Statutory and regulatory requirements Management should ensure that the organization has knowledge e of the statutory and regulatory requirements that apply to its products, processes and activities and should include such requirements as part of the quality management system. Consideration should also be given to - the promotion of ethical, effective and efficient compliance with current and prospective requirements, - the benefits to interested parties from exceeding compliance, and - the role of the organization in the protection of community interests. 5.3 Quality policy Top management should use the quality policy as a means of leading the organization toward improvement of its performance. An organization’s quality policy should be an equal and consistent part of the organization’s overall policies and strategy. In establishing the quality policy, top management should consider - the level and type of future improvement needed for the organization to be successful, - the expected or desired degree of customer satisfaction, - the development of people in the organization, - the needs and expectations of other interested parties, - the resources needed to go beyond ISO 9001 requirements, and - the potential contributions of suppliers and partners. The quality policy ca be used for improvement provided that - it is consistent with top management’s vision and strategy for the organization’s future, - it permits quality objectives to be understood and pursued throughout the organization, - it demonstrates top management’s commitment to quality and the provision of adequate resources for achievement of objectives, - it aids in promoting a commitment to quality throughout the organization, with clear leadership by top management, - it includes continual improvement as related to satisfaction of the needs and expectations of customers and other interested parties, and - it is effectively formulated ad efficiently communicated. As with other business policies, the quality policy should be periodically reviewed. ISO9001:2000, Quality management systems – Requirements 5.3 Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability
SO9004:2000E) 5.4 Planning 5.4.1 Quality objectives The organizations strategic planning and the quality policy provide a framework for the setting of quality objectives should be capable of being measured in order to facilitate an effective and efficient review management. When establishing these objectives, management should also consider current and future needs of the organization and the markets served relevant findings from management reviews. current product and process performance levels of satisfaction of interested parties, self-assessment results chmarking, competitor analysis, opportunities for improvement, and resources needed to meet the objectives. The quality objectives should be communicated in such a way that people in the organization can contribute to their achievement. Responsibility for deployment of qual ity objectives should be defined. Objectives should be systematically reviewed and revised as ne Iso 9001: 2000, Quality management systems - Requirements 5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy 5.4.2 Quality planning Management should take responsibility for the quality planning of the organization. This planning should cus on fining ded to meet effectively and efficiently the organization's quality objectives and requirements consistent with the strategy of the organization Inputs for effective ad efficient planning include strategies of the organization, defined organizational objectives, defined needs and expectations of the customers and other interested parties evaluation of statutory and regulatory requirements, evaluation of performance data of the products evaluation of performance data of processes lessons learned from previous experience indicated opportunities for improvement, and related risk assessment and mitigation data
ISO 9004:2000(E) 10 5.4 Planning 5.4.1 Quality objectives The organization’s strategic planning and the quality policy provide a framework for the setting of quality objectives should be capable of being measured in order to facilitate an effective and efficient review by management. When establishing these objectives, management should also consider - current and future needs of the organization and the markets served, - relevant findings from management reviews, - current product and process performance, - levels of satisfaction of interested parties, - self-assessment results, - benchmarking, competitor analysis, opportunities for improvement, and - resources needed to meet the objectives. The quality objectives should be communicated in such a way that people in the organization can contribute to their achievement. Responsibility for deployment of quality objectives should be defined. Objectives should be systematically reviewed and revised as necessary. 5.4.2 Quality planning Management should take responsibility for the quality planning of the organization. This planning should focus on defining the processes needed to meet effectively and efficiently the organization’s quality objectives and requirements consistent with the strategy of the organization. Inputs for effective ad efficient planning include - strategies of the organization, - defined organizational objectives, - defined needs and expectations of the customers and other interested parties, - evaluation of statutory and regulatory requirements, - evaluation of performance data of the products, - evaluation of performance data of processes, - lessons learned from previous experience, - indicated opportunities for improvement, and - related risk assessment and mitigation data. ISO 9001:2000, Quality management systems – Requirements 5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy