SO9004:2000E) 4 Quality management system 4.1 Managing systems and processes eading and operating an organization successfully requires managing it in a systematic and visible manner. Success should result from implementing and maintaining a management system that is deigned to continually improve the effectiveness and efficiency of the organizations performance by considering the needs of interested parties. Managing an organization includes quality management, among other management disciplines Top management should establish a customer-oriented organization a) by defining systems and processes that can be clearly understood, managed and improved in effectiveness a well as efficiency, and b) by ensuring effective and efficient operation and control of processes and the measures and data used determine satisfactory performance of the organization Examples of activities to establish a customer-oriented organization include defining and promoting processes that lead to improved organizational performance, acquiring and using process data and information on a continuing basis directing progress towards continual improvement, and using suitable methods to evaluate process improvement such as self-assessments and management review Examples of self-assessment and continual improvement processes are given in annexes A and B ISo 9001: 2000, Quality management systems - Requirements 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard The organization shall a)identify the processes needed for the quality management system and their application throughout the b)determine the sequence and interaction of these processes, c)determine criteria and methods needed to ensure that both the operation and control of these processes are effective d)ensure the availability of resources and information necessary to support the operation and monitoring o these processes, e)monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes These processes shall be managed by the organization in accordance with the requirements of this Where an organization chooses to outsource any process that affects product conformity with equirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurementISO 9004:2000(E) 2 4 Quality management system 4.1 Managing systems and processes Leading and operating an organization successfully requires managing it in a systematic and visible manner. Success should result from implementing and maintaining a management system that is deigned to continually improve the effectiveness and efficiency of the organization’s performance by considering the needs of interested parties. Managing an organization includes quality management, among other management disciplines. Top management should establish a customer-oriented organization a) by defining systems and processes that can be clearly understood, managed and improved in effectiveness a well as efficiency, and b) by ensuring effective and efficient operation and control of processes and the measures and data used determine satisfactory performance of the organization. Examples of activities to establish a customer-oriented organization include - defining and promoting processes that lead to improved organizational performance, - acquiring and using process data and information on a continuing basis, - directing progress towards continual improvement, and - using suitable methods to evaluate process improvement, such as self-assessments and management review. Examples of self-assessment and continual improvement processes are given in annexes A and B respectively. ISO 9001:2000, Quality management systems – Requirements 4 Quality management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall a)identify the processes needed for the quality management system and their application throughout the organization, b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring o these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement