1So9000:2000E Results are reviewed, as necessary, to determine further opportunities for improvement. In this way, improvement is a continual activity. Feedback from customers and other interested parties, audits and review of the quality management system can also be used to identify opportunities for improvement 2.10 Role of statistical techniques The use of statistical techniques can help in understanding variability, and thereby can help organizations to solve problems and improve effectiveness and efficiency. These techniques also facilitate better use of available data to assist in decision making Variability can be observed I the behaviour and outcome of many activities, even under conditions of apparent stability. Such variability can be observed in measurable characteristics of products ad processes and may be seen to exist at various stages over the life cycle of products from market research to customer service ad final disposal Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with a relatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of the nature, extent and causes of variability, thus helping to solve ad even prevent probl that may result from such variability, and to promote continual improvement Guidance on statistical techniques in a quality management system is given in ISO/TR 10017 2.11 Quality management systems and other management system focuses The quality management system is that part of the organization's management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate. The quality objectives complement other objectives of the organization such as those related to growth, funding, profitability, the environment and occupational health and safety. The various parts of an organization's management system might be integrated, together with the quality management system, into a single management system using common elements. This can facilitate planning, allocation of resources, definition of complementary objectives and evaluation of the overall effectiveness of the organization. The organizations management system can be assessed against the organizations management system requirements. The management system can also be audited against the requirements of International Standards such as ISo9001 and ISO 14001: 1996. These management system audits can be carried out separately or in combination 2.12 Relationship between quality management systems and excellence models organizational excellence models are based on common principles. Both approach y of standards and in The approaches of quality management systems given in the iso9000 family a)enable an organization to identify its strengths and weaknesses, b)contain provision for evaluation against generic models, c) provide a basis for continual improvement, and d)contain provision for external recognition The difference between the approaches of the quality management systems in the iso9000 family and the excellence models lies in their scope of application. The iso 9000 family of standards provides requirements for quality management systems and guidance for performance improvement; evaluation of quality management systems determines fulfillment of those requirements. The excellence models contain criteria that enable comparative evaluation of organizational performance and this is applicable to all activities and all interested parties of an organization Assessment criteria in excellence models provide a basis for an organization to compare its performance with the performance of other organizations
ISO9000:2000(E) 6 Results are reviewed, as necessary, to determine further opportunities for improvement. In this way, improvement is a continual activity. Feedback from customers and other interested parties, audits and review of the quality management system can also be used to identify opportunities for improvement. 2.10 Role of statistical techniques The use of statistical techniques can help in understanding variability, and thereby can help organizations to solve problems and improve effectiveness and efficiency. These techniques also facilitate better use of available data to assist in decision making. Variability can be observed I the behaviour and outcome of many activities, even under conditions of apparent stability. Such variability can be observed in measurable characteristics of products ad processes, and may be seen to exist at various stages over the life cycle of products from market research to customer service ad final disposal. Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with a relatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of the nature, extent and causes of variability, thus helping to solve ad even prevent problems that may result from such variability, and to promote continual improvement. Guidance on statistical techniques in a quality management system is given in ISO/TR 10017. 2.11 Quality management systems and other management system focuses The quality management system is that part of the organization’s management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate. The quality objectives complement other objectives of the organization such as those related to growth, funding, profitability, the environment and occupational health and safety. The various parts of an organization’s management system might be integrated, together with the quality management system, into a single management system using common elements. This can facilitate planning, allocation of resources, definition of complementary objectives and evaluation of the overall effectiveness of the organization. The organization’s management system can be assessed against the organization’s management system requirements. The management system can also be audited against the requirements of International Standards such as ISO9001 and ISO 14001:1996. These management system audits can be carried out separately or in combination. 2.12 Relationship between quality management systems and excellence models The approaches of quality management systems given in the ISO9000 family of standards and in organizational excellence models are based on common principles. Both approaches a) enable an organization to identify its strengths and weaknesses, b) contain provision for evaluation against generic models, c) provide a basis for continual improvement, and d) contain provision for external recognition. The difference between the approaches of the quality management systems in the ISO9000 family and the excellence models lies in their scope of application. The ISO 9000 family of standards provides requirements for quality management systems and guidance for performance improvement; evaluation of quality management systems determines fulfillment of those requirements. The excellence models contain criteria that enable comparative evaluation of organizational performance and this is applicable to all activities and all interested parties of an organization. Assessment criteria in excellence models provide a basis for an organization to compare its performance with the performance of other organizations
1So9000:2000E 3 Terms and definitions A term in a definition or note which is defined elsewhere in this clause is indicated by boldface followed by its entry number in parentheses. Such a boldface term may be replaced in the definition by its complete definition. For example product (3. 4.2)is defined as"result of a process(3.4. 1) process is defined as"set of interrelated or interacting activities which transforms inputs into outputs If the term"process"is replaced by its definition, as follows product then becomes "result of a set of interrelated or interacting activities which transforms inputs into A concept limited to a special meaning in a particular context is indicated by designating the subject field in angle brackets, o, before the definition, for example, technical expert <audit>(3.9.11) 3.1 Terms relating to quality 3.1.1 quality degree to which a set of inherent characteristics (3.5. 1)fulfils requirements(3.1.2) NoTE I The term"quality can be used with adjectives such as poor, good or excellent NOTE 2 Inherent, as opposed to assigned, means existing in something, especially as a permanent characteristic 3.1.2 requirement need or expectation that is stated, generally implied or obligatory NOTEl Generally implied"means that it is custom or common practice for the organization (3.3. 1),its customers(3.3. 5)and other interested parties (3.3.7), that the need or expectation under consideration is implied NoTE2 A qualifier can be used to denote a specific type of requirement, e.g product requirement, quality management requirement, custon NOTE3 A specified requirement is one which is stated, for example, in a document (3.7.2) NOTE4 Requirements can be generated by different interested parties 3.1.3 category or rank given to different quality requirements (3. 1. 2) for products(3.4. 2) processes(3. 4. 1)or systems (3.2. 1) having the same functional use EXAMPLE Class of airline ticket and category of hotel in a hotel guide NOTE 4 Requirements can be generated by different interested parties 3.1.4 customer satisfaction customer's perception of the degree to which the customers requirements(3. 1.2)have been fulfilled NOTEI Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction NOTE2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction
ISO9000:2000(E) 7 3 Terms and definitions A term in a definition or note which is defined elsewhere in this clause is indicated by boldface followed by its entry number in parentheses. Such a boldface term may be replaced in the definition by its complete definition. For example: product (3.4.2) is defined as “result of a process (3.4.1)”; process is defined as “set of interrelated or interacting activities which transforms inputs into outputs.” If the term “process” is replaced by its definition, as follows: product then becomes “result of a set of interrelated or interacting activities which transforms inputs into outputs.” A concept limited to a special meaning in a particular context is indicated by designating the subject field in angle brackets, <>, before the definition, for example, technical expert <audit> (3.9.11). 3.1 Terms relating to quality 3.1.1 quality degree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2) NOTE 1 The term “quality” can be used with adjectives such as poor, good or excellent. NOTE 2 “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic. 3.1.2 requirement need or expectation that is stated, generally implied or obligatory NOTE1 “Generally implied” means that it is custom or common practice for the organization (3.3.1), its customers (3.3.5) and other interested parties (3.3.7), that the need or expectation under consideration is implied: NOTE2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement. NOTE3 A specified requirement is one which is stated, for example, in a document (3.7.2). NOTE4 Requirements can be generated by different interested parties. 3.1.3 grade category or rank given to different quality requirements (3.1.2) for products (3.4.2) processes (3.4.1) or systems (3.2.1) having the same functional use EXAMPLE Class of airline ticket and category of hotel in a hotel guide. NOTE 4 Requirements can be generated by different interested parties. 3.1.4 customer satisfaction customer’s perception of the degree to which the customer’s requirements (3.1.2) have been fulfilled NOTE1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction. NOTE2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction
1So9000:2000E 3.1.5 capability ability of an organization (3. 3. 1), system(3.2. 1)or process(3.4. 1)to realize a product(3. 4. 2) that will fulfill the requirements (3. 1.2)for that product NoTE Process capability terms in the field of statistics are defined in ISO 3534.2 3.2 Terms relating to management 3.2.1 system set of interrelated or interacting elements 3.2.2 management system system(3.2. 1)to establish policy and objectives and to achieve those objectives NOTE A management system of an organization(3. 3. 1)can include different management system, such as a quality management system (3.2.3), a financial management system or an environmental management system 3.2.3 quality management system management system(3.2.2)to direct and control an organization(3.3. 1)with regard to quality (3.1.1) 3.2.4 quality policy overall intentions and direction of an organization(3. 3. 1)related to quality (3. 1. 1)as formally expressed by top management (3.2.7) NOTEl Generally the quality policy is consistent with the overall policy of the organization and provides a framework for the setting of quality objectives (3.2.5) NOTE2 Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy. (See.2.) 3.2.5 quality objective omething sought, or aimed for, related to quality (3.1.1) NOTE 1 Quality objectives are generally based on the organizations quality policy (3. 2. 4) NOTE2 Quality objectives are generally specified for relevant functions and levels in the organization (3.3.1). 3.2.6 management coordinated activities to direct and control an organization (3.3.1) NOTE In English, the term"management sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization. When"management" is used this sense it should always be used with some form of qualifier to avoid confusion with the concept “ management” defined above. For example,“ management shall..” is deprecated whereas“top management(3. 2. 7)shall .. is acceptable 3.2.7 top management person or group of people who direct and controls and organization(3.3. 1)at the highest level 3.2.8 ty manageme coordinated activities to direct and control an organization(3.3. 1)with regard to quality (3. 1. 1) 8
ISO9000:2000(E) 8 3.1.5 capability ability of an organization (3.3.1), system (3.2.1) or process (3.4.1) to realize a product (3.4.2) that will fulfill the requirements (3.1.2) for that product NOTE Process capability terms in the field of statistics are defined in ISO 3534.2. 3.2 Terms relating to management 3.2.1 system set of interrelated or interacting elements 3.2.2 management system system (3.2.1) to establish policy and objectives and to achieve those objectives NOTE A management system of an organization (3.3.1) can include different management system, such as a quality management system (3.2.3), a financial management system or an environmental management system. 3.2.3 quality management system management system (3.2.2) to direct and control an organization (3.3.1) with regard to quality (3.1.1) 3.2.4 quality policy overall intentions and direction of an organization (3.3.1) related to quality (3.1.1) as formally expressed by top management (3.2.7) NOTE1 Generally the quality policy is consistent with the overall policy of the organization and provides a framework for the setting of quality objectives(3.2.5). NOTE2 Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy. (See 0.2.) 3.2.5 quality objective something sought, or aimed for, related to quality (3.1.1) NOTE 1 Quality objectives are generally based on the organization’s quality policy (3.2.4). NOTE2 Quality objectives are generally specified for relevant functions and levels in the organization (3.3.1). 3.2.6 management coordinated activities to direct and control an organization (3.3.1) NOTE In English, the term “management” sometimes refers to people, i.e. a person or group of people with authority and responsibility for the conduct and control of an organization. When “management” is used in this sense it should always be used with some form of qualifier to avoid confusion with the concept “management” defined above. For example, “management shall…” is deprecated whereas “top management (3.2.7) shall …” is acceptable. 3.2.7 top management person or group of people who direct and controls and organization (3.3.1) at the highest level 3.2.8 quality management coordinated activities to direct and control an organization (3.3.1) with regard to quality (3.1.1)
So9000:2000E NOTE Direction and control with regard to quality generally includes establishment of the quality polie (3.2. 4)and quality objectives (3.2.5), quality planning(3.2.) quality control (3. 2. 10), quality assurance (3.2. 11)and quality improvement(3. 2. 12) 3.2.9 quality planning part of quality management(3.2.8)focused on setting quality objectives(3. 2. 5)and specifying necessary operational processes(3. 4. 1)and related resources to fulfill the quality objectives NOTE Establishing quality plans (3. 7.5)can be part of quality planning 3.2.10 art of quality management (3.2.8) focused on fulfilling quality requirements(3. 1.2) 3.2.1 art of quality management (3.2. 8)focused on providing confidence that quality requirements(3. 1.2) will be fulfilled 3.2.12 quality improvement part of quality management (3.2.8)focused on increasing the ability to fulfill quality requirements (3. 1.2) NoTE The requirements can be related to any aspect such as effectiveness(3.2. 14), efficiency (3.2.15)or traceability (3.5. 4) 3.2.13 continual improvement recurring activity to increase the ability to fulfill requirements(3. 1.2) NoTE The process (3. 4. 1)of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings(3.9.5)and audit conclusions(3.9.6), analysis of data, management reviews(3.8.7)or other means and generally leads to corrective action(3.6.5)or preventive action(3.6. 4) 3.2.14 effectiveness extent to which planned activities are realized and planned results achieved 3.2.15 efficiency relationship between the result achieved and the resources used 3.3 Terms relating to organization 3.3.1 group of people and facilities with an arrangement of responsibilities, authorities and relationships EXAMLE Company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combin NOTE I The arrangement is generally orderly NOTE 2 An organization can be public or private noTE 3 This definition is valid for the purposes of quality management system(3.2.3)standards. The term organization "is defined differently in ISO/IEC Guide 2 3.3.2 organizational structure arrangement of responsibilities, authorities and relationships between people
ISO9000:2000(E) 9 NOTE Direction and control with regard to quality generally includes establishment of the quality policy (3.2.4) and quality objectives (3.2.5), quality planning (3.2.9) quality control (3.2.10), quality assurance (3.2.11) and quality improvement (3.2.12). 3.2.9 quality planning part of quality management (3.2.8) focused on setting quality objectives (3.2.5) and specifying necessary operational processes (3.4.1) and related resources to fulfill the quality objectives NOTE Establishing quality plans (3.7.5) can be part of quality planning. 3.2.10 quality control part of quality management (3.2.8) focused on fulfilling quality requirements (3.1.2) 3.2.11 quality assurance part of quality management (3.2.8) focused on providing confidence that quality requirements (3.1.2) will be fulfilled 3.2.12 quality improvement part of quality management (3.2.8) focused on increasing the ability to fulfill quality requirements (3.1.2) NOTE The requirements can be related to any aspect such as effectiveness (3.2.14), efficiency (3.2...15) or traceability (3.5.4). 3.2.13 continual improvement recurring activity to increase the ability to fulfill requirements (3.1.2) NOTE The process (3.4.1) of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings (3.9.5) and audit conclusions (3.9.6), analysis of data, management reviews (3.8.7) or other means and generally leads to corrective action (3.6.5) or preventive action (3.6.4). 3.2.14 effectiveness extent to which planned activities are realized and planned results achieved 3.2.15 efficiency relationship between the result achieved and the resources used 3.3 Terms relating to organization 3.3.1 organization group of people and facilities with an arrangement of responsibilities, authorities and relationships EXAMLE Company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combination thereof. NOTE 1 The arrangement is generally orderly. NOTE 2 An organization can be public or private. NOTE 3 This definition is valid for the purposes of quality management system (3.2.3) standards. The term “organization” is defined differently in ISO/IEC Guide 2. 3.3.2 organizational structure arrangement of responsibilities, authorities and relationships between people
So9000:2000E NoTE 1 The arrangement is generally orderly NoTE 2 A formal expression of the organizational structure is often provided in a quality manual (3.7. 4)or a quality plan(3.7. 5)for a project(3.4.3) noTE 3 The scope of an organizational structure ca include relevant interfaces to external organizations (3.3.1) 3.3.3 <organization> system of facilities, equipment and services needed for the operation of an organization (3.3.1) 3.3.4 work environment set of conditions under which work is performed NOTE Conditions include physical, social, psychological and environmental factors(such as temperature, recognition schemes, ergonomics and atmospheric composition) 3.3.5 customer organization(3. 3. 1)or person that receives a product(3.4.2) EXAMPLE Consumer, client, end-user, retailer, beneficiary and purchaser NOTE A customer can be internal or external to the organization. supplier organization(3.3. 1)or person that provides a product (3.4.2 EXAMPLE Producer, distributor, retailer or vendor of a product, or provider of a service or information NOTE I Asupplier can be internal or external to the organization NOTE 2 In a contractual situation a supplier is sometimes called"contractor 3.3.7 interested party person or group having an interest in the performance or success of an organization(3. 3. 1) EXAMPLE Customers(3.3.5), owners, people in an organization, suppliers(3.3.6), bankers, unions, partners or society NOTE A group can comprise an organization, a part thereof, or more than one organization 3.4 Terms relating to process and product process set of interrelated or interacting activities which transforms inputs into outputs NOTE 1 Inputs to a process are generally outputs of other processes NOTE 2 Processes in an organization(3.3. 1) are generally planned and carried out under controlled conditions to add valu noTE 3 A process where the conformity (3.6. I)of the resulting product (3.4.2)cannot be readily or economically verified is frequently referred to as a"special process 3.4.2 esult of a process(3. 4.1) NoTEl There are four generic product categories, as follows
ISO9000:2000(E) 10 NOTE 1 The arrangement is generally orderly. NOTE 2 A formal expression of the organizational structure is often provided in a quality manual (3.7.4) or a quality plan (3.7.5) for a project (3.4.3). NOTE 3 The scope of an organizational structure ca include relevant interfaces to external organizations (3.3.1). 3.3.3 infrastructure <organization> system of facilities, equipment and services needed for the operation of an organization (3.3.1) 3.3.4 work environment set of conditions under which work is performed NOTE Conditions include physical, social, psychological and environmental factors (such as temperature, recognition schemes, ergonomics and atmospheric composition). 3.3.5 customer organization (3.3.1) or person that receives a product (3.4.2) EXAMPLE Consumer, client, end-user, retailer, beneficiary and purchaser. NOTE A customer can be internal or external to the organization. 3.3.6 supplier organization (3.3.1) or person that provides a product (3.4.2) EXAMPLE Producer, distributor, retailer or vendor of a product, or provider of a service or information. NOTE 1 A supplier can be internal or external to the organization. NOTE 2 In a contractual situation a supplier is sometimes called “contractor.” 3.3.7 interested party person or group having an interest in the performance or success of an organization (3.3.1) EXAMPLE Customers (3.3.5), owners, people in an organization, suppliers (3.3.6), bankers, unions, partners or society. NOTE A group can comprise an organization, a part thereof, or more than one organization. 3.4 Terms relating to process and product process set of interrelated or interacting activities which transforms inputs into outputs NOTE 1 Inputs to a process are generally outputs of other processes. NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value. NOTE 3 A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified is frequently referred to as a “special process.” 3.4.2 product result of a process (3.4.1) NOTE1 There are four generic product categories, as follows: