IsO9001:2000E) Quality management systems -Requirements IS This International Standard specifies requirements for a quality management system where an a)needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b)aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term"product"applies only to the product intended for, required by, a customer. 1. 2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size ad product provided. Where any requirements(s)of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. 2 Normative reference The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subseq uent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of iso and IEC maintain registers of currently valid International Standards. ISO 9000: 2000, Quality management systems -Fundamentals and vocabulary 3 Terms For the purposes of this International Standard, the terms and definitions given in Iso 9000 apply. The following terms, used in this edition of iso 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used supplier organization customer OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 1 Quality management systems –Requirements 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. NOTE In this International Standard, the term “product” applies only to the product intended for, or required by ,a customer. 1.2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size ad product provided. Where any requirements(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. 2 Normative reference The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. 3 Terms For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier organization customer
IsO9001:2000E) The term"organization"replaces the term"supplier"used I Iso 9001: 1994, and refers to the unit to which the International Standard applies. Also, the term " supplier"now replaces the term subcontractor Throughout the text of this International Standard, wherever the term"product"occurs, it can also 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 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 ad information necessary to support the operation and monitoring 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 choose outsource any process that affects product conformity with requirements, the organization 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. 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a)documented statements of a quality policy and quality objectives, b)a quality manual, c)documented procedures required by this International Standard d)documents needed by the organization to ensure the effective planning, operation and control of its e)records required by this International Standard( see 4.2.4) NOtE I Where the termdocumented procedure "appears within this International Standard, this means that the procedure is established, documented, implemented and maintained OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 2 The term “organization” replaces the term “supplier” used I ISO 9001:1994, and refers to the unit to which the International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”. 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 (see 1.2), 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 ad information necessary to support the operation and monitoring of 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. 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this International Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4) NOTE 1 Where the term “documented procedure ” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained
IsO9001:2000E) NOTE2 The extent of the quality management system documentation can differ from one organization to another due to type of acti b)the complexity of processes ad their interactions, and c)the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. 4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes a)the scope of the quality management system, including details of and justification for any exclusions (see12), b) the documented procedures established for the quality management system, or reference to them, and c)a description of the interaction between the processes of the quality management system. 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2. 4 a documented procedure shall be established to define the controls needed a)to approve documents for adequacy prior to issue. b)to review and update as necessary and re-approve documents, c)to ensure that changes and the current revision status of documents are identified d)to ensure that relevant versions of applicable documents are available at points of use. e)to ensure that documents remain legible and readily identifia ble f to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose 4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. a documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 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, OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 3 NOTE2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes ad their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. 4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 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
IsO9001:2000E) d )conducting management reviews, and e)ensuring the availability of resources. 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction(see 7.2.1 and 8.2.1). 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 5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product see 7.1 all, 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 management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 41, as well as the quality objectives, and b)the integrity of the quality management system is maintained when changes to the qualit management system are planned and implement 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are defined and communicated within the organization 5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 4 d) conducting management reviews, and e) ensuring the availability of resources. 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). 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. 5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a]], 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 management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 41, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained
IsO9001:2000E) b)reporting to top management on the performance of the quality management system and any need for improvement, and c)ensuring the promotion of awareness of customer requirements throughout the organization NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management review 5.6.1 General Top management shall review the organization's quality management system, at planed intervals, to ensure is continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained(see 4.2. 4) 5.6.2 Review input The input to management review shall include information on a)results of audits, c)process performance and product conformity, d ) status of preventive and corrective actions, e)follow-up actions from previous management reviews, f changes that could affect the quality management system, and g)recommendations for improvement 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b)improvement of product related to customer requirements, and c)resource needs. 6 Resource management 6.1 Provision of resources The organization shall determine and provide the resources needed a)to implement and maintain the quality management system and continually improve its effectiveness, b)to enhance customer satisfaction by meeting customer requirements. OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 5 b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization. NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management review 5.6.1 General Top management shall review the organization’s quality management system, at planed intervals, to ensure is continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see 4.2.4). 5.6.2 Review input The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement. 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 6 Resource management 6.1 Provision of resources The organization shall determine and provide the resources needed a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements
IsO9001:2000E) 6.2 Human resources 6.2.1 General Personnel performing work affecting product quality shall be competent on the basis of appropriate ducation, training, skills and experience. 6.2.2 Competence, awareness and training The organization shall a)determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c)evaluate the effectiveness of the actions taken, d)ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e)maintain appropriate records of education, training, skills and experience(see 4.2. 4). 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a)buildings, workspace and associated utilities, b)process equipment(both hardware and software), and c)supporting services(such as transport or communication) 6.4 Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. 7 Product realization 7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system(see 4.1). In planning product realization, the organization shall determine the following, as appropriate a)quality objectives ad requirements for the product b) the need to establish processes, documents, and provide resources specific to the product c)required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance d)records needed to provide evidence that the realization processes and resulting product meet requirements(see 4.2.4 OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 6 6.2 Human resources 6.2.1 General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. 6.2.2 Competence, awareness and training The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4). 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport or communication). 6.4 Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. 7 Product realization 7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives ad requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)
IsO9001:2000E) The output of this planning shall be in a from suitable for the organization's method of operations. NOTE 1 A document specifying the processes of the quality management system(including the product realization processes )and the resources to be applied to a specifie product, project or contract, can be referred to as a quality plan NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realIzaton processes. 7.2 Customer-related processes 7. 2. 1 Determination of requirements related to the product The organization shall determine a) requirements specified by the customer, including the requirements for delivery and post-delivery activities. b)requirements not stated by the 4 customer but necessary for specified or intended use, where known, d)any additional requirements determined by the organizatio p c)statutory and regulatory requirements related to the product, and 7. 2. 2 Review of requirements related to the product The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer(e.g. submission o tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that a)product requirements are defined b)contract or order requirements differing from those previously expressed are resolved, and c) the organization has the ability to meet the defined requirements Records of the results of the review and actins arising from the review shall be maintained (see 4.2.4) Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. the review can cover relevant product information such as catalogues or advertising materiar t:Instead NOTE In some situations, such as internet sales, a formal review is impractical for each orde 7.2.3 Customer communication The organization shall determine and implement effective arrangements for communicating with customers in relation to a)product information, b)enquiries, contracts or order handling, including amendments, and c)customer feedback, including customer complaints. OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 7 The output of this planning shall be in a from suitable for the organization’s method of operations. NOTE 1 A document specifying the processes of the quality management system (including the product realization processes ) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes. 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product The organization shall determine a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the4 customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. 7. 2.2 Review of requirements related to the product The organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission o tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) the organization has the ability to meet the defined requirements. Records of the results of the review and actins arising from the review shall be maintained (see 4.2.4). Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. 7.2.3 Customer communication The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints
IsO9001:2000E) 7.3 Design and development 7.3.1 Design and development planning The organization shall plan and control the design and development of product During the design and development planning, the organization shall determine a)the design and development stages. b)the review, verification and validation that are appropriate to each design and development stage, and c)the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. 7.3.2 Design and development inputs Inputs relating to product requirements shall be determined and records maintained (see 4.2 4). These inputs shall include a) functional and performance requirements, b)applicable statutory and regulatory requirements. c)where applicable, information derived from previous similar designs, and d )other requirements essential for design and development. These inputs shall be reviewed for adequacy. requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and development outputs The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall a)meet the input requirements for design and development, b)provide appropriate information for purchasing, production and for service provision, c) contain or reference productaccept6ance criteria, and d)specify the characteristics of the product that are essential for its safe and proper use. 7.3. 4 Design and development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements(see 7.3.1) a)to evaluate the ability of the results of design and development to meet requirements, and b)to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained(see 4.2.4) OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 8 7.3 Design and development 7.3.1 Design and development planning The organization shall plan and control the design and development of product. During the design and development planning, the organization shall determine a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. 7.3.2 Design and development inputs Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include a) functional and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and development outputs The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference productaccept6ance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use. 7.3.4 Design and development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4)
IsO9001:2000E) 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements(see 7.3. 1)to ensure that the design and development outputs have met the design and development input requirements, Records of the results of the verification and any necessary actions shall be maintained(see 4. 2. 4) 7.3.6D and development validation Design and development validation shall be performed in accordance with planned arrangements(see 7.3.1)to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actins shall be maintained (see 4.2.4 7.3. 7 Control of design and development changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained( see 4.2. 4 ). 7. 4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchase 3d product on subsequent product realization or the final product The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising form the evaluation shall be maintained(see 4.2. 4) 7. 4.2Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate al of product, procedures, proces equipment, b)requirements for qualification of personnel, and c)quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of purchased product The organization shall establish and implement the inspection or other activities necessary for en suring that purchased product meets specified purchase requirements. Where the organization or its customer intends to performs verification at the suppliers premises, the organization shall state the intended verification arrangements and method of product release in the urchasing information OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 9 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4) 7.3.6 Design and development validation Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actins shall be maintained (see 4.2.4) 7.3.7 Control of design and development changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). 7.4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchase3d product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising form the evaluation shall be maintained (see 4.2.4) 7.4.2Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c)quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of purchased product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to performs verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information
IsO9001:2000E) 7.5 Production and service provision 7.5.1 Control of production and service provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable a)the availability of information that describes the characteristics of the product, b)the availability of work instructions, as necessary, c)the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e)the implementation of monitoring and measurement, and f the implementation of release, delivery and post-delivery activities. 7.5.2 Validation of processes for production and service provision The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a)defined criteria for review and approval of the processes, b)approval of equipment and qualification of personnel, c)use of specific methods and procedure d)requirements for records(see 4.2. 4)and e)revalidation. 7.5.3 Identification and traceability Where appropriate the organization shall identify the product by suitable means throughout product ealization The organization shall identify the product status with respect to monitoring and measurement ts Where traceability is a requirement, the organization shall control and record the unique identification of the product(see 4.2.4) NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained 7.5.4 Customer property The organization shall exercise care with customer property while it is under the organization's control being used by the or ation. The organization shall identify, verify, protect ad safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use this shall be reported to the customer and records maintained (see 4.2. 4) NOTE Customer property can include intellectual property OISO2000-All rights reserved
ISO 9001： 2000(E) ©ISO2000 – All rights reserved 10 7.5 Production and service provision 7.5.1 Control of production and service provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post-delivery activities. 7.5.2 Validation of processes for production and service provision The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4) and e) revalidation. 7.5.3 Identification and traceability Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4) NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained. 7.5.4 Customer property The organization shall exercise care with customer property while it is under the organization’s control being used by the organization. The organization shall identify, verify, protect ad safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4) NOTE Customer property can include intellectual property
