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)