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 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 and product provided. Were any requirement(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 and definitions For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. The following items, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier → organization → customer The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this 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 continu中證集團iso認證的王老師 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 and 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. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of the organization and type of activities, b) the complexity of processes and their interactions, and c) the competencies 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 version 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 continu中證集團iso認證的王老師 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.
5.2 Customer focus Top management shall ensure that customer requirements are determined and 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 continu中證集團iso認證的王老師 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
4.1, 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 the responsibilities, 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, 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 planned intervals, to ensure its 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 review 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 relate 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 continu中證集團iso認證的王老師 improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements.
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 competency 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) building, 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 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 and 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). The output of this planning shall be in a form 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 requirement 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 the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements related to 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 of 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 actions 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 in 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.
7.3 Design and development
7.
3.1 Design and development planning The organization shall plan and control 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 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 product acceptance 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 result of the reviews and any necessary actions shall be maintained (see
4.
2.4)
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 actions 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 requir

哪位老兄來英文版的標準也發(fā)上來了，這可是侵犯AAA企業(yè)資質呀！ ISO會告你的。

1400
1、TS16949\OHSAS18001

目前，我國為質量體系認證咨詢提供的依據標準有iso9000、iso14000及qs9000標準。 iso9000族標準 是質量管理和質量保證的總稱。我國等同采用的單位標準代號為gb／t19000標準。該國際標準發(fā)布于1987年，于1994年進行了部分修訂，該族標準包括了約25個標準。iso9000標準總結了各工業(yè)發(fā)達單位在質量管理方面的先進經驗，主要用于企業(yè)質量管理體系的建立、實施和改進，為企業(yè)在質量管理和質量保證方面提供指南。其中iso900
1、iso900
2、iso9003標準，是針對企業(yè)iso三體系認證產生的不同過程，制訂了3種模式化的質量保證要求，作為質量管理體系認證咨詢的審核依據。目前，世界上80多個單位和地區(qū)的認證咨詢機構，均采用這3個標準進行第三方的質量管理體系認證咨詢。 iso14000標準 是環(huán)境管理體系系列標準總稱。該系列標準發(fā)布于1996年，到目前為止，該系列標準正式發(fā)布了5個標準。我國等同采用的單位標準代號是gb／t14000系列標準。 iso14000標準是在人類無限制地消耗自然資源、同時又破壞自然環(huán)境的情況下，規(guī)范從單位到企業(yè)等所有組織的環(huán)境行為，為企業(yè)建立并保持環(huán)境管理體系提供指導，使企業(yè)采取污染預防和持續(xù)改進的手段，達到降低資源消耗，改善環(huán)境質量，走可持續(xù)發(fā)展道路的目的。其中iso14001《環(huán)境管理體系 規(guī)范及使用指南》標準是環(huán)境管理體系認證咨詢所依據的標準。 iso14000標準發(fā)布后，在歐洲、英美等單位和地區(qū)，產生了強烈的反響，單位管理部門和一些企業(yè)要求其合約商或供貨方必須通過iso14001認證咨詢。我國在加入世貿組織后，許多iso三體系認證的出口將面臨這一挑戰(zhàn)。為適應這一需要，我國不少的認證咨詢機構已通過了環(huán)境認證咨詢認可機構批準，開始iso14001標準的認證咨詢。 qs9000等標準 是汽車行業(yè)在質量保證方面提出特殊要求的標準。該標準是美國三大汽車公司（福特、克萊斯勒、通用）為保證采購的汽車零部件質量，對提供iso三體系認證的供方提出的質量保證要求，屬于第二方認證咨詢，即需方對供方的申報或認證咨詢。但這些公司為節(jié)約審核經費而委托經認可的認證咨詢機構進行審核、發(fā)證。這類標準除qs9000標準外，還有dva－6．1標準（德國），eaqf標準（法國）和avsq標準（意大利）等。為打破各國之間的貿易壁壘，國際標準化組織（iso）已制訂iso／dtr16949《質量體系－汽車業(yè)供應方》標準草案稿，正提交技術委員會討論通過。它將代替美、德、法等單位同類標準。目前，我國方圓認證咨詢委員會等認證咨詢機構均已開展了qs9000等標準的認證咨詢工作。 iso9001叫質量管理體系，是規(guī)范各個企業(yè)在生產經營活動中的全方面事宜。 iso14001叫環(huán)境管理體系，較之iso9001具有更強的針對性，即為環(huán)境相關的約束管理行為。