INTERNATIONAL Iso STANDARD 9001 Fourth esiion 2008-11-15 Quality management systems — Requirements ‘Systemes de management de la qualité —- Exigances FRooference number 180 9001:2008(€} 2180 200810 9001:2008(E) POF dlactatmer ‘Tis POF fe may conta embedded typeface. In accordance wil Adobe’ Hoenslng poly, ths Me may be printed oF viewed Busha ‘are embedded are teansed to and istalled 0a be computes perovmng the edg i the "eaponsbiy of not inknging Agode's leenseg poley. The ISD Contal Saccetaat tradomatt ol Adobe Systems inatporated Detats of he soltware products uted 10 cleate ths POF fle can be found Inthe General nfo save 10 the He; the POF creation ‘rameters were oplinited for pring Evary care has Deen akan 9 ensue thatthe le stable fo use by ISO meamber bodes. In Unkialy event nat 8 plotar reaing to Ris fund pleese form me Carvat Secrotarat at ho aasrees gwen beiow A COPYRIGHT PROTECTED DOCUMENT e sso2me ‘ings roseved. 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Controt of nonconforming product 13 8 “ ‘Annex A (informative) Correspondence between 1S0 9001:2008 and ISO 14001:2004 415 Annex B (informative) Changes between ISO 9001;2000 and 1S0 9001:2008 2 26 (© 150 2008 ~ An ght 00rd a1S0 9001 :2008(€) Foreword 180 (the International Organization for Standardization) is a worldwide federation of national standards bodies (SO momber bodies). The work of preparing International Standards is normally cartied out through 1SO echnical committees. Each momber body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmontal and ‘non-governmental, in liaison with ISO, also take part in the work, ISO collaborates closely with the International Electrotechnical Commission (/EC) on all mattors of electrotechnical standardization. International Standards are drafted in accordance with the rufes givan in the ISONEG Directives, Part 2 ‘Tha main task of technical committees is to prepare Intemational Standards. Draft International Standards adopted by the technical committoss are circulated to the member bodies for voting. Publication as an {Intarnational Standard requites approval by at least 75 % of the member bodies casting a vote, ‘Attention is drawn to the possibilty that some of the elements of this document may be the subject of patent rights. ISO shall not be hold responsible for identifying any or all such patent rights. 180.9001 was propated by Technical Committee ISO/TC 176, Qualty management and quality assurance, Subcommittee SC 2, Quaity systems. ‘This fourth edition cancels and replaces the third edition (ISO 9001:2000), which has been amended to clarify points in the text and to enhance compatibility with ISO 14001:2004. Details of the changes botwoen the third edition and this fourth edition are given in Annax B. w (© 150 2008 - Alright reserved1S 9001:2008(E) introduction 0.1 Generat ‘The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality managemant system Is influenced by 2) its organizational environment, changes in that environment, and the risks associated with that ‘environment, b) Rs varying needs, ©) its particular objectives, 9) the products it provides, 8) the processes it employs, 4) its size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complomentary to requirements for products. information marked “NOTE is for guidance in understanding or clartying the associated requirement This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements. ‘The quality management principles stated in {SO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard, 0.2 Process approach This International Standard promotes the adoption of @ process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting ‘customer requirements. For an organization to function effectively, it has to determine and manage numerous linked activiies, An activity or set of activities using resources, and managed in order to enable the transformation of inputs into ‘outpuls, can be considered as a process. Olen the oulput fram one process directly forms the input to the next. ‘The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach". ‘An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as wall as over their combination and interaction. ‘When used within a quality management system, such an approach emphasizes the importance of a) understanding and meeting requirements, b)_ the need to consider processes in terms of added value, (©180 2008 - Au gts reserved vIso 9001:2008(E) ©) obtaining results of process performance and effectiveness, and 4) continual improvement of processes based on objective measurement. ‘The mode! of a process-based quality managemont system shown in Figure 1 ilustratas the process linkages presented in Clauses 4 to 8 This ilustvation shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating 10 customer perception as to whether the organization has met the customer requirements, The model shown in Figure 1 covers all the requirements of this International Standard, but doas no! show processes al a dotalled level NOTE In addition, tho methodology known as “Pian-Do-Chock Act" (POCA) can be appli to all processes. POCA can bo briefy describad as follows, Plan: establish the objectives and processos necessary to deliver results in accordance with customer requiroments and the ‘orgasization’s policies. Do: implemant the processes. Check: monitor and measure processes and product against potcies, objectives and requirements for the product and report the results ‘Act: take actions to continually Improve process performance. > value-adding aves === tnrmaton tow Figure 1 — Model of a process-based quality management system w (© 150 2008 At ighs reserved1SO 9001:2008(E) 0.3 Relationship with (SO 9004 1$0 9001 and ISO 004 are quality management system standards which have been designed to complement ‘each other, but can also be used independently. 180 9001 specifies requiraments for a quality management system that can be used for intornal application by ‘organizations, or for certification, or for contractual purposes. It focuses on ths effectiveness of the quality management system in meeting customer requirements. ‘At the time of publication of this international Standard, ISO 9004 ig under revision. The revised edition of 180 9004 witl provide guidance to management for achieving sustained sucoass for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization's performance. However, it is not Intended tor certification, reguiatory or contractual use, 0.4 Compatibility with other management systems, During tho development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004. This International Standard does not include requirements spocfic to other management systems, such as those particular 0 environmental management. occupational health and safety management, financial managoment or risk management. However, this International Standard enables an organization to align or integrate its own quality managament systam with related managemant system raquirements is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies withthe requirements ofthis Intornational Standard, (© 180 2008 Al rights reserved viiINTERNATIONAL STANDARD 1S0 9001:2008(6) Quality management systems — Requirements 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization ) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and 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 statutory and regulatory requirements. [NOTE 1 In this international Standard, tho tarm “product” only applies to 48) product intended fr, oF required by, a customer, 1b) any intended output resulting froin the product realization processes. NOTE2 Statutory and ragulatory requirements can be expressed as legal requirements. 4.2 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. ‘Where any requirement(s) ofthis 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, olaims 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, oF responsibilty, to provide product that meats customer and applicable statutory and regulatory requirements. 2 Normative references The following referenced documents are indispensable for the application of this document, For dated references, only the edition cited applies. For undated reterances, the latest edition of the referenced decument (including any amendments) applies. 180 9000:2005, Quality management systems — Fundamentals and vocabulary 3. Terms and definitions For the purposes of this document, tha terms and definitions given in 1SO 9000 apply. ‘Throughout the text of this (nternational Standard, wherever the term “product” occurs, it can also mean (© 150 2008 — Al gms reserved 1180 9001:2008(E) 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 ) determine the processes needed for the quality mattagement system and their application throughout the organization (see 1.2), ) dotermine the sequence and interaction of these processes, ©) determine criteria and methods nesded to ensure that both tha operation and control of these processes are effective, @) ensure the availabilty of resources and information necessary to support the operation and monitoring of these processes, ©). monitor, measure where applicable, and analyse these processes, and implement actions necessary to achieve planned results and continual improvement of these processes. ‘Those processes shall ba 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 to requirements, the ‘organization shall ensure control over such processes. The tyPe and extent of control 0 be applied to these: ‘outsourced processes shall be defined within the quailty management system. NOTE 1 Processes neoded for he qualty management system reterred to above include processes lor management activites, provision of resources, product realization, measurement, analysis and improvement. NOTE 2_ An “outsourced process" isa process that the organization needs for its qualty management system and which the oxganizaton choases 1o have performed by an extornal party NOTE 3 Ensuring control ever outsourced processes does not absolve the organization of tha responsibilty of conformity to all customer, stztory and regulatory requirements. Tho type and extent of control to be applied to the outsourced process can be infilenced by factors such as. 8} the potential impact of the outsourced process on the organization's capability to provide product that conforms to oquiremonts, b) the dogree to which the control for the process fs shared, 2) the capability of achieving tho necessary control through the application of 7.4. 4.2 Documentation requirements 42.1 General ‘The quality management system documentation shall inctude 8) documented statements of a quality policy and quality objectives, b) a quality manual, ©) documented proceduras and records required by this International Standard, and 4d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control ofits processes. 2 {©150 2008 — A rights reservedISO 9001:2008(E) NOTE 1 Whore the torm “documented procedure" appears within this Intomationa! Standard, this moans thst the procedure is ostabished, documented, implomonted and maintained. A singio document may address the requirements for ‘one or mare procedures. A requirement for a documented procedure may be covared by more than one document, NOTE 2. Tne oxont of tne quality managoment systom documantation can difer from one orgarization to another Sue to 18) the size of organization and type of activitios, ) the complexity of processes and that intoractions, and ©) the competence of porscanet. NOTE 3. The documentation can be In ary 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 {s00 1.2), b) the documented procedures established for the quality management system, or reference to them, and ‘¢)__a description of the interaction between the processes of tho quality management system, 423 Control of documents Documents required by the quality management system shall be controled. Records are a spacial type of ‘document and shall be controlled according to the requirements given in 4.2.4. ‘A documented procedure shall be establishad to define the controls needed 8) 10 approve documents for adequacy prior to issue, ) to reviow and update as necessary and re-approve documents, ©) to ensure thal changes and the current revision status of documents are identified, ) to ensure that relevant versions of applicable documents are available at points of use, 8) to-ensure that documents remain legible and readily identifiabie, 1 to-ensure that documents of external origin determined by the organization to be necessary forthe planning land operation ofthe quality management system are identified and ther distribution controled, and 9) to prevent the unintended use of obsolete documents, and to apply suitable identiication to them if they are fetained for any purpose, 4.2.4 Control of records. Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shail be controlled. ‘The organization shall establish a documented procedure to define the controls ni storage, protection, retrioval, retention and disposition of records. }ded for the identification, Records shall remain legible, readily identifiable and retrievable. 5 Management responsibility 5.1, Management commitment ‘Top management shall provide evidence of Its commitment to the da ‘quality management system and continually improving its effectiveness (© 180 2008 ~ aa eight served 31$0 9001:2008(E) a) communicating to the erganization the importance of meeting customer as well as statutory and regulatory requirements, 'b) establishing the quality policy, '©), ensuring that quality objectives are estabvished, 4) conducting management reviews, and 9) onsuring the availabilty of resources. 5.2 Customer focus Top management shall ensure that customer requlremants 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 qualiy policy is appropriate to the purpose of the organization, ) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, ©) provides a framework tor establishing and reviewing quality objectives, 4) is communicated and understood within the organization, and ©) 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 2). the planning of the quality management system is carried out in order to mest the requirements given in 4.1, as well as the quality objectives, and ) the intogrty of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication 5.5.4 Responsibility and authority ‘Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. 4 ©1S0 2008 - At nghts reservedISO 9001:2008(E) 8.5.2 Management representative Top management shall appoint a member of the organization's management who, irrespective of other responsibiities, shall have responsibilty and authority that includes: a) ensuring that processes nesded for the quality management system are established, implemented and maintained, ) reporting to top management on the performance of the quality management system and any need for improvement, and ©) ensuring the promotion of awareness of customer requirements throughout the organization. NOTE The responsibitty of a management reprasantative can include lialzon with external parties on matters relating to the quality management System. 8.5.3 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 systam, 5.6 Management review 5.8.1 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 reviews shall ba maintained (see 4.2.4), 5.6.2 Review Input ‘The input to management review shall include information on 2} results of audits, ) customer feedback, ©) process performance and product conformity, 4) status of preventive and corrective actions, ©) follow-up actions from previous management reviews, 4) changes that could affect the quality management system, and {9}. recommendations for improvemont. 5.6.3 Review output ‘The output from the management review shall include any decisions and actions related to 8) improvement of the effectiveness of the quallly management system and its processes, b)_ improvement of product related to customer requirements, and ©) resource needs. (© 1S0 2008 — Al rights ronerved 5180 9001:2008(€) 6 Resource management 6.1 Provision of resources ‘Tho organization shall determine and provide the resources needed 8), to implement and maintain the quality managemont system and continually improve its effectiveness, and b)_ to enhance customer satistaction by meeting customer requirements. 6.2 Human resources 62.1 General Personne! performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience. NOTE Conformity to product requirements can be affected dlrwcly or indirectly by personnel performing any task within the {quality management system. 6.2.2 Competence, training and awareness ‘Tha organization shall 1) determine the necessary competence for personnel performing work affecting conformity to product requirements, b)_ where applicable, provide training or take other actions to achieve the necessary competence, ‘¢) evaluate the effectiveness of the actions taken, 4) 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 @}, maintain appropriate records of education, training, skils 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, 2) buildings, workspace and associated ulilties, )_ process equipment {both hardware and software), and, ©) supporting services (such as transport, communication oF information systems) 6.4 Work environment ‘The organization shall determine and manage the work environment needed fo achieve conformity to product requirements. NOTE Tha term ‘work environment” relates to those conditions under which work is performed including physical, ‘environmental anc other factors (such as noise, temperature, humidity lighting or weather) 6 (© 180.2008 - ai igs racorvedISO 9001:2008(E) 7 Product realization 7.1 Planning of product realization ‘The organization shalt plan and develop the processes neaded 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). {n planning product alization, the organization shail determine the following, as appropriate: 8) quality objectives and requiremants for the product; bb). the need to establish processes and documents, and to provide resources specific to the product: ©) required verification, validation, monitoring, measurement, inspection and test activities specitic to the product and the criteria for product acceptance; 4) records neaded to provide evidence that the realization processes and resulting product mest requirements {see 42.4). ‘Tho output ofthis planning shall be in a form suitable for the organization's method of operations. NOTE 1 A document specitying the processes of the quality management systam (Including the product realization Processes) and the resources to be applied toa specifi product, projector contract can be referred to as a qualty plan, NOTE2 The organization may also apply tha requirements given in 7.2 to the development of product realization processes. 7.2 Customerretated processes 7.2.1 Determination of requirements related to the product The organization shall determine ) requirements specified by the customer, including the requirements for delivery and post-delivery actives, ) requirements not stated by the customer but necessary for specified or intended use, whore known, ©) statutory and regulatory requirements applicabie to the product, and 4d) any additional requirements considered necessary by the organization. NOTE Post-dolivary actives include, for example, actions under warranty provsione, contractual obligations such as ‘maintenance services, and supplementary services such as recyciing o nt disposal. 7.2.2 Review of requirements related to the product ‘The organization shall raview the requirements related to the product. This review shall be conducted prior 10 tne organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes te contracts or orders) and shall ensure that 4) product requirements are defined, 1) contract or order requirements difering from those previously expressed are resolved, and ©) the organization has the ability to moot the defined requirements. Records of the results of the review and actions arising from the review shall De 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, (©180 2008 ~ Al ight reserved 71S0 9001:2008(E) Where product requirements are changed, the organization shall ensure that relevant documents are amended. and that relevant personnel aro made aware of the changed requirements, NOTE In somo situations, such as inlomet sales, a formal review is impractical for each ordor. Instead the review can cover ‘relevant product information such as calalogues 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 ©) customer feedback, including customer complaints. 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 8) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and ) the responsibilities and authorities for design and development. ‘The organization shall manage the interfaces between ditfarent groups involved in design and development to ensure effective communication and clear assignment of responsibil Planning output shall be updated, as appropriate, as the design and development progresses. NOTE Design and development review. recorded separately orn any combinato fication and vaiéation have distinct purposes. They can be conducted and suitable forthe product and the organization, 7.3.2. Design and development Inputs Inputs relating to product requirements shall be determined and records maintained (soe 4.2.4). These inputs shalt inctude 1a) functional and performance requirements, ) applicable statutory and regulatory requirements, ¢) where applicable, information derived from previous similar designs, and <)_ other requirements essential for design and development, ‘Tha 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 in a form suitable for verification against the design and development input and shall be approved prior to release, 8 (©180 2008 ~ al tts reserved1S0 9001:2008(E) Design and development outputs shall 8) meet the input requlroments for design and dovelopment ©) provide appropriate information for purchasing, production and service provision, €) contain or raterance product acceptance criteria, and ) specity the characteristics ofthe product that are essential forts sate and proper use. NOTE. Information for production and service provision can include details forthe preservation of product. 7.34 Design and development review ‘At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (se0 7.3.1) a) to evaluate the abllty of the results of dasign and development to mest requirements, and b)_ to identity 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 ofthe results ofthe reviews and any necessary actions shall be maintained (s00 4.2.4). 7.8.5. Design and development verification Verification shall be performed in accordance with planned arrangements ($98 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) 7.8.6 Design and devetopment validation Design and development validation shail be performed in accordance with planned arrangements (see 7.3.1) to ‘ensure that the resulting product is capable of mesting 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 esign and developmont 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 dovoiopment 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 7.41 Purchasing process ‘The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of contro! apptied to the supplier and the purchased product shall be dependent upon the effect of purchased product on subsequent product realization or the final product. (© 150.2008 — A rights rosorved 9150 9001:2008(E) ‘The organization shall evaluate and select suppliors based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall bo established Records of the results of evaluations and any necessary actions arising trom the evaluation shall be maintained (s00 4.2.4) 7.42 Purchasing 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 ©) quality management system requirements. “The organization shall ensure the adequacy of spocified purchase requirements prior to thelr communication to the supplier. 7.4.3 Verification of purchased product ‘Tho organization shail establish and implement the inspection or other activities necessary for ensuring that purchased product maets specified purchase requirements, Where the organization or its customer intends to perform verification at the supplier's premises, the corgarization shall state the intended veriication arrangements and metnod of product release in the purchasing information. 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 applicabio, a) the availabilty of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c)_ the use of suitable equipment, 4) the availabilty and use of monitoring and measuring equipment, ©) the implementation of monitoring and measurement, and 1) the implementation of product 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 and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered, Validation shall demonstrate the abilly of these processes fo achive planned results, ‘Tho 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, ©) use of specific methods and procedures, 10 1©180.2008 - Al ights reserved4) requirements for rooords (see 4.2.4). and ) revalidation, 78.3. Identification and traceability Where appropriat ‘the organization shail identity the product by suitable means throughout product realization ‘The organization shall identify the product status with rospect to monitoring and measurement requirements throughout product realization, ‘Whare traceability is a requirement, the organization shall control the unique identiication of the product and maintain records (see 4.2.4) NOTE In some industy sectors, configuration management 's @ means by which identification and traceability ara maintained, 7.5.4 Customer property “The organization shall exercise care with customer property whila itis under the organization's contro! or being used by the organization. The organization shall identity, verify, protect and safeguard customer property provided for use or incorporation into the product. f any customer property is lost, damaged or otherwise found {0 be unsuitable for use, the organization shall report this to the customer and maintain records (sae 4.2.4), NOTE Customer property can inolude intellectual property and personal data 7.58. Preservation of product ‘The organization shall preserve the product during interna processing and delivery 10 the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. 7.6 Control of monitoring and measuring equipment ‘The organization shall determine the monitoring and measurement to be undertaken and the montoring and ‘measuring equipment needed to provide evidence of conformity of product to determined requirements. ‘Tho organization shall establish processes to ensure that monitoring and measurement can be carried out and ‘are cartied out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall 8) be Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards ‘traceable to international or national measurement standards; where no such standards exist, the basis ‘used for calibration or verification shall be recorded (see 4.2.4). b) be adjusted or re-adjusted as necessary: ‘¢)_ have identification in order to determine its calibration status; 9) be safeguarded from adjustments that would invalidate the measurement result 8). be protected from damage and deterioration during handling, maintenance and storage. In addition, the organization shall assess and record the validty of the previous measuring results when the ‘equipment is found not to conform to requirements. The organization shall take appropriate action on the ‘equipment and any product atfected. Records of the results of calibration and verification shail be maintained (see 4.2.4), (© 150 2008 ~ at rghts reserved "1$0 9001:2008(E) ‘When used in the monitoring and measurement of specitieg requirements, the ablity of computer software 10 satisly the intended application shall be confirmed. This shall bo undertaken prior to tniial use and reconfirmed as necassary. NOTE Confiemation of the ability of computer software to sattsly the inlended application would typically include its \orificaton and configuration management to maintain its suitability for vse. 8 Measurement, analysis and improvement 8.1 Gener ‘The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed a) to demonstrate conformity to product requirements, b) to ensure conformity of the quality management system, and ©). to continually improve the effectiveness of the quality management system. ‘This shall include determination of applicable methods, including statistical techniques, and the extent of their use, 8.2 Monitoring and measurement 82.1 Customer satistaction ‘As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer fequiroments. Tho methods for obtaining and using this information shall be determined. NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, Customer data on delivered product qual, user opinion aurveys, lost business analysts, compliments, warranty claims and | |Terms ‘and dfinitors fQuaity management system (ive ony) _[_[eiremenia nega ey eqns [General requirements Ja [1 [Genova requroments [Documentation requirements (ie ony) lea [General [424 [aaa [Documentation [Quetty manual laze [Contra of documents ja23 [448 [Control of documents [Contra f rovords faze [454 [Control of records [Management responsibly (ile only) is Management commitment 31 [a2 [enaronmonalpoicy 4.4.1. [Resources roles, responsibilty and authority Gustomer focus 2 |aa.1 |Environmertal aspects 4.32 |Legal and other requrements J4.6___|Managementreviow Cusity poiey [53 [42 _[Ervronmental policy Ptanning (de oni) 54 [43 [Pranring (ite onl) Cuatty cbjectives 5.41 [4.9.3 _[Objecves, wrgets and programmets) [Qualty management system planning 5.42 [499 | Objoctves, wrgote and programmes) Reseosty,aahety anc commencaion (a (55 Responsbilty and authority 551 [a1 |General requirements 4.4.1 | Resources, ole, responstlity and authority [Management represeniaive [552 [44.1 [Resources roles, responsibilty and aunty internat communication [553 {44.5 [Communication Management review (tl only) [56/46 [Management review [General [561 [#6 [Management review Review input [562 [4.6 [Management review Rowew output [503 |86 | Managomont review (©1530 2008 ~ al rights roserved180 9001:2008() Table A.1 — Correspondence between ISO 9001:2008 and ISO 14001:2004 (continued) 150 90072008 15 1400732008 Revource management (ile ony) o Provision of resources [61 [#A1 [Resources oles, responsibly and authonty Human resources (ile only) lez [General ls. [442 [Competence waning and awareness (Competence, valning and awareness [522 [42 _[Competonce, waning and awareness infastucture [53 [41 [Resource roles, responsiblity and author Wark environment oa Product realizaton (ie ony) 7___ [44 |Implomantation and operation (te ony) Panning of product realization 71__[4:46 [Operational control [Custemer-rolated processes (te ony) i Determination of requkomentsrlaod tothe (72-1 lEiironmenia’aspoce Product |Legat and other requirements ‘Operational conte [Reviow of equiremenis latedio he product (722 Enironmentalaspeds ‘Operational contret Suatomor communication 728 [communication Design and development ite oni) i [Design and development planing [784 _[446 [Operational contol [Design and development inputs [732 [446 [Operational contol [Design and development outputs [733 _[448 Operational contol [Design and development review F726 [a46 [Operational contol Design and development veriication 7:33 [a6 [Operational contot Design and development valiaion 736 [446 {Operational contrat [Control of design and development changes [7.37 [446 [Operational contol [Purenasing ito ony) ina Purchasing process [74.1 [446 [Operational contol Purchasing information faz [446 |Operatonal contol eritcation of purchased product [74a [44.6 | Operatonal conto: Prediction and sores provision (le ony) (7.5 [Conta of production ane servic provision i781 [446 [Operatonal conwol — alain of processes for produaton and sonics 7.52 46 [Operational convo rovson aenifieation and wacoabhiy 73 [Customer property rsa Preservation of product [755 [4:46 | Operational control [Contot of montorng and measuring equipment 7.68 |4.5.1_[Monitoring and measurement Messurement analysis ane improverient (We ony)]8 [45 __Joneckng (te oni) [Genera [51 [45.1 [Monitoring and measurement Monitoring and measurement (ile ony) ez Customer satisfaction eat internal aust [e22 [655 _[mernal ava Monitoring end measurement of processes 29 [451 [Monitoring and measurement [452 [Evaluation of comptance 16 © 180.2008 ~All ight ceserved1S0 9001:2008(E) ‘Table A.1 — Correspondence betwen !S0 9001:2008 and ISO 14001:2094 (continued) 130 9007;2008 150 14001:2008 [Monaaring and measurement of prodoct [az [85.1 |Montoring and measurement |4.52 [Evaluation of compliance [Contra of noncontorning proauct [a3 [4.4.7 Emergency preparedness anc rosponse 14.5.3 |Noncontormity, corrective action and proventiva| Jaction [Anaiysis of data lat [45:1 |Montoring and maacuroment [improvement (ito only) as [Continual improvement [a5 (82 — {Enaronmental poly [43.3 [Odjoctives, targots and programme(s) }4.6__[Managoment review [Corrective action B52 [483° |Nonconiormin, conective acon and proven on [Preventive action 125.3 [452 |Noncontormty, comectve action and preventive action (© 180 2008 ~ At rights reserved 7ts0 9001:2008(E) Teble A.2— Correspondence between ISO 14001:2004 and ISO 9001:2008 150 14001-2004 1S0-8001:2008, troduction nirocecion tie ony) Jot [Genera Jo.2 _|erocess approach Jo.3 | Relationship with $0 9004 Joa |Compatioity wth otter managemont systems [Scope Yr] c0pe tte niyy 1 [Genera 5.2 {application Normative retorences [2 [2 ___[Nocmative references Terms and dofiaions [s___ [a Terms and detingions [Environmental management system requirements |4 [4 |Qualiy managemont system (Ite ony) tte ony) [Generat requirements laa [at [Genera requirements 5.8 Responsibly, auhorty and communication (ite ony) 5.5.1. |Responstilty and auhorty [Environmental policy |<2 [5.1 [Managoment commitment [5.3 [auatty poticy 13.5.1 _|Continual improvement |Planning (ito only) Jaa 154 [Planning (tle oniyp | [Environmental sepocs last |s2 [Customer focus 1721 [Determination ot roquiromonts related to. tel product 17.22 _|Review of requirements relate tothe product [Legal and other roqureronia 1232/62 — [Customer cue 17.2.1 [Determination of roquiromonts rolatod to tho] product [Objectives targets and programmers) i238 [5.4.1 [Quality objectives 15.42 |Qvality management system planning [85.1 _|Continualimorovement implementation and operation (ile only) laa _[7___[Productrealzation {ile only) Resources, roles, responsibily and authorty __|aa.t [Management commutmont [Responsibility and authority [Management representative Provision of resources Infrasteueure [Competence waning and awareness aad fluman resources) General [Competence taining and awareness [Communication iaas internal communication |Gustomor communication [Documentation [444 [42.1 [Documentation requirements) General rol of documents [248 [429 |Contot of documents 18 19180 2008 - All ahs aero180 9001:2008(E) Table A.2 — Correspondence between ISO 14001:2004 and ISO 9001:2008 (continued, 150 14001:2008 150 9007:2008 — [Operational contol [46 [7.1 [Planning of product eaizaton 7.2 |Gustomor-seiatod processes (te only 7.2.1 |Detormination of roquiromonts lated to. te] product 17.22 |Review of equiemants related 0 the product 7.3.1 |Desiga and development planaing 17.32 {Design and development inputs 7.83 | Design and development outputs [7.8.4 |Oesign and development reviow 73.5. |Design and development verification 7.38 [Design and development validation 7.8.7 |Control of design and development changes 74.1 Purchasing process 17.4.2 [Purchasing inormation 17.4.3. |Voriteation of purchased product 17.5 |Preduation and service provision itl only) 175.1 |Contto| of production and service provision 1752. |Valdation of processos for production and sorvic} Provision 17.5.5 |Presorvaion of product lEmergency preparedness and respanse J447 _]6.3 [Control of nonconforming product [hocking (ie only) [45 [6 [Moasurament, analysis and improvoment (ito ony) Monitoring and measurement [4.5.1 [7.6 _ [Control of monitoring and moasuring equipment (Measurement, analysis and improvement) Gonerall Monitoring and measurement ol processes [Monitoring and measurement of product Anaiysis of data Evalvaion of compliance jase [Moniioring and measurement of processes IMontoring and measurement of product Nonconformiy, comective action and preventive 145.3 [Corare of nonconforming product ection Analysis of data (Corrective action [Preventive action [Corirol of records Ja54 [424 [Control of records internal auch [65S [e22 [intemal avdt | Management review [46 [51 ‘Management commitment [5.6 [Management reviow tte only) 5.6.1 |Genera) 15.62 |Roviow input i563 (Review output 6.5.1 [Continual improvement (© 150.2008 - Al sight reserved 19180 9001:2008(&) Annex B (informative) Changes between ISO 9001:2000 and ISO 9001:2008 ‘Table B.1 — Changes between ISO 9001:2000 and IS 9001:2008 evap | Salon 180 9001:2000) Figure’ | (A) or : ‘Classe No. | Table’ | Detation ‘Aronia tex noe | tO) Foreword |Paaa [D+ A |imemational Sundards are dranod i accordance uit he rue given Ihe BONED Diretves, pera Pan. Foreword [Paras, [A | Eaamainimakoltechasalcemmtizes im renava ieioanonal Sanda. [Sentence + JForowod — |Paraa, [D0 +A [ARenton © drawn to the possbity that some of he claves of tis teratenal Stender [Sentence + degument may be he subject of patent rights. JForewora [arms [0 |itomatonct Standard 150 s00' was prevared by Technical Commitee ISOITO 176, Quaiy] Imanegamer! end quelty assurance, Surcommitee SC 2, Qual sysiams. fFoewore [Pam's [> ik on re Forewors — [Pame —_|o Foreword {New para [A oa [Paes |B [Sentence 2 la (9 taste and organtetionsl auc, [Sertencas [Nowa [Rie not ho imont of fie ntematonal Standard wo imply unm in te etuctre of quay Jnew para management systems oF untormty of documentation, loa lpoaa |e his ttornational Standard can be vend by nleral and ermal parte, Inching cerca leedes. to assess tho organvzaton’s abiiy 0 meet customer sialry and raguietcry| requirements apaleable ta Ra produc, end he organtator's own roqulerrens. loz [Parez [B¥A |For an organization to Tuncion aflectvey, i hos to senbly delannna and menage rarerou| red aces. An act oe alacteies wing resources, and managed In order to enabe tne transtormation of inputs Ino out, can be considered as a process. 20 (©180 2008 — Al rights reserved1S0 9001:2008(E) Table 8.1 — Changes between ISO 90012000 and ISO 9001:2008 (continued) lis0 s001:2000 ‘Siause No, Paragraph Figure! “Table! Note ‘aaanion | a) or Daotion ©) ‘Amended text loz Paras Im "The anpicaton of ayatom of procastoe wibin an eganizalan, topetiet wah toe Menten] land inerectons of these processes, and tor managemont io produce the dasa outcome | lan be ralrred to asthe "process approaen. los [Paras Dee [Zresprsant eanone 01150 000 and 150 9004 have boon dowslapsd asa conduatent pao ar] lquaity management eystom standards wren havo Deon cesigned to complomamt each otha [bu can algo bo used sidependenty. ANhough-ite Wo Ieiarnatenat Slendarde-havo- deren! [Paras om law Peat cer ha autor) Butet vy Nowe New Note 2 > Ja) ne66s w domonstato is aby to consistent provide product Pat masts customer and Jappicabtestansiry and regulatory raqutemenis, and 2) sie to enhance customer stistacion though te effective application o! the system, inauting processes or conteusl improvement ate system ad he assurance ! conform Jcustorer and appicantesituocy and regulatory raqurernenis. re Faas |Whore exchisions are made, claims of contrray to tis Intematonal Standard are na Jaccoptable unless these exclusions are med Yo foquitomonts within Ciauee 7, and suet Jexcisions do not afect tre organization's aby, or responsibilty, to provide product mat meets Jeustomer and appicable salulnwy and reguatorycequlements. Dee lows (©1850-2000 - Al rights reserved 24ISO 9001:2008(E) ‘Table 8.1 — Changes between ISO 9001:2000 and ISO 9001:2008 (continued) ‘Paragraph’ Addition iso s001:2000} Figure’ | (A)or ‘ClauseNo. | Table’ | Balaton ‘Amonced toxt Ce) PF Pama 1 |OrA [For tho purposes of is document WworatonatSlandavd, te fare and Gallons given | 180 9000 apoty. lb Paras 3 [0 | he tohowng lor, weed ht ecton-oF1S0-000'-10-deeoibetho-evnpl-ehain-have- oon [hanged tool! dn vovabulsry evo Veo (scroller > organization >-avetomer "Faoterecorganinton=rplanoe the tem “suppor sedi 160-2001 4064 and store -tho| yo when thi Intnl andar epples ce he hrm “euppher” now rakaooe Pe orm “caboontracer lar fBunets) [DA _[a) tently determina tre processes ncodod Torte qually management sysien andthe [apptcaton troughout ta ciganization (00 1.2), a Buscts) ta (2) monkor, measure abate annicabie, and analyse these processes, and 4 Para |0+A’ [Where an organization chooses to ovtsurce any process hal alecs product cartomy waz Irequrements the erganzation shel eraure contol over auch processes. Ina ype and 2xtent a | \contolio be noplad io hese ousourced processes shall be dened wiin the cust. \lanagament aster. aa (Nolet |D+A [NOTE Processes nooded for the qualty management sysiem relrred 1 above ohestd include processes for managemant acthis, provision cf resocToes, product teatzatn. endl |measurement, anata and imocaverasi, la New [A |NOTE2 An Salscusmed omcsss” ma nenoaaa thal the oiganialion needs ax ik culty] Motos 283 |managament system and whi the-ciganizaen chasaes in have peared hy ar-extsnal leas jeametey fa aaa feureta) JAD laa [Butera lez [Nowe leas four |x |Svilon contol, and [eae [Part |0-+A |Recoids shake estanisned ena-maiained wo prove evtonce of confor to equremens| lara ot re etectve operation of me quay management syator ' docurerid procedure shal-be-ootetiched to define tho Jconsola noeded fr te entiation, storage, protection, retiva,etonion Ws and dsposnen| lot records. caida shall cemaln ene. sadly eniiabia and ceivabia, ssa Peat [a Top management shell appolas member of arganizatian management who, Frospectve a lotr reeponettries, sna ave responeblty and autorty that inclados ear Porat [A+ [Peon perornng work afocing sonianiy ta produ qwaity caqukements shall bo] Jcompetent onthe basis of appropriate education, rating ile ang xpetience. now note [a 22 1©150 2008 - lights roservedISO 9001:2008(E) ‘Table B.1 — Changes between ISO 9001-2000 and ISO 9001:2008 (continued) Paragraph | Adaiton| 150 9001:2000) Figure! | (A) or smenced tox Clause Ne. | Table’ | Batetion ‘Amonsed text Note | ©) fe22 (Gauss mio [A+ D (Competence, Kalinga awareness ano wong — laze [Bates [A>D a} determina the nacossary competence fr pareornel poroiring work afleCing dont ID 340) product quay teauzemenis Di_where apalcaba, prowde training oko other actions to eatety-shano-noeds achive th] Inecessan-sarapelence, a aura | je) supparing services (ouch a vanepen, conmarieaton gr infotmation sytem) er ‘Now Note [a |MGTE The tstm "aor envionment cela io ieee condiions under which wack is nade] leclusing styasalenvionmental ad other facts (aver as-noisecemparature numidiy Jisnioa ocwestes. a Buletb) [AD |b) thereodto-statish processes and documers, and ia prove resources specie To he proauet. ir oar |e le) requred verieation, vaidaton, monforng, eaguemenl, spect and test activities specie to te product and te ettara foe produc! acceptance, ra iButerc) [D+ A [ey aantoryand regulatory requirements rested analcals tothe produ ar feutera. [Dea iNew note [a ran now now a rsa lPara2 [O=A |Fhoco The tipuia shal be reviewed lor adequacy. Foguirements shai be compl lusambiguous and nol n conte wi each oer. ras (Parat [D=A |The ouiputs of design and development shall be prowded-r-e-torn at onablos a fin euabi for vrsiaton agers! he design and development put and shall be approved prior to] retoase. lras JBureta) |DB) provide approprate wloralion for purchasing, production and lr service provain, fras [Now Nowe [a Par [Paras 182 [Notert [Design and development changos shel/be Wonilied and records maintained. Tha changes shal change. |be rovewed, varfod and valdated, appropriate, and approved belo plementation. Two Paras |tovow of design ad developriont changes shal Include evalvaon of th eect of te changes naw [on consttuent parts snd product aleady delivered. Records of the resus of the review cf merged [changes and ary necessary actions shall be attained (206 4.2.4). aaa Jeunera [OTA 6) tho avalabiy and vee of montonng and measuring device equament rea jeune a 1) the implementation of padi relwase, deivery and postaelvery aclutins ivsa arnt |B+A |The organization shal valdaie any processes for production and service provision where the -eouting output cannot be verted by subsequent montodrg er measurement Fre neko any prooeeeee more and. as. conskaqutnce, deficiencies become apparentonty ater the produc is le-use or the servew has been detvored. lrsa Fama [a The organization eval idonty to product salve wih respecte monkorng an reasvremeni requrements thoughout ocoductralztion rea Farad [OA [whore uacsabity is a requirement to orgarizaton shall convol and-reoord the unigua ldenticaton of the product anc malian records (ee 42.4. aa Paras, [+A _ |Wtany customer propery ws toat, camaged of oferwise Wound fo be unautabie for use, Wer ahaH ‘Sentence 3 lno~eporied t-te ovetemor-and-vovorae-mawsined the organization shal reno tha aa customer and mainiain recs (00 4.24), No A INOTE Customer propery can inctce intllactual property acd parzonal cata, (© 180.2000 — Ags ressrved 23180 9001:2008(E) ‘Table B.1 — Changes between ISO 9001:2000 and ISO 9001:2008 (continued) Wor et ‘Amnonded toxt now | WO) ras Pert 1D +A |The ogentzaton shal preserve fe oanlomeyo product Gung nieral processing and dalvery tote intended vestinaton ian to malnain conform to requyemans. Fle Aa anptoabi | lpraervation shai Inckide denifcatlon, handing, packaging. crage and protecion| [Preservation shal alo apoly to tho constiuect pats of product. e Tie JD +A _|Conicl of montoring and measuring dovews aauomact re Para —]O+A |The organtation shan determine the mentoring and measurement t be underaken ara He Imontoring and measuring devese eauloment needed to provide evdence of contarmily ol [product to determined eqvierente fone}, zm fsoneta) A __|a)_ be calbvated or worilod, ahah, at epectied tervals, or porto use, against mensurerent [standards Wacoabia i Intaatonal o naonal monsurerent eandards; where no such [standards ot, the basle uoed fr cadbraion or veticaton shall bo recorded fe 42.4) re [Bitelc) |0 +A |e}-wr\onitleat-onablo to oalbralon slated be-detorninod: [cL nave identfcationnoxder in detamina ha carton satis. ig [Para 4, |Now now [Records of to roout of calbration and vaticalon ehallbe maintained (8 42.4), [Semtence 9 [para 6. [trout Jesange. ire Nowe‘ Owa lan Jauteta) [Ova ea [New Note [a Ey lpwa2 x [sentence 2 is22 INew Para [a joae Jpama [Now Jpara« bea joaz [Paras jeaz [Now [va leas leet [0 [Sentence 3 joao New Note [A laze rate Ppom2 own |cwsdenos ot sntormty- wh the socoptance crtora ahat-he-mainianed Rocce ne pereon(s) autorting elon of product for delivery io the cusimar (200 42.4). Pema [D+A | Praduet-release-end-sonsee-detvory The islaaas of oinduct and dabvery of stvie_to thal Jaiamer ehat not proceed unti te pianned srrangemens (see 7/1) ave boon sattciony Jcompoted, unless obverwise approved by a relevant auhorty and, where appleatie, by me] Jovetomer. 28 ©180.2008 ~ at thts reservedTable B.1 — Changes between ISO 9001:2000 and ISO 9001:2008 (continued) co Pargraphv | Adon 1s0 s001:2000| Figures | (A) or Amended toxt ‘Clause No. | Table’ | Ostation vaed Note (0) lea [Para t, [Dv A | fhe-sontole-ans-roaed evponcibitoe ambewhorttoe tr doaing-mih-nonconormning produel [Sentence 2 ichalbedolinad in dooumontos prodedire: | Astosimanted secede shaitbe-seianiened e-iofne the contol and felbied-eeponesbidets| anc authoroa-or dealing win eonontormig duel lpaae Ya where anita, te organization shall Goal wih nonconforming product by ane or mare ofthe] towing ways: [as [new la /oh_t/Aaking acton aseroorian nina effects. patna fects, of the nancontormly wher, [outer /noconloxing oduct is detect ater dalvery or use has started. Paras | Moved to |Fooordo_ot the -natite-—ot-nonoontormiice_and-any-eunsequent-auintakon, snoling ba Pare 4 |ooneoewone-obiainod eral ue maintained (ese-4-24) Para4 | Movedto !Wvhen nonconforming product is corrected it shal be subject io re~etiication to demonstrate be Para 3 conformity to te requicemeris, Records of the nature of nonconformbies and any subsequent actions taken, inclding |concossions obtained, al be maintained (see 4.2.4), Pues |Nownaw | en nonoontonming xoduetiedotactod after savatyobute Aan stated the o-ganinaton cna iputet d)|inta sovomappropdate te she ofocts, or poleniiatoate, ol tho eonaontanmniy, lax [Bute by {>A | Updated to rafact 150 8007-2008 versus 150 50012000 [Bbogapry [New ana |0+A [Updated to retect new standards (ratuding 150 8004, euranty under revision), new eations Jamended standards, or witcrawn standard. (0180 2008 ~ Ax rights rsarved180 9001:2008(E) 2) @ 4) i 6) (8) (8) [10] 4} (12) 013] (14) (15) (18) on (18) 9] (20) (ey Bibliography 180 9004:—", Managing for the sustained success of an organization — A quality management approach 1$0 10001:2007, Quakty management — Customer satisfaction — Guidelines for codes of conduct for organizations 10 10002:2004, Quarity management — Customer satistaction — Guidelines for complaints handling in ‘organizations 180 10008:2007. Quality management — Customer satisfaction — Guidefines for alspute resolution ‘external to organizations 1S0 10008:2005, Quality management systems — Guidelines for quality plans 180 10006:2003, Quaiity management systems — Guidelines for quality management in projects 180 10007:2008, Quatity management systems — Guidelines for configuration management 10 10012:2003, Measurement management systems — Requirements for measurement processes and ‘measuring equipment ISO/TR 10013:2001, Guidelines for qualty management system documentation ISO 10014:2006, Quality management — Guidelines for realizing financial and economic benefits ISO 10018:1999, Quatty management — Guidelines for training ISO/TR 10017:2008, Guidance on statistical techniques for ISO 9001:2000 ISO 10019:2005, Guidelines for the selection of quality management system consultants and use of their services 180 14001:2004, Environmental management systems — Requirements with guidance for use 180 19011:2002, Guidelines for quality and/or environmental management systems auditing EC 60300-1:2003, Dependability management — Part 1: Dependability management systems IEG 61160:2006, Design review ISONEC 90003:2004, Software enginesring — Guidelines for the application of ISO 9001:2000 10 ‘computer software Quality management principles), ISO, 2001 10 9000 — Selection and use ®!, SO, 2008 180 9001 for Small Businessas — What to do; Advice from ISO/TC 176°), ISO, 2002 1) To bo published. (Revision of $0 9004:2000) 2) Available from website: nipuwuwiso.or9. 9). To be updated and aligned with ISO 9001:2008. {© 180 2008 — ait rigts reserved180 9001 :2008(€) {22] [SO Management Systoms* [23] Roforence web sites: hilpiiveris0.0%g tpvfvneto1 76.008 hitpitivo iso orgitet76'se2 hip #ivwaiso.orghe1 761150900 1 AudhingPracticesGroup 4) A bimonthly publication which provides comprohensivw coverage of international developments relating to ISO's ‘management system standards, Including news of their implementation by diverse organizations around the wort. ‘Availabe from ISO Central Secretariat (sales@iso 0*9) (© 150 2008 — Al sights reserved. ar1S0 9001:2008(E) Ics 03.120.10 Pie based on 27 ages (0180 2008 ~ Al rights reserved