PHILIPPINE NATIONAL STANDARD PNS ISO 9001:2008 (180 published 2008) 1S 03,120.10 Quality management systems - Requirements dt BUREAU OF PRODUCT STANDARDS Member the emetone! Crgerzaton fr Stdezaon ($0) IGEN Serer and Conlomanco Porat” yams laoxahPHILIPPINE NATIONAL STANDARD PNS ISO 9001: (ISO publishe National Foreword This Philippine National Standard is identical with International Standars ‘SO 9001:2008, Quality management systems — Requirements. It was approves adoption as a Philippine National Standard by the Bureau of Product Ste! ‘accordance with the BPS Directives Parts 1 and 2.and PNS ISO Guide 2" ‘his fourth edition cancels and replaces PNS ISO 9001:2000, wh ich amended to clarify points in the text and to enhance: compatibility with PN 14001:2004. Details of the changes between the third edition and this fourth edition are given ir AnnexB. ‘The ISO (International Organization far Standardization) and the IAF (Internationa Accreditation Forum) have agreed an implementation plan to ensure @ smooth migration of accredited cattification to ISO 9001:2008. ‘One year after Publication of ISO 9001:2008 all accredited certifications Issued (new certifications or re-certifications) shall be to SO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid Within-the text of the standard, the words “International Standard” shall mean “National Standard”.INTERNATIONAL Iso STANDARD 9007 2008-11-18 Quality management systems — Requirements ‘Systemes de management de la qualité — Exigences Relerence number 180 9001:2008(E)PNS iSO 9001:2008(E) POF declaior this POF Re may cornered ypataces. in acrordane wih Adi eaning poy, thle maybe ponte or Wane at tbo edad ress ha Ypeacen wo fe enc and aioe Go compe pring te en cts tn eles aes raaponty ot nt naingng Adobe's Toney. pt. Te 180 Cont Secrest Septrnobaaty mises. deh reer of debe Systems ncororted. Detas ofthe sctware products used to crete this PDF f¥e can be found Inthe General info relative to the fie; tre POF-creaton aa ore wore optinized for pining. Every ere hae been akan to ancure that ef suitable for use by {SO mambor bodes. ne ins cuentas problem eleting is found ploaselnvorm the Cerra Secretariat athe adcrevs given Below, A COPYRIGHT PROTECTED DOCUMENT © 1802008 ‘ng reerve. Unless otherwise spots, no pro is pubtcaton maybe repauced or ized in any om “ any frm o by any means, Sccamertey tsecoues theresa ens mem ets tem oar 6D eke aren owt BO cepyeeht ace Gas poses 88 CH-121% anova 20 Tekeat 2270001 11 Fase 4422-74900 47 Ernal copyht @eoora Woo vowelaorg Pubened in Suze (0190-2008 All ight reservedPNS ISO 9001:2008(E) 7 Product reaiization 74. Planning of product realization ... 7.2 Customer-related procasses MANN ea an one as nwunwninn nae 7.8. Design and development ~... 8 74 Purchasing 9 7.5 Production and Service PrOVISION senmnanennannnnenenenenanineennnnm 10 7.8 Control of monitoring and messuring equipment ne ewnmme " 8 Measurement, analysis and improvement wnonarenm - 12 a 2 8.2 Monitoring and messurement ... 2 83. Control of nonconforming product .. 13 84 Analysis of data 3 BS TenCOVEENOA anes = —_ 4 Annex A (informative) Correspondence between ISO 9001:2008 and ISO 14001:2004 ‘Annex B (informative) Changes between ISO 8101:2000 and ISO 9001:2008 Bibliography .... ‘© 1SO 2008 — All rights reserved aPNS 180 8001:2008(E) Foreword 180 (the International Organtzation for Standardization) is a worldwide federation of national standards bodies {iSO member bodies). The work of preparing inter ‘Siandards is normaliy carried out through iSG ‘technical committees. Each member body interested in a subject for which a technical committee haa been ‘establiched has the right to be represented on that committee. International organizations, governmental and ‘non-governmental, in liaison with ISO, algo take part in the work. ISO collaborates closely wih the international Etectrotechnical Commission (EC) cn all matters of electrotechnical standardization. International Standards are drafted in accordance with the rutes given in the ISO/IEC Directives, Part 2. ‘The main task of technical committees is to prepare Intemational Standards. Draft International Standards ‘adopted by the technical committees are circulated to the member bodies for voting. Publication as an international Standard requires approve! by at least 75 % of the member bodies casting a vote, Attention Is érawn to the possibilty that some of the elements of this document may be the subject of patent Tights. ISO shall not be held responsible for idantiying any oral such patent right. 180 9001 wes prepared by Technical Committee ISO/TC 176, Qualty management and quailty assurance, ‘Subcommites 5G 2, ually systems. ‘This fourth edition cancels and replaces the third edition (180 9001:2000), which hee been amendod to clarty points in he text anc-to enhance compatibility with SO 14001:2004. Details of the changes between ths third edition and this fourth edition are given in Annex 8 ” (0180 2008 Al gh reseredPNS 180 9001:2008(E) introduction 0.1 General ‘The adoption of a quality management system should be a strategic decision of an organization. The design ‘and implementation of an organization's quality management system is influenced by @) is organizational environment, changes in that environment, and the risks associated with that environment, ) its varying needs, ©) ‘its particular objectives, ) the products it provides, 2) the processes it employe, 1) te size and organizational structure, ft fs 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 complomontary to requirements for products. information marked "NOTE" is for guidance in understanding or clarifying the associated requirement. ‘This international Standard can be used by internal and external parties, including certification bodies, 10 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 iSO 9000 and iSO 9004 have been taken into consideration during the development of this International Standard. 0.2 Process approach ‘This internation! Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance cusiomer saiislaction by meeting ‘customer requirements. serene i ac eee celle hl mage Cea Wem cco A activily oF seul of activities using resources, and «managed in order Lo enable the Iratnsivrmation: of io ‘utpute, can be coneidered as a process. Otten the ouput trom one process diecty form the input othe nex The appiication of a system of processes within an organization, together withthe 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 well 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, ') the need to consider processes in terms of added value, (© 180 2008 Al rights rsrvedPNS ISO 9001:2008(E) ©) obtaining results of process performance and effectiveness, and )_ continual improvement of processes based on objective measurement. The model ot proces hme quay anager! ese shown Figure | ates he proces rages presented in Clauses 4 to 8 This itiustraiien ‘s that customers play a significant rois in detin requirements as inputs. Monitoring of customer ieecacsee requires the evaluation of information relating 0 customer perception as to whether the organization has met the customer requirements. The model shown in Figure ¢ covers all the requirements ofthis International Standard, but dons not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-De-Chect-Act" (PDA) can be applied to all processas. PDCA can be ‘ely desorbed as follows, Plan: statist the objactves and processes necessary 10 deliver results in accordance wih customer requicements and the organization's pofcles. De nplement the processes. Check: monitor and measure processes and product against polices, objectives and raquirements for the product and report the results, ‘Act: take actions to continually improve process performance. Continual improvement of the quality management system key = vaue-20ting stvtion === teoeration tw Figure 1 — Model of a process-based quality management system wi © 180 2008 All rights reservedPNS ISO 9001:2008(E) 0.3 Relationship with ISO 9004 180 9001 and 150 9004 are quality management system standards which have bacn designed to eomploment ‘each other, but can also be used independently. 180 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality ‘management system in meeting customer requirements. ‘At the time of publication of this international Standard, ISO 9004 is under revision. The revised edition of 180 9004 wil provide guidance to management for achieving sustained euccess 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 satisfaction, by the systematic aind vontinual improvement ofthe oryanization’s performance. However, iis rot Intended for certification, regulatory or contractual use. 0.4 Compatibility with other management systems During the development of this International Standard, due consideration was given to the provisions of 180 14001:2004 to enhance the compaibiliy of ihe two standards for the bonelit of the user community. ‘Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004. This Intemational Standard does not include requirements specific to other management systems, such as those particular to environmental management. occupational health and safety management, financial management of risk management. However, this International Standard enables an organization to align or integrate Its own quality management system with related management system requirements. itis possible for ptits existing managemant system(e) in orc fabish a quality menagement system the requirements of this international Standard. (© 180-2008 — Al rights reserved wilINTERNATIONAL STANDARD PNS ISO 9001:2008(E) Quality management systems — Requirements 1 Scope 11 General ‘This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ablity to consistently provide product that meets customer and applicable statutory and regulatory requirements, and )_aims to enhance customer satisfaction through the eflective application of the system, including processes: for continual improvement of the system and the assurance of conformity to customor and applicable statutory and regulatory requirements. NOTE 1. In this international Standard, the torm “product” only applies to 8) product intended for, oF required by, a customer, 1b) any Intendet! output resulting from the product realization processes. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 1.2. Application At requirements of this International Standard are generic and are intended to be applicable to all organizations regardless of fype, size and produc! provided. Where 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 o this international Standard are not acceptable uniess these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's billy, or responsibilty, to provide product that mseis customer and applicable statutory and regulatory requirements, 2 Normative references ‘The following reierenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 180 9000:2005, Quaiity management systems — Fundamentals and vocabulery 3 Terms and definitions For the purposes ofthis document, the terms and definitions givon in ISO 9009 opply. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean "service". (© 1S0 2008 ~All rights roserved 1PNS ISO 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 a) determina the processes needed for the quality management system and their application throughout tha organization (soe 1.2), 6). determine the sequence and interaction of these processes, ©) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, ) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, ) monitor, measure where applicable, and analyse these processes, and 1) imploment actions necessary to achieve planned results and continual improvement of these processé ‘These processes shell 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 to requirements, the ‘organization shall ensure control over such processes. The type and extent of control to be applied to these culsourced processes shall be defined within the qualiy management sysiom. NOTE 1 Processes needed for the quality management system referred to above inchide processes for management activities, provision of resources, product realization, measurament, analysis and improvemont, NOTE 2 An “outsourced process" is a process thal the organization needs for its quaily management system and which the organization chooses to have performed by an external party. NOTE S Ensuring contro over outsourced processes does not absolve the organization of the responsibilty of conformity to all customer, statutory and regulatory coquiraments. The type and extent of contr to be applied to the outsourced process can be influenced by factors such as 8) the potential impact of the outsourced process on the organization's capability to provide product thal conforms to requitements, 1b) the degree to which the contre! for the process is shared, ©) the capabiity of achieving the necessary contro through the application of 7.4. 4.2 Documentation requirements 42.1 General ‘The quality management system documentation shail include ‘2) documented statements of a quality policy and quailty objectives, ) a quality manuel, ©) documented procedures and records required by this international Standerd, and ) documents, including records, determined by the organization to be necessary to ensure the elfective planning, operation and control ofits processes. 2 180.2008 - Al ight reseedPNS ISO 9001:2008(E) NOTE 1 Where the term “documented procedure’ appeare within this international Standard, this means thal the ‘procodure is established, documonted, implomontad and mainiainod. A single document may address the requirements for ‘one or mare procedures. A requirement or a documeniad procedure may be covered by more than one document. zation to anchor du to NOTE 2 The extent ofthe quail managomont syetom documentation can differ tr {9}. the size of organization and type of activities, ') the complexty of processes and thir interactions, and 1) the competence of personnel. NOTE 3. Tho documentation can be in any form or ype of medium, 42.2 Quality manual ‘The organization shall establish and maintain a quality manual that includes 1) te scope of he quty management sytem Including details of and justification for any exclusions (see 1.2), )_ the documented procedures established for the quality management system, or reierence to them, and ©) 8 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 controled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4 ‘A.documanted procedure shall be established to define the controls needed 8) to approve documents for adequacy prior to issue, ) to review and update as necessary and re-approve documents, @} to encure that changes and the current revision status of documents are identified, 4) to engure that relevant versions of applicable documents are available at points of use, @) to ensure that documents remain legible and readily identifiable, ) to ensure that documents of extemal origin determined by the organization to be necessary for the planning ‘and operation of the quality management system are identified and tneir distribution controlled, and 9) te provent the unintended use of obsolete documents, and to apply suitable ide retained for any purpose. 9 tham Hf thoy oro 42.4 Control of records. Records established to provide avidenca of conformity to requirements and of the effective operation of the quality management system shall be controlled. ‘The organization shail establish a documented procedure to define the controls needed for the storage, protection, retrieval, retention and disposition of records. Records shall ramain legible, readily identifiable and retrievable. 5 Management responsibility 5.1 Management commitment ‘Top management shail provide evidence of ile commitment to the development and implementation of the quality management system and continually improving its effectiveness by (© 180.2008 — Al rights reserved 3PNS ISO 9001:2008(E) 8) communicating to the organization the importance of mesting customer as well as statutory and regulatory requirements, 0) establishing the quality policy, 2} ensuring that quality objectives are established, ) conducting management reviews, and e) ensuring the availability of resources. 5.2 Customer focus ‘Top management shell ensure that customer requirements are determined and are met with the aim of ‘enhancing customer salistaction (see 7.2.1 and 8.2.1). 5.3 Quality policy “Top manegernent shail ensure thatthe quality policy 4) is appropriate to the purpose of the organization, ) includes a commiiment io comply with requirements and coniinuaiy improve the effectiveness of ihe quality management system, ©) provides a framework for establishing and reviewing quality objectives, ) is communicated and understood within the organization, and ©) is reviewed for continuing suitability. 5.4 Planning 5.41 Quality objectives “Top management shall ensure that quality objectives, including those needed to moet requirements for product {Soe 7.1 a), are established af relevant functions and levels within the organtzation, The quallly objectives shat be measurabie and consistent with the quality policy. 5.42 Quality management system planning ‘Top management shall ensure that 2) the planning ofthe quality management system is carried out in order to meat the requirements given in 4.1, fs wollas the qually objectives, and om ° ial ) the integrity of the quality management system Is maintained when changes to the quality management system are planned and implemantod. 5.5 Responsibility, authority and communication 5.54 Responsibility and authority ‘Top management shaii ensure that responsibilities and authorities aro daiined and communicated within the organization. (© 1S0 2008 ~All rights reservedPNS ISO 9004:2008(E) 6.5.2 Management representative ‘Top management shall appoint a member of the organization's management who, irrespective of other responsiblties, shall have responsiblity and autnonty thet includes 8) ensuring that processes needed for the quality management system are established, implemented and ‘maintained, 1b) reporting to top management on the performance of the quality management sysiem and any nosd for improvement, and ©} ensuring the promotion of awareriess of customer requirements throughout the organization. NOTE The responsiblity of a management representative can include laison with external partes on matters relating to ‘the quality management system. 5.5.3. Internal communication ‘Top management shail 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 Ganerai ‘Top management shail 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 trom management reviews shail be maintained (see 4.2.4). 5.8.2 Review input ‘The input to management review shall include information on 8). results of audits, b) customer foodback, (6), process performance and product conformity, 4) status of preventive and corrective actions, 9) follow-up actions from previous management eviews, 4) changes that could affect the quality management system, and 9) recommendations for improvement. 5.6.3 Review output ‘The output from the management review shall include any decisions and actions related to 2), Improvoment of the effectiveness of the quality management system and ite processes, 1b). improvement of product related to customer requirements, and ©) resource needs. (© 1S0 2008 ~ Al ighis rasorved 5PNS 180 9001:2008(6) 6 Resource management 6.1 Provision of resources ‘The organization shall determine and provide the resources needed 2) toimplement and maintain the quality management system and continually improve its effectiveness, and 1b) fo enhance customer satiataction hy meeting customer requirements. 6.2 Human resources 6.2.1 Goneral Personnel performing work affecting conformity 1o product requirements shall bo competent on the basis of appropriate education, taining, skils and experiance. NOTE Conformity to product requirements can be affected lrectly or indirectly by personne! performing any task within tho ually management system. 62.2 Competence, training and awareness “The organization shat 2) determine the necessary competence for personnel performing work affecting conformity to product requirements, )_ where applicable, provide training or take other actions to achieve the necessary competence, ©) evaluate the effectiveness of the actions taken, 4} onsure that its personne! are aware of the relevance and importance of their activities and how they ‘contribute to the achievernent of the quality objectives, and 2) maintain appropriate records of education, traning, skills and experience (se0 4.2.4). 6.3 Infrastructure ‘The organization shall determine, provide and maintain the infrastructure nesded to achieve conformity to product requirements. infrastructure includes, as applicable, a) buildings, workspace and associated utitfes, 'b)_ process equipment (both hardware and software), and. ©} supporting services (such as transport, communication formation systems). 6.4 Work environment ‘The organization shail determine and manage the work environment nesded to achieve conformity to product requirements. NOTE The tom ‘work environment” relates to those conditions under which work ie performed including physical, ‘environmental anc athar factors (such as noise, temperature, humid, ighting or waster). 6 ‘© 180 2008 — Al rights reservedPINS ISO 9001:2008(E) 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 shali be consisient with the requirements of the other processes of the qualily management system (00 4.1). 'n planning product realization, the organization shall determine the folowing, as appropriate: 2) quality objectives and requirements for the product; 5) the need to astablish processes and documents, and to provide resource epecife to the product ©) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptanca; 9 (eaids ngade to provide evidence that the realization processes and resulting product moet requirements 42.4 The oytput of this pi NOTE 1 A document specilying the processes of the quality management system (including the product realization Processes) and the resources to be applied to @ specific product, projector contract can be referred to as a quay plan. NOTE2 The organization may also apply the requirements given in 7.3 to the development of product realization ‘processes. ing shal be in a form suitable for the organization's method of operations. 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product The organization shall determine 2) requirements specitied by the customer, including the requirements for delivery and post-dellvery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, ©) statutory and regulatory requirements applicable to the product, and 4) any additional requirements considered necessary by the organization. NOTE Posi-delivery activiies include, for example, actions under warranty provisions, contractual obligations such as ‘maintenance aervices, and supplementary services such as recycling or final isposal, 7.2.2 Ruview of requirements related to the preduct ‘The organization shall review the requirements related to the product. This review shall be conducted prior to ‘the organization's commitment to supply @ 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 8) product requirements are defined, ') contract or order requirements differing tram those previously exprossad are resolved, and ©} the organization has the abiity to mest the defined requirements. Records of the results of the review and actions arising from the review shall bé maintained (se9 4.2.4). Where the custcmer provides no documented siatement of requirement, the customer requirements shall be ‘confirmed by the organization before acceptance, (© 150 2008 ~ Alt rights reserved 1PNS ISO 9001:2008(E) Where product requirements are changed, the orgenization shail ensure that relevant documents are amended ‘end that relevant personnel are made aware of the changed requirements. NOTE: Income situations, such as internet sales, a formal roviow is impractical for each order. Instead the review can cover ‘relevant product information such as catalogues or advertising matedal. 7.2.3 Customer communication ‘The organization shell deferming and implement effective arranyernenis ‘or communicating with customers in relation to ‘@) product information, Db) enquifes, 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 dasign and development planning, the organization shall determine 4) the design and development stages, ) 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 betwaen different groups involved in design and development to ‘ensure effective communication and clear assignmant of reeponsibilty, Planning output shall be updated, as appropriate, as the design and development progresses. NOTE Design and development review, verifcation and validation hava distinct purposes. They can be conducted and recorded separataly orin any combination, as sutable forthe product and the organization. 7.3.2. Design and development inputs !rputs relating to produetrequrements shal be detomined and records maintained (808 42.4. These inputs ) functional and performance requirements, )_ applicable statutory and regulatory requirements, ©), where applicable, information derived from previous similar designs, and @) ther requirements essential for design and development. ‘The Inputs shall bo reviewed for ad Requirements shat! be and not i Yas bose ta jequacy. Req ‘compiete, unambiguous and not in conflict 7.8.3 Dealgn and development outputs ‘The outputs of design and development shall be in a form suitable for verificat i eualooment Int and shall be approved prlor to relsase, " saath Kennan (© 180 2008 — Al rights reservedPNS ISO 9001:2008(E} ‘Design and development outputs shall 8) meet the Input requirements for design and development, b) provide appropriate information for purchasing, production and service provision, ‘¢) contain or reference product acceptance criteria, and 4) specily the characteristics of the product that are essential for its safe and proper use. NOTE. Information for production and service provision can include dotalis for the preservation of product. 7.34 Design and development raview At suitabio stages, systematic reviews of design and development shall be performed In accordance with planned arrangements (see 7.3.1) 2) to evaluate the ability of the results of design and development to meet requirements, and ) 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 of the resutts of the reviews and any necessary actions shall be ‘mmaintained (see 4.2.4). 7.35 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the dasign and development outputs have met the design and development input raquiromonts. Racorde of the results of ‘he verification and any necessary actions shail be maintained (see 4.2.4). 7.36 Design and development validation Design and clevelopment validation shall be performed in accordance with planned arrangements (see 7.3.1) 10 ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, whera known, Wherever practicablo, 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). 7.8.7 Control of design and development changes Design and dovolopment changas chali be igeniffied and records maintained. The changes shall be raviowed, ‘verified and validated, as appropriate, and approved before impiemenialion, The review of design and {development changes shall include evaluation of the effect of the changes ori constituent parts and product already deliverad. Records of the resulls of the review of changes and any necessary actions shall be maintained (see 4.2.4). 7.4 Purchasing TAA Purchasing process ‘The organization shall ensure that purchased product conforms to spacified purchase requirements. The type land extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purenazed product on subsequent product realization or the final product, (© 180 2008 — Al righ reserved 5PNS ISO 9001:2008(E) ‘The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements, Criteria for selection, ‘e-evahiaiion shail be esiablished. Records of the results of evaluations and any neccazary actions arising trorn the evaluation shall be rmaintained {900 42.4), 742 Purchasing information Purchasing information shall describe the product to be purchased, including, where appropriate, ) requirements for approval of product, procedures, processes and ¢ 0) requirements for qualification of personnel, and ©} Quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of purchased product ‘Tho organization shail esiablish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends ta partorm verifiestion at the suppliore promise, the ‘organization shall state the intended verification arrangements and method of product release in the purchasing information, 7.5 Production and service provision 7.8.1 Control of production and service provision The argarization shell plan and camy out production and service provision under controlled conditions. Coniroiied concitions shall include, as applicable, 2) the avaliabiity of information that describes the characteristics of the product, ») the avaliablity of work instructions, as necessary, ©) the use of suitable equipenent, @) the avaiablty and use of monitoring and measuring equipment, ©) the implamentation of monitoring and measurement, and 1) the implementation of product release, delivery and post-delvery activiios. 7.5.2 Validation of processes for production and service provision ‘The organization shall validate any processes for production and service provision where the output cannot be varied by subsequent monitoring or measurement and, as a consequence, Ueliciencies become ‘apparent only after the product isin use or he service has been delivered. ‘Validation shall derronstrate the abiity of these processes to achieve planned results ‘The organization shall establish arrangements for these processes inciuding, a8 applicablo, 4) defined criteria for raview and approval of the processes, 5) approve! of equioment and quaitication of personnel, ©} use of specific methods and procedures, oe 8180 2008 — Al rights reservedPRS ISO 9901:2008(E) 4) requirements for records (see 4.2.4). and ©) revalidation. 7.53 \dentitication and traceability ‘Where appropriate, the organization shall identity he product by suitable means throughout product realization, ‘The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. Where traceability is a requirement, the organizalion shail controt the unique identitication of the product and ‘maintain recorda (aes 4.2.4) NOTE in soma industry sectors, configuration management is = means by wh maintained. ss end Waceatiny are 7.54 Customer property ‘The organization shall exercise care with customer property while itis under the organization's control or being used by the organization. The organization shail identity, verify, protect and safeguard customer property provided for use or incorporation into the product. if any customer properly is fost, darmaged or olherwise found {0 be unsuitable for use, the organization shall port this 10 the customer and maintain records (see 4.2.4). NOTE Customer property can include intoloctual property and personal data. 7.55 Preservation of product ‘The organization shail preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include Identification, handling, packaging, storage and protection. Preservation shall iso apply to the constituent parts of a product. 7.6 Controt of monitoring and measuring equipment The organization shall determine the monitoring and measurement to be undertaken and tha monitoring and ‘measuring equipment needed to provide evidence of conformity of product to determined requirements. ‘The organization shall establish processes to ensure that monitoring and measurement can be carried out and ‘are carried out in a manner that 's consistent with the monitoring and measurement requirements. ‘Where necessary to enure valid rosults, measuring equipment shalt 1) be calibrated or verified, or both, at specified intervals, of 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 identtication in order to determine its calibration status; 4) be saieguarted from adjustments that would invalidate the measurement result ©) be protected from damage and deterioration during handling, maintenance and storage. {n addition, the organization shail assess and record the validity of the previous measuring results when the ‘eauioment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shail be maintained (see 4.2.4). (©180 2008 —Al ight reserved "PNS ISO 9001:2008(E) When used in the monitoring and measurement of specified requirements, the ability of computer software to Salisly the iniendied application shalt be coniirmed. This shall be undertaken prior to initial use and reconfirmed ‘as necessary. NOTE Confirmation of the abilty of computer software to salisty the Intended application would typically include Rs verification and configuration management fo maintain its suitability for us 8 Measurement, analysis and imptovement 8.1 General ‘The organization shall plan and implement the monitoring, measurement, analysis and improvement processes. needed 8} to demonstrate conformity to produit requirements, ) 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 8.2 Monitoring and measurement 8.2.1 Customer satisfaction ‘As one of the measurements of the performance of the quality management system, the organization chal! monitor information relating to customer perception as to whether the organization has met custom ‘requirements. The methods for obtaining and using this information shall be determined. NOTE Monitoring customer perception can include obtaining input from sources such as customer satistaction surveys, ‘customar data on deivered product quality, user opinion surveys, lost business analyeis, compliments, warranty claims an dealer reports. 8.2.2 Internal audit ‘The organization shall conduct internal audits at planned intervals to determine whether the quality management system 8} conforms to the planned arrangements (see 7.1), to the requirements of this international Standard and to ‘the quality management system requirements esiablished by the organization, and ) is effectively implemented and maintained. ‘An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of aucitors and conduct ot audits shall encure objectivity and imparialty of the audit process. Aucitore shall not aust their own work, A.documented procedure shail be established fo define the responsibilities and requirements for planning and conducting audits, establishing records and reporting result Records of the audits and their results shell be maintained (see 4.2.4). ‘The management responsible for the area being audited shail ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nenconformities and their causes. 12 (© 1S0 2008 ~All rights reservedPNS ISO 9001:2008(E) Follow-up activiies shall include the verification of the actions taken and the reporting of verification results (606 8.5.2), NOTE See 180 19011 for guidance. 823 Monitoring and measurement of processes. ‘The organization shall apply sultable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes lo achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as ‘appropriate, NOTE When determining suitable methods, ts advisable that the organization consider the type and extent of monitoring ‘of measurement appropriate to each of ite processes in relation to their Impact on the conformily to product requirements, ‘and on the effectiveness of the quality management system. 8.2.4 Monitoring and measurement of product The organization shall monitor and moasure tne characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product resiization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained. ‘Records shail indicate the person(s) authorizing release ot product for delivery to the customer (see 4.2.4). ‘The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed. unless otherwise approved by a relevant authority and, where applicable, by the customer. 8.3 Control of nonconforming product ‘The orgenization shall ensure that product which does noi conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procecure shall be established to define the ccontrols and related responsibilities and authorities for dealing with nonconforming product. Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceplance under concession by & relevent authority and, whore ‘applicable, by the customer; ©), by taking action to preclude its originat intended use or application; 4) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product Is datected after dolivary or use has started. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the roquiramonts.. Records of the natura of nonconformities and any subsequent actions taken, inciuding concessions obtained, shall be maintained (see 4.2.4), 8.4 Analysis of data The organization shall determine, collect and anaiyes appropriate data to demonstrate the sultabilty and ‘effectiveness of the quality management system and to evaluate where continual improvement of the sfiectivenass of the quailly management eysiem can be made, This shail include data generated as a result of ‘monitoring and measurement and from other relevant sources. 180 2008 -Al ght reserved 3PNS ISO 9001:2008(E) ‘Table A.1 — Correspondence botwean !S0 9001:2008 and ISO 14001:2004 {continued} Teo so0r:3008 150 vant 008 [Monitoring and measurement of product [824 [45.1 [Monitoring and meesurement |4.5.2_ [Evaluation of compliance [Control of nonconforming product las |44.7 |Emergency preparedness and response 45.3 [a4 [45.1 [Monitoring and measurement [abt [42 [Environmental policy 14.3.3 Objectives, targets and programmo(s) 14.6 _|Management review [Corrective action j852 [45.9 |Nonconformity, corrective action and preventive| laction Preventive action [853 [4.5.3 |Nonconfonnity, corrective action and preventive| action (© 180 2006 ~Alrights reservedPNS ISO 9001:2008(E) ‘Table A.2 — Correspondence between ISO 14001:2004 and ISO 9001:2008 150 Taner 00 Wo 90012008 inieducion = Tie ony los |cenarat loz | Process approach 103 _{Retetionship wit IS0 8004 0.4 __|Compatiity wit ofr management systems [Scope Hh |1 [Scope tite ony) 1.1 [Genorat 112 [Application [Normative retorencea lz [2 | Normative reterences Horne and deftones fs _[3 Terms and definitions [Environmental management system requirements ie ony I Ie [Qualiy managemont system (ite only) (Genera emiernanie ls7 [41 [General requirements 55 [Responebay,autorty and conmunoaton 5.5.1_ [Responsibility and authorky rn a + 5.2 |avatty potey [8.5.1 _| Continual improvement [Pianning (ite ory) Jas [54 [Planning (ite ony) [Environmental aspscia last [52 [Customer tous 172.1 [Determination of requirements releted to thel ln22 Legal and other requirements las (52 172.1 |Determination of requirements related to the] 7 product lobjectves, targets and programms(s) [ass [51 |Guainy objectives 5.4.2 |Qualny management system planning 125.1 | Continual improvement [implementation and operation (ile only) lax |? [Product realization (ie oni) Resources, roles, responsibilty and authority [44.1 [5.1 __ | Management commitment 8.8.1, |Responsibity and authority 5.5.2 [Management representative 6.1 [Provision of resources lea [Infrastructure [Competence raining and awareness [442 [621 |(Human resources) General [8.22 _|Compstence, traning and awaranass [Communication jaa3 553 [Internal commurication 17.2.3 _|Gustomer communication [Documentation — [444 |421 _|(Documentation requirements) General [Control of documents [a5 [423 [Control of doouments 18 (© 180 2008 ~All rights reservedPNS ISO 9001:2008(E) ‘Table A.2— Correspondence between ISO 140012004 and ISO 9001:2008 (continued) 150 9001;2008 (0 140072004 [Operational control [eas ra ne i724 [Planning of product realization Customar-related processes (ttle only} Determination of requirements related to the| product 7.2.2 |Review of requirements reiated to the product [7.3.1 [Design and development planning 17.82 Design and development inputs 17.3 | Design and development oulputs 17.34 }Design ang development review 17.88 [Design and development verifcation 17.38 [Design and devolopment vaidation 17.3.7. |Contot of dosign and development changes 7.0. [Purchasing process \7.42 [Purchasing information 7.43 |Verieaton ot purchased product 7.5 | Production and service provision (te only) 17.51 |Contrl ot production and service provision 752. |vekdaton of procetos for production and sro provision 17.5.5 _ [Preservation of product [Emergency preparedness and response [447_[0.5 _ [Contol af nancontorming prostck [Checking (tie only) [25 [@ | Measurement, analysis and improvement ite oni) Monitoring and measurement [451 [7.6 |Contol of mantoring and measuring equipment 181 |(Moasurement, analysis and improvamant} General 6.2.3 |Montoring and measurement of processes 12.2.4 |Montoring and measurement of product a4 |Anaiysis of data Evaluation of compliance [452 [0.29 [Monitoring and measurement of processes [8.24 _|Monitoring and measurement of product INonconformity, correcive action and preventive [45.3 [83 |Conlrol ol nonconforming product ee Jaa JAnelyais of data 18.5.9 _|Proventive action [Contra of racaree Jaa [4.24 [Control of record irtornal auc 455 [8.22 _|Inlornal audi [Management review [46 [5.1 [Management commitment (6 | Management review title only) Is.61 |General 6.62 |Review input 5.6.2 |Reviow output [25.1 [Continual improvement (© 1S0 2008 — Al rights rasrved 19PNS ISO 9001:2008(E) Annex B (informative) Changes between ISO 9001:2000 and ISO 9001:2008 ‘Table 8.1 — Changes between ISO 9001:2000 and ISO 9001 :2008 Paragreph | Adin Figure! Tabley note (Aor @ ‘Amend text psa Tntornatonal Standards are drafiod in accordance wit ha rules glen nthe ISO/IEC Dvectves, JPaw2 ean Peas, Sentence t in (ue al ask finial comma ao raparn intarnatonal Standards, [paras [Sentence t Bsa [Ateniion ia drawn tothe possbity thal some of to elements oF this iterations) Standard \desumanl may be the subject! patent ights Faas [intomatonal-Gtandard 150 0001 wee propared ly Technical Commitee 1SO/TO 176, Quel] menegemont and qually assurance, Suscomvmitioe SC 2, Quay ayers. Pome [zhi thic-aaicw ala att aanaia and rapinass ha aooend odlion (6 cons-tessbeoqeior Forewors (Pam? [New para? lor [Para 7, Sentence 2 [or apentaninstesteas: JO theproducte Borden: lo) Soe cencnasea B employs: tinal and organizational snstir, owe jnew para {management systems or uniormiy of documentation. is nok the tort of thie heamatonal Standard to imply uritormity in the structure of quit} lor Paraa [This iteratonal Stndard can be used by nial and external pares, including certicaon| bodies, to assess tho organizaton’s sblty 12 meet customer, stahudarand reguiator| requirements appiahle tn te ard, ond the orgizafon's own requirements, Pore? ova [Foran organkzaton to foncion efecvely, haa to only daianmina and manage numero inked setvdes. An a-tvty oc gaol acs using resources, and managed in order to ensbl| the traneiormation of inputs ito outputs, can be considered as a process. (© 180 2008 — All rights reservedPNS ISO 9001:2008(E) ‘Table B.1 — Changes between ISO 9001:2000 and ISO 9001:2008 (continued) I joa hese] Sas ae =e ‘Clause No. | ‘Table’ | Deletion head tow eo 2 a ison dineasme mope moet eee Sa ST eens sae meena cane mana nae echoes yeeros i) a ia a TaN ieanonamaaniieamoee ee ebm sets er erie re sacchari tt oar cere eon a [aunera) [A [a)_ needs to demonstrae te ably: consietenty provide product thal meots customer and Pasian seems sus |. Ly mmneeneemns crea tre ote pte en ee ee [customer and applicable stalulory and regulatory requirements. enstoraa + foe tne enact santa ncincacnen [) cemennetntasennt sense eves |s aes ac tani seein iz Paras Ja [Where excisions are made, claims of coniormily 10 this Intemational Standard are rot] Seep eel esi Sie eins Se cocoons aaa ou oa lz Fara! [D+ A [he foluwing-noumaiive document-ooniauns-prove-one whan through referee b-hie-tnt ——— ee toen eae | Seceorcereateninemnere cena | applying the-most recent editian-t-iie-normalive-dooument_Indiealod-bolow-For-undaled , (© 180 2008 ~All rights reserved aPNS ISO 9001:2008(E) — Changes between 80 9001:2000 and 180 8001:2008 (continued) 180 9001:2000) ‘Clause No. cae oe ‘Amandod txt ID+A |For te purposes of tie cacumant Iniareainal Standard, the trie nd dafiatons ghen Ih 's0 000 app. Pamaa towing toms-ad ih thie olen of ISO 000% to dacoibe te auppy- chal -have-bosn| |cnanged 19 rete tho vocabulary orentyused [supplier > organization ovstomer “Parton oynanaation yes tiyertioneanetaliec oats JRE Sst, eet nt to-whschhisntamatianatSuanseut-anplae Alcor arn cuppa raplanns tho ttn teuboontractor laa [Butet a) JD>A |a) lsentiy determina the processes needed forthe qualiy management ayslom and their lappcationtoughout ie ononizaan ave 1.2), lar [Bue @) ia Je) monitr, measure where anacable, and analy Mee processes, and [Paras [DA |Wwhere an erganizaon chooses o alsourc any prasoss ha allel product conlormiy wih ta requtomoris the ergazaton shal endure contol ver such proossses, The ibe ant stent iti he aay. jmanagementaysem, lax ‘Note lDvA|NOTET Procesies needed for te qually manépement ayslem reload To above shoul lociude proceesvs for management an [measurement anatala and nprovemgal. laa Now Notas 283 Inthe dear. to which. thecontoLor. he process shared, cl the cans of achieving ta necessary convo! ough the application ot 74, [aaa utat JA ___|®? Gocumeniod procscures and reconis required by this iniemational Standard, and jaan (Bator) [AD |9) documents. ncuding records, needed dalzaninad by the organization io he neceasay'6 leur the cflecis pining, oparaton and contol of ls procossue. ond laa uote) [D__|e}-reeorde equiod-by the Intornabonal Standard Yeoe 42-4, lear None ia INOTE + Where the torn ‘documeniea procedure appears win Wig itoratonel Sardar ths mean tat the procedure i estabished, documento, implemented and mala. |socumented procedure mm-be cnaced hy mors nen ana decuman. leas ater TI) to ensure that documenis of external arin = stilacrinad by ha erganizaion io ba necaaaacy tee the stanning and ualty management slum are Wentied and tell Iisebuton controled, and aaa Pat JOA [Record sna'be esiabished and malniaind to provide edonce of conform to reqiremenial atid ofthe eflectve operon of he quaity management system shall he conoied. Record [shat romainieplbo-roaly ontabearevioabie. ' documented procedure ehal-be-cstabshod to deine th| |conrois neeged forthe ientcaton, storage, protec, retrieval, rtenion tna and dlepason| fot recor. | Besant sat semaine cendiyieotable and reravaba. \ssz [Para t ia ——— lthor responsi, shal have responsibly ang autery tat nce isan Part Now Note [A+D [Personnel portorning work aitecing canlouniy-in product quality ranulas chat bo |competent on the basis of appropiate education, Vaining, ells and exparence. 'A NONE Conformiy te procs ooueomants 23a be allecied ckecty of ieacty by oan [pedocming any task whi te quay anagem System. (© 180 2008 ~All rights reservedPNS ISO 9001:2008(E) — Changes between ISO 9001:2000 and ISO 9001:2008 (continued) jpurota), [o+a aes eos ‘Amended text © Ga [Clause tile |A+0 | Competence, xaning.and awareness and ralring jee Jeuiets —A+D |) determine the necassary competence for personnel periorming work alecing sontonmly to ja) &) |productqualty reaucements, Ikt_wihexe sanicaiie, provide wainng or take othar action to salishy hose nods achieve the! jnssessary compsiunc, [es fauiete) [A [2)_supportng services (such as anspor, communication ac infarmatinn systems). ea New tote | MOTE Tha term “work. ardronment slates to cee canditons under which work x paced {isha or weather. Ira [eutotb)— JA+D {6} the need to eelablsh proowsees ans dooumenis, and ie provide resources spectic tothe Jproduct; Ira faulty | [e) required veriication, validation, mentoring, mgasuremert,inspecton and test actives |specitic to the product and the erteria for product sccaptancs; Za Buletc) [+A Jo)” statutory and regulatory requirements related Eoplcable to the product, and Inewnore Jaf Jeonicual abigatons such at mainiecance sacdous ans supflemetiay saicas such as| [o) any addtional requirements determined considered nacoasscy by te organization, |wOTE. Postdeivery_oaiins Incite for_xampie ecions unde wananty_oxovsions | eo) |rseycing octinal stspocal. pat [New Nolo [a [NOTE Dasion and devcionment roe, variicalian and valldation.bave plalinct purposes Toy {aan be conducted and seconded separalely oc in any combina. as suitable ‘or the product an| jne-cxpanization, 732 [Paa2 —|0+A [Fees ‘The inpule shall be reviewed tor adequacy Requirements shall be completa, {unambiguous and notin cont with each other. ras Para 1 JD+A |The oulpuis of design and development chail be grovided-in-0-torm-that-anablos in a farm sultabe for varticaton against the design and development Input and shall be approved prior to} release, [733 Jaulat 6) [O [b)_ provide appropriate information for purchasing, production and lr service provision, [rsa [New Note |x NOTE information for reduction snd earvien provision san ince sete fx he preservation. ptomostat. rar [Paras 1 & 2 [No ext —|Dosign ané development changes shal be identiiod and records mainiained. The changes shal |change. [be reviewed, veritas and valated, a2 appropriate, and approved betore implementation. The Paras review of dasign and development changes shal inciude evaluation of the aloct ofthe changes} Jnow Jon consstvent parts and product aiready delivered. Records of Uiw resus of the reviow ol Jmerged |changes and any necessary actions shail be maintained (see 4.24). i751 Butta) [+A [6)_the avalinblty and use of monktoring and measuring devises equipment, [rsa [euler fA 0 the implementation of prduct release, delivery and post-«A _ovideno of aromiy wih ho aaron sete shal be mashed Recods shal nd i preons autora velar of rode! ix ars aia sua ne 2) runs |0+A |evedet- lan andes Te smc stant rome une rangers oe ees Sen [ee See i i and a © 180 2008—Al rights reservedPNS ISO 9001:2008(E) ‘Table B.1 — Changes between ISO 9001:2000 and ISO 8001:2008 (continued) Paragraph | Ati i: 180 e001:2000| Figure! | (A) or y ‘Giause No. | Table’ | Doietion — woe |) ies iperat, [O+A [Sentence 2 is3 Peaa (a butt a Pas |Woa |Reore-ot nore nonenlrie. nd ar. subeoqiet Sto ten-eteg ara 4 | concessions obtcined;hattbe-meintained {eee iit) lpera4 | Moved vo [Whan nonconforming preduct Is corrected it shall be subject to re-veiicaton to demonstrate} be Para 3 conformity othe requirements. [Records of ine nature oF noncontormiies and any subsequent actions taken, Incuting| [concessions obiaine, shall bo mantalned (208 4.24). |wnen-nencontorming produois tector deter oie nae siatedthe organization sha [bho aston anpropits te the flacts-orpotantia-altectn-of he nonesntnemy 1b) eonlormiy to product raquromente oe 7) (aan B28), luiats) JA |e. characeaties and tds of processes and products, nding opportune x prevectie i scion ana head 824), end euters) Ja |) supers ana. eae rat 10+ 8 [ina ergntanton chal aw con wo imino te vuon caus of rencontre nae fiat JA | rvowing he llcnaaaat lhe covecve action tater fs ulate) Jk a) voewingmatlibaname al he provi aon ton. | Paez Ya [SA [Update eet 50 06042008 versa ISO 140012004 fer [a lA [panied elle 50 GO 2008 ver TSO BOT EOD [sibiography |New and [D+A | Updaied to rellecl new siandards (including ISO 9004, curreniiy under revision), new edons senda ncaa, oF winrann endor etree £©180 2008 — Al rights servedPNS ISO 9001:2008(E) a ICS 03.120.10 Pri based on 27 pages (©1590 2006 ~ Al ight reservedBibliography 1S0 8004", Managing for the sustained success of an organization — A quality management approach {SO 10001:2007, Quatity management — Customer satisfaction — Guidelines for codes of conduct for organizations 1S0 19002:2004, Quality mangement — Customer satisfaction — Guidelines for complaints handling in organizations ISO 10003:2007, Quality management — Customer satisfaction — Guideli extemal to organizations 'S0 10005:2005, Quality management systems —~ Guidelines for quality plens 1SO 10006:2003, Quality management systems — Guidetines for quality management in projects 'SO 10007:2003, Quality management systems — Guidelines for configuration management 180 10012:2003, Measurement management systems — Requirements for measurement processes anc ‘measuring equipment ISO/TR 10013:2001, Guidelines for quality management system documentation 'SO 10014:2006, Quality management — Guidelines for realizing financial and economic benefits 1SO 10015:1999, Quality management — Guidelines for training ISO/TR 10017:2003, Guidance on statistical techniques for ISO 9001:2000 |S0 10019:2008, Guidelines for the selection of quality management system consultants and use of their services ISO 14001-2004, Environmental management systems — Requirements with guidance for use 'S0 19011:2002, Guidelines for quality and/or environmental management systems aueliting 'EC 60300-1:2003, Dependability management —- Part 1: Dependability manegement systems 1EC 61160:2008, Design review ISO/IEC 90003:2004, Software engineering — Guidelines for the application of iSO 9001:2000 to computer software Quality management principles ®, 180, 2001 1S0 9000— Selection and use”, 10, 2008 1SO 9001 for Small Businesses — What to do; Advice from ISO/TG 176%, ISO, 2002 1SO Management Systems” Reference web sites: ttpsiwww.iso.o1g hitpuhwww.te178.0rg hitpuyAwwwiso.orgite176/sc2 bitp:/hwww.Js0. orale! 76IS09001 AuditingPracticesGroup for dispute rasolution “To be published. (Revision of 180 9004-2000) Availabe from website: hitpulwntie0.0rg. ‘To be updated and aligned with [80 8001:2008, 4 pimonthly publealion which proves comprsnensive of itematonal developments relat sancarés Includig news of thar implemantaton by diverse crganizatons around the word. A (salee@iso.o7). {9180's management system from 180 Contra Secretariatyour partner in product quailty end safety BUREAU OF PRODUCT STANDARDS Floor, Trade and Industry Building 361 Sen. Gil J, Puyat Avenue, Makati City 1200, Metro Manta, Philippinos Tol. Nos, 751-5125; 751-3123; 751-4735 Fax Nos. 751-4706; 751-4731 E-mail Address: bos(@clicov.oh