INTERNATIONAL Iso STANDARD 9001 it etion Quality management systems — Requirements _Sjtimes de management de la qalté— Exgences e1so2015,180 9001:2015(6) AX. covmicurononecrenvocoest ‘tla pane Rmion conte mghted ocak MO tie et ow of OT nearly coal af canreoboor 4 (01502015 -AghereenedContents Foreword Introcution 1 Scope 2 Normative references 3. Termsand definitions 4 Context the organization 4 Understanding the organization and ts context. 42 Understanding the netds and expectations of nerested parties 43 Determining te scope ofthe qualty management system Quali management stem andits processes Leadership 51 Lesdership and commitment Si Gener S12 Cosomer focus 52 Policy 521 Establishing the quality pli 522 Communicating the quality policy 53 Organizational roles, responsibilities nd authorities ining 1 Retons to address risks and opportunites 62 Qual objectives and planning achive them 63 Planning ofchanges Support 7a Resources Tia General 712 People 713 Inirastrutare 714 Environment forthe operation of processes 713 Monieringand measuring resource 716 _ Organizatonal knowledge 12. Competence 73 Awareness 14 Communieation 75 Documented information 784 General 752 Creating and updating 783 Controlef documented infermtion Operation BL) Operational planning and control 182 Requirements for products and services 821 Customer communication 822 Determining the requirement or product and services 823 _ Review ofthe requirements or products and servEes 824 Changes to requtrements fr products and seriest 83 Design and development of products andservces 831 General 832 _Designand developmen planning 833 Designand development inputs 834 Designand development controls 835 Designanddevelopment outputs 83.6 Design and development changes Page180 9001:2015(8) 84 control ofexterrally provided processes, products and services a 841 General a B42 Typeand extent ofcontra 3 843 Information for extern! providers a3 185 Production and service provision ub 1851 Control of production and service provision i 852 entiicaton and traceablty it 1353 _ Property belonging to customers or external providers a 254 Preservation a B35 _Postdlivery atvitios 15 856 _ Control ofchonges 116 Release of products and services 87 Control of nonconforming outputs 9 Performance evaluation 94. Monitoring measurement, analysis and evaluation Sat Genera 812 Cistomer satiation 9:13 _ Analysis and evaluation 92 Internal audi 93 Management reviw. 531 Gener 932 Management review inputs 933. Management review opus. 10 Improvement a 208” General Ye 102 _Nonconlrmity nd corrective action 1° 103 Continual improvement Fs [Annex A(eformative) Clarification of new structure, terminology and concepts 2 [Annes B (informative) Other International Standards on quality management and quality ‘management systems developed by S0/TE 376 2 liopraphy 2 ‘e1so2mis aForeword 150 (the International Organization for Standardization) is a worldwide federation of mation standards Soules (150 member bodies. The work of preparing International Standards is normally carried out ‘through 10 technical committes. Each manber body interested in a subec for which a technical committee has been establshed has the right to be Fepresented on that committee International ‘Srganiaa ons, governmental and non-governmental, i ats wth 180, ago take pare In the work 158 volagraisetawely withthe Imetnatonal Elecirovchateal Commision IEC) on all eters of slectrtaehnical standardization. ‘The procedures used to develop this document and those intended fr is further maintenance are described in the ISO/IEC Directives, art In particular the diferent approval criteria needed fr the ‘ferent types of 80 documents shouldbe noted. This document was drafted in accordance withthe fitorarules ofthe IS0/IEC Directives, Part 2 (cea warwlsparglditees). Attentior is drawn to the possibilty that some ofthe elements of tis document may be te subject of ute as 80 al pot eel epee Mem ayo al uh poten Ma Bras of Tights denied during the developmen ofthe document willbe inthe ltrodton and/or fan the 180 lato patent declarations received ce warelsaats/oatens). Any trads name used inthis documents nformation given forthe convenience of users and doesnot consttta an endorsement Foran explanation onthe meaning of1S0spcificterme andexpressionsrelstedtoconformity assessment, 22 wll information sbout ISO adherence to the Worl Trade Organization (WTO) principles Inthe “Technical arrersto Trade (TAT) se the folowing URL: worwisa.rg/so/oreword NAL ‘The comittee responsible or this dacument is Tenical Committee IS0/TC 76, Quality management and quel essurance, Subcommittee C2, Quality systems. ‘Thiet edition cancels and replaces the fourth edition (150 9001:2008), which hasbeen technically revise, through the adoption ofa revised clause sequence and the adaptation ofthe revised ualty ‘management princplas and of now concepts I also cancels and replaces the Techical Corigendim ‘So 990r2008/Cor1-2008, 210205 -ategsreured ’180 9001:2015(6) Introduction 01 General ‘The adoption ofa quality management system ia strategie dcisior for an organization that con help tolmprove its overall performance and provide a sound basi for sustainable development itive. “The potential benefits to an organization of implementing 2 quality nanagement system based on this International Standard sre 2) the ability to consistently provide products and services thit meet customer and applicable "Satatory and repultory requirements 1) fectating opportunities to enhance customer satisfaction; ©) sddresing isha and opportuntinsevciated with tx content and bieetivs, 4) theabilityto demonstrate conformity to speified quality management system requirements. ‘Ts imernatonal Standard ean be used by internal and external parties, leis nthe intent ofthis International Standard imply the need fr: = uniformity inthe structure of ciferent quality management systems; — alignment of documentation tothe clause structure ofthis international Standard — thouse ofthe specific terminology ofthis International Standard within the organization ‘The quality management system requirements specified in this International Standard. are complementary to requirements for products and services. ‘This international Standard employs the process approach, which incrporates the Pla Do-Chece Act (Oca) eyele and risk based thinking. “The process approach enables an organization to plants processes and thei interactions. “The POCA cycle enables an organization to ensure that ts proceres are adequately resourced and ‘managed, and that opportunites for improvement are detertained ad acted on [Risk-based thinkingenabes an organisation to determine the fctorsthat could cause its processes and ins quality management system to deviate rom the planned results -o uti place preventive contls to minimize negative effets and o make riaxinum us of ppoc tunities as they arise (se Clause A), Consistently meeting requirements and aressng future needs and expectations poses a challenge for organizations in a increasingly dynamic and complex environment. To seheve this objective, the ‘organtation might find necessary fo adap various forme of improvement in sdtion to correction Sn cncingal improvement, such a breakthrough change, innovation snd e-organiaation, In this nernatona Standard the following verbal forms are used — “shall indicates requirement; — “Phoul indicates recommendation: = “may” indicates permission: — “ta indieates a possibilty ora capably Information marksdas NOTE" sor gudanceInunderstandingor lying theassocited requirement. % 21502015180 9001:2015(6) 0.2 Qualitymanagement principles This Internationa Stand is based on the quality management principles described in 150 9000. The descriptions nelude statement ofeach pina ratinsle of why te principles important forthe organization some examples of benefits esoclated with the prielpe sd examples of typical actions tolimprove the organisations performance whe sppiyighe pits ‘The quality management principles are: = custome: focus — aera — engagement of people: = processapproach = improvement; — evidence based decision making: = relationship management 0.3 Process approach 0.3. General ‘his Incerntional Standard promotes the adoption of 2 process approach when developing implementing and improving the effectiveness af a quality management systom, to enhance customer siistaction by meeting customer requirement, Specific requirements considered essential tthe ‘option ofa process approach areleeuded In 8. Understending and managing interrelated processes as » system contributes to the organizations ctfectivowss and efficiency in achleving slated results: This approach enables te organization to conta the intersationshipe and interdependencie among the processes of he system so thatthe ‘overall performance ofthe organlzatio canbe enbanced, ‘The process approath involves the systematic definition and management of processes, and the interactions, s0 3 to achieve the intended results accordance withthe quality policy and strategic Alrectar af he argansation. Management ofthe processes and the syctem ara whole canbe achieved ‘sing the PDCA cycle (eee 0.3.2) with on averall focus on ikehased thinking (eee 0.3) aimed at aking ‘vantage af opportunities and preventing undesirable elt, ‘The appzaton of the proces approach na quality mangement system enables 2) understanding and cansisency in meeting requirements: 1) the consideration of processesin terms ofadded value ©) thesehievemento elective process performance: 4) improvement of processes based on evaluation of data and information, ‘igure. gives a schematic representation of any process an shows the interaction ofits elements. The ‘monitoring and measuring cheek points which are necessary for contra, are specie to each process and wil ary depending on the related sks, (802015 -aegsreseed wi180 9004.2015(E) Source ofp eros Figure 1 — Schematierepresentation ofthe elements ofa single process 03.2 Plan-De-cheelcAet cele ‘The POCA cycle can be applied to all processes and to the quay management system asa whole ‘igure2ilasteates how Clauss to 10 can be grouped nrlation the POCA eye ‘ pate) NOTE Numbers in brackets rferco the cuss nthis Internationa Standard Figure2 — Representation ofthe structure of his International Standard in the PDCA cycle wi “01602015 -Aghs ered‘ToePOCA cyce canbe briefly described as olows = Plan: establish the ajectivesof the system andits processes, and the resources needed to élver sults in accordanes with customers’ requirements and the ergantzaton plies, ad Kenly fn addres risks and opportunites = Do: implement what was planned: = heck monitor and (where applicable) measure processes andthe resulting products and services ‘agaist plies objectives, coqulrements and planned ativiies snd report the result: = Aetake ations to improve performance, a necessary, 102.3 Rsicbased thinking Risk-based thinking (see Cause 4.4) is essential for achieving an elective quality management s/stem. “The concep of risk-based thinking hasbeen impli in previous editions of hs International Stendard ‘lading for example, carrying ou preventive ston ta eliminate potential oncontorites analysing ty noneonformites that do occa Sn taking Sto t prevent recurrene thats appropriate or the ‘ects ofthe nonconformiy, “To conturm to the requirements of this International Standard, an organization needs to plen and liplement actions to address risks and opportunities. Adéressing both risks and opportenitis ‘eaabllstes a basis for Increasing the ellcivences of the quality management system, cheving Improved results nd preventing negative effects ‘Opportunies can aree as a result ofa situation favourable to achleving an Intended rest for ‘stamp 4 et of ereumstances that slow the organisation a atrateartomers devel neve products ‘Sd services, reduce waste oF improve productivity. Actions to address opportunities canals iclude ‘onsideraton of associated risks. Risk the ellect uncertainty and any such uncertainty ca have Pastive or negative effects. A postive deviation arising from a isk en provide an opportunity Aut Not 2iipostve effects of lak result in opportunities, ‘04 Relationship with other management system standards ‘This Inrnationa Standard apples the framework developed by SO o improve alignment among is Tnternatonal Standards for management systems (se Cae A). ‘his International standard enables an organlzation to use the process approach, coupled wih the DCA cycle and rskcased thinking, to align or integrate ts quality management system wih the quirements af ther management system standards. ‘This Ineenational Standard relates to 10 9000 and 10 9004 as fllows — 180 9000 Quelcy management stent — Fundamentals and vocsbulory provides. eset! bchground forthe proper understanding and implementation of hs fnternatignal Standard = 1509008 Managing for the sustained success of on organization ~ A quality management epproach prondes guidance for organizations that choose to progress beyond the reqiremants af tis freracional Standard Annex B provides dotalis of other International Standards on quality management and quality ‘anogeent systems that have been developed by ISO/TC 176, ‘This Inerational Standard doesnot incl requirements specifi to other management sytem Such as those for environmental management, occupational heath and safety Managemen, ot Sectorspacife quality management system standards based on the requirements ofthis Internation Standard have been developed fora number of sectors. Some of these standards speci addtional 3walty management system requirements, while others are limited to providing guldance tothe 2plicatnn ofthis international Standard within the particular sector. 9180 2015-acypureered &150 9001:2015(6) the previous edition (180 9001:2008) can be found an the IS0/TC 176/S¢ 2 open access web site a ‘sn orelici76/sc02/oubli. x 1802015 AlgerINTERNATIONAL STANDARD 180 9001:2015(8) Quality management systems — Requirements 1 Scope ‘This imtormtional Standard specifies requirements for a quality management system when an ‘rgainstion 4) needs ta demonstrate it ablit to consistently provide products and services that meet customer Bnd applicable statutory and regulatory requirements and ‘b) sims toemhance customer satisfetion through the effective application ofthe system, including Drocessis for improvement of the system and the assurance of conformity to customer and ppicble statory end regulatory requirements Allthe eguements ofthis International Standard are generic and ate intended to be applicable to any ‘organization, regardless ofits ype or size, or the products and services i provides NOTE nes international Standart tems produt”or"seviee" only apy to products and services NOTE? _ setutoryand regulatory requirements can be expressed as ga requiremets 2 Normative references “The following documents, i whole or in part, are normatvely reference inthis document and are Sndispencabie for te appietion. Fr dated references, ony the edition cited applies. For undated Felerenes, elatest elton othe relerenced document (incding any amendment) applies. 150 3000:2015, Quality management systems — Fundamentals and vocabulary 3. Termsand defi For the purses ofthis document, the trms and definions given in 150 9000-2015 apy 4 Context of the organization 4.1 Understanding the organization and its context ‘The organkation shall determine external and intemal eter that are relevant to its purpose and Its staegie direction and that afect Is abllty to aehlove the intended results) of ts quality ‘The organization shall monitor and review information about these external and internal issues. Usderstaning the externa cotext can be falta by anldering fsb arising (rom Iga eal compat, markt cultural socal and economic nvranments whether eration ato Nore Understanding ira conten con be aantey oss related vale care, (0902015 Argent a180 9001:2015(6) 4.2. Understanding the needs and expectations of interested parties ue to ther effet or potential effect on the organization’ abily to consistently provide products and service tht meet customer and applicable statutory and regulatory requirements, the organization Shall determine 2} theloterested parties that are relevant tothe quality management system 1b) the requirements of thes interested partes that ae relevanccothe quality management system, ‘The orgonization shall monitor and review informtion about these interested partes and their relevant requirements 43. Determining the scope ofthe quality management system ‘The organization shall determine the boundaries and applicability cfthe quality management system toestablish ke seope ‘When determining this scope, the orgonization shall consider: 3) theexternal and internal issues relerred ton 4: 1B) therequlrements of elevant intrested parties referred tind ©) theproduts and services ofthe organization ‘The organization shall apply ll he requirements ofthis International Standard if they are applicable ‘within the determined seope ofits quality management system, ‘The scope ofthe organization's qually management system shall be avallable and be malntained 38 documented information. The scope skall state the typeof productsand sevice covered, nd povice Justeston for any requirement oti International Seandar thatthe orgenaaton determines not applicable to the scope ats quality management system, Conformity to this International Standard may only be claimed ithe requirements determined as not ‘bing applicable donot tect the organizations aby or responsiblity to ensure the conformity of te products and services sd the enhancement of eastomer satisfaction, 44 Quality management system and its processes 44.1 The organization shall establish, implement, malntan and continually improve 2 quality Imanagement system, incuding the processes nended and thei intractns in accordance with the ‘equiements ofthis international Stare ‘The organization shall determine the processes needed forthe quality management system and thelr {pplication throughout the organiaaton, aad shall, 3) determine the inputs required andthe outputs expected frm those processes; 3) determine the sequence and interaction ofthese processes; ©) determine and apply the erters and methods (icloding monitoring, measurements and related performance ndieators) needed to ensue the elective operation and contol of these processes 48) determine the resources needed for these processes and ensure their svilabliy ©) assign the responsibilities and authorities for these processes, f)sddress the risks and opportunities a determined in accordance with he requirements of 6 2) evaluate these processes and implement any changes needed to ensure that these processesachieve ‘heir intended results 2 Cotso2015-anighareened180 9001:2015(6) 1) improve the processes and the quality management system. 442 Tothe extent necessary the organization shal: 4] mamtan documented inormation to support the operation a ts processes 1) retin documented information to have confidence that the processes are being cared ou as pianeed 5 Leadership 5.1 Leadership and commitment S42 General Te ampenent sal demonstrate leadership and comment with rerpect to he gutiy management system by: 13) takieg accountability for the effectiveness ofthe quality management system; 1) ensuring thatthe quality policy and quality objectives are established fr the quality management "yeti and are compatible wlth the context and strategic direction of the organization, ©) ensuring the integration ofthe quality management systom requirement inte the orgenzaten's business processes: 4) promoting the use ofthe process approach and rst based thinking: ©) ensuring thatthe resources needed forthe quay management system are avalable 1) communicating te importance of elective quality management and of conforming othe qualty 8) ensuring thatthe quality management system achieves its intended results 1) engaging. directing and supporting persons to contribute to the effectiveness of the quaity management systom, 1 promoting improvernent: |)_supprting other relavant management ols to demonstrate their leadership as it applies otheir sven of responsi. NOTE. Refeonce to busines” I he InternatioalStndsed can be oerpreted broadly to mean hoe $start perp fhe gainer noanaton oe 5.412 Customer focus “Top managemant stall demonstrate leadership and commitment with respect to customer focus by cnguringrtha: 8) cestomer and applicable statutory and regulatory requirements are determined, understood snd ‘consetently met 1b) the risks and opportunities that can affoct conformity of products and services and the ability to ‘enhance customer salsfacton are determined and sddrerted; ©) the icuson enhancing customer satefaction is mataine, © SommS -Aleghsrened 310 9001:2015(6) 52 Polley ‘52.1. Establishing the quality policy ‘Top management shall establish, implement and maintain quality poley that: 2) Isappropriateto the purpose and context ofthe organization and support ts strtepie direction 1) provdesa framework fr setting quality obectives; ©) Includes commitment to satisfy applicable requirements 4) Incldesa commitment to continua improvement ofthe quality management system. 5.22 Communteating the quality policy ‘The quality pie shal 28) boavalableand be maintained as documented information: 1) becommunicated, understocd and applied within the organitatin: ©) beavallabeto relevant interested partes, as appropriate 5.3 Organizational roles, responsibilities and authorities Top management shall ensure that the responsibilities and authorities for relevant roles are asigned, Communisted and understood within the organization. ‘op management shall assign the responsibility and athority for 8) ensuring that the quality management system conforms to the requirements ef this International Standard 1b) ensuring thatthe processes are delivering thelr intended outputs ©) reporting on the performance of the quality management system and on opportunites for immpovement (se 103), in partcar top management; 4) ensuring the promotion of customer focus throughout the organization; ©) ensuring that the integrity ofthe quality management system is maintained whan changes to the {ually management system are planned snd inplemented 6 Planning 6.1 Actions to address risks and opportunities 6.1.1 When planning forthe quality management system, the organization sal consider the lesues Feferred ton and the requirements referred to ln 42 and determine the risks and opportunities ae 5) ive assurance that the quality management system can achieve is intended result(s) 1) enhance desirable eects: ©) prevent. ar reduce, undesired effets: 4) achieve improvement180 9003:2015(6) 6.1.2. Thesrgantzation shall pan: 4} actions address these risks and opportunities; howto: 4) teyrate and implement the ations ito its quality management systom processes (ee 44): 2) evaluate the elfectivenes ofthese actions. Actions taken to address risks and opportunites shal be proportionate tothe potential impact onthe Conformity ef products and serves, NOTE Opins to addres rics com Ince avelding rick, taking skin order to pareve ab opportunity, ‘Miminacing thers sores changing the ind oe consquenees staring the Fe or eae ik NOTE2 Opportunites can lod tothe adoption of new practices Inunching new produc opening ne Imarets, ads ner castomer ling parenurshipe wing naw ecology and other Csr ond vse 6.2 Quality objectives and planning to achieve them 621. The organization shall establish quality objectives at relevant functions, levels and processes noeded for he quality management system, The quality cbjetives shall: 8) be consistent with the quality pole 1) bemeasiabie: ©) take ntc acount appiele requirements 4} be eleven to conformity of products and services and to enhancement of customer satisfaction; ©) bemoaned; 1 be communicated: 8) beupdated as appropriate ‘The arganzstion shall maintain documented information on the quality abjecives. {62.2 Wher planning how to achieve its quality ajectives, the organization shall determine: 3) what willbe done: 1) what resurces wil be required ©) who wile exponsiie, 8) when twill be competed, )_how the results will be evaluated 63. Planning of changes ‘When he organization determines the need fr changes tothe quality managementsystem,the changes salle carried out ina planned manner (se 44) (21502015 rered 5180 9001:2015(8) ‘The organization shal consider 23) the purpose ofthe changes and thelr potential consequences 1) thedntogity ofthe quality management system: ©) theavailabity of resources 4) thellocation o reallocation of responsbltes and authorities. 7 Support 7A Resources 741 General ‘The organization shall determine and_ provide the resources needed for the establishment, Implementation, maintenance and continual provement othe quality management stem, ‘The organzation shall consider: 2) thecapablitiesof and constraints on exctnginteral resources; 1b) what needs tobe obtained from external providers, ‘The artanization shall determine and provide the persons necessary forthe elective implemesttion ofits quality management system and for the operation and contol ots process. 743. Infrastructure ‘The organlation shall determine, provide and maintin the infrastructure necessary forthe operation ofits processes andta achieve conformity of product and services NOTE Infrastructerocam ince: 2) buldiegs ane sssocated ue: 1) equipment ncaing hardware snd tftwre: ©) transportation roma 4 information 20d communication ecology 7.14 Environment forthe operation of processes The organization shall determine, provide and maintain the environment necessary forthe operation ts processes ant ahiove conformity of products and services, NOTE Asultobleenvronmentcan bea combination ohana and physical factors, uch 3 2) social (4. noniserintntory calm, on-contonttoal: 1 payetelogeal (eg streseceducng, brsout preveation, emelosly pretest: 6) physical (og temperatrs st mi ight ale yin nie ‘These actors can differ substantially depending the products and serves proved,150 9003.2015(8) 745 Moritoringand measuring resources 7.81 General ‘The organization shall determine and provide tho resources needed to ensure valid and reliable ‘esuls whes monitoring or measuring used to verily the conformity of products and services to requirements ‘The organzstion shall ensure thatthe resources provided 8} aresutable or te specie type ofmontoring ad measurement scutes being undertaken: 1b) aremsintaned to ensure their continuing feness for thelr purpose. “The onganition shall resin appropriate documented information a evidence of iness for purpose of ‘the monitoring and measurement resources, 7AS2 Measurement traceability ‘When meastrementraceabiltyIs2 requirement ori considered by the organization tobe an essential part of providing confidence inthe validity of measurement results, measuring equipment shall be: 8) calibrated or verified. or both at pected intervals or prirto use. against measurement standards {taceabé co tncernatinal or national measurement standards; when fo such standards exis, the bsiustd for elibratin or verification shal be retained a documented information| ‘W) deed inorder to determine thelr status 16) safequaded from adjustments, damage oF deterioration that would invalidate the calibration Status and subsequent measurement resuls “The organization shall determine ifthe validity of previous measurement results has been adversely fected wien mensuring equipment is found to be nit for ks intended purpose, spd shal ake ‘appropratesclon as necessary. 7.6 Organizational knowledge “The organtation shall determine the knowledge necessary forthe operation of ts processes and to _hlavecontnmity of products and serves. ‘This knowledge shall be maintained and be made availble tothe extent necessary. Whon addressing changing needs and trends the organization shall consider its curren knowledge [nd determne new to sequlre ar access any necessary additional kowledge and required update. NOTE: _Oanaationl knots knoe specif te erations i gneriy uod by NOTE? —Onganitatonal knowledge canbe brid on 2) Internal sources (eine property: knowledge soe from experince lero naraed from {aures and sucess esc oparing ond shcing undocumented Rraledge ad erpercce: Oe resus Inaprovemais in roetten prac sn services 1)__extermt sources (og. standards: academia conferences: gathering knowledge from customers or ‘xcersal prods 1502615 -Att voce a180 9001:2015(6) 72 Competence ‘The orgalzation shal: 3) determine the necessary competence of persons) doing work under is control that afects the performance and effectiveness othe qual management system 1) easure that these persons are competent on the basis of appropriate education training, ar fxperence: 6) where applicable take ationé to acquire the neces the ations take competence and evaluate the effectiveness 4) retain appropriate documented information a evidence of competence. NOTE _Appiable ston ean feu, or example, the provision of traning t,he mentoring of thet: sigament furrentiy empayee person arth hing ar contracting compen errs 73. Awareness ‘The organization shall ensure that persons doing work under the organizations control ae aware ef 23) the quality potey 1b) relevancquality objectives © telecontbaion he eectienes ofthe ually managment system ling the bens of Improved pertormance 4) thetiplications of not conforming with the quality management system requirement, 74 Communication ‘The organization shall determine the internal and external communications eelevant tothe quslity management system, including 8) onwhat ie will communicate: 5) when to communicate: 6) with whom to communicate 4) how to communicate: ©) who communeates 7.5. Documented information 75 General ‘The organizations quality management system shal include 3) documented information required by this International Standard; 1) documented information determined by the organization as beng necessary forthe effectiveness ofthe quality management system, = the ze of organization and its type of actives, processes, produts and serves: 8 (1502015 -anesgaresere180 9001:2015(6) = the compevityofprotesses andar tracts: ~ tocompetnce porons 78.2 Creating and updating ‘When creating andupdating documented information, the organization shall ensure appropriate: 8} identification and description (eg tila, date, author or reference amber: 1 format (eg language, software version graphs) and medla eg, pape, electronic) 6) review and approral for sultabllty and adequacy. 254. Control of documented information 2534 Docamenedinfrnatinrequrdby the gly menagementsytem aby tsar ‘Standard shall be ccntrotled to ensure: “nen " a) itisa 1) iisadequately protected (eg. ram loss of confidentiality, improper use, orlos of integrity). lable ad suitable for use, where and when is needed: 753.2. For the ctrl of documented information, the onganinstion shall addcess the following ‘etnies a8 apple 3) distribution acess retrieval and use; 1) storage and preservation Including preservation af legibility, ©) contra of changes (eg version control: 4) retention and postion. Documented information of external origin determined bythe organization ty be necessary forthe planning and operation ofthe quality management system shal be identified as appropriate, 2nd be controled Decurented inforration retained as evidence of conformity shall be protested from unintended aieratone NOTE Access cn imply a decison regarding the permission to view the dacumetted information oni oF ‘he permission and authority to wand cangetne documented Inormaton. * 8 Operation 8.41 Operationalplanningand control ‘The organization shall plan imploment and control the processes (see 4.) needed to meet the tegument or te provision of product and series, nfo npn heaton deine in 3) detormining the requlrements fo the products and services 1) establishing erkeria for: 1D) the processes; 2) theaccepance of products an services ©) determining the resources needed to achieve conformity tothe product andservice requirements (21502015 anid serene °10 9004.2015(8) 8) tmplementing contol ofthe prcesses in accordance with the eritria, ©) determining, maintaining and retaining documented information othe extent necessary: 1). tohave confidence thatthe processes have been caried out asplanned: 2) to demonstrate the conformity of products and services to their requirement, ‘The output ofthis planning sal be suitable forthe organization's operations. ‘The organization shall control planned changes and review the consequences of unintended changes, takingacton to mitigate any adverse effets, as necessary. ‘The organization shall ensue that outsourced processes are controle cee 4) 8.2 Requirements for products and services 82.1. Customer communication ‘Communication with customers shall include 19 providing information relating to products and services 1) handling enquires, contracts oF orders incading changes; (©) obtaining customer fedbac relating to products and services incuding customer complaints; 4) banding or controling customer property ©) establishing specific equiremencs fr contingency actions, when cleat. 8.22 Determining the requirement for products and services When determining the requirements for the products and services to be offered! to customers, the organtation shal ensure that 2) the requirements forthe product and services are define, ncuding 1) any applicable statutory and regulatory requirements 2) those considered necesary by the organization 1b) theorganization can met the clans forthe products and servicers 8.23 Review ofthe requirements for products and services 8.23.1 The organization shall ensure tha tha the ability to meet the requirements for products and Services tbe offered to cistomers, The orgenzaton shall conta ev ew before commiting supply products and serves to aeustomer toile 2) requlroments spelled by the custome, inching the requirements far delivery and post datvery activities, ®) requirements not sated bythe stam bt neesiry forthe speci or intended use, when 6) requirements specified by the organization: 4) statutory an regulatory requirements applicable tothe products and services ©) contract or order requirements difering from those previously exressed, 10 11502015 eres180 9001:2015(6) ‘The orgenization shall ensure tht contrac or order requlrements differing from those previously etined are resolved, ‘The customer's requirements shall be confirmed by the organization before acceptance, when :he ‘Customer does not provides documented statement fthel requirements NOTE tasome stations such as internet sles formal review is practi for ech order. nent ‘view cancoverriavant prac inormaton, ch ag catlogues 8232 The organization shall retain documented information se apliable: 23) ontte results ofthe review: 1b) onary new requirements forthe products and services, 824 Changesto requirements for products and services ‘The organization shall ensure tht relevant documented information is amended, and tha relevant persons are made aware of the changed requirements, when the requirements for products sd ‘Fervices tre changed 83. Designand development of products and services 834. Ceneral “The organization shal estas, implement and maintain a design and development process that i _approprtet ensure the subsequent provision of products and services. ‘832 Design and development planning Im dtermining the stages and contro fr design and development, the organization shall consider 3) therature duration and complexity of the design and devslpment activities 1b) therequired process stages. including applicable design and development reviews: '@)theraquired design and development verification and validation activites; 1d) the rsponsibitos and authorities involved inthe design and development process: '9) the interna and external resource needs forthe design and development of products and services, 4) the need wo control interfaces between persons involved in the design and development proces 4) themed for involvement of customers and users inthe design and development process 10) the rquirements for subsequent provision of products and services; 4) the vol of contol expected for the design and development process by customers and other felewane interested partes 4) the cocumentd information needed to demonstrate that design and development requirements havebecn met ‘833 Design and developmentinputs “The organization shall determine the requirements essential forthe specifi types of products and servicestobe designed and developed. The organzation shall conser 2). Functional and performance requirements 'S 802018-Atigho seed au180 9001:2015(8) 1) information derived from previous similar design and development sets 6) statotory and regulatory requirements 4) standards or codes of pratice thatthe organization has committed to implement {potential consequences failure due to the nature ofthe product and services. Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs shall be resolved. ‘The organization shall etain documented information on design and development inputs 834 Design and development controls ‘The organization shall apply controls to the design and development process to ensure tht: 5) theresultstobe achieved are defined 1b) eviews are conducted to evaluate the ablity ofthe results of design and development to mest Fequirementss ©)verication activities are condected to ensure thatthe design and dev Inputrequiemeats 4) validation activities are conducted to ensure thatthe resulting products and services mest the requrements forthe spected application or intended wey ©) any necessary ations ae taken on problems determined during the reviews, or verison and ‘aldation activites, 1) documented information ofthese atvtiesis retained NOTE Design and development reviews, verification and validation be datoct purpose. They can be fondoctedsepustl orn any combination issuable fr he proaacts and ericson organ, 835 Design and development outputs Theor zation sal ensure that design and development outputs 2) meet the input requirements 1b) areadequate forthe subsequent processes forthe provision af products and services: ©) neue or reference montoringand measuring requirements. as appeopriat, and accoptancecriteris; 4) specltythecharacterstes ofthe products and services that are essential fr their intended purpose hd thee Ste and proper provision, ‘The organization shall retain documented information on design and development output. 83.6 Design and development changes “The organization shall entify, review and contol changes made during, or subsequent to, the design and development of products and services, tothe extant necessary Uo ensure that tere ls no averse Inmpacton conformity to requirements ‘The organization shall retain documented information o 2) design and development change 1b) theresultsof eviews; 2 (etsoams ates rsd150 9004.2015(8) ©) theauthorization of the changes 4) theactions taken to preventadiverse impacts, 8.4 Control externally provided processes, products and services The organization shall ensure tat externally provided processes, products and services conform to requirements ‘The organization shall determine the controls tobe applied to externally provided processes, products sind services when 2) roductandservstrom cera provers areintenedorirporaionin the organs bun produts and serves: 1) products and services ae provided directly tthe customer{s by external providers on bebalf of the organization ©) process, or par ofa process i provided by an external prover asa result of decsion by the ‘nganization. ‘The organization shall determine and apply criteria forthe evalation, selection, monitoring of performance, ad re-evaluation of external providers, based on thelr ability to provide processes ot Dradcts and services in accordance with requirements. The organization shal retain documented Information ofthese activites and any necessary actions arising from the evaluations 842 Typeandextentof control ‘The organization shall ensure that externally provided processes, products and services do not Acverselyafet the organization bility to cansstenty deliver conforming products snd services to ‘The organaation shal 2) ensure that externally prosded processes remain within the control of its quality management ‘systems 1) define both the controls thatitintendsto apply to anexteral provider and those itintendso2pply tothe resulting output 6) take nto consideration: 1) the potential Impact of the externally provided processes, products and serves on the organization's ability to consistently meet customer nd applicable statutory and regulatory Fegurements 2) thecffecivenss ofthe controls applied by the exterl provider: 4) determine the verification, or other activites, necessary to ensure thatthe externally provided proceses products and services moet requirements 84.3 Information fr external providers ‘The organization shall ensure the adequacy of requirements prior to their communication ¢o the external provider ‘The organkation shall communicate to external providers Rs requirement or 23} theprocesses, products andservicesto be provided (21502015 Arig reseed 8180 9001:2015(8) 1) theapprovalof 1 products and services 2), methods, processes and equipment: 3} therelease of products and serves ©) competence including any required qualifiation of persons 4) theexternal provider interactions with the organization; 1) conroland monitoring ofthe external providers’ porormance te be applied by the erganiztion 1) vercatin o validation activities thatthe organization, o its customer, intends to perform atthe ‘eternal provider premises Production and service provision 85.1 Control of production and service provision ‘The organization shall implement production and service provision under controlled conditions Controlled conditions sal include, as appicble: 3} theavalabilty of documented information that defines: 4) the characterises ofthe products to be produce, the services tobe provided, oF the activities tobe performed 2) theresultstobe achieve: 1) the availabilty and use of stable monitoring and measuring resources ©) theimplomentation of monitoring and measurement activities at appropriate stages to verify that trite fr contra of proceser or outputs, and acceptance criteria for praducte and sevice, fave been met 4) theuseof suitable fnfrastructore and environment for the operation of processes ©) theappointment of competent persons Including any required qualifeation 1) the validation, and periodic revalidation, ofthe ability to achieve panned results ofthe processes for production and service provision, where the resulting output cannot be verified hy subsequent onloring or measurement 8) thetimpementation of actions to prevent human eon; 1) thelmplementation of release delvery and postdelivery activities, 852 Identiieation and traceability ‘The organization shall use suitable means to dently outputs when It is necessary to ensure the conformity ofpreducts and services ‘The organization shal Hestfy the stats of outputs with respect to monitoring and measurement requirements throughout production and service provsin The organization shal control the unique identication of the outputs when traceailty is 2 ‘requirement, nd shal retain the documented information necessary tenable traceability, “ (21502018 -Alhigho veered180 9001:2015(6) 8.53 Property belonging to customers or external providers ‘The organization shall exercise care with property belonging to customers or external providers while icisunder the organization's control belagused by the orgonisation. ‘The organization shall deni. verity. protect and safeguard customers or external providers’ property provided or use or incorporation into the products and services, ‘When the property of a customer or external provider is lost, damaged or otherce found to be tunsitale for use, the orgenaation shal report this tothe customer a external provider and retain ensure that thelr organizations appiying the practices contained in the 150 qalty management system standards = 180 10007 Quay management systems — Guidelines for configuration management is to assist ‘organizations applying configuration management fr the techical and administraive drectlsn ‘over the fe eye of product. Configuration management ean be used to eet the prod ‘denuteaion snd waceaity eequiremens specified inthis international Standard. — 150 10008 Quality management — Customer satlsfction — Guldelies for businessto-consumar ‘electaniecammerce transactions gives guidance on how organlations can implement an effective nd efficent businessdo-consumer electronic cammeree transaction (B2C ECT) system, 38d {hereby provide basis for consumers to have increased confidence in B20 EcTs enhancethe ably ‘of organtzation to stialy consumers and hap reduce complaints and disputes. — 150 10012 Measurement management stems — Requirements Jor mecrurementproceses and measuring equipment provides guidance forthe management of measurement processes Std ‘metrological confirmation of measuring egulpment used to support and demonstrate compilan ‘vithmetrologiel requirement [5010012 rovidesquaity managementertteraforameasuremert ‘management sytem to ensure metclogial requirements are met. = 1S0/TR 10013 Guidelines for quality monogement system documentation provides guidelines for the development and matotenance of the dacumentaion necessary fora quality management fystem. 1S0/TE 10013 can be ured to document management system other than those of fe {80 quality management system standards, eg enviconmental management systems and fey ‘management systems = 15010014 Quay menagoment ~ Guidelines for realizing nancial end economic beneisis addressed {oop management. [tprovies guidelines for realizing financial and economic bene through te pplication of qualixy management principles. facltatessppliston of management principles hd selection of methods and tools that enable he sustsinable sere fan organaation — 15010015 Quality management —Cuielins for raining provides guldelins to assist organlnations Im addressing issues related to training S0 10015 can be applied sehonoverguicanc i requied to interpret references to “eduction” and ‘ralning” within the ISO quality management system Standards Any reference to "raling”incudes all types of ediestion and traning = 150/TR 10017 Guidnce onsite! techniques for I0 90012000 explains statistical techniques lh follow frm the variety that ean be abserved inthe behaviour and result of processes, ren unde conditions of apparent tality. Salsa techniques allow better use of avaleble da to asist in decison making, and thereby help to cotiuslly improve the quality of prodicts and Dracetsesto achieve customer satisfaction. 26 21502015 Agha reese— 180 10018 Quoty managersent — Guidelines on people involvement and competence provides fuidelines which influence people invalvement and competence. A qualiy management system flepends on the invalvemem of competent people and the way that they are introduced and Integrated nto the organization, I's ertealto determine, develop and evaluate the knowledge. Sill behaviour end work environment required = 15010018 Guidetnesjoreheseecton of qulty managementysten consultants anduseotheirservices provides guidance forthe sebction of quality management system consultants the ase oftheir Efrvies. gives guance ox the process for evaluating te competence of 2 qualty management System constant nd proves confidence ht he organ eed nd expectation fre ‘consultant services vill be met = 180 19011 Guldeines or auding management systems provides guidance onthe management ofan audit programme, on the planning and conducting of an audit of s management system, 5 wel 3 ‘onthe competence and evaliton af snsuditer and an audit team ISO 19011 ielntended to pply to ‘dior, organizations implementing management ystems, and organizations nedingto condict Suds of management syste. ‘Table Bt —Rolationship between other International Standards on quality management and ‘quality managenientsystems and the clauses of this International standard ‘Other inter ‘Glseta hs iternaional andar Sona standard} — o_o 5 ni Oe ec? iso9600 fan an dan fanaa ja isoo00e [alan [an [ania Jan [a iso10001 | [aazaei [oad iso 10002 jazi fair (aodd iso 10003 iaaz iso 10004 | az ai 010005 | ea (aaa [an fat fax ‘ae so 10006 a fan fan aula [an an so 10007 lesz soro00s an [an —_[aw ana an [a iso 10012 a sore 1013 25 soos fafa [ana __[at Ja —_[a iso 0015 [ zz [sore 10037, a i lax [iso oore [an fan jana alan la [isoxo0i9 | — iat iso90u1 [az180 9001:2015(8) o @ 8 “ 61 oT "1 ®) °1 wo} uy 02) 13} 4) ts) ns} 7) (18) 09) po, en ea pa rea) es} es) Bibliography 1509004, Managing forthe sustoned successofon organization —A quality management approach 150 10001, Quoly management — Customer satisfaction — Gulelines for codes of conduct for organizations 150 10002, Quality management — Customer satisfaction — Gudelnes for complaint handing in organizations 150 10003, Quality management — Customer satisfaction — Gudolies for dispute resolution external co organizations 150 10004, uly management ~ Customer satfcton — Guidelinesformontoringand measuring 150 10005, quality management systems — Guidelines for quality pans 150 10006, qualty manegement systems — Guidlines for quality management projets 150 10007, quality menggement stom: — Culdelins for configuration management 150 10008, Quatty management — Customer satisfaction — Guidelines or snes to-consumer stectrone commerce transactions 150 10012, Measurement management systems — Requirements for measurement processes and ‘measuring equipment 'S0/TR 10013, Guidelines or quality management system documentation 150 10014, uolty management — Guidelines fo ealzing fnanctal and economic benefits 150 10015, Quality management ~ Guidelines or training 10/7R 10017, Guidance on statistical techniques for [$0 90012000 150 10018, ualty monagement — Gudeineson people involvement ond competence 10 10019, Guidelines for ee selection of quallty management system constants and use of thei services 150 14001, Environmental management systems — Requirements with guldance for use 150 19011, culdelines or auditing management systems 15031000, sk management — Principles and guidlines 150 37500, Guidance on outsourcing 'SOPIEC 90003, Software engineering — Guidelines for the application of 180 90012008 to computer software 18603001, Dependabity menagement — Part I Guidance formanagementond application 18¢ 61160, Design review (quality management principles. 80" Selection and use ofthe 150 9000 family of standards, I) 150 9001 for Small Businesses — What to do, S019 1) Arable fom website brad nenssnaes (01502018 anaphora150 9001:2015(E) "271 Integrated wse of managemencsystem standards, 1809) (2a) warisnone/tk76/ecO2/oublic (29) wrong /es76/1S09001AutingPractiesGoun 2802815 Als revel 2»180 9001:2015(E) Wes 03.4200 (01502015 Aleghsresered