BSI Standards Publication BS EN ISO 9001:2015 Quality management systems RequirementsBS EN 150 9001:2015, BRITISH STANDARD National foreword ‘Thi rsh Standard ithe UK implementation of EN 150 9001-2016 Rsuparsedes 6 EV 180 900112008 which withdrawn ‘The UK participation nits preparation vas entrusted to Technical Committee OS, Quay management and qual sssurance procedures. Alistof organizations represent on this committee can be btained on request tos secretay, ‘This publication doos net purport to include ll he necesary prowsions of a contract Uses are responsible for fs correct, Spolcation (©The Beith Sardar nstusion 2015, Published by 8s Standards umited 2015 'sBN 978 0580918162 cs03.12010 ‘Compliance wit 2 British Standard cannot confer immunity from legal obligations. ‘This British Standard wos published under the authority ofthe Standards Paley and Svategy Commatte on 30 September 2015, “Amendments sued since publication ate TextatiecesEUROPEAN STANDARD. ENIsO9001 NORME EUROPEENNE, EUROPAISCHENORM Sepeember 2015, Superdes 4180 903.2008 English Version Quality management systems - Requirements (ISO 9001:2015) Sythe siege a gut iene (50 _uattenanaponensystene Aafererngen 80 “ss ‘Sooo -q2vzemerae tun sy wth ENV CENLEC nr Reins ih ttn cnn ig i “een Sad cn etc ns gh. Far wenn na mb std Antes elu Dulari, rats Cyprus Coch ep eam Ein. acto a Garay Cent tye ean ava La oy Pan Poa Romi Sara Sven Sin Sunn, Setar Try 04 z& ‘QN-CENELEC Management Cente: Avenue Mara25 EN 150 900122015, [ENISO 9001:2015 (6) European foreword ‘Tle document (EN 1S0001:2015) hasbeen prepared by Technical Committe IS0/TC 176 "Quality management and quay assurance ‘This Coropeon Standard shall be piven the status ofa ational standard, ether by publication of an dente text or by endorsement atte atest by March 2016, and concn national standards shall bewithdrawn at the lates by March 2016 ‘tention is draen to the possibly that some ofthe elements of this document may be the subject of pte right. CEN [and/er CENELEC] shall ot be hela responsible for identifying any o al such patent ries ‘This document supersedes EN 150 9001:2008, ‘This document has ben arepared under 2 mandate piven to CEN by the European Commision and he ‘European Free Trade Associaton, and supports essential requirements of BU Directives). According tothe CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement ths European Standard: Austra, Belgium, Bulgar, ‘Croatia, Cyprus, Czech Republic, Denmark Estonia, Finland, Former Yugoslav Republi of Macedon, France, Germany, Greece, Hungary, lean, Ireland, Ttaly, Latvia, Lithuania, Laxembourg, Maka, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Swedea, Switeras “Turkey andthe United Kingdom Endorsement notice ‘The text of $0 9001-2015 hasbeen approved by CEN as EN ISO 9001:2015 without any modification.SEN $0 9001:2015, 150 9001:2015(8) 2 8 g & g & a [Normative references ‘Terms and definitions i Context ofthe organization 41 Understanding ne organization ad es conta z z 42. Undersanding te needs and expectations of interested parties 43 Determining the seope of tie quality management system 44 Quality management system snd its processes en 5 Leadership. ‘51 Leadeship and commitment —— Sil Genera : 512 Cusumertoas 8 52 Policy : 521" Establishing the quality policy E 522 _Communieting the quality pais 53° Organizational rls, responsbilties and authors. ce 6 Planning 61 Actions w addres sks and oppotnities, {52 Qual objectives and planning achieve them 63° Panning ofehanges 7 Support. Ta Resources = Fal ene 712 People 73 Infrastructure A Environment or the operation of processes ZS. Monioring and measuring resourees 7.6 Organzational knowledge 72 Compeence 73 Awareness. 74 Commancation 75 Documented inormation 781 General 752 Creating and updating 783 Control of documented information 8 Operation 81° Operational planning and contol 82 Reyuirements or pradts and services 821 Costomerconmuniestion 822 _Betermningthe requirements for products ad services 823 _ Reviewar te reqlrements for products and services 823 Changes to requtements for products and services 4 83 —_Designand development of products and servien un St Genera a 832 _Designand development planing i 833 Designand developmentinputs ity 834 _Designand development controls 2 835 _Designand development outputs 2 B36 Design and development changes 2 {21602085 rsed ui18S EN 50 9001:2015, 180 9001:2015(E) 84 Conrolof exernlly provided processes, products and services, 3 Sar Coen ae pees ae a 842 Type and een of contol 3 {143 Information fo external providers 3 : 85 Production and service provson cae 5.1 Control of potion and service eovsion uf 822 dentfeation and traceability oe 853 Property belonging to customer or exernal providers. 2 ¢ 854 Preseraton aS 855 Postedelvery acts eee 836 Control of chnges . isa 46 Release of products and series ue 85 Canto of fonconforming ouput SRSA ae 9 Performance evaluation <9 3 Mantring messurenent analysand evaluation : sce St General use 9:2 Castomersistacton — ct S113. Anais und evaluation ir Be Inert cnn 7 53 Management review = ies S31 Gener | 93.2 Management review inputs acces 93.3. Managemen review outputs = = a: 10° tmprovement prio g 104 General ne 102 Nonconormiy and corecive action ae 4103 Continual improvement. @ ‘Annex (informatie) Clarification ofnew structure, terminology and concepts 2 Annex 8 informative) Other International Standards on quality management and quality ‘management systems developed by 1S0/TC 176 23 ‘biography 2 v 1502015 apse185 EN 150 9001:2015| 180 9001:2015(E) Foreword 150 he International Organization fr Standardization) isa worldwide federation ofnational standards bodies (ISO member bodies). The wrk of preparing International Standards is ormaly carried out through IS0 tecnica committee. Esch member body interested In a subject fr which tehsil = Commitee hes been established has the right to be fepresented on that eommittee,Ieersalsal ‘organisations, governmental and non-governmental, in alson wih ISO, aso ake part in the werk {Sb collaborates closely withthe International Bectotechneal Commission (IEC) om all matters of ‘ectrtechneal standardization ‘The procedures used to develop this dacoment and those intended for ts further maintenance are described inthe ISO/IEC Directives, Part I Inpalular the aiferent approval rtria needed (othe “iferent types of 190 documents should be noted. This document was dated in accordance withthe ‘litora les ofthe 10/1BC Diective, Part 2 ove wrwwuiso.ona/ directives) tention ie drawn tothe possibly that some of he elements of his document may be the subj of patent rights 190 shal not beheld responsible Yor dentifying any oll such patent rights. Detals of Sry paent rights identified daring the development ofthe document will ben the ftroduction air nthe ISO listo patent celsrations receve (se wastisa.are/ patent) [Any trade name used i this docureat information give forthe convenience of users and does not fonetitate an endorsement oranexplanationon he meaning ofs0 specie terms anexpression elated to conformity assesment {wl ag information about ISOs adherence to the Word Trade Organization (WTO) prlalpes the ‘Technical Barriers o Trade (TST) see the folowing URL: wisn or/iso/frewar ‘The committe responsible for this documents Technical Committee ISO/TC 196, Quality management ‘and ql assurance Subcommitee C2, Quality systems. g ‘This Ht edition cancels and replaces the fourth edition (180 9001:2008), which has been technically ‘evised through the adoption of revised cause sequence andthe adaptation of the revised quity ‘management principles and of new concepts It iso cancels and repaces the Techalal Coreigensum 180 9001-2008/Coe1-2008,85 EN 150 9001:2015 150 9001:2015(8) Introduction ‘The adoption oa quality management system is a strategie decision for an organization that can belp to mprave es overall performance and provide a sound bass for sustainable development initia ves ‘The potential benefits oan organlztion of mpementing a quality management system base on tis International Standard are 5 2} the ability to consistantly provide products and services that meet customer and applicable = Statutory and regulatory requirements: 1b) eticating opportunities to enhance customer satisfaction: 19) dressing risks and opportunies associsted with ts context and objectives 4) ‘theabilty to demonstrate conformity to specie qualty management system requleements This International Standard canbe used by Internal and external partes. ‘kis nt the intent ofthis ntervational Standard to imply the need for = uniformisy inthe structure of itferent quality management systems = alignment of documentation othe cause structure ofthis international Standard = theuse ofthe specie terminology ofthis tnternationa standard within the organization, ‘The quality management system requlrements specified in this International Standard. are Complementary to requirements Tor pradicts nd services 2 This International Standard employs the process approach, whith Incorporates the Pla-Do-CheckeAet (POCA eye and risk-based thinking, ‘The process approach enables an organization o pan ts processes an thelr Interactions ‘The POCA cycle enables an onganiation to ensure that its processes are adequately resourced and ‘managed, ad tha opportunities for improvement are determined and acted om Risk-based thinking enables an organization to determine the factors that cou cause processes and Its quality management system to deviate from te planned resis, to pst n place preventive controls to minimize negative effects and to make maximum use of opportunities as they are (Ge Clause A) i Consistently meeting requirements and addressing future needs and expectations poses a challenge for urganieauons in an increasingly dynamic an complex environment. fo achieve ths wbestiv, the brganzation might fin te necessary to adopt various forms of improvement aditon ta correction = $n eantnal improvement, sich a breakthrough change innovation and re-organietin, In this Iternationl Standard, he following verbal forms are wed = “shall indeatesa requirement; = “shou indicates recommendation = “may indicates a permission; — ‘can inicates a posstilty oF a capability Information markedas NOTE" for guidance nunderstandingor laying the associated requirement.SEN 150 900122015 150 9001:2015(E) (02 Quality management principles : ‘Tis mernational Standards hase onthe quality management principles described is 1S09000.The = ‘eserptons include a statement ofeach principle a rationale of why the panel Is important for he ‘organization, some examples of benefit sasoctated witht principle aod examples of typical actions + tlinpeove the organization’ performance when apolving the ping “The quality management priaeples are = customer fous, = leaders = engagement of people = process approach = improvement: = evidence-based decision making: — relationship management. 03 Processapproach 03. Genera ‘hig International Standard promotes the adoption of a process approach when developing. Itaplementing and improving the effectiveness ofa quality management system, to enhance custemer Satislotion by meeting customer requirements, Specise requirements considered esental tothe !idoption ofa process approach are inched in Understanding and managing Inerelated processes ae 9 system contributes to the organization's tlfecivenes snd efficiency in Achieving ts intended eesults. This approach enables the orgaiztion {o control he ntereationships and interdependencies among the processes athe system so tha-the bverall performance ofthe organization ean be eahaneed ‘The process approach involves the systematic definition and management of processes, and thelr Interaetons soos to achieve the intended results in accordance withthe quality paley and strategie {lrectan ofthe organisation, Management ofthe processes an the system asa Whole canbe achieved ting the PCA evel (se 0.3.2) with an overall foes on riskebased inking Gee 0.3.3) aimed at aking, ‘vantage of opportunities and preventing undesirable results. The application of the process approach na quality management system enables 2} understanding nd consistency in meeting requirements: 1b) the consieration af processes in terms of adted value i 6) theachivement of effective process performance: 4) provement of processes based on evaluation of data and information ist give aasemats eprenetaton fay process ant shows the mteractin of ty cloments monitoring and measuring check pointe which are neceseary Tor contra are specie to exch process = Shut wil vary dependingon te elated risks,85 EN 150 90012015. 180 9001:2015(E) Figure 1 — Schematic representation ofthe elements ofa singleprocess 032 Plan-Do-Chedk-Acteyele ‘The POCA eyce can be applcd to all processes and tothe quality management system as a whole ‘igure. ustrates how Cases to 10 can be grouped in relation the POCA ose "Taig Hageman San We = ‘seas sptnea | | a | reticent | "sw teciemt_| | coins | } woresea moe) \. a NCTE Numbers inbracate cle to th clases in ths neratina tad Figure 2 — Representation ofthe structre ofthis International Standardin the POCA cycle wi 01802015 Arpeee5 EN 150 9001:2015 180 9001:2015(8) “The POCA cycle can be briefly describe as follows _— Phan: establish the objectives ofthe system and its process, and the resources needed to deliver {esl In accordance with customers requirements tn ke organisation’ polices, snd entity Sd addres aks and opportunities — Do: implemen what was planned — Check: monitor and (where applicable) measure processes and the resulting products and services| against pales objectives, requirements and planed ative, ad report the results — et take actions to improve performance, as necessary. 033 Risicbased thinking Risk-based thinking (ee Cause A.) i essential for achieving aneffectve quality management system ‘The concep of risk-based iaking has been Implicit ia prevousediions of tis Interational Standard Inclading for example carrying out preventive action to eliminate potenti noncoaTormies2na)sing {ty noneonformites that do aecur and taking atin fo prevent recurrence tht Is appropriate fo the ‘tecteoFthe monconformity. ‘To conform to the requirements of this international Standard, an organization needs to plan and Implement actions to arse risks and opportunitie. Addressing both Fsks and opportunites frtablches 4 basis for increasing the efeetieness ofthe quality management system, acleving Improved results and preventing negative effects, Opportunities can arise as a result ofa situation favourable to achioving an intended result or trample, ase of eireumstanoes that allow the orgameaton to lac customers, davelop new products nd serves, reduce waste o improve productivity. Actions to adress portunities can also include ‘onsieraton of associated risks Rik the eet of uncercaity and any such uncertainty can have postlve or negative eters. A positive deviation arising frm ask can provide an opportunity, bt not Elfpotivertfects of rsk result opportunities. (04 Relationship with other management system standard: ‘This International Standard applies the framework developed ty ISO to improve alignment among its International Standards for management systems (se Clause AD) ‘This International Standard enables an organization to use the process approach, coupled withthe POCA eyce and risiebased thinking, to sign or integrates ually management system with the requirements of other management system standards ‘Ths International Standard relates to150 9000 and 1S0 9008 asfllows — 1$0 9000 Quality management systems — Fundamental and vocabulary provides essential background forthe proper understanding and implementation this International Standard: — 150.9004 Monaping for the sustained success of an organization ~ A quality management approach provides guidance for organizations that ose Co proess beyond the requtrements of this Invernatonal Standard Annes. provides details of other International Standards on quality mangement and quality ‘management systems that hate een developed Oy 190/417 This neenational Standard does not include requirements specific other management systems Such a those for environmental management occupational heath and alety management, or finanei management ‘Sectorpecii quality management system standards based onthe requirement ofthis nterationl ‘Standard have een developed for number of sectors. Some ofthese stands specsfy addtional ‘ality management system requirements, while others are inited to providing guidance tb the ‘Split of thi International Standard within the particular ecto.185 EN 509001:2015 ‘Amatrix showing the corrlation between the dauses ofthis etion ofthis International Standard and the previae edition (180 9001:2008) can be Found onthe ISO/TC T7W/SC 2 pen access web site a selsoorgdtea/sc02/ouble2S EN 150 90012015, INTERNATIONAL STANDARD 150 9001:2015(6) Quality management systems — Requirements 1 Scope ‘This International Standard specifies requirements for a quality management system when an organization: 4) needs to demonstrate ts ably to consistently provide products and services that meet customer © nd appliable statutory and regulatory requsements and 1) aims to enhance customer satisfaction through the effective apliatlos ofthe system, including processes for improvement af the system and the assurance of conformity ta customer and Spplcable statutory and regulatory quirements llth requirements ofthis International Standard are generic and ae intended tobe applicable any ‘nganiation, earls Ks type nese, the products and serves provides. 3 NOTE: this ineratonal Sanda, he terms “produc” or "servic" oni ap to product nd services NoTE2 Stutory and segustary egurementscan be expressed as legal equlremats 2. Normative references ‘The following documents, in whole ori par, are normativly referenced inthis document and are Indispensable for it application, For dated reerences, only the edition cted apples. For undated Feferences, the atest edition ofthe referenced document (including any amerdments) applies. 150 9000:2015, uoiy managsmentystams — Fundementas and vocabulary 3. Terms and definitions or the purposes ofthis dacument, the terms and defiitions yen in S0 90(0:2015 apply 4 Context ofthe organization 4.1. Understanding the organization and its context z ‘The organization shall determine external and internal sues that are relevant to ls purpose and ite strategic direction and that affect its ability to achieve the intended result(s) ofits quality management system ‘The organization shall monitor nd review information about these external and internal issues, NOTE Issues can neue postive and negative Fctorsoranitins or consideration 3 NoTE2 Understanding the extern context con be facitatd by conserng tes arising fom ep techologiea compete market ctr sell and canons enefnment whether neato, toa NOTES Understanding the eral contest cane fated by casing sues late a vals clr 101503915 scene85 EN 150 s001,2015, 180 9001:2015(6) 42 Understanding the needs and expectations of interested parties Duct ther effect or potential effect on the organization’ ably to consistently provide products and Serices that meet customer and applicable statutory and reguletory tequremints sever nee Shall deteroine 4} the interested parties that are relevant othe quality management system: 1) the requirements of hes interested parties that are relevant tothe quality management system The organization shall monitor and revew information about these interested parties and thelr relevant equlrements ‘43. Determining the scope of the quality management system ‘The organization shall determine the boundaries and appleby of the quality management system toestabish Rs scope When determining this scope, the organization shall consider 8) theextenal and internal issues referred tind BF therequirementsofrelovant intrested pies referred ton dh 9) the products and services of the organzation is oranication skal apply al the requlretents of his international Standard they are applicable thin the determined seope ats quallty management syste ‘he scope ofthe organization's quality management system shal be aallable and be eralntaned as documented infrsiation. The scope hal state the typeof Product a services covered aed rede justification fr any requiremest ofthis Internationa Standard thatthe organization deceranca oe pplicable tothe sepe os quality management nate, anfrmity to this toterntional Standard may only be claimed ifthe requirements determined as not being apoliable do ot affect the onanaatons ably or respons to ensure the caer ain Products and servcesand the enhancement of eastomer satiocte 44 Quality management system and its processes Aaa The organization shall establish implement, maintain and continalyinproe a quality Management system, Including the processes needed and thet int-acions, a acerdorec WB requirements ofthis international Standare ‘The organization shall determine the processes needed forthe quality management system and thelr application throughout he organization an shale 8) determine the inputs required and the outputs expected from these processes; 5) determine the sequence an interaction ofthese processes 1) determine and apply the erteria and methods (incuding monitoring, measurements and related Performance indicators) needed to ensure the effective operation an contra ofthese determine the resources nesded for these processes and ensure their avalbly ©) assign the responsibities and authorities fr these processes: 1D adress the risks and opportunities as determined in acordance with the requirements of #8) graluate these processes and implement any changes needeto ensure tha these processes achieve their intended results 2 1502015 Aephsreserd5 EN 150 9001:2015 180 9001:2015(8) improve the proceses andthe quality management system. AA2 Tothe extent necessary the onanization shall 2) maintain documerted information to support the operation ofits processes; 1) retain documented information to have confidence thatthe processes are being carved out as planes. 5 Leadership 5.1 Leadership and commitment 54 General ‘Top management shall demonstrate leadership and commitment with respect to the quality management syst 3}. taking accountability forthe effectiveness ofthe quality management system; b) ensuring thatthe qualty policy and quality objectives are established fr the quality management System and are compatible with the context and strategie direction ofthe organization’ © ensuring the iteration ofthe qualty management system requlrementsintothe organizations 3 business processes 3 4) promoting the ase the process approach and riscbased thinking: g ©) ensuring thatthe esources needed forthe quality management system ar avaible; 1D communicating the importance of efetive quality management and of conforming tothe quality. 2 ‘management system requlrements 3 18} ensuringthat the quality management system achieves its intended results E 1h) engaging, directing and supporting persons to contribute to the effectiveness of the quality ‘management system $ 2) promoting improvement; i) supporting other relevant management roles to demonstrate thei leadership af aplis tothe 2 seeas of responsi. 3 NOTE Reference t “business” inthis Internationa Standard canbe nterpeted broadly to nan those estrone tate pps oh opin estes, wheter nernatn spb ote 54.2 Customer focus Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that 2} customer and app able statutory and regulatory requtements are determine understood and | ansstently met : 1b) the risks and opportunites that can atfect conformity of peeducts and serviesand the abit to ‘ahance eustomersatisfaction are determined and addressed ©) the focus on enharcing customer satisfactions maintained, © 802015- Agreed a8S EN 150 900.2015, 150 9001:2015(E) 52. Polley S21 Establishing the quality policy ‘Top management shall establish, implement and maintain a quay policy that : 2) sspnropriete tothe purpose and context of the organization and support its strategie direction 5) provides framework fr setting quality objectives 9) Includes a commitment esti spplibte esuirements; {includes a commtment to continual improvement ofthe quality management system 52.2 Communicating the quality potiey ‘The quality poli shall: 3) beavatlable and te maintained as documented information; 8) becommunicsted understood and aplied within the organizations 9) beavalabetoebvant interested partes as appropriate 53. Organizational oles, responsibilities and authorities eaamanament hal ensure thatthe reaponsibiltes and authorities for relevant res re assigned, ‘ommunicated and unterstood within the organization ‘Top management shallassig the esponsibility and authority for: ®) gmsuring that the quality management system conforms to the requirements of this International Stardaed ) ensuring that he processes ae delivering their lncended outputs; 9 porting on the performance ofthe quality management system and on opportunities for Improvement (se 2.1), mpartculartotop madapenens 4) ensuring the promotion of customer fous throughout the organzation; 9 SLEWLng thatthe tegrity ofthe quality management system is maintalned when changes to the ‘ality Management system are planned and inplemanied 6 Planning 6.41 Actions to address risks and opportunities sated en Panning or the qualty management system, the organization shall consider th nsues ‘Reged tind andthe reqirements reeredtoin 42 and determine there and oro ea ees reed to be addressed to 3} assurance hate quality manogenten system can achiev its intended rest) 1) enhance desirable ects ©) prevent, o reduce undesired effects 4) achieve improverer7 SEN 'S0.9001:2015 180 9001:2015(8) 64.2 The onaniaton shall plan 4) actions to addres these risks and opportunites: i 1) howto 1) invgrat and implement the actions int fs quality management system processes (se 4.4), 2) evaluate the effectiveness ofthese actions i Actions taken to addres iss and opportunities shall be proportionate to the potential impacton the Conformity of products and services. NOTE Options to ares aks can nce wong ri tang risk moder to pursue an opportunity Dimiatng te risk sure: changing the Manado consequences, ssrng the Fk or etaiing Sk informed dest, NOTE2 Opportunites can lad tothe adoption of mow practices, nuehing new products, opening new Inatats addressing now curomers bling prtncstinsuling new techmlogy an eter desirable and vabie Deiisostonddras the erganizaonsor customers eds 3 62 Quality objectives and planning to achieve them i 62.4. The organization shall esablsh quality objectives at celevan functions, levels and processes 4 needed forthe gualty management system : ‘The quality objectives shall: g 3) be consistent with the quality pale 1) bemessurable: ©) take into account applicable requirements; 4) elevantto conformity of proicts and services and to enhancement of customersatisfaction, = 6} bemonitores 1) becommunicted: g &) beupdated as appropiate 5 ‘The orgnnation shall maintain docurened information onthe quay objectives 3 4622 When plnning how to achiev its quality objectives, the organization sal determine 2) what will be done: 1b) what resources will erequte 5 ©) who will be responsi ween wil be completed ow the results wil be evaluated 63. Planning of changes : When the organization determines the need for changes tothe quality management system, thechanges: shall be carried out ina planned manner (se 48) (21502015 Ags rn 5Bs EN 150 9001-2015 180 9001:2015(E) ‘The organization shal consider 83) the purpose ofthe changes anther potential consequences 1) the integrity ofthe quality management system: 6) theavalabiliy of resources {the atlocation o reallocation of responsibiities and authorities. 7 Support 74. Resources TAA Generat The organization shall determine and provide the resources needed for the establishment, Implementation, maintenance and contnial improvement of the qualty management syste, ‘The organlzation shall consider 8) the capabilities of and constraits on existing internal resources 1) whatncedsto be obtained fom external providers 712 People ‘The oganization shall determine and provide the persons necessary fr the effective implementation ofits qualty management system and forthe operston an contro ote processes 743 Infrastructure ‘The organization shall determine, provide and maintaln the Infrastructure necessary for the operation. its process and 0 achieve confarmiy of products and services. 2) binge and ascot tities ' equpmen oclug hardware and software: 6) eanporaton resources, 8) information na comunization techs 744 Environmentfor the operation of processes ‘Tie organization shal determine, provide and maintain the environ nent necessary forthe operation alts proceses ano achieve conformity of prt and serves, NOTE Asutableenvironinent en be combination ofhiman and physcal factors, such 2) socal (4. tor-iscriintary cl, om-confontoa ©) poyhalapeal (eg reseeducing bro prevention. motional fective physical (og temperature est mit, ih setlow yan nie) “Ths factors can ler substantial depending on he product and servic provided 6 (01502015 ngs ceseres15 EN 150 9001:2015, 180 9001:2015(F) 74 Monitoring and measuring resources TASA General ‘The organization shall determine and provide the resources needed to ensre ‘alld and reliable Tesults when monitoring of measuring is used to verify the conformity of produc and serves 0 Feaqivements ‘The organization shall ensure that the resources provided: 2) aresultabe forthe spect type of monitving and measurement activites being undertaken 1b} aremaintaned to ensure thei continuing itnes fo thelr purpose ‘The organization stall retain appropriate documented information as evidence of fites for purpose of ‘thesmonitoring and measurement resources, 74152 Measurement traceability ‘When measurement traceability isa requirement, ors considered by the organization tobe an essential part of providing coutdence Inthe validity of measurement results measuring eqieat shall be 4) calbrated or verified orboth, at specified intervals, or prior to use, against measurement standards {raceable to international or national measurement standards when no such standards exst, the ‘sis used fr calipaton or verification shall be retained as documented information: 1b) denied in order to determine their status; 6) safeguarded from adjustments, damage or deterioration that would invalidate the calfration Status and subsequent measurement results ‘The organization shall determine if he validity of previous measurement results as been adversely ‘Mected when measuring equipment is found to be uni for 1s Intended purpose, and shall take Sppropriste ation as necessary. 74.6 Organizational knowledge ‘The organization shall determine the knowledge necessary forthe operation of ts processes and to ache conformity of products and sevies, ‘This knowledge shall be maintained and be made avalale othe extent necessary. When addressing changing needs and sends, the organization shall consider its current knowledge tnd determine how to acuive or actess any necessary addtional knowledge and requeed updates. NOTE 1 Organatona! Koowledge Is knowledge specie to the organization: is goerally gave by ‘eperience ii nfrmatin that used an shared to achieve the orsneaton jective NOTE? Orgnistional knowledge can be based on 2) imernal sources (eg inlets property: Knowledge gained from expen: Issons leaned fom ‘Bares anasto opr ad shang documents Knowledge ea experience: the ress o Inprovemonsin process produts am sere) 1 eternal sources (og standard academia: cotroces: ering Kn wedge rom costes o Chace pond 21902015 Aris resem 7{85 EN so 9001:2015 150 9001:2015(8) 7.2 Competence ‘The organization shall: 4) determine the necessary competence of person(s) Going wark under its control that affects the performance and effectiveness ofthe quality management system: 1) ensure that these persons are competent on the basis of appropriate education, traning, or ©) whore applicable take actions toaequire the necessary competence, and erahate te eletiveness ifthe actians taken 4) retain appropriate documented information as evidence of competence NOTE Applicable ctins can nla fr example provision of trsning t,he mentoring of or the *sigament ofcurerlympjed persone the ringar contracting of compete parsons 73. Awareness ‘The organization shall ensure that persons doing work under the organization's controlar aware of 3) thequalty policy 2) relevant quality objectives: 1) theircontribuion to the effectiveness ofthe quality management system, incuding the benefits of Improved performance 4) theimplicaions of nat conforming withthe quality management system requirements, 74 Communication ‘The organization shall determine the interna ‘management system, incuding 1nd external communications relevant tothe quality 23) onwhat twit communicate; 1) when to communicate ©) with whom ro communicate 4) how wo communicate; 19) who communicates 7.5 Documented information 754. General ‘The orgalzaion's quality management system shall include: 3} documented information required by ths International Standard 1) documented information determined bythe organization as Belng necessary fr the effectiveness ofthe quality management system, NOTE The exten of documented information for a quality management sytem can afer fom one Grganaationtoanotherdue to ~ tes oforgntzationandits typeof actvtas, processs produsts and seri. 85 EN 150 9001:2015 180 9001:2015(6) the comple af procese pd hee interactions = the competence of persons 752 Creatingand updating ‘When eeating and updating documented information, the oryanizatio shal enstre appropiate 4} dentifeaton nd description eg atl date, author o reference number} 1) format (og language, software version, graphs) and media eg, paper electonie ©) review and approval for suitability and adequacy. 78.3. Control of documented information 3 75.31 Documented information required by the quality management system and by this International Standard shall be contralled to ensure" ql 2) itivavailable and suitable for use, where and when is needed: ¢ 1) lel adequately protected (fom loss of confidentiality, improper use, oF os afintegety. 753.2 For the control of documented information, the organization shall aldress the folowing actives, a applicable 43} Alstribtion, aces, retrieval and use: 1) storage and preservation including preservation flesblty ©) control ofchanges (eg version contro; 4) retention and dspostion Documented information of external origin determined bythe organization tobe necessary forthe Planning and operation of the quality management system shall be identified as appropriate and be controle, Documented information retained a5 evidence of conformity shall be protected from unintended alterations: NOTE Access an ply decison regarding te persion to view te documestd information oor {he permit and utr to view and change te documented information 8 Operation 8.1 Operational planning and control z “The organization shall plan, implement and control the processes (Gee 44) needed to meet the Fequrements forthe provision of products and services, and to implement the ations determined in = aus by a} determining the emsiements forthe products and serves; 1b) establishing ever for: 2) he processes: 2) the acceptance of products and services; ©) determining the resources needed to achieve conformity to the product and service requirements esozms-ateghereend >85 EN so 9001:2015 150 9001:2015(E) 4) Implementing conto ofthe processes in accordance withthe criteria; ©) determining, maintalaing ad retaining documented information tothe extent necessary: 1) cohave contidence that he processes have been carried outs panned; 2) todemonstrate the conformity of products an services to thee requirements, ‘The output ofthis planing shal be suitable for he organizations operations ‘The organization shall control planned changes and review the consequences of unintended changes, taking ation to mitigate any adverse ellects se necesser. ‘The organization shall ensure that outsonrced processes are controled (se 8.4), 82. Requirements for products and services 8241 Customer communication Communication with customer shall include 3} providing information relating to products and services; 1) handing enquiries, contracts orders, acuding changes ©) obtaining customer feedback relating to products and services, including customer complains 4) handing or contelling customer property: ©) establishing speci requirement for cotingeney actons, when relevant 82.2 Determining the requirements for products and services| When determining the requlrements forthe products and services to be offered to customers, the organization shall ensure that 4) the requirements or he products and services are defined, incuding 1) any applicable statutory and regulatory requirements 2) those considered necessary by he organization; 1b) the organization can meet the aims or the product and services toler 1823 Review ofthe requirements for products aid services 823.1 The onganization shall ensure that thas the ality to meet the requirements or products an services to beofered to customer. The organization shall conduc review before commiting a sup} Droduets an services oa customer onde 8) requirements specified by the customer, including the requirements for delivery and post Uelvery activities 5) requirements not stated by the customer, but necessary forthe specified or intended use when inowne ©) requirements speed by the organization 4) statutory and regulatory requirements appliable othe products and services 2) contract or order requirements differing frm those previously expressed 10 moms15 EN ISO 9001:2015 150 9001:2015(F) ‘The organization shall ensure that contractor order requirements difring ftom those previeusly defined are ceslve, ‘The customers reulrements shall be confirmed by the organization before acceptance, when the {ustomer doesnot provide dctumented statement of tel equlrements NOTE nsome stations such as erne sales aFrmal review is impactica foreach order nse, the Fevlew can cover elvan prod information. such ctlogus 82.32 The organization shall retain documented information, as applicable 2) onthe resus ofthe review; 1) omany new regulrements fr the productsand servies 824 Changes to requirements fr products and serve ‘The organization shall ensure that eelevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and Service are caged 83 Design and development of products and services 83.1 General ‘The organization shall establish, implement and maintain a design and develogment process thats ppropritetoensurethe subsequent provision of products nd services. 83.2 Design and development planning In determining the states and controls for design and development, the organization shall consider 2} thenature,duratin and complexity ofthe design and development activities 1b) the required process stages, including applicable design and development reviews 16) the required desiq and development verification and validation activites: 44) the cesponsblites and authorities involved in the design and development process; ©) theierna and external resource neds fo the design and development of products and services 1) the need to contd interfaces between persons involved in the design and development process 2) theneed for ivakement customers and users the design and development races; 1) the requirements ‘or subsequent provision of products and services 1) the level of contol expected for the design and development proces by customers and other Felevant intrestel parties 1) the documented information needed to demonstrate that design and development requirements have been met. 82.3 Design and development inputs “The organization shat determine the requirements essential forthe specific types of produets and Services tobe designe! and developed. The eganzation shal consider 2) fanetionaland peformance requirements; 21902095 gsr a85 EN 50 9001:2015 180 9001:2015(8) D) formation dered frum pres snl design and development acer ©) statutory and regulatory requirements standards or codes of practic tha the organization as comme implement; © _Poenial consequencesof allure du tothe nature ofthe products and serves [ios hal be adequnt for dengan esepmen purposes, comets ed naniguo onfliting dest and development inputs shall be resolved, ‘i nolo shall ean documented information on design an. development pes 834 Design and development controls ‘Tre ranean shall aly cones tothe design and devlopmertproces tease that 3) theresutsto be achieved are defined; 2 eensoeee oevaante he ably fhe ress of design and deopmen to meet requirements 9 petseyars tt re conducted wo ensue ta the design ad developmen cts eet the ‘pat equirementse © Fanuromeagi re sanded wo ensare hat the reuking prods and serves meet. he "equirements forthe specified application snare are © Sahay alos ae tate on probes determined durin the eis or veriaton and validation atvties, documented information ofthese activites i retained. Since psa emma res wriion and vad he tinct prgses They canbe “enGcesepermyorinan/conhintin ais staorhe pds ee ea 35 Design and development outputs ‘The organlzation tall ensure that design and develope ouput: 4} meet the input requirements 2) aseadequte forthe subsequent processes othe prrlston of products and seve; a ieee tfrenc montoringandmetaringrequemens.sappropie and ecelanc ete o nese lie ots an svi thatare eset tinea urpne anther sate and proper provsirs Thorns tal ean documented formation on design nd development ouput 3.6 Design and development changes dnd copa Sa ety review an contra changes ade dari subsequent tthe design impact on ataer eaus td svi tthe exten aeesry war ee enh es impactonconfocmityto requirements ‘The organization shal retain documented information on: 3} design and development changes; 1) theresutsorevtews 2 1502015 Arig ser85 EN Iso 9001:2015 1s0 9001:2015(E) 6) the authorization ofthe changes 48) thesctions taken to prevent adverseiepacts i 8A Control of externally provided processes, produ:ts and services 84.1 General “The organlzation shall ensure that externally provided processes, products and services conform to requirements 2 ‘The organization shall determine the controls tobe applied te externally provided processes, products sind services when 8) products nd services from external providersareintended er incorporation into the organization's bun products and services, 1) products and services are provided directly tothe custarer(s) by external provides on behalf of be organization 1) aproces, or part of proces, x provided by an externl provider a result ofa decision by the organization ‘The organization shall determine and apply criteria forthe evaluation, selection, monitoring of performance, ad reevaluation of external providers, based on their abil to provide processes or Drodvets and servies in accordance with reutrements. Te organization shall retain Uocumented {nformation ofthese atts snd any necessary actions arising rom the evaluations. 2 Type and exten ofcontrol, ‘The organization shall ensure tha externally provided processes, products and services do not Aaversey affect the organisations ably to consistently dlver conforming products and services to ‘The organization shall: 43) ensure that externally provided processes remain within the control ofits quality management system: b)- define both the controls thatit intends toapply tan external provider andthose itintendsto apply 6) take into consideration 1) the potential impact of the externally proved processes products and services on the longanization's aby to consistently meet customer and apolcabe statutory an regulatory = 2). the ffecivenes ofthe controls applied hy the external provider: 4) determine the verification, or other activities, necesaty to ensure thatthe externally provided processes products and services et requirements. 3 43 woviders “The organization shall ensure the adequacy of requirements prior to thele communication to the external provider ‘The organization shall communicate toexternal providers its requirement oF: 3} the processes, products and services tobe provid: isons aaron 325 EN IS0 9901-2015 150 9001:2015(8) 8) the approval of 1) produets and services 2) methods, processes and equipment; 3) the release ofproductsand srhices {competence incuding any required qualifestion of persons "9 theesteral providers’ interactions with the onganieation, ©) control and monitoring of the external providers Performance t be applied bythe organization; ‘external providers premises, 85. Production and service provision 85. Control of production and service provision causation sal implenent production and serve vison adr cond cndtons Controlled condition shalnclude, a applicable 4) theavaitabiity of documented information that defines 9 ahetamertes othe products to be produce, the evi oe provide, octhe activities tobe performed 2) the results tobe achieved, D) the avaalty and se of ube monitoring and meesuringreseuree; a ert a con of umtagan easement acest propre aes tery that have Been en POE OF cutputs, and sceptanee cnkgas ene services, have been me thease of sable inrasructure and envirnmet forthe operat processes ©) thesppoinanent of competent persons ng any required qualieaon 7 ras 2h Pra evasion ofthe ily co aeieve planned rests of he processes montero nna eve Provision where the eninge cnn at subsequent 1 the implementation of actions to prevent human eror 1) the implementation o release, delivery and postelivery aetvtis 85.2 Identification and traceability Coretta tattle mean o ely ouput when ¢ i aeesny to ensure the Contormityofpeaduets ant serves Teja a emt the an ouput th espet to montana measurement ‘quirements throughout production and service eos reingetzation Sal contol the unique Weston of the euputs when traceability is a Ceateemen. and shllectain te documented norton necessary ose eee ae 102015 AgereEN 150 9001:2015 1s0 9001:2015(8) 854 Property belonging to customers or external providers “The organization shall exercise car with property belonging to customers or external providers while itis unde the organization's conta or being used by the orgaaion ‘The organization shall dentiy very, protectand safeguard customers or enteral providers property provided for use orincorportion int the prodicts and secs. When the property ofa customer or external provider is lost; damaged or otherwise ound to be Unrultable for use, the organization shall eport this to the custamer or extermal provider and etn {ocuntented fafornation on whathas occured NOTE Acustomersor enteral provides property canfaclade materials componets bolsand equipment, premises, mlletul property abd personel dt, 854, Preservation ‘The organization shall preserve the outputs during production and service provision to the extent necessary to ensure conformity to reqlrements NOTE Preservation can indude dntifeaton, handling, contamination contol packaging, storage, {wansmissnr transportation and potion. 5S Postdeivery activities ‘The organization shall met requirements fr postdelivery activites assoclated with the products and serves. In determining the extent of ost delivery activities that are requeed the organiza shal consider 3} satuory and regulatory requirements 1b) the potential undesired consequences associated with ts products and services; ©) the nature, useand intended ifetime ofits produc and services 4) customer requirements; ©) customer feedback NOTE Posdlvery activites can nce utions under warranty provisos contractual bligtion suck ‘Shsitentnce service an suppimetary eviews sch aseeyehngr ial disposal 85.6 Control of changes “The organization shall review and contro changes for praduction or service provision, to the extent necessary tense conknuing conformity with requirements “The organization shall retain dacumente information describing the results ofthe eview of changes. the persons) authorizing the change and ay necessary actions aisng am he review. 86 Release of products and services ‘The organization shall implement planned arrangements, at appropriate stages. to verify that the productand service requirements have been mt ‘The release of products and services tothe customer sll nt proceed inti the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as Applicable, bythe custome. ‘o1s02015-Atiee rene 618S EN 150 900122015 180 9001:2015(8) ‘The organization shal retain documented information on the release of prodicts and services, The documented infornation shall include: 23) evidence of conformity with the acceptance criteria 1b) traceability tothe person(s) authorizing the release 8.7 Control ofxonconforming outputs 87. The organization shall ensure that outputs that do not conform to thie requirements are ntiied and conoid to prevent their anintended use or delivery ‘The organization sal take appropriate action based onthe nature ofthe noncenformity anit effect ‘on the conformity f products and services, This shal lso apply to noncon eming products and Services detected after dalivery of products, during oafter the provision o services ‘The organization shal del with nonconforming outputs in one or more ofthe flowing ways 23) correction: 1) segregation, catainment, return oF suspension of provision of products and services 6) Informing sheeustomer, 4) obtaining atorzation for acceptance under concession. Conformity totherequirements shal be verified when nonconforming outputs re corrected, 187.2 The organization shall retain documented information that 8) describes the ronconformiy: 1) describes the xetions ken; 6} describes any concessions obtained: 4) ‘denis the authority deciding the atin in respect the nonconformity. 9 Performance evaluation ‘9.1 Monitoring, measurement, analysis and evaluation, 94.4 General “The orpantaton shall determine 3) whatnecis tobe monitored and measure 1) the methods for monitoring, measurement, analyse and evaluation needed to ensure validresults ‘when themontoring and measuring shall be performed: 14) when terest rom monitoring and measurement shall be analysed and evaluated ‘Theorganzaion shall evaluatethe performance and the effectiveness ofthe quality managemen! syste The organization shall retain appropriate documented information as evidence ofthe results. 16 e025 Atratercenet85 EN so 9001:2015 180 9001:2015(6) 912 Customer satisfaction ‘The organization shall monitor customers’ perceptions of the degree to which their needs and apestations have been fllile. The organimation shall determine the metheds Yor obtaining ‘monitoring and reviewing this information. oT Examples of monitoring customer perceptions can iu customer surveys. cstomer feedback Up delerad product ad rien: mectings with customers mcketshare anaiss compliments, warranty ‘Shine and desler repo 943 Anatysisand evaluation “The organization shall analyse and evaluate appropriate dataand Information ising from monitoring and measurement. ‘The results of analysis shall be used to evaluate 8) conformity of products and services: 1b) the degree of eutomer satisfaction: 6) the performance and effectiveness othe quality management system 4) Mplanainghas been implemented elective ©) thecffetiveness of action taken to address risks and oypartuttles; 1) the performance af external providers: 4) theneed for improvements tothe quality management system, NOTE Methods to anaie ata can inlae statistical chines 92 Internalaudit 9.2.1 The organization shall conduct internal auits a penne intervals to provide information om ‘whether the quay management system: 3) conforms to 1) the organizations wn requirements forts quality management ystems 2} therequiements ofthis international Standard 1b) isotectively implemented and maintained, 922 Theorpanization shal 2) plan establish, implement and maintain an audit pogeamme(s including the frequency, methods, Fesponsilites, panning reguremente and reporting, which shal tke ico consideration the wportance of the processes concerned, changes affecting the organization, and the results of previous audits 1b) define the audit xteria an scope for each aud 6) select auditors and cond audits toensure objectivity andthe impartiality ofthe audit process 4) ensue that he results of the audits are reported to relevant management 1) take appropriate corertian and eneretive actions without undue dla: ‘Bis 01s assed ” a[BSEN 180 9001:2015 150 9001:2015(8) 1) retain documented information as evidence ofthe implementation ofthe audit programme and the audit results NOTE Seet80 19011 or glance 93 Managementreview 93.1 General ‘ensure is continuing suitability, adequacy, eflectiveness and alignment withthe strategie direction of the organization, 932 Management review inputs ‘The management review shall be planned an carvied out taking nt consideration: 3} the status of aetins trom previous management reviews; 1) changes in external nd internal sues that are relevant the quality management system; ©) Information on the performance and eectiveness of the quality management system, sneluding trends i 1) customer station and feedback from relevant intrested parties: 2} theextenttowhich quality objectives have heen mei 23) process performance and conformity of products and services 4) nonconformities and corrective ations; 5) monitoring snd measurement results: 6) auditeesults 17) the performance of external provides: 4) theadequacy of esoures ©) theeffectvenestof actions taken to adress risks and opportunities (8) 1 opportunities for improvement. 933 Management review outputs ‘The outputs ofthe management review sal inclu decisions and actions related to 4) opportunites for improvement 1b) any need for changes tothe quality management system; ©) resourcenceds. ‘The organization shal retsn documented information a evidence ofthe results of management reviews 8 S020 ~Anguseseved1 EN 50 9001:2015 150 9001:2015(E) 10 Improvement 10.1 General : The oration shal deaminase oppor o improvement and plement ecesory actions to meet customer fequlrerments and eniance customer satsactio, i ‘These shall ncude: 5) improving products and services to meet requcements as well a to address ture needs and. © expectations 1) corsectng preventing or reducing undesired effect; © improving he pesformance and effectiveness ofthe quality management system NOTE Examples of improvement can inde correction, corrective action, coil Improvement, Ureakshrough cng, innovation ad re oratlaation. 1022 Nonconformity and corrective action 102.1 When a nonconformity occurs, nlung any arising from complaints. the organization shal 23) reaetto the aanconformity and, a applicable 1) take action to control and correctits 2} deal with the consequences a 1b) evaluate the need fraction eliminate he causes) ofthe nonconformity in order that it doesnot feu or occur elsewhere, by 1) reviewing and analysing the nonconformity, 2} determining the causes of the nonconformity: 5 3) determining sinilar nonconformlties exist, or could potentially oceur: i ©) implementany action needed 4) review the effectiveness of any corrective action take: <2 plat risks and opportunites determined during panning necessary: make changes tothe quality management syste. Inecessary, Corrective actions shal be appropriate to the effects ofthe nonconformities encwunteed. 40.2.2 The organization shal retain documented information a evidence of: 5 23} the ature ofthe nonconformiles and any subsequent actions taker 1b) theresulsofany corrective action 10.3 Continual improvement “The organization sallcotinlly prove the suitably, adequacy and eteciveness ofthe quality management system ‘eiso ms Angier 1%1 EN 150 9001:2015 150 9001:2015(E) “The orgaization shall consider the results of analysis and evaltion, and the outpts from management review to determine there are needs or opportunities thitshallbeaddressedas pata | fontinual mprovemeat. i 20 enSEN 150 9001:2015 0 9001:2015(6) Annex A (informative) . Clarification of new structure, terminology and concepts Ad Structure and terminology “The clause structure (se, cause sequence) and some of the terminology of this elton ofthis International Standards in eonparson with the previous edition (50 9001:2008), have been changed to improve alignment with ater management systems standards ‘There is no requirement in ths International Standard for its structure and terminology to be applied {othe documented informatin ofan organizations quality management system “The structure of causes ie Intended to provide a coherent presentation of requirements, ther than a ‘Rodel for documenting an onanzatiowsplces, objectives and processes, The structure and content ‘Ol documented information rated toa quality management system can often be more relevant to ts User if relates to both the processes operated bythe organization and information maintained for other purposes. ‘Theres no requirement forthe ters used by an organization tobe replaced by the terms used in this Inernationdl Standard to spaciy quality management system Fequitements Organizations can choose tse terms which suit thei peratons (eg using "records documentation or “protocols rather than documented formate orsuppler, "partner" at "vendor rather than “external provider”) {Ble A shows the mor fiferences in terminology between this edition of this Intemational Standard andthe previous ed tion ‘Table A — Major differences i terminology between 150 9001:2008 and 150 9001:2015 150 90012008 o9nDTIOTS Prokes [raduts and services exclusions INocusee see cause AS for dartcation of applicability) iisnagement representative Not used | simile responses and autboriesare assigned Ibu requirement for asingle management rare sentative) JOocumentaion, quality manual. documented pro Jeedures records Documented information Work environment Environment for the operation of processes Purchased product supper [esternaly provided product: and services Monitoring and [Exteena provider A2 Products and services 1509001:2008 used the term ‘pradtto include al output categories. This edition ofthis International Standard uses “products an services Praductsandservces include all output categories (hardware Services software and processed materials). a185 NSO 9001:2015 Z 180 9001:2015(E) ‘The specific inclusion of “services is Intended to highlight the diferences between profucts and services i the aplieation of some requirements: The characteristic of services i that least part of {he outputs realized atthe interface With the customer. This means, for example that conform) (0 reuirements cannot necessarily be confirmed belore service delivery. In most cases, products and services are uso together: Most outputs that organizations provi to cislomers, of are supplied to chem by external providers, include bath products and services. For ‘example a tengble or intangible product can have some associated service or a service can have some ‘sesclted tangible rttangible product. AS _ Understanding the needs and expectations of interested parties Subslause 42 specifies requirements forthe organtzation to determine the interested parties that drerrelevantto the quality management system and the eequiremeats of those interested parte However, 42 does not imply extension of quay management system requirements beyond the scope ofthis International standard As stated inthe Sope this International Standaed i appliabe where fn organization needs to demonstrate its ability to consistently provide products and services that ‘meet customer and applicable statiary and regulatory Fequlremeats, and alms to enhance customer ‘estaction ‘There is no requirement in this Inernatlonal Standard forthe organaaton to consider Interested pares where has decided tha those parties are not relevant ots quality management system 15 forthe organization to decide i's parlcular requirement af relevant terested party ts elevane fais ‘uty management system, A4 Risk-based thinking ‘The concept of isk-based thinking hasbeen implicit i previous editions ofthis international Standard, eg. thraugh requirements for planning. review and improvement. This International Standard ‘Speils requirements for the organization to understand ts context (see 41) and determine risks 38 4 bss for planning (se 6.1). This represents the applieaon of risk-based thinking to planning and inementng uly management sem process Gee) and wil asin determining ent (ne ofthe Key purposes ofa quality management system isto act a5 a preventive tol. Consequenty ths International Standard does not havea separate clause or subelsoe on preventive action. THe concept of preventive action is expressed through the use of rikebased thinking i formulating ually ‘The riskbased thinking applied in this International Sandard has enabled some reduction in prescriptwe requirements and thet replacement by performance-based reuirements-Ther is reat Fenty than in 130 9001-2008 inthe requirements for processes, documented information and Drgniational responsible, Altough 6 specties thatthe organization sal plan actions to addres risks, there iso requirement forfarmal methods or rik management ora documented risk anagenen process. Organistions can decide whether o not to develop 2 more extensive risk management methodology than is required by thir Internationa Standard, eq through th application o other uldanceor standard, Not al the processes of quality management system represen the same level af ski terms of the ‘onganiation® ably to mete objectives and the effects of uncertainty are not the Same oral (ganizations Under the regurements od, the organization i esbonsble fo its application of isk based thinking and the acsons takes to adress risk including whether er not to retain documented Information a evadence oft determination fish 2 10 2018-Ategsenonet: 1S EN 0 9001:2015 AS Applicability This International Standard does not refer to “exclusions” in relation to the appleality of is “Tequirement tothe organtatons quay management system. However, an organization can review Th applichility of requirements de tothe sae ar complesty ofthe orpaniatio, the management model adopts, the range ofthe organizations aes and the nature ofthe sks and opportunities FRencountere ‘The requirements for applicability are adressed in 4.3, which defines conditions unde which an ‘onganiation can decide that requlremant cannot be applied to ay ofthe processes within the scope irs quality management systems The organization ean aly docie thats requtementis not applcale {tits decison wll ae esut in falur to enleve conorty of products and services. AG Documented information [As part ofthe alignment with other mangement system standards 2 common cause on “dacumented Information” has been adopted without significant change or sdeltion (se 2.8). Where appropriate, text elenhece in thle International Standard has been aligned with its requtements. Consequently, ocumented informaton” is Used for all ocument requirements. {Where $0 9001:2008 used specific terminology such a5 “document” oF “documented procedures "ually manual” oF “ualgy pan, this eiion of his International Standard defines requirements to “fualntsin documented information’ ‘Where 150 9001:2008 used the term “records” to denote documents needed to provide evidence ‘of conformity sith requirements, ths Is now expressed a5 a requirement to “retain documented information" The organization is respossble for determing what documented information needs to beretained. the period of tine for hishie isto be retained andthe media tobe used fr is atention. | ragulrament to “maintain” documested information does not exclude the possibilty that the Crganiation might aso need to retain’ tha same documented formation fra particular purpose fe toetain previous versions of ‘Where his nernational Stand refers to information rather than “documented information (ein 2p The organization shall monitor and review thelnformationsbaut ese eternal andinteral issues), ‘here is no requirement tat this information ito be documented. such situations, the organization ‘an decile whether or not tis necessary or appeopeateto malntan documented information AZ Organizational knowledge In 246 this International Standacd aldresses the need to determine and manage the knowledge Imaitaived by the organization, to ensre the Operaion of ks processes and that ican achieve ontacmity of products and serves Requtentents regarding organizational enowledge were introduced forthe purpose of: 8) safeguarding the organization fromloss of knowledge. © = through ttf urnover — failure tocapeure and share infrmation; 1) encouraging the organization to acuire knowledge, eg — earning fom experience = mentoring: = benchmackig ISN ZOIS=Aneeer 23