INTERNATIONAL Iso STANDARD 9001 Quality management systems — Requirements Systimesde management dee qualité ~ Erigences iso 50012005)180 9001:2015(8) ‘COPYRIGHT PROTECTED DOCUMENT Als ese els there psi. no arto th pablo mayb rpc ile teri ym ‘tbyany ens eectronc or meson nding potpyng or post ne nero an tant toa roe Seer ia bd Rte ano BOR and ony (Sede ocho bce 40 Sree ‘ 0102015 ps rseed10 9001:2015(6) Contents Foreword . 1 Scope 2 Normative references 3 Terms.nd definitions. 4 Context of the organization AI Understanding the organieation and its context 42 Understanding the needs and expectations of interested partes 43 Determining the scope ofthe quality management sytem 44 Quality management system and ts processes 5 Leadership. 1 Leadership and commitment Sia General 312 Customer focus 52 Paley S21 Establishing the quality policy 522 _ Communicating the quality policy 53 Organizational ales, responsbliies nd authorities 6 Planning 1 Attions to address risk and opportunities 62 Quality objectives and planning to achieve them 63 Panningof changes 7 Support 7a Resources TAA General 712 People 73 nfastructare TAA Environment forthe operation of processes 7S Moaitoringand measuring resources 716 _ Organizational knowledge 72° Comperence 73 Awareness 74 Communiaton 75 Documented information 231 General 752 _ Creetingand updating 783 Control of documented information. 8 Operation 81 Operational planning and control 82 Requirement for products and services 10 821 Castomer communication 10 222 Determining the requirement or product and ervices 10 823 _ Review ofthe cequlrements for products and sevices 10 824 Changes o requirements for products and servies 1 83 _Designand development of products and services an B31 General. a 832 Design and developmen planning a 833 _ Design and development inputs i 834 Design anddevelopment controls 2 B35 Design and development outputs 2 836 Design and development changes. 2 1s02015-Alvphsrsred ca180 9001:2015(8) 10 84 Controtefexternally provided processes, praduct and services| 842. Typeand extent ofcomtrol 843 _nlormation foresters provider 8 Preductanand service provision 851 Contra of production and service provision 852 dentiintion and traceability 353 _>roperty belonging to customers ar external provers 854 reseration B83 Postdalivery actives 286 Control ofchanges 15 Releaseof products and services 27 Control eFronconforming outputs. Performance eraluation 3.1 Monitoring measurement, analysis and evaluation Sa Genera 912 Customer satstaction 9.13 _ Analsisand evaluation 92 nternataudl 93 Management review 93a Generst 932 Management review inputs 9133 Managemen review outputs Improvement 101 General 41.2 Nanernfrmity an enerative action 103 Continval improvement “Annex (informative Clarification of new structure, terminology and concepts ‘Annex (informative) Dther International Standards on quality managementand quality ‘management systems developed by 150/TC176 ibllography. 13 ir Gu 5 te ie is is is ie te 16 te a 7 ie le 16 1s 1s 2 28 {0150201 A gsr180 9001:2015(8) Introduction ‘The adoption ofa qullty management system sa strategie decision for an organization that can help tolimpraveits overall performance nd proidea sound basis for sistainabe development natives, ‘The potential benefits to an organization ofimplementing a quality management system based on this International Standard ae 1) the ability to consietntly provide praducte and services that mect customer and applicable statutory and eegulatory requirements 1b) facitatng opportunities to enhance customer satisfaction; 6) addressing risks and opportunities asseciated with ts context and oblecives; 4) theabilty to demonstrate conformity te speified quality management system requirements ‘This International Standard can be ured by internal and external partis, leis not the intent ofthis International Standard to imply the need for — riformity in the structure of ferent quality management systems; — alignment of documentation tothe clause structure ofthis International Standard; = theuse ofthe specific terminology ofths International Standard within the organization. ‘The quality management system requirements specified in this International Standard are complementary to requtements for products and services. ‘This International Standard employs the process approach which incorporates the Pan-Do-Check-Act (POCA eye and esk-based thinking. “The process approach enables an organization to plan is processes nd thet interaction. ‘The POCA cycle enables an organization to ensure that its processes are adequately resourced snd managed, and tat opportunities for improvement are determined ad acted on Risk-based thinking enables an organzatioto determine the factors that could causes processes and {ts quality menagement system to deviate fom the planned results, to pu in pace preventive controls tominimize negative effects and to make maximum use of opportuities as they arise (se Clause A) Consistently meeting requtements and addressing future needs and expectations poses a challenge for organizations in an Increasingly dynam and complex environment. To achleve this objective, the ‘organization might ind it necessary to adoxt various forms of Improvement in addition to correction 8nd continual improvement, such as breakttrough change Innovation and e-organeaton. {nthis international Standard the fellowingverbal forms are use: — “shall indcatess requirement — “Should” indicates a recommendation; — "may" Indieates a permission: — “ean indicates 2 possiiity ora capably. Information markedas NOTE" is for guidance inunderstanding or clarifying the associated requirement. « 180 2415p180 9001:2015(6) Foreword $0 {the tacernational Oganizatlon fr Stanaeditin) 6 swore defedrat nt tonal standards Soules (0 member bodies). The ork of pepacing International Stnards is normally cared dat "rough 80 tochnieal committer. Each morbar body interested in subject fr whi 3 Yechial ‘ommmitee has been established has the right to be represented on that commits. International organizations, governmental and non governmental, it talon with 10, also take part inthe work '0 collaborates closely with the International Elecicatecteal Cammission (IEC) on all matters of tlectrotechnial standardization ‘The procedures used to develop this document and those intended for it further maintenance are Aeserbed inthe ISO/IEC Directives, Part I-In particular the different approval vtrla needed forthe ‘lMeren pes of SO documents should be noted. Ths document was rafted in accordance withthe ‘atrial rules ofthe 1S0/1EC Directives, Part 2 (see ‘tention s drawn to the possiblity that some ofthe elements ofthis document maybe the subject of, Daten rights 1S0 shall not beheld response Yor identying any’ oral such patent rights. Detalls of {ny patent rights eatiied during the development ofthe document will bein the Introdetion and/or nthe ISO lis of patent declarations received (se ‘Any trade name used inthis documents information given forthe convenience of users and doesnot ‘onsite an endorsement Foranexplanatin on the meaning of $0 specifcterms and expressions related to conformity assessment, ‘rll as Information about ISO adherence tothe World Trade Organization (WTO) priteples inthe Technical Barriers to Trade (TET) see the follwing URL: wstuenoe isa/forsssad A ‘The committee responsible for this dacument i Technical Commitee 150/TC 176, Quality management and quality assurane, Subcommittee SC 2, Quality systems. This fifth edition cancels and replaces the fourth edition 150 9001-2008), which has been technically Fevised, through the adoption of revised easse sequence snd the adaptation of the revised quality ‘management principles and of new concepts. lsa cancels and replaces the Technical Corrigendum '$00001:2006/Cor1:2008. (02015 -Alghsresered y90 9u01:2015(6) 02 Quality management principles ‘This Imernational Sandard is based onthe quatty management principle daseribed in 0 8600 The {eserptoneincladea statement of exch principle, rationale of why the pencpe s myortant for she prgontetion, some examples of benefits assented with the principle and examples a typical actions Tolimprove the organizations performance when applviog the prince. ‘The qualty management principles are customer focus = lenders engagement of people: process approaeh = Improvement = evidence-based decision making — relationship management. 0.3 Process approach 0.3. General ‘This ternational Standard promotes the aloption of a process approach when developing, Inpleneating ad improving te effectiveness ofa quality mangement system, to enhance customer nection fy mesting customer requirement. Specific requirements considered essential to the $doption ofa process approach are Included ind, Understanding and managing inerrlated processes a a systom contributes tothe organization's tieetveness Sn effeeney ig achieving Ws lntended results, This approach enables the organization {o contol the nterrlationships and iterdependences among the processes ofthe system, so thatthe ‘overall performance ofthe organization canbe enhanced ‘The process approach involves the systematic definition and menagement of processes, and their Interactions sb as to achieve the intended results in accordance withthe gualtypoley and strategic llrection ofthe organization. Management ofthe processes and th systema. ioe can be achieved the PDEA cyte (see 0.2) with am overall focus on Fiskhased chk (ee 0.3.3 aimed a taking Svantage of opportunites and preventing undesirable results. “The application ofthe process approach in quality management system enables 4) understanding and consistency i meeting requirements 1) the consideration of processes in terms of added value; 6) the achievement of effective process performance: 4) improvement of processes based on evaluation of data and information ‘igure elves a schemati representation of any process and showsthe interaction ofks elements. The fmonlforing and measuring eheck points which are necessary for eontrol are specific to each process Sind wil vary depending on the related risks, (0150205 Aber rezoved w180 9001:2015(6) oui crmt : Figure 1 — Schematic representation of the elements ofa single process 0.3.2 Plan Do-Chede Act ele ‘The POCA cycle can be applied to all processes and co the quality management system as a whole, Eiqure2 lustrates how Gausas to 1'can be grouped in relation tothe PDCA cycle. Gaia tarot en ~\ = \ a | ™“s to | Em Figure 2 — Representation ofthe structure of this International Standard inthe POCA cycle vi {2150 2015- Ares reed180 9001:2015(6) ‘The POCA cyte canbe brietly deserbed as fllows Plan: establish the abjective: of the system and is processes, athe resources needed to deliver reslls i accordance with customers’ requirentants and the organaatios policies, and Wnty fd address risks ad opportunities: a: implemen what was panne ~ check: monitor and (where applicable) mensire processes and the resuhing products and services Spain polices, objectives, quirements ana planned stile, Sod report the asl — et take actions to improve performance as necessary. 03.3 Ristebased thinking Rsksbase thinking (Se Clauss.) is essen fr achieving an effective sulity management system. ‘The concept of risk based thinking has been Impliccin previous edition ofthis Ineernational Standard {nclading for example, carrying ou preventive action to eliminate potential ronconformitie, analysing Sty nonconformitis that do out and taking ation to prevent recurrence hati appropriate for the tect ofthe nonconformiy, ‘To conform tothe requcements of this International Standard, an organtation needs to plan and Implement actions to. address risks and. opportunities. Addressing bath risks and opportunities tstablishes a basis for increasing the effectiveness of the quality management system, achieving Improved results and preventing negative effects Opportunities can arise as a result of a situation favourable to achieving an intended result, for fetample a sto dreumstances that alow the organization to altract customers, develop new products Snd services, redice waste or improve productivity. Actions toaddress opportunities cam also include ‘Consideration of associated risks. Risk ste effect of uncertainty and any such uncertainty ean have positive or negative efecs.A poritve deviation arising (rom a iskean prove am opportunity, but not Blpositive effect of risk result in opportunities, (04 Relationship with other management system standards ‘This International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (ee Case}. ‘The International Standard enables an organization to use the process approach, coupled with the POCA ele and risk-based thinking, to alga or integrate ls quallty management system with the ‘equlrements of other management system standards. ‘This International Standard relates to 80 9000 and 1S0 9004 as fllows: = 150 9000 Quality monagement systems — Fundomentals and vocabulary provides essen bockeraund forthe proper understanding and iiplementation ofthis International Standare: = 180 9004 Managing forthe sustained success of en organization — A quaity management approach proves gular or orgiiations tat choose fo progres bond the requirements of his Ineerratonal Standard, Annex H provides details of ther International Standards on quality management and quality ‘management systems that have been developed by 1SO/TC 176. ‘This International Standard does not inchde requirements speci o other management systems, such as those for environmental management occupational health and safety management, oF Financial management Sectorspecifc quay management aystem standards based onthe requirerents ofthis International Standard have been developed for a number of sectors. Some ofthese standards specify addtional fualey management system requirements, while others ae limited to providing guidance to the pplication ofthis international Standard within the partiulr sector. (21502015 Argh reserved be180 9001:2015(6) ‘Amatrix showing the crretation betwoen the causes ofthis edition ofthis International Standard and {he previue edition (180 9001:2003) eam fe Ful om the 150/TC 176/SC 2 open access we ie ssieelsnanyiet 76/2 /ouble x 10 5 -AligereeedINTERNATIONAL STANDARD 180 9001:2015(8) Quality management systems — Requirements © scope This International Standard specifies requirements for 2 quality management system when an organization 2) eds to demonstrates abit to const provide products and sats that mest aston And applieable statutory and regulatory requirements, 1) aims to enhance customer satisfaction through the effective aplication of the system, including rocestes for ingenusment ofthe system and the assirane of conformity fo cusomer and pplcablestatatory and regalatory equlrorant ‘Allthe requirements of his International Standard are generic and are intended tobe applicableto any ‘rganization, regardless oft ype or sie, orthe products and service proves. NOTE tn hie lotscnational Standard, the rms product” o “serve” ony apply to product and servis Intended fr required by, aeurtomer. NOTE? Statutory nd ceguatory requirements can be expressed legalequrements, @ Normative references *130.9000:2015, Quality management systems — Fundamentals and vocabulary @ Terms and deisitons @ camesc orth organization 1G) onteraning te rntatonan scones The organization shall datermine external and internal issues that are relevant to its purpose and is strategie direction and that affect is ablity to achive the intended result(s) of ts qualty ‘management system ‘The organization shall monitor and review information about thes external and interal issues. NOTE teruercan include postive and negative actors conditions for consideration. NOTE2 Understanding the external comer canbe fctated by considering issues ising tom leg Teknologi compote, maria catural sal and economic nvronments, whether ieternational national NOTES Understanding th ineral context canbe faciitated by considering sees related to vals cultura, Tenge an perfrmans 1s 2016 =p . 1150.900: 015(E) 42. Understanding the needs and expectations of interested parties Duet ther effet oe potential effect on the organization's ability wo consistently prove prncts and Serviees tat meet customer and appliable statutory and regulatory requiertents the orgaalzaion Shall determine: 2} theinterested partes tht are relevant tothe quality management system; 1) therequirements ofthese interested artes that are relevant tothe quality management system ‘The organization shall monitor and review information about these interested parties and theit relevant requirements 43 Determining the scope of the quality management system, ‘The organization shall determine the boundaries and applicability of the quality management system torestabish ts scope = When determining this scope, the organization shall consider 2) theexternal and internal issues referred tind 1) thecequirements of relevant interested parties referred to in h2: 1) the productsand services ofthe organtzation, ‘The organization shall apply all the requirements ofthis International Standard if they are applicable within the determined Seope ats quality management system, ‘The scope ofthe organization's quality management system shall be available and be maintained as documented information The scope shall state te types of products and services covered, and provide justiieation for ay requirement of his International Stara thatthe organtation determines isnot pplicableo the scope ofits qualty management system Conformity to this International Standard may ony be claimed ifthe requirements detrinlned as not being apliable donot affect the organization’ abiity or responsibly to ensure the conformity of ts products and services and theenhancement of customer sosfacton. 44 Quality management system and its processes 44.1 The onganization shall establish, implement, msitain and continually improve 2 quality Tmanagement system, including the processes needed and thelr Interactions, in azcordance withthe requirements ofthis international Standard. ‘The organization shll determine the processes needed fr the quality management system and their pplication throughout the organization, and shal: 5) determine the inputs required andthe output expected from there processes; 1b) determine the sequence and interaction ofthese processes; 6) determine and apply the criteria and methods (inclading monitoring, measurements and related performance ndeators) needed to ensure the effective operation and contra af these processes, 4), dtermine the resources needed fr these processes and ensure ther avallabilty: ©) assign the responsibilities and authorities fr these processes addres the risks and opportunities as determined in accordance with the requirements of 6: 2) evaluate these processes and implement any changes needed to ensure that these processes achieve thle intended result 2 (21502018 - ag sre150 9001:2015(6) 1) improve the proces 1 the quality manajenwat system 12 Totho oxent necessary, the onpnzaton sl 4} msineain documented information te sappot the operation af ts process anf 1 eetain documented information to bave confidence thatthe process are bet ca 5 Leadership 5.41 Leadership and commitment Sad General ‘op management shall demonstrate leadership and commitment with respect to the quality Inunagement system by {taking accountability forthe effectiveness ofthe quality management system 1) ensuring thatthe quality policy and quality objectives are established forthe quality management Sytem and are compatible with the context an strateglc direction ofthe organization: 0) gearing he etgration fhe quay management system requirement the ogaiatns sine processes 4) promoting the use of the process approach and risk-based thinking 1) ensuring thatthe resources needed forthe quality management system are avallble; 1) communicating the importance of effective quality management and of conforming tothe quality ‘management system requirement 1) ensuring that the quality management system achieves its intended results; 1) engaging. directing and supporting persons to contribute to the effectiveness of the quality sranagement system: 1) promoting improvement: 1) supporting other relevant management roles to demonstrate thelr leadership as itapplies to thei, arene of responsiblity. NOTE. Reference to “busiest In this International Standard can be ioterprted broadly to man those ‘es thtarecore tothe purposes the organiatons existence, whether organization s publ Pat, Te prattor ator pote 54.2 Customer focus ‘Top management shall demonstrate leadership and commitment with respect to customer focus by cesurlng that: 4) customer ad applicable statutory and regulatory requirements are determined, understood and ‘consistently met 8) the sks and opportunities that can affect conformity of products an services andthe ability to ‘enhance customer sallsfactin are determined and addressed: ‘he focus on enhancing customer satisfactions maintained. (© 80 2015 atrihsesered 3150 9001:2015(6) 52. Policy 5:21 Fstablish ‘qual poicy Top management sal establish 2) SORE nc 1. providers mae for sting aloo 6) includes commitment tosis PBN roquirement 4) Includes cameo SATIRE te qs management yen 5.2.2 Communicating the quality policy plete ad raintaina quality policy that: content of the organization and supports its strategic retin ‘The quality policy shal 2) beavallbleand be 1), ecoMTS, AERST and apld within the oraizaton ©. beavalsbeto rele RRTREARR os ppropit 5.3 Organizational roles, responsibilities and authorities ‘Top management shall ensure that the respansbltles and authorities for relevant roles ae assigned, communicated and understood within the organization, ‘Top management shall assign the responsiblity and authority for: 4) ensuring that the quality management system conforms to the requirements of this International Standard: 1b) ensuring that the processes are delivering thei intended outputs; 2 reporting on the performance of the quality management system and on opportunites for Improvement (e021). in particular top management 48) ensuring the promation of customer focus throughout the organization ) ensuing thatthe integrity ofthe quality management system Is maincained when changes tothe ‘walty management system are planned nd implemented. 6 Planning GAL Actions to address risks and opportunities 6.4.1 _ When planning forthe quality management system, the organization shall consider the Issues refered tin andthe requirement refered toin 22 and determine therskyandoppaiuniis hat ‘eed tbe addressed tor 2) give assurance that he quallty management system can achlevelts intended result 1) enhance dsirabe 59 preven. of ede isnt 2) adereimprovement 4 {1S02m15 -Aeigharearicd180 9001:2015(8) 5.2 The nganizaton shal pio > esi 9 owt wudrss these sks and opportuni 1) Invgrate and implement the actions at Ws quality management system processes (4. 2) evaluate the effectiveness ofthese actions Actions taken toauldress sks and opportunities shal be proportionate tothe potenti laspat on the Conformity o products and serves SOT Opts wares ris can mule wrk ing i mre o rse a AR ‘Eni fe arctan ao Sag eo og a NOTE? _Opporntis cn eal th alotin of nw rates. cing new gros openng nw Inaetsaddesting neve casters bulingprtnrstia wing se echoloy aed other dara and able Pessbiie to adaresstho organiza ors custome nets 6.2. Quality objectives and planning to achieve them 62.4. The orsnizaton shall establish quality objectives at relevant fnctons, eels and processes needed forthe quality management system. The quality objectives shal: 2) bese ne uy pot 2 bess 2 te relevantto conormity of produets and services nd tenhancement of customer stcton 9. bean 4) becomes i 8) be ypdaatstopproprate ‘he organization shall maintain documented information onthe quality objectives 622 When planning how to achieve its quality objectives, the organization shall determine: _ 2) LA done: 0 ifessrcs wil be rece 2 sin be response: 3) Ei be cmp © ie resus berate, 63. Planning of changes When the organization determines the need for changestothe quality management system, the changes shall be carried cut ina planned manner see 4). (01502015 apsrourad 5150 9001.20:5(0) The organization shal consider 8) the purpose ofthe chang and thelr pana consequences b) thetoreety ofthe quality management system ©) theavalabiity of resources 4) the allocation or reallocation of esponsibiites and authorities 7 Support 7A Resources TAA General ‘The organization shall determine and provide the resources needed for the establishment, Inplemortation maintenance and continual improvement of te qualty management system. ‘The organization shall consider: 2) the capabilites of ad constraints on, exiting internal resources: 1) whatngeds tobe obtained from external providers 142 People ‘The organization shal determine and provide the persons necessary fo the elective implementation ‘ts uality management system and forthe operation and contra fs processes, TA Infrastructere ‘he erganzaton shall determin, provide and maltaln the infrastructure necessary forthe operation ffs processes anda achive conformity af pradets snd services OTE —nfrastuctute conics 2) buildings and aesociatd wien 1) equipment including hardware and satware 6 transportation resources: 4) informstion and commuricitontechsoony. 714 Environment forthe operation of processes “he organization shal determine, provide and maintain the environment necessary fr the operation ofits processes and achieve conformity of products and services. 8 soil eg. non-dscriminator, cal, noconfrontationa 1 psychological (og trees reducing barat prevention emily protective): physio tempera, eat, mi it it hypo, oe) ‘These fctrs afer sbstaallydependingoa he products and services rode 6 19 0288 -Algh reseed y4 naaannsf Ran RARR ORRIN ae150 9001:2015(6) 2.5 Monitoringand measuring resources The organiration shall determine and pruvide the resources needod to ensure valid and reliable ests whan monitoring or ineasuring fused to verity the conformity of prousts and services to “equieements ‘The organiaton shall ensure thatthe resoures provide: 2) are suitable forthe specific type of monitoring and measurement activities being undertaken: 9) are maintained to ensure heir continuing nes or thee purpose, ‘The organization shall retain appropiate documented information a evidence of fitness for purpose of ‘he monltoring and measurement resources 7AS2_ Measurement traceability ‘en measurement traceability is2 requirement ors considered by the organization tobean essential part of providing confidence in the valdtyof measurement results, measuring equipment shal be: 1) calbeated or verified, orboth a specified intervals, orprior vouse against messurementstandards {raceabl to international or national measurement standards; when no such standards exist, the bosisused for ealration or verification stall be retained as dacamented information: 1) identified in order to determine their states 9) safeguarded from adjustments, damage or deterioration that would Invaliate the calibration SYatusand subsequent measurement results ‘The organization shall determine if the validity of previous measurement results has been adversoly ‘feted when measuring equipment Is found to be unfit for is intended purpose, and shal tke appropriate action as necessary 7.16 Organizational knowledge ‘The organization shall determine the knowledge necessary fo the operation of Its processes and to Achieve conforaty of products and services. This knowledge shall be maintained and be made avaiable tothe extent necessary ‘Wen addressing changing needs and trends, the organization shall consier its current knowledge ‘nd determine howto acquire or access any necessary additional knowledge and required updates NOTE Ovganzationat keowedge ie kyowledee soecfic to the orsnizatin: i ic generally esined by ‘Spevitnc I nfarmaion thats ued and shared chev th ongonaions betes, NOTE? Organizatonat knowledge canbe based on: 1) itera sources (eg, inellctal property: knowledge gained from experienc: lseons learned frome ‘tures and sucess projet capturing and saving undacumereed knowledge and experone: teresa af Improvomentsin rocesren products and servis 1) external sources (e, standards; academia: conferences: gathering knowledge from customers oF ‘ternal provides)