1SO 9001:2015, Quality management systems — Requirements This International Standard. specifies requirements for a quality management system where an | ‘organization: / 2) news lo demonstrate ts ablty to | consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. b) All the requirements of this International. Standard are generic and are intended to be applicable to any | cxgarizations, regardless of its type oF size or the | products and services provides. | NOTE 1 In this Intemational Standard, the terms “product” or "service" only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. The following documents, in whole or in part, are ‘ormatively referenced in this document and are Indispensable for its application. For dated | references, only the edition dted applies.’ For | undated references, the latest edition of the referenced document (Including any amendments) applies. 180 9000:2015, Quality management systems ~ ‘Fundamentals and vocabulary B Terms and definitiong | For the ‘purposes of this document, the terms and efintions given in 9000:2015 apply. | anasg num naaiudseysiorimundtuseuun ravine agian Vidsaseins: a) diagesuaastvivhufs — anuaunsntunrty Aust usetms Aasaffusiarmmunand uaz Wangmune —wavdaileduviusvundteMeatne sahiaa, uae Sidhmne tautueramonatauavan i nankyndlaeuuvsiieantia, mute pienumsdrmtunmaltinkvadiweataswes ‘qe untnalretuenumanndosrinniariua wavand) —unefangmine — uastiatotuv asegnatal b) arhrmuafownniavwrqss uennaaiiutishilarmua wath) uarfliaaurtausegnstal eidwtuasdns far Tag bidrdds aman wa mine via wéadouviuae maths wanuig 1 hanessmarnaasid dri “Halos v80 ‘uimy" hid dutuantnnviamndnty wo soanasdatu qniiiten win winwing 2 siovMuaRangyne uAEngRSouiodAy manaauiitatenuy armuamsngyane toneniotitaraactanfewua via ursazudagn Sotunassufi — uacitudoshuilutumnlsegnsita Aunsdivanenavidodednaeytudauthiy — thisey sawvatuvitiw — tunsdidhanansdd ded tose | Maw imnufisianarscrdoatuanas (souMonsdit Sinasuldruules) 4SO 9000:2015, revumstamanniam - udnnrs whugin ween sowtufenimassaannesgiudty — wenawviuacey Shifeanuriiwustatunargm ISO 9000:2015 an abeqinetel Warsion 3 107-01-2017) By avakors SES ACADEMY) Paget ofaISO 900" Quality Management Context of the organizatior 4.1. Understanding the organization and its context ‘The organization shall determine external and internal issues that are relevant to its purpose and its lity. to quality strategic direction and that affect its abil achieve the intended result(s) of its management system. ‘The organization shall monitor and information about these external and internal issues. NOTE 1 Issues can include postive and negative Factors oF conditions for consideration. NOTE 2 Understanding the external context can be’ faditated by considering issues arlsing from legal technological, economic environments, regional or local. ‘whether International, national NOTE 3 Understanding the internal context can be faaliteted by considering issues related to values, culture, knowledge and performance of the organization. 4.2 Understanding the needs and expectations of interested parties Due to their effect or potential effect on the ‘organization’s ability to consistently provide products and services that meet customer and applicable. statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. ‘The organization shall monitor relevant requirements. 4.3 Determining the scope of the qui management system ‘The organization shail determine the boundaries and applicability of the quality management system to establish its scope. \When determining this scope, the organization shall consider: a) the external and internal issues referred to in at; Version 3701-207) review compettive, market, culturel, social, and and review information about these interested parties and their 015 Systems — Requirements 4.1 aru taassins uauunuasaseins asinaaysoue anwdumuuan uavaleudumitud Wunsfasdonnsbofuymlstad warvirmonaiméuas assing uaenanimy Man rwaasauasasdnstuns usrqnadusenivinantstidasuun Law aAm AH aodnsdanthé@amn —_uacwurnusiauaddersiogt aiedumuuan uacieamum maturation | varuinn isakusiey munsenaitesfitletomorn ane ynaau Waannaesion aatarienayann wanuwag, 2 evauthtasuvimouanansasta sn aan Usuduteniaviy agwnd matutad amwmsuriody mraaane Senussmy Ayan uavarenarioumasasists vo Tundivlan weauind seflunsima waoseétviaaty vanume 3. anudhtavhmmutuaansaianntdean deudusivieaiasty asaryandau Saruezal aoderTay wae ‘sussouruavnaeing | 4.2. arnnuitta fonrumoonraacA nun rants ‘aod dauAuraiavtiiiauts tdagainuansemy va arariathifiawansemusiaa ya sunsnuasasdinstumsnda nando uae Zofites biatsasadastiniormuauasgnt) waviiadue navngyany saudesedusniatsauvifiensiavachwesh sara agdnaniaoviinasa uA a) dfidructoasiavrilrautafuseuuutmsqain iy b) darmusuasrsidmuherias tren fatuc uy ufvraqun agrinsdoavh fas, waenuyaw \Renalaafiursteuforaiaortiraute arog tfluatiag soyarnseanves tuned ua 4.3 msfrmunnou reas UUUTN TIAMAT asdnwiasruauaune uaznvnieuitwrannnn ‘ahissgnd tale ydun ari nnuenauiveauaareu unt anam idasertimarruuauina asdinsiaonansanigs a) sbadumeuanuacabefumuty sresoorania fine 4.1ISO 9001:2015 Quality Management Systems — Requirements b) the requirements of relevant interested parties referred to in 4.2; ©) the products and services of the organization. ‘The organization shall apply all the requirements of this Intemational Standard if they are applicable within the determined scope of Its quality management system. | The scope of the organization's quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide Justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard may only be claimed if the requirements determined as. not being applicable do not affect the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction, 4.4 Quality management system and its processes 4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. ‘The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a) determine the inputs required and the ‘outputs expected from these processes; b) determine the sequence and interaction of these processes; determine and apply the criteria and | methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; determine the resources needed for these | processes and ensure their availability; assign the responsibilities and authorities for | these processes; address the risks and opportunities as determined in accordance with the Co) requirements of 6.1; evaluate these processes and implement any changes needed to ensure that these | processes achieve their intended results; Improve the processes and the quality 9) h) management system. b) dlarhmuemasdiiduiaeauitinauts swes snusiartayun 4,2 C) nAndinustuautmsuavascns asdnsdanvnmalseundlaiianmuaviomianas anasgtuannaaitud Tunsetvlarunsouseynatalle malevauimmaseuustyrsqaimnmsiariued au emacreuuyiyisqnimmrasasdnssiostavind uadthsstnentihuanarsnsauna waucemdaorey WDuriarrmesaunasts woewoandasat uasytes wacArdiuascyingaa adwiumsblannsouseyndlay Tarhmuatey — wassvarhouanssgmarnaatiutl f9tu saULImDsANSHSRONTH emumenesavManargmuanaatui — arsavearse nehadho'te Tauimrtahieundtshiarhmuastivy siastsl donanmmudannueant wa @nufuaeraumes aveins latishvtasioamamanadavtundnanivinas inns waemateduanattonatauargne 4.4 samuutinaqainw waeazanuAds 4.4.1 asdnseias Savin wibhlfale sisvinw uae Uhalarematnaqammadhedatias muita amanumsvidy — uaclgautudsawuasnsanums 9197 oanfarrmussosnessTuannaadutl astnssasmamuesanumadtidh dwturewuatins ana —uasmmlmgnatiinaanviavioaorins wae aeMv: a) Ammuaiainivahyidasms —— uavnadinatt eranfomnnranumanent ued itive unal§dintuduaonnv mamaat Arua wanleund hl in wavs (sma mathatyianw maaan uardzita mussourvifiviios) — Asnuthudlatvitutacia akvavsuauaonymudum — waen aA uA rmanumawartl _ Armumotmanathuth zamena usnhuteitegacrwotoona dawmnum wsuAaion shvunseanummnand Amusuasayernius uaetama vilendas ffuniariawun 6.1 - abvguvavasnsanumsinard waenrnivl Usiduavniulduudastiniy — wlavhty aiutavnemummuendidodonaddenat rome h) aitnkserununrs wacruuvinsaainn b) 9 a °) uagenamint 9) Wesion3 Page 3 122