> NGR-007112 PHILIPPINE NATIONAL 4 STANDARD si Zz PNS ISO ed 20) (ISO published 2015) ICS: 03.120.10 eles Quality management systems — Requirements~ BUREAU OF PHILIPPINE STANDARDS =| ~ Member to the intemational Organization for Standarcization tS ‘Standards and Conformance Portal waw bos.cii gov ohAl UU PHILIPPINE NATIONAL STANDARD” + PNS ISO 9001:2015 \ = (ISO published 2015) National Foreword ‘ J This Philippine National Standard is identical with Intemational Standard ISO 9001:2015, Quality management systems - Requirements. 4f was approved for adoption as a Philippine National Standard by the Bureau of Philippine Standards. Within thé text of the standard, the following are the minimal editorial changes” a) the decimal comma shall be interpreted as 2 decimal point to be consistent with existing convention on our number format b) the words “International Standards” shall Mean “Philippine National Standards” 7 i = This standard cancels and replaces PINS ISO 9001:2008 (ISO published 2008) Y ~~ & G 2 - . / \ x s 4 = ) es a noe = —~ | i eta a — \ = an i of~ eerie > NCR-007 INTERNATIONAL. wis STANDARD , _ ROS Fifth edition 2015209-15 Quality managementsystems os Requirements ‘ aa Systemes de management de\laglalité — Exigences. ie | \ Reference nfimber 1s0 9001:2015(E) * a _ 2015 eis5 _ 10 9001:2015(6) i oJ = j = y ; } Bee I # = = s ) si a C e § Cr ~ a ve aoe ; & i 7 c oN i A Ror COPYRIGHT PROTECTED DOCUMENT © 150 2015, Published in Switeriand ‘rg reserved Unless terse pected no pr fthispublaion nay bpd of wasd arent fy or by any means, elecronle oF ‘oritten permission, Permission can be requested from either 5 the requester ISO copyright office Chewtewlandonnet 86 CP401 CH-1214 Vergfer, Geneva, ‘Tel +4122 7490111 Far +4122 749 09 4 perpright@isaorg ‘wwveis0.org i y EXCLUSIVE USE br DEVELOPMENT 3° Pe nm ny iso avis — an nets 1Y OF THE P Fee ae a ee,Contents ae Foreword, Introduction. 1 Scope... = 2 Normative references a 3. Terms and definitions 4 Context of the organization... 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties. 43. Determining the scope of the quclity management system 44 — Quality management system and its processes... 5 Leadership Leadership and commitment. S11 General 5.1.2 | Customer focus ~ 52 Policy 5.2.1 Establishing the quality policy. 7 522 Communicating the quality poli 53. Organizational roles, respons: a 6 Planning aA 6.1 Actions to address risks and opportunities Quality objectives and plz Rebs i - %3 Planning of changes....... - 7 Support 7a Resources 711 General, 712 Peofle Sy. 7.13 Infrastrycture ~ 7.14 © Environment for the operation of processes... 7.1.5 Monitoring and measuring resources... 7.1.6) OFganizational knowledge... 7.2. Competence 73,¢° Aareness = 74 “Communication — - 7.5 ‘Documented information... ~* FSA General cnn = : % 75.2 Creating and updating... A 7.5.3 Control of documented information... Ae operation 2 = 82 Operational planning and control... 82 Requirements for products and services... 82.1 Customer communicatfon.. —— 822 Deterinining the requirements for products and services. 823 Review ofthe en pn ‘: 8.2.4 Changes to requirements for products and services. 83 Design and development of products and services. B31 General. 83.2 _ Design and developmentplanning, 83.3 Design and development inputs... 834 Design and development controls~. es 83.5 Design and development outputs .. 83.6 Design and development changes., 181502015 - llrightsreserved NCR-007 ISO 9001:20: EXCLUSIVE USE OF DEVELOPMENT ACADEMY OF THE PHILIPPI DOOIVAATATO VNas eRe Rw © ows Z =i,5 A _ {80 9002:2015(6) a 8.4 Control of externally provided processes, products and services 13 - At General. 13 4.2 Type and extent of control. aeeenetn B 84.3 _ Information for external providers Lovet 85 Production and service provision... " 4 8.5.1 Control of production and service provision i 14 852 _ Identification and traceability a aa 85.3. Property belonging to customers or external providers. " 15 85.4 Preservation. ~ 18 B55 Post-lelivery activities 15 8.5.6 Control of changes... - z AAS 86 — Reléase of products and services - a5 8,7 Control of nonconforming outputs. Sy Ae 9 Performance evaluation... anf 16 9.41 Monitoring, measurement, analysis and evaluation “ Jo 16 2 9.11 General... . . 2 16 9.1.2 Customer satisfaction... - a7 7 94.3 Analysis and evaluation. 2 7 9.2. Internal audit... 2 K 7 9.3 Management review. i G 18 93.1 General. EA ¢ . 18 “~~ 932 Management review inputs. = ~- 18 983. Management review outputs fy. " 18 10 Improvement, ncn eo-2oeenennns . 19 10.1 General - 19 2 10.2 Nonconformity and corrective action... ~ 19 103 Continual improvement.. x 19 Annex A (informative) Clarification of new structure, terminology and concepts... 21 ‘nex B (informative) Other International Standards’on quality management and quality | management systems developed by IS0/TC.176 25 Bibliography... aoa ¢ ae ~ 4 j xe ANY © eae = uw Z see i Ser ce. ; i - oe a \ \ . i a = j r ; e A a ) ee \Foreword 7 150 (the international Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carrie out through-1S0 technical committees. Each member body interested in a subject for which a techhical committee has been established has the right to be represented dn that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take-part in the work 1SO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization 4 The procedures used to develop this document and those thtended for its further ifaintenanc described in the [ISO/IEC Directives, Part 1. In particular the different approval different types of ISO documents should be noted. This document was arate cordance witl editorial rules of the ISO/IEC Directives, Part 2 (see wwwiiso.org/diréctives). rc Attention is drawn to the possibility that some of the elements of this doumént may be the si patent rights. ISO shall not be held responsible for identifying any any patent rights identified during the development of the documept Will be in the Introduction ai on the ISO list of patent declarations received (see } Any trade name used in this documentis information re a convenience of users and does not constitute an endorsement. ¢ Foran explanation onthe meaningof1SO speciictermgndexpressions related to conformity assess as well as information about |S0's adherence to one i Trade Organization (WTO) principles i Technical Barriers to Trade (TBT) see the follo on he committee responsible for this doc: ‘and quality assurance, Subcommittee SC 2, hy ystems t This fifth edition cancels and replagdtpe fo fourth edition (ISO 9001:2008), which has been techni revised, through the adoption sete clause sequence and the adaptation of the revised ql management principles and of ‘oficepts. It also cancels and replaces the Technical Corrige ISO 9001:2008/Cor.1:2009, areé itehia needed fof the b the cof I such patent rights. Detafls of aor ent, the fechnical Committee IS0/TC 176; Quality management, ally ity lumAl 5 ‘180 9001:2015(E) bn = eee 0.1 General aor c 2s ‘The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are:, = : a) the ability to consistently provide products apd services that meet customer and applicabte statutory and fegulatory requirements; ') facilitating opportunities to enhance customer satisfaction; 64) addressing risks anll opportunities associated with is context and objectives @)_ the ability to demonstrate conformity to specified quality*anagement system requirements This Infernational Standard can be used by internal and external parties, t = It is not the intent of this International Standard to imply the need for Ly management system) es — Uniformity in the structure of different qual — alignnient of documentation to the clause structure of this Interfagional Standard; — the use of the specific terminology of this International Staftdard within the organization. ‘The quality management system réquirements specified in this International Standard ar complementary to requirements for products and services? \ ‘Fhis International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. ‘The process approach enables an organization.t0 plan its processes and theff interactions. The PDCA cycle enables an organization, to ensure that its processes are adequately resourced and managed, and that opportunities for intprovement are determined and acted on. by] a Rislebased thinking enables anorgapization to determine the factors that could cause its processes arc it, tualtty management sVsteth tb deviate from the planned results, te putin place preventive contrcis its quality management eae Jeo make monimum use of opportunites as they ariee (see Cause A Consistently meeting requirements and addressing future needs and expectations poses a challenge for ofganizations imanincreasingly dynamic and tomplex environment. To achieve this objective, the organization might find it necesSary to adopt various forms of improvementin addition to correction and cofitinaal improvement, such as breakthrough change, innovation and re-organization. In this International Standard, the following verbal forms are usect — “shall” indicates @ requirement: — “should” indicates a recommendation; — “may” indicates a permission; ad — “cant indicates a possibilty or a capability. X Information nfarked as "NOTE" is for guidandé in understanding or clarifyingtheassociated requtrement, \ — q r ee7 int — 1 2 NCR-007116 - 180 9001:2045(8) a a 4 Fer ce 0.2 ‘Quality management principles e ; This International Standard is based on the quality management principles described in ISO 9008. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical aftions to improve the organization's performance when applying the principle. ‘The quality management principles are: — customer focus;, } leadership; — engagement of people; ~ — process approach; — improvement; . — evidence-based decision making; — relationship management ~~ 0.3 Process approach 2 \Y 0.3.1 General re) j This International Standard promotes the ay, of @ process approach when developing, implementing and improving the ertecrvegeed "quality management system, to enhance customer. satisfaction by meeting customer re hes. Specific requirements consideréd essential Yo the “adoption of a process approach are included in 4.4. Understanding and managing interfelated processes as a system contributes to the organization's effectivenéss and efficiency in sag its intended results. This approach enables the organitation 0 control the interretationshipé and interdependencies among the processes of the System, so thpt the overall performance of the ongafization can be enhanced. The process approach Bree the systematic definition and management of processes, and| interactions, so as tO@ehiéve the intended results in accordance with the quality poligy and str; direction of the or; rion. Management of the processes and the system as a whole\can be ac! using the PD #ee.0.3.2) with an overall focus on risk-based thinking (see 0.3,3) aimed at advantage of opportunities and preventing undesirable results. y ‘The applicatiobof the process approach in a quality management system enables ) understanding and consistency in meeting requirements; 3 ) (thé consideration of processes in terms of added value; ie “g) the achievement of effective process performance; 4) Improvement of processes based on evaluation of data and inforsfation, Eigute Lgives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for controlyare specific to each process ~ and will vary depending on the related risks. I - a © 150 2015 ~ All rights reserved vil SIVE USE OF DEVELOPMENT ACADEMY OF THE PHILIPPI ES |a 150 9001:2015(E) hi is eves pee feseoecesson | Iarren, eo t sarier sgsequerr forocesses- | Hewencr | NERC Iegeeorotcrs | nrotanion. | | 2FORATION ee (iermtorecimay| — legnae | me Feel oe oeR, rr [perro eenate! rapes | eoter rer WoL > Figure 1— Schematic representation of the elements ofa singleprocess 0.3.2 Plan-Do-Check-Act cycle’ ~ 5 ¢ ‘The PDCA cycle can be applied to all processes and to the quality,management system as a whole. Figure2 illustrates how Clauses 4to 10 can be grouped in relation sg eh8 POCA cycle NG wt oY Quality Management Sytem f_Y e NOTE__ Numbers in brackets refer tothe causes in tis Inteagtional Standard. r : Z ; re ae Figure 2— Representation of the structure of this International Standard in the PDCA cycle \ vill EXCLUSIVE USE DF DEVELOPI= = pen NCR-007117 a | 180 9001:20415(E) me as aa ¢ ‘The PDCA cycle can be briefly described as follows: _ > — Plan: establish the objectives of the system and its processes, and the resources needed to dpliver results in accordance with customers’ requirements and the organization's policies, and id4ntify and address risks and opportunities; — Do: implement what was planned, - i — Check: monitor and (where applicable) measure processes and the resulting products and seqvices against policies, objectives. requirements and planned activities, and report the result: —_ Act: take actions to improve performance, as necessary. 0.3.3 Risk-based thinking Ps The concept of risk-based thinking has been implicit in previous editionSof this International Stadard secing forename carting ou: reventiveston eine potenti ncenormieeamang any nonconformities that do occur. and taking action to prevent re¢yrrence that is appropriate far the effects of the nonconformity. Risk-based thinking (see Claus= 4.4) is essential for achieving an effective quality’ management sybtem. teh To conform to the requirements of this International semgoat ‘an organization needs to-flak and implement actions to address risks and opportunities=Addressing both risks and opportupities establishes a basis for increasing the effect. veness_o mproved results and preventing negative a) fal 1@ quality management system, achipving Opportunities can arise as a result of a situati@m faVourable to achieving an intended tesuk, for example, a set of circumstances that allow th; Myteation to attract customers, develop new products and services, reduce waste or iiprove agaist. Actans to address opportunieles can alse ude ‘onsideration of associated risks. Risk Ne effect of uncertainty and any such uncertainty can have _/ positive or negative effects. A positivg deviation arising from a risk can provide an opportunity, bit not all positive effects of risk result in oporgunities, 0.4 Relationship with other management system standards = This international Standard apples the framework developed;by ISO to improve alignment amohg its International Standagds Aor fhaniagement systems (see Clause 4.3). This International Sagar enables an organization to use the process approach, cbupled with the PDCA cycle and pisk-Based thinking, to align or integrate its quality management system with the requirement ofta¢her management system standards. a This Intefnatiopal Standard relates to ISO 9000 and ISO 9004 as follows: oa SQ, 2000 Quatity management systems — Fundamentals and vocabulary provides esspntial (ex feround for she proper understanding and implementation of this International Sandard a '180 9004 Managing:fr the sustained success of anrganization — A quality management apphaach provides guidance for organizations that choose to progress beyond the requirements of this ternational Standard. Sunei 8 provides details-of ocher Internatiowal Standards on quality management and. qlalit management systems that have been developed by ISO/TC 176, aa This International Standard does not inélude requirements specific to bther mana such as those for. environment financial management, t .gement systems, management, occupational health and safety managemerft, of og c Sectar-specific quality management system standards bqSéd on the requirements of this Internatfonal Standard have been developed for a number of sectors. Some of these standards specify additional quality. management gystem requirements, while others are limited to providing gui guality ma eq , dane ~All rights reserved ixa 180 9001:2015(E) 7 J 5 a A matrix showing the correlation between the clauses of this edition of this taternational Standard and the-previous eflition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at wwuniseorg/i176/sc02/public, a ie = 4 a 7 \ 5 = # ) N > 7 et eae ; = d a 5 ¢ ) 2 af c i: - ~ B ye see = L ko ; ” oe oe eae \ } 4 7 a j y! a2 NCR- INTERNATIONAL STANDARD J 1s0 9001:2015(E) Quality management systems — Requirements 1 Scope Fs This International Standard specifies requirements for a quality management system whpn an organization: a) needs to demonstrate its ability to consistently provide products and serviceSthat meet customef” and applicable statutory and regulatory requirements, and Gee oak b) aims to enhance customer satisfaction through the effective applicatiof of the system, including processes for improvement of the system and the assurance ofconformity to customer and applicable statutory and regulatory requirements. 8 All the requirements of this International Standard are generic and Se intended to be applicable fo any organization, regardless of its type or size, or the products and séryices it provides. NOTE 2 Eis International Standard, she tims “produtaag Service” only apply to products and sfvies intended for, or required by, a customer. TED Sandor ety Fauiranians yee eed sea rou 2 Normative references . “The following documents, in whole or iMtpart, are normatively referenced in this document amd are indispensable for its application. Far dated references, only the edition cited applies. For uldated references-the latest edition of theeferenced document (Including any amendments) applies 180 9000:2015, Quality mauagelrehespstems — Fundamentals and vocabulary 3. Terms and definitions For the purposes ofthis Wocument, the terms and definitions given in ISO 9000:2015 apply 4 Context of the organization— di 4.1. Understanding the organization and its context \ The Otganization shall determine external and internal issues that are relevant 16 its purpose acdhies strategic direction and chat affect its ability(to achieve the intended result(s) Gf its quality ‘management system. The organization shall monitor and review information about these eternal and internal issues. NOTE t _-ssues can include postive and negative factors or conditions for consideration. NOTE, Understanding the external conte can be faclated by consdefing Issues arising from) egal, fechnological, competitive, market, cultural, social and economie environ international ato tscnciogial compe ents, whether international, national, NOTE Understanding the internal context caf'be facilitated by considering issues r (| knoviedge and performance ofthe organization ne bY considering issues related to values, eture, ( \ ( / i : i fn 180 2015 ~ All rights reserved 1 /SIVE USE OF DEVELOPMENT ACADEMY OF THE PHILIPPINESa 150 9001:2015(E) L - ir ex 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 orgamization shall determine: - a)_ the interested parties that are relevantto the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. ‘The organization shall ménitor and review information about these interested parties and their relevant requirements. 4 4.3 Determining the scope of the quality management system ‘The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider: e a) the external and internal issues referred to ind.1; = b) ~the requirements of relevaiit interested parties referred to in 4.2; )_ the products and services of the organization. ‘The organization shall apply alf the requirements of this Internatignal’Standard if they are applicable within the determined scope of its quality management system. ‘The scope of the organization's quality management syatem shall be available and be maintained as documented information. The scope shall state the types ofpproducts and services covered, and provide justification for any requirement of this International Standard that the organization determines is not ‘applicable to the-séope ofits quality management system Conférmity to this Internationa Standard may*only be claimed if the requirements determined as not being applicabledo not affect the organizations ability or responsibility to nsure the conforinity of products and services and the enhancemtentof customer satisfaction. 4.4., Quality management system and its processes 444 The organizatioN Shiil éstaBlish, impleme®t- maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this brterngtional Standard. ‘The drganization shall Geterming the processes néeded for the quality management system and their applicationbroughout the organization, and shall: > a) determine'the inputs FEquired and the outputs expected from these processes; 1b) 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 pracesses; dl). determine the resources needed for these processes and ensure their availability; ~ ©) assign the responsibilities and authorities for these pr6eesses; f) address the risks and opportunities as determined in accordance with-the requirements of 6. g) evaluate these processes and implementany changes needed to ensure that these pracecsec achieve their intended results; oS {© 180 2615 - Al rights reserve EXCLUSIVE USE [oF¥ > NGR-003 119 - } ISO 9001:204} 1) improve the processes and the quality management system. 44.2. To the extent necessary, the organization shall a) maintain docuriented information to support the operation of its processes; b) retain documented information to have confidence that the processes are being carried{ohit as planned. S Leadership + 5.1 Leadership and commitment = ~ 5.1.1 General Top management shall demonstrate leadershfp and commitment with respect to thé qijlity ‘management system by: a a) taking accountability for the effectiveness of the quality maftagement system; 8) ensuring that the quality policy and quality objectivgs te established for the quality management system and are compatible wich the context and steategic direction of the organization; = 6) ensuring the integration of the quality angering system requirements into the organization's business processes, Ay Y _d) promoting the use ofthe process — risk-based thinking; 2 ¢) ensuring that the resources needed for'tie quality management systefn are available; £) communicating the Importancéof effective quality management and of conforming to the quality management system requizéihepts/ ad 8) ensuring that the quality imahagement system achieves its intended results; y i h) engaging, directing ayd’ supporting persons to contribute to the effectiveness of the quality management system { 4 |) promoting improvement; |) supportitig other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. O “NOTE, “Ny Reference to “business” in this International Standard can be interpreted broadly to mean those activites tha are core to the purposes of the organization’ existence, whether the organization igpublic private, for Brofit or not for profit, 7 ? e ‘1.2 Customer focus - e Top management shall demanstrate leadership-and commitment with respect to customer focds by ensuring that: ~ 8) customer and applicable statutory atid regulatory requirements are fletermined, understood and consistently met | b) the risks and opportunities that can affece conformity of products and services and the abili ryto enhance customer satisfaction are determined and adressed: 5 i ©) the focus on enhancing customer satisfaction is maintained, \ = 7x ) , Fights reserved USE OF DEVELOPMENT ACADEMY OF THE PHILIPPINES.D 180 9001:2015(E) be - Ds 5.2 Policy | 2 5.2.1 Establishing the quality policy ee ‘Top management shall establish, implement and maintain a quality policy that: a) is appropriate to the purpose and context of the organization and supports ite-strategic direction 8) provides a framework for setting quality objectives; c / 6) includes a commitment‘o satisfy applicable requirements: y @)_ includes a coffimitment to continual improvement of the quality management system. 5.2.2 Communicating the quality policy The quality policy shall tained as documented information = a) be available and bem b) be communicated, understood and applied within the organization; 9 ~be available to relevant intafested parties, as appropriate ? . 5.3 Organizational roles, responsibilities and authorities ‘Top management shall ensure that the responsibilities-and authoFities for relevant roles are assigned. communicated and understood within the organization. ‘Top management shall assign the responsibility and authoyity for: K i @ ensuring that the quality management ” = “) be measurable; = \ / )__ take into account applicable requirements; d) be relevant to conformity. df'products and services and to enhancement of customer satisfaction; ©) be monitored; . A) be communicated; 2) be updated ag appropriate ‘The organization shall maintain documented information on the quality objectives. 6.2.2 «When planning how to achieve its quality objectives, the organization shall determine: \ a) iwhat will be done; Cc a q b) what resources will be required; <) who will be responsible; 4) when e will be completed; ©) how the results will be evaluated. _~ 6.3 Planning of changes : When the organization determines the need forchanges tothe quali e ali Inge shall arsed out ina planned manner (ee ad). ee SalkY management system, the changes \ / if 7 asia © 180.2025 -All rights reserved -) EXCLUSIVE USE OF DEVELOPMENT ACADEMY OF THE PHILIPPINES4 180 9001:2015(E) = - The organization shall consider: z = \ a) “the purpose of the changes and their potential consequences; b)_ the integrity ofthe quality management system; the availability of resources; 4) the allocation or reallocation of responsibilities and authorities. i i x 6 = 7 Support 7.1. Resources TAA General The organization shall determine and provide the resources needed for the establishment implementation, maintenance and continual improvement of the quality managementsystem. — ~ The organization shall consider: o a) ~the-capabilities of, and constraints on, existing internal resgurces: (“™ ~ 8) what qeeds tobe abtained from external providers, 2 74.2 People ~ OA The organization shall determine and provide thé'pergons netéssary for the effective implementation of its quality management system, and for the operation aud control ofits procestes. © erent S. The dvgantzation shall determife, provide. ran atest the infrastructure necessary for the operation of its processes aid to achieve conformity Apbaucts and services < * NOTE___ Infrastructure can include: es 2) teulldngs and associated uttieg hy” 7 Jb) equipment, incudinghakdwareandepttware; ) transportation resources; f 4) information and cémmunication technology: 7.1.4 © Envifonttent for the operation of pracesses ‘The organization shall determine, provide and maintain the environment necessary for the aperation of its processes and {9 achieve conformity of products and services. NOTE suitable environment can be a combination of human ané physical factors, such as 4 social (2g. non-discriminator}, calm, non-confrontatignal) iz a 1) psychological (eg, stress-reducing, burnout prevention, emotionally protective); i 6) pFaieal (eg tomperaturd heat, humidity ight afl, nytene se) i = These factors can differ substantially depending on the products and services prOvT \ = k oe 6 EX€LUSIVE USE [OF DEVELOPM= Y- : ; ASR eEG i (E) = ar 9 7.1.5 Monitoring and measuring resources » 7.15.1 General aa The organization shall determine and provide the resources needed to ensure_valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. ae \ The organization shall ensure that the resources provided: a} are suitable for the specific type of monitoring and measurement activities being undertaken; 2 b) are maintained to ensure cheir continuing fitness for their purpose. > ‘The organization shall retain appropriate documented information avévident@ fitness for purpgse of the monitoring and measurement resources. 4 7.1.5.2 Measurement traceability IF When measurement traceability is a requirement, of is considere he organization to be an essential part of providing confidence in the validity of measurement résuifs, measuring equipment shail b¢: a) calibrated or verified, or tenh. wsaiifed ater oa to use, against measurement standards traceable to international or national measuremefitstandards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information; . b) identified in order to determine their an 6) safeguarded from adjustments, dafhege of deterioration that would invalidate the calibyation status and subsequent measurement régults / ol ‘The organiaation shall determine Dye idity of previous measurement results has been adversely atfected when measuring equipfheniy/found to be unfit for its intended purpase, and shall take appropriate action as neces! y 7.1.6 Organizational RnoWledge The organization sh détermine the knowledge necessary for the operation of its Hrocesses and to achieve confc ‘at products and services. ‘This knowletige shill be maintained and be made.@vailable to the extent necessaty. When addressing changing needs and trends, the organization shall consider its current kendo ‘ad determine how to acquire or accessany necessary additional knowledge and required updat NOTE 2) Organizational knowledge is knowledge specitic to the organization; it is generGilly gainkd by “gsperience. tts information that is used and shared to achieve the organization's objectives. Xe 3) internal sources (eg. intellectual property knowledge gained from experience; lessons learned| from tailures and successful projects: vapruring and sharing undocumented knowledge and experience; the Fests of improvements in processes, products and services}: Organizational knowledge can be based on: bj external sources (eg. standards: academia; conferences: gathering Mpowledge from eustamdes or external providers}- i ae ctae 2 2 015(E) L - i pe 7.2 Competence a The iron shall: a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system th) ensure thatthese persons are competent on the basis of appropriate elication, training, or experience; c ©) where applicable, take dctions to acquire the necessary competence, and evaluate the effectiveness, of the actions taken; 7 “ 4) retain appropriate documented information as evidence of competence. NOTE Applicable actibns can inchide, for examplenthe provision of training to, thetentoring of o? the assignment of currently employed persons; ar the hiring or contracting of competent persons 7.3. Awareness be The organization shall ensure that persons doing york under the organization’seontrol are asare of a) _the quality policy; é »)_ relevant quality objectives; q ) 7 )_ their contribution to the effectiveness of the quali improved performance; a anagément system, including the benefits of ~d)_ the implications of not conforming @ith the qiiality'management system requirements. / y \ 7,4 Communication : ‘The organization shall determine the internal and external communications relevant to the quality management system, including: Z a) onwhat it will communicate: 4 7 b) _ when to communicate; 9. withwi i a J) with whom to comipnicate; “, d) “howto communicate; €) who communicates. [ 4 4 / 7.5 Documented information eo“ oy 7.5.1 General ae ‘The organization's quality management system shall include: 2) documented information yequired by this International Standaré; bv) documented information determined by the organization as beinghecessary for the effectiveness ofthe quality management system. ss NOTE The extent of ddcumented information for a quality management system can differ {yom one organization t6 another due to: is = - — the sizeof erganiation and its type of activities, processes, products and services: A J oe Ee © 180.2615 — Allnches reserve aeeleagis . LOPME 8 EXCLUSIVE USE |OF DEV4 * — & 5 | ISO 9001:2045(E) = 5 2n § — the complexity of processes and their interactions; rs be 7 — the competence of persons, | 7.5.2 Creating and updating ii When creating and updating documented information, the organization shall ensure appropriaté: 4) Identification and description (e.g. title, date, author, or reference number); a d} format (langage, software version, graphies) and media (eg. paper, electronic) 4 4 c J review and approval for suitability and adequacy. 7.3.3 Control of documented information ey 4 1 Documented information required bythe quality management syStli and by this Inteenstional ‘ard shall be controlled to ensure - )) it isavailable and suitable for use, where and when it 7 b)_ itis adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). 7.3.3.2 For the control of documented informatioh, the organization shall address the following ~ activities. as applicable: ie t a) distribution, access, retrieval and uséjay 4. ») 4 we b) on any new requirements for the productsand services. a 8.24 Changes to requirements for products and services The organization shall ensure that relevant Cocumented information is amended, and that relEvant persons are made aware of the changed requirements, when thé requirements for product and services are changed. ~ oe ~ iy 83 Design and development of products and servites” 83.1 General _ E L The organization shall establish, implement ari@\maintain a design and development process that is 2ppropriate te ensure the subsequent provisionof products and services, Y 8.3.2 Design and development planning ‘ # In determimiing the stages and contrls feb design and development, the organization shall consid 8) she nature, duration and eompleSity of the design and development activities; a b) required process stages, including applicable design and development reviews; ©) the required design and development verification and validation activities; f 4) the responsitlities and authorities involved in the design and development process: 2) the inferifal and external resource needs for the design and development of produets and services; she requirements for subsequent provision of products and services; } the level of control expected for the design and development process by customers and relevant interested parties: 2) the qocumented information needed to demonstrate that design and development require have been met. z : ( 8.3.3 Design and development inputs | ‘The organization shall determine the requiféments essential for the specific {ypes of product: services to be designed and developed. The organization shall consider: a) functional and performance requirements: o "©.802015 -Alrighs reserved ote NCR-007 180 9001:20 The customer's requirements shall be confirmed by the organization before acceptance, whe| = e feed to control interfaces between persons involved in the design and development proces: the néed for involvement of customers and users in the design and development Process; L {In some situations, such as internet sales, 2 formal review is impractical for each order. Instead, the ther ents and i EoD \IS0 9001:2015(E) - = a - ) information derived from previous similar design and development activities; = \ ) "statutorynd regulatory requirements; ) standards or codes of practice that the organizatibn has committed to implement: ” ©) potential consequences of failure due to the nature of the products and services. Inputs shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and devptopment inputs shall be resolved. The organization shall retain documented information on design and development inputs. 8.3.4 Design and development controls mas | No i= Bote ‘The organization shall Apply controls to the design and development process to ensure that: / a) the results to be achieved are defined; y oe 8) reviews are conducted to-evaluate the ability of the results of design axd/development to meet requirements. e zh €)~wosification activities are conducted to ensure hat the design and( development outputs meet the input requirements; r d) validation activities are cohducted to ensure that the resiiltindiproducts and services meet the requirements for the specified application or intended us@. * ~? @) any necessary actions are taken op-problems-detérntined’ during the reviews, or verification and validation activities; > \ 1) documented information ofthese activities igrétained. NOTE Design and development reviews, vetfitationand validation have distinct purposes. They can be Condicted separately or in any combination, fig stable forthe prodicts and services ofthe organization 8.3.5 Design and development outputs ‘The prganization shall ensure that'design apd development outputs a) meetthe input requikements; ea b) "are Adequate for the subSequent processes for the provision of products and services ©) inghudeorreferéce mgnitoring and measuring requirements as aBbropriate,and acceptance citer pose 4). specifiy the characteristics of the products and services that are essentialfor their intended p and theif safe and proper provision. ‘ ‘The organization shall retain documented information on design and development outputs 8.3.6 Design and development changes " ‘The organization shall identif}, review and control phanges made during, or subsequent to, the design and development of products and services, to the extent necessary toZnsure that there ism adverse impact on conformity to requirements. st : ‘The Organizagion shall retain document a) design and development changes: by The results of reviews: af . 21802615 - 12 EXCLUSIVE USEJOF DEVELOPMENT 1Y OF TH© 84.3 Information for external providers | > a — + , = NCR-007124 ~ | ISO 9001:2015(E) — fe a 4 & 9 ©) the authorization of the changes: si 3 . 4) the actions taken to prevent adverse impacts aH 84 Control of externally provided processes, products and services _ 84.1 General ~ = ‘The organization shall ensure that externally provided processes, products and services conform to Fequirements. oa ‘The organization shall determine the controls to be applied to externally provided procestes, progiucts and services when: ~ a) products and services from external providers are intended for incorporatidh into the ofganization’s own products and services, b) products and services are provided directly to the customer(s)(Byexternal providers on behpf of the organization; ° 3) aprocess, or part ofa process, is provided by an externalprovider asa result of a decision by the organization. Ss ‘The organization shall determine and apply — ‘the evaluation, jselection, monitoring of performance, and recevaluation of external prov: ised on their ability to provide processes or products and services in accordance with req ‘The organization shall retain dobumgnted information of these activities and any nese ae arising from the evaluations, “84.2” Typeandextentofcontrol 2 2 The orga tion shall ensure ot Geo provided processes, products and services dg not adversely affect the or; anizatio ‘to consistently deliver conforming products and servides to 8: BP its customers. — The organization shall: Y re 8} ensure that extertially provided processes remain within the control ofits quality managefnent system; al 8) define both the controls that i intends to applyso an external provider and those it intends to apply to the'reSulting output; i ©) takeinto consideration ie *)) the potential impact of the externally provided processes, products and services of the organization's ability to consistently meet customer and applicable statutory and regulatory requirements: 2)_ the effectiveness ofthe controls applied by the external provider; 4) determine the verification, or other activités, necessary to ensure that the externally provided procéSses, products and services meet requirements. i = The organizatiog shall ensure the adequacy of requirements prior to their communication tq the external provider. rc f \ The organization shall communicate to external providers its requirements for: \. pel Al heprocesses, products and services to be provided) at 1502015 Al rigs reserved 13 S USE OF DEVELOPMENT ACADEMY OF THE PHILIPPI NES