INTERNATIONAL ISO STANDARD 9001 Third ection 7000-12-45 Quality management systems — Requirements Systémes de management de la qualité — Exigences SB WFO Cente Paiva Lied ‘68, South Extension 1 New bth 110019 Phone O11 4611991654292 Fax “O11 4627072 Esai: standard ée8 vane fn Relerence number 180 9001:2000(€) ©150 20001S0 9001:2000(6) POF disclaimer ‘This POF tle may contain embadied typotaces.n accordance with Adobu's oensing policy. his te may be printed er viewed but sha eotbe edited unloss the ypelaces which are embeced ae heences to andinsated onthe computer perf the ectng In dowricasing tt, partes accopt merein tho responsiblity of et itinging Adobe's Heensing poy. The ISO Genial Sacimiuat accepts nabity mins area, | ‘Adobo a trademark of Adobe Systems Incorporate. Dota ofthe software products used to create tis POF to can be foundin he Genera lo elative to the fe: the POF-cseaton parameters ‘wore optimized fr prning. Every eno has been Laken to entre that te fla eulaie tor vse ty ISO mernbet boss. nine cme even | = at a problem relating lo his foun, pleas inform he Cental Secretariat at te acres given below. ¢ © 1802000 i Altcghts reserved. Unies ctharwcespocited. nn part a a pubcation may be reproduced oF Ligeia any i oF by any mesa. Eee won er mechanical, nludng photocopying and mertim, without pormission in wig rom exter ISO at te audress below ISOs ime = ¢ =: ‘ber body in the county of ho raqucter. 180 copyinotica (Case pastale $6 «CH-1211 Genova 20 Tel ea 2272901 11 Fax 4 4122749 09 47 = Erma copyeght@isoen f ‘Wes wontisoch Pritedin Swtzerand ©1S0 2000 - At ightcesened180 9001:2000(E) Contents 1 Scope .. 44 General 1.2 Application 2. Northative reference 3. Terms and definitions 4 Quality management system .. 44 General requirements sa. 4.2 Documentation requirements 5 Management easponeibilty 5.1 Management commitment 5.2 Customer focus 53° Quality policy .. 54. Plannin a 5.5 Responsibiliy, authority and communication 5.6 Management review 6 Resource management 6.1 Provision of resources . 62 Human resources 63° Inlrastructure .. 6.4 Work environment 7 Product realization 7.4 Planning of product realization . 7.2 Customer-related processes .... 7.3 Design and development 74 Purchasing ... 7.5 Production and service provision —— 10 7.6 Control of monitoring and measuring devices u 8 Measurement, analysis and improvement n 8.1 Genera... o n 8.2 Monitoring and measurement " 8.3 Control of nonconforming product 12 8.4 Analysis of data ... 13 8.5. Improvement 2 13 Annexes A Correspondence betwiean ISO 9001:2000 and ISO 14001:1996. 15 B Correspondence between ISO 9001:2000 and ISO 9001:1994 19 Bibliography. 23 (91802000 at rigns reserved ii1S0 9001:2000(E) Foreword SO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical ‘committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on ihat committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on alt matters of olectrotechnical standardization, International Standards are dratted in accordance with the rules given in the ISONEC Directives, Part 3. Dralt Internationa! Standards adopted by the technical committees are circulated to the member bodies for voting Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibilty that come of the elements of this International Standard may be the subject uf patent rights. ISO shall not be held responsibie for identifying any er all such patent rights. International Standard ISO 9001 was prepared by Technical Commiltee ISO/TC 176, Quality manegement and quality assurance, Subcommittee SC 2, Quality systems. This third edition of 180.9001 cancels and replaces the second edition (ISO.9001:1994) together with 1SO 9002:1894 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organizations ‘which have used 1SO 8002:1994 and ISO 9003:1994 in the past may use this Intemational Standard by excluding Certain requirements in accordance with 1.2. ‘The title of 150 9001 has been revised in this edition and no longer includes the term “Quality assurance’, This reflects the fact that the qualiy management systom requirements specified in this edition of ISO 800%, in addition to {Quality assurance of produc, also aim to enhance customer zatiziaction, Annexes A and 8 of this International Standard are for information only. 150 2000 Aa nights reservesISO 9001:2000(6) Introduction 0.1 General ‘The adoption of a quality management system should be a strates implementation of an organization's quality management system is inlluenced by varying needs. paticuler phleetives, the products provided, the processes wiployed and the size and structure ofthe organization, It's not ine intent o this International Standard to imply uniformity in the suucture of quality management systems ot untormity of documentation, gic decision of an organization. The design and The ,Gually management system requirements specified in this International Standard are complementary to fequirements for products. Information marked “NOTE” is for guidance in understanding or clarilying the associcted requirarnan. This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's abilty to meet customer, ret sGulatory and the organization's own requirements. ‘The quality management principles stated in ISO 9000 and !SO 8004 have been taken into consideration during the dovelopment ofthis International Stannard, 0.2 Process approach This International Standard promotes the ado; improving the ellectiveness of a quality manageme requirements, n of a process approach when developing, implementing and nt system, to enhance customer satisfaction by meeting customer For an organization to function ellectively, it has to ident Fesources, and managed in order to enable the trans process. Otten the output trom one process di ty and manage numerous linked activities, An activity using formation of inputs into outputs, can be considered as a rectly forms the input to the next ‘The application of a system of processes Within an organization, together with the identification and interactions of these processes, and their management, ‘can be referred to as the “process approach" ‘An advantage of the process approach is th he ongoing contro! tha it provides over the linkage between the individual processes within the syster sm of processes, as well as over their combination and interaction, When used within a quality management system, such an approach emphasizes the importance of @) understanding and meeting requirements, )_ the need to consider processes in terms of addled value, €)_ obtaining results of process perlormance and ellectiveness, and 4) continual improvement of processes based on objective measurement The model of a process-based quality management system shown in Figure 1 illust presented in clauses 4 to 8. This ilustralion shows that customers play a eignificant 1. inputs. Monitering of customer sat'staction requires the evaluation of information relati to whether the organization has met the customer requirements. The mode! ‘requirements of this International Standard, bul does not show processes at a det ales the process linkages ic in detining requirements ws ing to customer perception as shown in Figure 1 covers all the tailed love. ©180 2000 — ai sights versedISO 9001:2000(E) NOTE Inagaon, me methodology known as Plan-Do-Check-Act"(PDCA) can be applied lo all processes. POCA can be belly described as follows, Plan: establish the objectives and process tho oxganization’s palicie. necessary to dolver resis in accordance wil eustomnnr requirements ard Do: implement the processes ‘Check: monitor and measure proces: and product against policies, objectives and requirements forthe prowuct and report the resus, ‘Act: take actions to continually improve process performance. Continual'improvement of the quality management system Customers, Tieasurement, pee ‘analysis an Customers, Saristctien [Reauirements teatraton> >| Key — voho- acting etvitos Figure 1— Model of a process-based quality management system 0.3 Relationship with ISO 9004 ‘The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality menagement system standards which have been designed to complement each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist theit application as a consistent pair. 1S0 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certilication, or for contractual purposes. Il focuses on the effectiveness of the quality ‘management system in meeting customer requirements, wi 12150 2000 - Atvightsvesenod| 1 180 9001:2000(E) 1SO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO $001, particularly for the continual improvement of an organization's overall performance and efficiency. as elfectiveness. 1S0 9004 is recommended as a quide for organizations whose top management wis beyond the requirements of ISO 9001, in pursuit of continsn intended for certilication oF for contractual purposes, ell as iis 6 10 move improvement of performance. However, it is not 0.4 Compatibility other management systems ‘This International Standard has been aligned with [SO 14001:1996 in order to enhance the compatibiliy of the two standards for the benefit of the user community. This International Standard does not include requirements specie to other management systema, such as those Particular to environmental management, occupational health and safely management, financial management or risk Management. However, this International Standard enables an organization to align or integral ‘management system with related management sy: own quality sm requirements. It is possible for an organization to adapt is existing management system(s) in order to establish a quality management system thal complies with the requirements of this International Standard. 191802000 Asights reservedINTERNATIONAL STANDARD. 150 9001:2000(E) Quality management syslems — Requirements 1 Scope 4.1 General This tote national Standard specifies requirements for a quality management system where an organization 2) neces o demonstrate ils abilly lo consistently provide product that meets customer and applicable regulatory requirements, and oar e,anhance customer satiation though the elfective application of the system, including processes for Foplneal improvement of the system and the assurance of conformity to customer and applicable regulatory requirements, NOTE tn is International Standard, the term “product” applies only tothe produc intended for, or required by 1.2 Application AA segulzements ofthis International Standard are generic and are intended to be applicable to all organizations, tegardiess of type, size and product provided. eet any tequirement(e) ofthis International Standard vannot be applied due tothe nature of an organization and its product, this can be considered for exclusion Where exclusions are made, claims of conformity to this International St ‘exclusions are fimited to requirements within clause 7, and such es responsibilty, to provide product that meets customer and appli Standard are not acceptable unless these sions do not aflect the organization's ability, oF icable regulatory requirements, 2. Normative reference The following normative document contains provisions which, through relerence in this text, cons this International Standard. For dated relerences, subsequent amendments to, or revisions Publications do not apply. However, pacties to agreements based on this International Stanciar investigate the possibilty of applying the most recent edition relerences, the latest edition of the normative document 1 registers of currently valid International Standards, stitute provisions of of, any of these are encouraged to of the normative document indicated below. For undated referred to applies. Members of [SO and IEC maintain 'S0 8000:2000, Quality management systems — Fundamentals and vocabulary. 3. Terms and definitions For the purposes of this International Standard, the terms and daltons given in ISO 8000 opp Tae lowing ters, used In his edition ot ISO 9001 to describe the supply chain, have been changed to retlect the vocabulary currently used: supplier = ——>> organization customer © 150.2000 ~ lt eights roserved180 9001:2000(E) The term “organization” replaces the term “supplier” used in ISO 9001:1994, and relers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor Throughout the text of this International Standard, whierever the terrn “product” occurs, it can alee mean “service” 4 Quality management system 4.4 General requirements The arganization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard, ‘The organization shall a) identify the processes needed for the quality management system and their application throughout the ‘organization (see 1.2), b) determine the sequence and interaction of these processes, ©) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, 4) ensure the availabilty of resources and information necessary to support the operation and maritaring af thase processes, 2) monitor, measure and analyse these processes, and 1) implement actions necessary to achieve planned results and continual improvement of these processes. ‘These processes stall be managed by ine organization In accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that alfects product conformity with requirements, the organization shall ensure control over such processes. Control of such oulsourced processes shall be identified within the quality management system, NOTE Processes needed for the qualily activi f qyally management ays reeted to above shoud indude processes for management 5, provision of resources, product realization and measurement, 4.2 Documentation requirements 4.2.1 General ‘The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, ° b) quality manual, ©) documented procedures required by this International Standard, a documents needed by the organization to ensure the effective planning, operation and controt ofits processes, and, ©} records required by this International Standard (see 4.2.4). NOTE 1 Where the term “documented procedure" appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. 10 2009 - AN rights reconedae = 1SO 9001:2000(E) NOTE 2 The extent ofthe quality management system documentation can dilfer from one organization to another due to 8), the sizo of organization and typo of activites, b) the complexity of processes and their interactions, and €)_ the competence of personne! NOTES The documentation can be in any form or type of medium 4.2.2. Quality manual ‘The organization shall establish: nnd maintain a quality manual that ides 2) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and ©) description ofthe interaction between the processes of the quality management system. 42.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document {and shall be controlled according to the requirements given in 4.2.4 ‘A documented procedure shall be established to define the controls needed a) to approve documents for adequacy p toissue, ) to review and update as necessary and re-approve documents, ©)_ Wo ensure that changes and the current revision status of documents are identilied, 9) to ensure that relevant versions of applicable documents ace available at points of use, ©) {0 ensure that documents remain legibte and readily ident ble, 4) to ensure that documents of external origin are identified and their distribution controlled, and 9) {0 prevent the unintended use of obsolete documents, and to apply suitable identtication to them if they are retained for any purpose. 4.24 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system, Records shall remain legible, readily identifiable and retwovable a Cocumented procedure shall be established to define the controls needed for the identification, storage, protection, fetrieval, retention time and disposition of records. 5 Management responsibility 5.1. Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quafiy management system and continually improving its effectiveness by ‘@) communicating to the organization the im portance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, ©) ensuring that quality objectives are established, (0180 2000 ~ Airigis reserved‘ ISO 9001:2000(E) 4) conducting management reviews, and ©}. ensuring the availabilty of resources. 5.2 Customer focus ‘Top management shall ensure that customer requirements are determined and are m customer satistaction (see 7.2.1 and 8.2.1). with the aim of enhancing 5.3 Quality policy ‘Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, ) includes a commitment to comply with requirements and continually improve the elfectiveness of the quality ‘management system, ©) provides a framework for establishing and reviewing quality objectives, 4) Is communicated and understood within the organization, and €) is revievied for continuing suitabitiy, 5.4 Planning 8.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements lor product {coe 7.1 a)], ate established at relevant functions and levels within the organization. The quality objectives shall be ‘measurable and consistent with the quality policy. 5.4.2 Quality management system planning Top management shall engure that ) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and . b) the integrity of the quality management system is mai are planned and implemented, ined when changes to the quality management system 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority ‘Top management shall ensure that responsibilities and authorities are defined and communicated within the organization 5.5.2 Management representative ‘Top management shall appoint a member of management who, irtespective of other responsibilities, shall have responsibilily and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, 180.2000 - Ai igns reserved180 9001:2000(E) ©) reporting to tue inanagement on the perlormance of the qualily management system and any need lor improvement, and ©) ensuring the promotion of awareness of customer requirements throughout the oxganization, NOTE The responsitiity of a management representative can include fais 108 with external parties on matters relating to the quality management system, . 5.5.3 Internal communication ‘Top management shallensure that appropriate comm runication processes are established within the organization ‘and that communication takes place regarding the elf tiveness of the quality management system, 5.6 Management review 5.6.1 General Joa manngement shall roview the organization's quality management system, at planned intervals, to ensure its aod ee iatily adecuacy and ellectiveness, This review shall include assessing opportunities forimpenrcment and the need for changos tothe quality management system, including the qualiy policy and qualty obseetoes, Records from management reviews shall be maintained (see 4.2.4). 56.2 Review put The input to management review shail include information on @) results of audits, b) customer feedback, ©) process performance and product conformity, 4) status of preventive and cox fective actions, @) follow-up actions from previous management reviews, 1) changes that could affect the quality management system, and 9) recommends 1s for improvement. 5.6.3 Review output 2)_ improvement of the effectiveness of the qually management system and its processes, 5) improvement of product related to customer requirements, and ©) resource need: . 6 Resource management 6.1. Provision of resources ‘The organization shall determine and provide the resources needed 2) toimplement and maintain the quality management system and continually improve its ellectiveness, and b) to enhance customer satisfaction by meeting customer requirements, i | Tre ulpt tom he managentnt ei chal include ay doce ad actions latest 4 | 4 | i |ISO 9001:2000(E) 6.2 Human resources 6241 General Personnel performing work allecting product quality shall be competent on the basis of appropriate education, Uaining, skills and experience. 6.2.2 Competence, awareness and training ‘The organization shall a) determine the necessary competence for personnel perlorming work allecting product quality, b) provide training or take other actions to satisly these needs, ©) evaluate the effectiveness of the actions taken, @) ensure that its personnel are aware of the relevance and importance of theit activities and how they conte to the achievernent of the quality objectives, and €) maintain appropriate records of education, training, skills and experience (see 4.2.4). 6.3 Infrastructure Tho organization shall determine, provide and maintain the infrastructure needed to achiave conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utiles, b) process equipment (both hardware and software), and ©) supporting services (such as transport or communication), 6.4 Work environment, The organization shall determine and manage the work environment needed to achieve conformity to product requirements. 7 Product realization 7A Planning of product realization ‘The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1) In planning product realization, the organization shall determine the follovdng, as eppropriate: a) quality objectives and requiremen ts for the product; b) the need to establish processes, documents, and provide resources specilc to the product ©) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for provurt acreptance; 4) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). 19180-2000 ~All ngnisroeereIso 9001:2000(E) ‘THe output ofthis plansiny sia be Ina form suitable for the organization's method of operations NOTE 1 A document pecitying the processes ofthe qual ty management systom (ineluding the produet ‘nd the resources to be applied to a specie prow Project oF contact, nn be ralerred to a2 a quay plow, NOTE 2 The organization may aso apply the requirements given in 7.3 o the development of pert reason pro 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product ‘The organization shall determine ®) requiements specified by the customer, including the requirements lor delivery and post-deivery actives, 2) requirements not stated by the customer but necessary for speci d or intended use, where known, ©) Statutory and regulatory requirements related to the product, and 9), any addtional requirements determined by the organization, 7.22 Review of requirements related to the product Zhe organization shall review the requirements related o the product. This review shat Crganization's commitment to supply a product to the customar (e.g. submission of lena oF orders, acceptance of changes to contracts or orders) and shall ensure that Il be conducted prior to the fers, acceptance of contracts, ) product requirements are defined b) contract or order rea ments differing trom those previously expressed are resolved, and ©) the organization has the ability to meet the defined requirements, Records of the resuits of the review and actions arising from the review shall be maintained (s00 4.2.4) Where the custome: provides no documented Statement of requitement, the cusiomer requirements shall be Confirmed by the organization belore acceptance. rate eredust requirements ar changed, the organization shal ensure that relevant documents are emended and that relevant personne! are made aware of the changed requicementa, relvant prod lion, such as intennet sales, a formal review is impracis!or each oid. Instead the review can cover ‘etevant product information such as catalogues or advertising materia 7.2.3 Customer communication The organization shall determine and implemen * effective arrangements for communicating with custoiners in felation to a) product information, ) enquiries, contracts or order handling, including amendments, and ©) customer feedback, including customer complaints 2180 2000 ~ al gts reserved u_ RETA Se ISO 9001:2000(E) 73 Desi n and development 7.3.4. Design and development planning The organization shal plan and control the design and development of product. During the design and development plansing, the organization shall determine 2) the design and development stages, ) the review, veiication and validation that are appropriate to each design and development stage, and ©) the responsibilities and authorities for design and development, ‘The organization shall manage the interlaces between different groups involved in design and development to ensure elfective communication and clear assignment of responsibilty Planning output shall be updated, as appropriate, as the design and development progresses. 7.32. Design and development inputs Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include 8) functional and performance requirements, b)_ applicable statutory and regutatory requirements, ©) where applicable, information derived trom previous similar designs, and 0) other requirements essential for design and development ‘These inputs shall be reviewed for adequacy. Requitements chall be complete, unamhiguows and not in eontlict with each other. 7.3.3. Design and development outputs ‘The outputs of design and development shall be provided in a formn that enables veritication against the design and. development input and shall be approved prior to release, Design and development outputs shal a) meet the input requirements for design and development, b)_ provide appropriate information for purchasing, preduetion and for service provision ©) contain o relerence product acceptance criteria, and 4) specity the characteristics of the product that are essential for its safe and proper use. 7.3.4. Design and development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) a) to evaluate the abil of the results of design and development to meet requirements, and 1b) to identity any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stago(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 42.4). (0180 2000 aight reserves1S0 9001:2000(€) 7.3.8 Design and dovelopment verification sentation shal be performed in accordance wih planned arrangements (see 7.3.1) to ensute thal the design and Gevetopment outputs have met the design and development input requirernents. Records ol te resets et ne verification and any necessary actions shall be maintained (see 4.2.4), 7.3.6 Design and development validation 28si90 and development validation shall be pevlormed in accordance with planned arrangements (see 7.3.1) E7aure thatthe resulling produet ie capable of meeting the requirements for the specitied application er tended use, where known. Wherever practicable, validation shall be completed prior 10 the delivery or implementation of too product. Records of the results of validation and any necessary actions shall be mainten 7.87 Control of design and development changes Design and development changes shall be identi verified and validated, as appropriate, and approved ‘changes shail include evaluation of the elect of the ch «d and records maintained. The changes shall be raviewed, before implementation. The review of design and development hanges on constituent parts and product alteady delivered, Fesords of tho results ofthe review of changes and any necessary actions shall be maintained (see 42.4) 7.4 Purchasing TAA Purchasing process Eng grGanization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of contro! applied to the supplier and the purchased product shall be dependem upon tha attest ot ire Purchased product on subsequent product realizalion or tne final produc ‘The organization shall evaluate and select s ‘organization's requiremants. Criteria lor sele¢ results of evaluations and any uppliers based on their ability to supply product in accordance with the ction, evaluation and re-evaluation shall be established. Records of the Necessary actions arising trom the evaluation shall be maintained (see 4 2:4). 7.42 Purchasing information Purchasing information shall describe the praduct to be purchased, including where appropriate 4) requirements for approval of product, procedures, processes and equipment, b) requirements for quaiiication of personnel, and ©) quality management system requirements. ‘The organization shall ensure the adec quacy of specilied purchase requirements prior to their communication to the supplier, 7.4.3. Verification of purchased product Zhe organization shall establish and implement the inspection or other activities necessary for ensuring that Purchased product meets speciied purchase requirements, Where the o:ganization or its customer int lends to pertorm verification at the supplier's premises, the organization shall state the intended verification arrange ments and method of product release in the purchasing information1S0 9001:2000(E) 7.5. Production and service provision 7.5.1 Control of production and service pro ‘The organization shall plan and carry out production and service provision under contiolled conditians. Controlled conditions shall include, as applicable 2). the availabilty of information that describes the characteristics of the product, b)! the av lly of work instructions, as necessary, ©) the use of suitable equipment, 4) the availabilty and use of monitoring and measuring devices, €), the implementation of monitoring and measurement, and {the implementation of release, delivery and post-delivery activities. 7.5.2. Validation of processes for production and service provision ' ‘The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only alter the product is in use or the service has been delivered, Validation shall demonstrate the ability of these processes to achieve planned results. ‘The organization shall establish arrangements for these processes including, as applicable a) defined crite for review and approval of the processes, b)' approval of equipmont and qualilication of personnel, ©)" use of specific methods and procedures, d)_ requirements for records (see 4.2.4), and ) revalidation. 7.8.3. Wentitication and traceabi ‘Where appropriate, the organization shall identity the product by suitable means throughout product realization. ‘The organization shall identity the produet status with espect to monitoring and measurement requirements. ‘Where traceability isa requirement, the organization shall control and record the unique identitication of the product (soe 4.2.4). NOTE Income industry sectors, configuration management is a means by which ideniiealon and traceability are maintained, 75.4 Customer property ‘The organization shail exercise care with customer property while itis under the organization's control or being used by the organization. The organization shall identity, verily, protect and saleguard customer property provided for use €or incorporation into the product. I any customer property is lost, damaged or otherwise found to be unsuitable for Use, this shall be reported to the customer and records maintained (see 4.2.4) NOTE Custoiner property can include intellectual property 10 (© 150 2000 Alrignis reserved1S0 9001:2000(€) 7.55 Preservation of product The organization shall preserve the conformity of product during internal processing and delivery to the intended Gestination. This preservation shall include identitication, handling, packaging, storage and protecton, Prosemation shall also apply to the constituent parts of a product. 7.6 Control of monitoring and measuring devices The organization shall determine the monitoring and measurement to be undertaken and the mohitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1) The ofganization shall establish processes to ensure that monitoring and measurement can be ca carried out in.a manner that is consistent with the monitoring and measurement requirements. out and are Where necessary to ensure valid results, measuring equipment shall 8) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; b) be adjusted or re-adjusted as necessary; ©) be identified to enable the calibration status to be determined: ¢)_be safeguarded from adjustments that would invalidate the measurement result @)_ be protected trom damage and deterioration during handling, maintenance and storage. {a addition, the organization shall assess and record the validity of the previous measuring results when the Eauipment is found not to conform to requirements, The organization shal take appropriate action onthe equipment ‘end any product affected. Records ofthe results of cafation and verification shall be mainlained (see 4.2.4), When used in the monitoring and measurement of specified requirements, the abilty of computer sofware to satisly tho intended application shall be vonfirmed. This shall be undertaken prior to intial use and reconlimned ae necessary, NOTE See 1SO 100121 and SO 10012.2 for guidance. 8 Measurement, analysis and improvement 8.1 General ‘The organization shall needed 8) 10 demonstrate conformity af the: product, Plan and implement the monitoring, measurement, analysis and improvement processes 1b) to ensure conformity of the quality management system, and ©) to continually improve the etlectiveness of the quality management system, ‘This shall include determination of applicable methods, including statstical techniques, and the extent of their use. 8.2 Monitoring and measurement 82.4 Customer satistaction ‘As one of the measurements of the performance of ine quality management system, the organization shal! monitor information relating to customer perception as to whether the organization has met customer requirements, The methods for obtaining and using this information shall be determined, (©180.2000~ An syhis vexerved u: i p : 1SO 9001:2000(E) 8.2.2 Internal audit ‘The organization shall conduct internal audits at planned intervals to determine whether the quality management system, 1) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the ‘quality management system requirements established by the organization, and b) Is offectively implemented and maintained, ‘An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, trequency and methods shall bo defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit pro ‘Auditors shall not audit their own work ‘The responsibilities and requirements for planning and conducting aucits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. ‘The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Followup activities shall include the veriication of the actions taken and the reporting of verlication results (see 6.5.2). NOTE See ISO 10011-1, 180 1004-2 and ISO 10011-3 for guidance, 82.3. Monitoring and measurement of processes ‘The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality ‘management system processes. These methods shall demonstrate the abilly of the processes to achieve planned resulls. When planned results are not achieved, correction and corrective action shall be taken, a3 appropriate, to ensure conformity of the product. 82.4 Monitoring and measurement of product i ‘The organization shall monitor and measure the characteristics of the product to verily that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with, the planned arrangements {see 7.1). Evidence of conformity with the acceptance criteria shall be maintained, Records shall indicate the person(s) authorizing release of product (see 4.2.4). Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been ‘salisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer, 3 Control of nonconforming product The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibiliies and authorities for dealing with nonconforming product shall be defined in a documented procedure. ‘The organization shall deal with noncontorming product by one or more of the following ways: a) by taking action to eliminate the detected noneonformity; )_by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; ©) by taking action to preclude its original intended use or application, Records of the nature of noncantormities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4) 2 1©1S0 2000~ ai sights eservesISO 9001:2000(€) Wien nonconforming product Is corrected it shall be subject to re-verlication to demonstrate conformity to the requirements, When nonconforming product is detected alter delivery or use hi 5 started, the organization shall take action ‘appropriate to the effects, or potential elects, of the nonconformty 8.4 Analysis of data « The organization shall determine, collect and analyse appropriate data to demorttrate the suitability and the uatieas of the quality management system and to evaluate where continual improvementol nelle eee, the quality management system can be made. This shall inclode cats generated as a result of monitoring and Measurement and from other relevant sources, The analysis of data shall provide information relating to @) customer satistaction (sce 8.2.1), ©) conformity to product requituinents (see 7.2.1), ©) characteristics and trends of processes and products including opportunities foe preventive acon, and ©) suppliers. 8.5 Improvement £851 Continual improvement Tne Organization shal continvally improve the etlstvences of the qualty management system through the use o Re ually policy, quality objectives, audit results, analysis of data, corrective and preventing cement cee, ‘managoment review. v 8.5.2 Corrective action The organization shall take action to eliminate the cause of noncontor rmilies in order to prevent recurrence. Corrective actions shall be appropriate to the elects of the noncontor encountered, .A documented procedure shall be established to define requirements for 8) reviewing noncontormities (including customer complaint) b). determi ing the causes of nonconformites, ©) evaluating the need for action to ensure that nonconiormities do not recut, @) determining and implementing action needed, ©) fecords ofthe results of action taken (see 4.2.4), and 4) reviewing corective action taken, 8.5.3 Proves action The organization shall determine action to eliminate the causes of potential noncontormities in order to prevent their occurrence, Preventive actions shall be appropriate to the effect is of the potential problems. (2150 2000 — Agni eserves 13i 150 9001:2000(E) a F] —Acocumented procedure shal be estabished to denne requirement fr Hs) etemiing pena oncontrnites andthe causes, F 'b)_ evaluating the need for action to prevent occurrerice of noncontormi a ©) determining and implementing action needed, 9) records of resus of action taken (see 4.2.4), and €}_ reviewing preventive action taken, ©180.2000.~ At rights reserved= 180 9001:2000(E) Annex A (informative) Correspondence between ISO 9001:2000 and ISO 14001:1996 Table A.1 — Correspondence between ISO $001:2000 and ISO 44001.1998 150 9607000 150 T4001:1536 introduction iniroauaton 5 Genera os Process approach oz Retaonsip wth 150 8c08 oa Compatbity wih other management ystems fo. Scope i rape ene hs ertcation 2 Normative reference g Nornatve rterenoes i Tecms and dehintions > |oerations vatiy management system |? _—_|fvronmentaT management system FeGUTEROATS General equremenis CN CR Decimentatonrequremenis ae . Jaane! J.21 Jat |Fmianmontat management aystem documentation lousy manual Js22 |.a¢ _|Emironmenta management ystem documentation Contet ot documents Je29 eas Joocunent conto! Conve ot econ Jeza {esa _|recorts Management responsibility is [a1 |Stocture and responsiaiy fanagemant conmiment EV a> ewan potay a1 |Sracure and espohstity ectomer toss E2——}a3.1 —|Envronmontal apes 23.2 |Legatand ote reaaterents at patey [a2 Environment pata Planning sa 43) Planning [Quality objectives [541 [43.3 [Onjectwes end targets catiy management olen pang [542 — 43.4 —|Endvoneenal managemea pagamme) [Responsibily, authority and communication 55 ar [General requirements espansbiy and auhorty 51 jaa.t —|Sirctie and rsponcbily Management copresentatve ss2 internal communication 553 [443 _|Communcation tanagement review 56 ]a8—|itanagoment revawr Loner 56.1 Resiow input se2 Resiow output S03 [Resource management ie aa.1 | Stracture and responsibity Provision of resources x Human resources a2 cone s21 | | Competence, auareness and Vang Jez |aae |g, anavanese and emmporence nacre as eat —|Sirare a espns Biay Work envenment oa ©150 2000 — Altights reserved150 9001:2000(E) Table A.1 — Correepondence between 180 9001:2000 and ISO 14001:1996 (continvew) \Customer-reated processes 150 9001:2000, 150 44001:1596, Product reatization 7 [<4 implementation end operation 14.4.6 [Operational contol Panning of produel realization =a — Operational eontet - * [Determination of requremenis waied tothe [727 Envronmantal aspects product Legat and other requirements Js4.6 _ |Operatonat contrat Review of requrementsralatedtoihe product |722 —]&8 |Operational control [43.1 |Ervivonmontal aspects [Gusiomor commarieaton za Jaa — [Communicavons Design and deveiprent on Design and development planning [73.1 |2.46 [operations cont : Design and development inputs raz Design and development outputs ras Design and development review naa Design and development veritication 735 Design and development vakdation 736 [contol of design and development changes [7.3.7 Purchasing 74 {446 Joperational contr! Purchasing process rat Purchasing information naz Veritcation of purchased product 743 Production and serves provision 78 [446 operational contrl conto of production and sence provision —|75.1 4 [¥atdaton of processes for production an |7.82 service provision ideniication and traceability 753 Customer property rs. Preservation ot product 75.5 [Cantor of mentoring and measuring devices —_|7.6 —|@E1— |Monliodng and measurement Rieasurement, analysis and improvement [#5 |Ghecking and ecirectve action ISenerar [25.1 — [Monitoring and measurement Monitring and measurement lcustomersatstacton niernar avai [25a |Envronmeniat managment eyaten Boat : Monitoring and measurement ol processes 82.5 [48.1 — |Momtoring and measurement Monitoring and measurement ol product az [Gontot of nonsonierming product a3 Noncontormance end eorecine ard provenive scion Emoryency preparedness and response lanalaie of data aa [onioring and measurement improvement as Environmental policy Continual mpreversent as Environmental managoment programmels) (Coreatve acon B52 —|43.2 —|fvoncontarmanee and eorccive and provenive Bevan Preventive action esa 16 ©0150 2000 Atha resenesTable A.2 — Cunespondence between ISO 14001 1S 9001:2000(€) 1996 and 180 9001:2000 150 Ta00TTO56 To soar intaaction = oanaton Jos [cnet oz |racess approach 3 |reisonstip wih Iso 9004 4 __|Compareity win chor management eytoms Scope 7 7 —Freope fr senerr 1 : 1.2 |Application arava vatarences a _lermatveeterenee Detnkions [i ——[Ferms and deinitone Environmental management ayaa Je Java mangement pate requirements Sener ceqaremenis lax jaa [eneatvequvements 5:5 | responsi, author and communication 51 |responstity and auoy i Enron paiay f= Js —Jitanagement commimen 53 Jovattypotey as improvement Planning 43 [54 [Planning [Environmental aspects 43.1 [52 |Customer locus 7.21 [oeteminatonet requirements elated tthe produc 7.22 _ [review ot reurements lated tothe predict egaTand amar veqavemans ea [82 Customer ocus 72.1__|oteninaton of egiements elated to ve produc ijecives and ages e334 [Ovaliy abjectvos Emvicnmenial management proganmels) a4 —|&a2~ jOuay manage Glen UOAp 25.1 _|continal improvement inemariaten and oeraTon faa 7 Jrock reatation 7.1 |Ptaming ot product eateation Sear and esponiy cai |= —|Management responsiiiiy 5.1. |esanagement commitment 581 |responsitty and auhariy 552 _tanagemen reprecenaive 6 resource management 61 Jerson et resources 62 |ruman esouces 621 |oenerat sa Jax |worcenironment ising acarenats and conpeionso [e42__[628 — | Competence. awareness and Tang Eonmucicaton jaa3 [653 [ineralcommonzavon 723 |custemor communication Ecnmenta managomen sytem dasumeniaion [Ea — [42 |Dosumantatonenireren 421 |oener! 422 [ovat manuat 12150 2000 ~ al gn resoned 71S0 9001:2000(E) Table A.2— Correspondence between ISO 1400 1996 and ISO 9001:2000 (continued) TSO TAHT 58E 150 9001:2000 Document contrat [R25 [@22_ [Convvate documents [Operational control eae Product realization 7.1 | Planning of product realization 72 |Customer-related processes 72.1 |Determination of requirements related to the product 1722 | Review of requirements rlated to the product 7:3 | Design and development [7.3.1 Design and dovelopmont planning 7.32 — |Desiga and development inputs 7.33 |Design and development outputs 7.3.4 [Design and development ceviewr 17.35 | Design and development vesitication 17.36 — |Desiga and development validation 12.37 |Contot af design and development chenges 74 |Purchasing 7.4.1 |Purchacing process 17.42 [Purchasing information 17.43 |Vertcation of purchased product preventive action fs fProducton and sare provision 751 [contol of production and sence provision | 753 |Ieoniicaton and aceabiiy 754 [customer property 755 |Presoraton of product 152 |vaiation of processes for production and service provicion Eriergency preparedness and eaponse [aa7 [83 Conirtetnonconloing produc (Shecking and corecive acon 125 [a Heasorement, analysis and improverett Monitoring and measurement [451 —]7.8 | Conot of montaring and measuring devices es |oeneat 22 Mentoring and measurement | n21 [customer eatstocion i Ja22 |sontoring and measurement o processes { 1o2.4 _|stontoring and measurement of product | Jat [Analysis of data |_| Roncontonmance and conecive ara 752 Jaa —|Controt of mnconferning produ | les2 — |cowective action lesa [Preventive action i Records J42.4 [Control ofrecords [Environmental management system audi jas4__|e22_ |internatacat Management review a6 [56 | Management review — 7 56.1 |Genorat 5.62 |Review input i __|563__ Review output | i = 518 : ©180 2000 atrights reservesISO 9001:2000(E) : . Annex B (informative) Correspondence between ISO 9001:2000 and ISO 9001:1994 Table B.1 — Correspondence between 10 $001:1994 anid ISO 9001:2000 150 s00T:t995 150 s00T:2000 ft Scope 2 Normative reference 3 Definitions , fs Guaiity system requirements [ie oni] [2-1 Management responsibil [tle only] . 41.1 Qualiy policy presaesas | 4.1.2 Organization [to ony) | 4.4.21 Responsity and author Iss i s1.22 Resources ors62s ' +.1.2.8 Management representative ss2 i 4.1.3 Management review 6.1405. ; [4.2 Quatiy ayatem ito oni] | 4.2.1 Genarat teres i 4:22 Ouniy ystem procedures leo i 4.2.3 Quality planning [S424 74 \ [3 Contract review (ite oni] - | 5.31 Genera i 4.3.2 Reviow se+rererazer2s | 3.93 Amendment toa contact, ees | 2.34 Records 22 i 54 Design contd ite ony] | 24.1 General | 42 Ossgn and dertopment ning a i 144.3 Organizational and tech hos i erneerea eee 2.45 design output naa 5.4.5 Design review rae 8.4.7 Dacian vericton ras 4.4.8 Design vacation . ras 4.4.9 Design changes naz 5 Document and data cone fie oni | a 65.1 General lk2o |. 652 Document and data approval ond eave lnzo /" 453 Document and data changes w29 [6 Purchasing tite only] | 6.8.1 Genera! 5.6.2 Evaluation of subcontractors ra 4.63 Purchasing data rae S 84 Vetiicaton of purchased product 4.3 (0180 2000 ~ At ignEET 1S0 9001:2000(E) ‘Table B.1 — Correspondence between ISO 9001:1994 and ISO 9001:2000 (continued) Bo soTAgo 150 500172000 [a7 Cont of customer auppled prodkel rsa [8 Produet identiication and vacoabiiy ss [&.9 Process control jes +6a+751+752 = a-10 inspection and teting [ale nh] ~ 4.10.1 General tsar 6.102 Receiving inspection and testing 7494824 4.10: in-process inspection and testing 2a 4.10.4 Final inepecion and testing ona __ |8:105 inspection and tst records 7534024 3.17 Control of nspecton, measuring and Yel equpment {ile ony] — 4.11.1 General Ins. 6.11.2 Conte procedure 76 12 nepecton ana est sam Fas a.13 Contra ot nonconforming prodiet [ie oni 4.13.1 General le 4.1322 Reviw and disposition of nonconforming product ea 1-14 Corrective end preventive ection {ile onl] - 6.14.1 Generat lesz+ess 4.14.2 Corectve action es2 4.14.3 Preventive action ass s.18 Handing, storago, pacaging,proservaton & dalvry [ale oni] 4.18.1 General 6.15.2 Handing 755 6.15.3 Storage 755 s.15.4 Packaging 755 2.18.5 Preservation + * 755 6.15.6 Detvery Ins. .16 Coniot of ual records jaa 47 tnternal quality audi aa2 +23 fa.18 taining jeaz 3.19 Servicing rst 5:20 Statistical echniques file oni 4.20.1 idenitation of need e1se23+e24s04 4.202 Procedures orso2ssazecad 20 (0180 2000 - All aghis reserved—— 'S0 s001:2000(¢) { Table B.2— Correspondence between ISO £001:2000 and ISU 8001:1994 | 480 9001:2000 'S0 so0tz1994 7] Scope Fi ! 1.1 General | 12 Aeplcaton 2 Wotmativereferonee i Terms and detinifons i # Quality management system [ite oni) i [4.1 General requirements 424 - 4-2 Documentation requirements [li ori] ~ 4.2.1 Genera laze ‘ }2.22 Quatty manuat a2 * 4.2.3 Control of decuments, 45144524453 24 Con! of records eas [SHianagement responsiblity fe aay] 5.1 Mananemont eam fara 5.2 Customer focus _ 43.2 53 uaiypotey lana [5 Planing loon 54.1 Quay bjocives ans $4.2 Qvatiy management sytem planing soa 5.5 Responsibly, authoriy end: communication {ttle only) 5.5.1 Responsiitiy and authority eras / 55.2 Managomen representative ize 1 5.5.3 Internal communication } 5.6 Managensunt review file ony] 4 56.1 General jaa j 5.6.2 Review input | 5.6.3 Review output | 8.1 Provision of resources: 4.122 | 6:2 Haman resources fale ony) | 16.2.1 Genera anze 1 6.22 Competence, avaveness and tining are 8.3 Infrastructure 4.9 | 5: Work environment las |? Product realization ie oni 7.41 Planning ef product sealzaton - 23> a0. — 7.2 Customer-rolaied processes [title only] | , 7.2.1 Detonation of raquitemantsrelsed tothe produc 4324444 7 7-22 Review of requirements related tothe product 2246290454 7-29 Customer communication leaz i 7.3 Design and development} Title only) ~ “| | 7.2.1 Design and development planing aazeaes | 7.32 Design and development hputs lea | i (2150 2000 - Al gts reserved150 9001:2000(E) ‘Table 8.2 — Correspondence between ISU YUUT:ZUVY and ISO 9001:1994 (continued) 150 9001:2000 1S0 9001:1908 17.3.3 Design and development ouipate nae a 7.2.4 Design and development review! aac 7.3.5 Design ond development vesization 347 7.3.8 Design and development validation aa.8 7.3.7 Contot of design and development changes 44.9 17.4 Purchasing [ile eniy] 7.4.1 Purchasing process 46.2 7.4.2 Purchasing information 46a 7.43 Vesitcation of purchased product 26.44 4.10.2 7.5 Production and senvice prevsion [ile only) 7.8.1 Control ot produation and service provision 7.5.2 Validation ef processes for production and service prevision 7.5.3 tdenticatinn ana teaeeahilty 17.5.4 Customar property 7.5.5 Preservation of product 7.6 Conical of monitoring and measuring Jovices 4944.156+4.19 4s eo 2,105 44.12 7 15.24 4.15.96 4.15.44.4155 janis att [o Measurement, analysis and improvement [lic only) lant General [8.2 Monitoring and measurement [tle only) 6.2.1 Customer satisfaction 5.2.2 eternal aves 10.2. Monitoring end measurement ol processes 2.2.4 Monitoring and measurement ot product [a101 +4201 +4202 aa Ja17 + 420.1 44.202 4.102 + 4.103 + 4.104 + 4.105 +4:20144202 6.3 Contral of nonconforming product aia 4132 8.4 Analysis of data [4.20.1 + 4202 [8.5 improvernent lie ony) 6.5.1 Continual improvement les 8.5.2 Corrective action lear 44.142 8.5.3 Preventive action Jerat sates. 22 (© 10 2009 - rights recerves1S0 9001:2000(E) Bibliography [1] 180 9000.3:1997, Quality management and quality assurance standards — Part 3: Guidetines for tho pplication of ISO $001;1994 to the development, supply, installation end maintenance of computer soltware. f| {2} 180 9004:2000, Quality management systems — Guidelines for performance improvements, [8] 180 16005:1998, Quatty management — Guidel ines for quality plans. ! [4] 180 10006:1997, Quality management — Guidetines to quality in project managemant. Hl {5] 180 10007:1995; Quality managomént — Guidelines for configuration management. {6] 180 10051-1:1990, Guidotines for auditing quality systems — Part 1: Auditing", 7] 10 10011-21991, Guidelines for auditing quality systems — Part 2: Qualification extera for quality systems + auditors" ro 1S0 10011-3:1991, Guidelines for auaiting quality systems — Part 3: Management of audit programmes [9] ISO 10012-1:1992; ‘Quality assurance requirements for measuring equipmieit — Part 1: Metrological Contirmation system for moasurina equipment. {10} 180 10012-2:1997, Quality assurance for measuring equipment— Part 2: Guidelines for contro! of ‘measurement processes. [1] 180 10018:1995, Guidelines for developing quality manvals. [12] ISO/TR 10014:1998, Guidetines for managing the economics of qualiy. [19] 1S0 10015:1999, Quality management — Guidelines for training. {141 1SO/TB 10017:1999, Guidance on statistical techniques for ISO 9001-1994, [15] 180 14001:1996, Environmental management systems — Speciation with guidance for use, [16] IEC 60300-1:—"), Dependability management — Part 1: Dependability programme management. (17) Quatity management Principles Brochure [18] 150 9000 + 1SO 14000 News (a bimonthly publication which provides comprehensive coverage of international developments relating to ISO's management system standards, including news of their implementation by diverse organizations around the world}, [19] Relerence websites: hitp:wwiso.ch bitpufveewbsi.org.ubliso- 176-802 1) Tobe revised as 30 19011, Guidelines on quality andor environmental management systems auditing, 2) Tobe published. (Revision of ISO 9000-4:1993) 3). Available rom website: hipitwwiiso.ch 4) Avalsble trom ISO Central Secretariat (gales @iso.ch). © 180 2000-~ Alright reserved 23