Al Jaber Grinaker-LTA FACSIMILE To: ALEC Site Office (Ruwais) Attn: Mr. John (Dberholzer Fax: 02-876 0089 From: Rob Mather Copy: Site D/C ped (AB) LED ea I NS Al Jaber - LTA Engineering & Contracting (A.L.E.C.) L.L.C. Company Registration No, 41332 EOree g Jatt Uae Captal Bahar 25 Bion Pesche Yo: Plot No 325, Tarif Road ANTE Mafraq, Abu Cheb whl dee PO Box 45386, Abu Dhabi ea terre United Arab Emiatns Fosday ro jr Phone: 4971 2 $82 2288, ae Pc” dart an2 2800 seni oes Pages: 36 (Inclufing this one) > organization ——>> = customer © 1S0.2000~ Al igs reserved L.TsAs PROCESS ENGINEERING LTD1S0 9001:2000(E) ‘The term “organizaticti" replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this tnternational Standard|applies. Also, the term “supplier” now replaces the term “subcontractor. ‘Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service” 4 Quality management system: 4.1. General requirements ‘The organization shalljestablish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requitements of this International Standard. ‘The organization shan, i 2) dently the needed for the qualty management system and their application throughout the organization (see 1 >) determine the sequence and interaction of these processes, °) determine criteria nd mathods needed to ensure that both the operation and control ot these processes are @, d) ensure the availabilty of resources and information necessary to Support the operation and monitoring of these processes. ©) monitor, measure ghd analyse these processes, and f) implement actions hhecessary to achieve planried results and continual Improvement of these processes. ‘These processes shall/be managed by the organization in accordance with the requirements of this International Standard. Where an organization) chooses to outsource any process that affects product conformity with requirements, the organization shall ensijre control aver such processes. Control of such outsourced processes shall be identified within the quaity manaement system, NOTE Processes needelt for ine quality management systom referred to above should Include processes for management activities, provision of resijurces, product realization and measurement. 42. Documentation, requirements 424 General ‘The quality management system documentation shall include @) documented staterents of a quality policy and quailty objectives, ) equally manual, | ©) documented procedures required by this International Standard, 9 ocumente needed by the organization to ensure the effective planning, operation and control of its processes, ©) seconds required by this international Standard (see 4.2.4), NOTE 1 Where the term *éocumonted provaduré” appears within this Intemational Standard, this means that the procedure is ‘sstabtshed, documented, implemented ang mantainod.10 9001:2000(E) NOTE2 ‘The extent ofthe quality management system documentation can difer from one organization to another due to 8) the size of organization and type of activities, >). the complexity of proyesses and their interactions, and c) the competence of personnel, NOTE 3 The documemtation can be In any frm oF type of medium, 4.2.2 Quality manual The organization shalljpstablish and maintain a quality manual that includes a) 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 ©) a description of the interaction between the processes cf the quality management system, 42.3 Control of docyments Documents required byithe quality management system shal! be controlled. Records are a special type of document and shall Be comtoted pevoreng fo the requirements given in 4.24 A documented proceduje shail be estatiished to define the contrals needed a) to approve documents for adequacy prior to issue, b) to review and updaip as necessary and re-approve documents, ©) te encure that changes and the current revision status of documents are Wenttied, 4), to ensure that relevant versions of applicable documents are available at points of use, e} to ensure that documents remain legible and readily identifiable, 1) to ensure that docynents ot external origin are identfied and their distribution contrelled, and 9) to prevent the uninlended use of obsolete documents, and to anply suitable identification to them if they are retained for any putpose. 4.2.4 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 retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time iind disposition of records. 5 Management responsibility 5.1. Management commitment Top management shall provide evidence ot Its commitment to the develapment and implementation of the quality ‘nanagement system ari continually improving its efectiveness by 4) communicating 10 tte organization the importance of meeting customer as well as statutory and regulatory requirements, 2) establishing the quality policy, 2) ensuring that quality objectives are established, "160 #000 Aight event LATA. PROCESS ENGINEERING L1D1S0 9001:2000(€) conducting manayernent reviews, and ©) ensuring the availpbillty of resources. 5.2 Customer focus ‘Top management sha}f ensure that customer requirements are determined and are met with the aim of enhancing ‘customer Satistaction {see 7.2.1 and 8.2.1). 5.3 Quality polley ‘Top management shal! ensure thet the quality policy 2) is appropriate to the purpose of the organization, ) Includes a commiment to comply with requirements and continually improve the effectiveness of the auality management systpm, ©) provides a framewrk for establishing and reviewing quality abjectives, d)_ is communicated énd understeod within the organization, and ) Is reviewed for conkinuing suitability. 5.4 Planning 54.4 Qualtty objectives ‘Top management bel ensure that quality objectives, including those neaded to meet requirements for product (see. 74 al), are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 54.2 Quality managment system planning ‘Top management shalllensure that a) the planning of the! management system Is carried out in order to meet the requirements given in 4.1, as well as the quality (bj ‘and D) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility!pnd authority ‘Top management shail ensure that responsibiities and authorities are defined and communicated within the ‘organization. 55.2. Management ripresentativo ‘Top management shall, appoint @ member of management who, irespective of other responsibilities, shall have responsibly and authority that includes @) ensuring thal processes needed for the quality management system are established, implemented and maintained, 4 (© 1SO.2000 Al rinhte memnet1S0 9001:2000(E) b) reporting to top management on the performance of the quality management system and any need for Improvement, and ©). ensuring the prometion of awareness of customer requirements throughout the orgerization. MOTE Tho rosponsitity of a managerant representatve can include alson with externel parties on matters relating to the ‘quakty managornontsysty. 5.5.3. Internal comminteation ‘Top management al ensure that appropriate communication processes are established within the organization and that commureatioh takes Place regarding the effectiveness ofthe qualty management system, 5.6 Management réview 5.6.1 General ‘Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitabiity, agequacy and effectiveness, This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quallly policy and quality objectives. Records from manageshent reviews shall be maintained (see 4.2.4). i 5.6.2 Review Input | ‘The input to management review shall inctude information on a) results of audits, ») customer feedback, ©) process performance and product conformity, @) status of preventive and corrective actions, 2) follow-up actions from previous management reviews, 9) changes that could fect the quality management system, and 19). recommendations fyr improvernent. 5.6.3 Review output | ‘The output from the management review shall include any decisions and actions related to. 2) improvement of the'pftectiveness of the quality management system end its processes, b) Improvement of projjuct related to customer requirements, and ¢) fesource needs. | 6 Resource management 6.1. Provision of rejourcas ‘The organization shall determine and provide the resources needed 8). to implement and maintain the quailty management system and continually improve its eMectiveness, and ) 10 enhance customer satisfaction by meeting customer requirements. . PROCESS ENGHIEERING LTD gs. 2150 2000 ~ Alig reserved Lt,ISO 9001:2000(E) 6.2 Human resources 6.2.1. General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skifis and lence. 62.2 Competence) awareness and training ‘The organization shalt )_ determine the nelessary competence for personnel performing work affecting product quality, ) provide training of take other actions to satisfy these needs, c) evaluate the effetitiveness of the actions taken, ©) ensure that its pérsonne! are aware of the relevance and importance oftheir activities and how they contribute to the achlevementipf the quality objectives, and ©) mairtain appropriate records of education, training, skis ant experience (see 4.2.4), 63 Infrastructure ‘The organization shai! determine, provide and maintain the infastructure needed to achieve conformity to product rcuvetnon astaure nudes, os apleae : 8) builngs, workspace and associated utes, >) process equipmeiit (botn hardware and software), and ©). supporting servicys (such as vansport or communication). 6.4 Work environtnent ‘The organization shaft determine and manage the work environment’needed 10 achieve conformity to product requirements, | 7 Product realization 7.4 Planning of product reslization ‘The organization shal plan and develop the processes needed for procuct realization, Planning of product realization shall De consistent with the requirements of the other processes of the quality management system (se0 4.1). ‘in planning product realization, the organization shall determine the following, as appropriate: 2) qualty objectives ind requirements for the product; ) the need to establish processes, documents, and provide resources specific tothe product; ©} requited verifcatioh, validation, monitoring, inspection and test activities specific to the product and the criteria ‘or product aoceptinncs; ¢ eee needed tc provide evidence that tne realization processes and resulting product meet requirements 9 4.2.8). 5 (© /S0 2000~ Aut rights reservedISO 9001:2000(E) ‘The output ofthis plarjning shall be in a form sutable for the organization's method of operations. NOTE 1 A document sjectying the processes of the quality management system [inching the produc realization processes) and the resources to belapplied toa specie product, projector contract, can be referred toms a qualty qian. NOTE2 The orpanizatiyn may eiso appiy the requirements given in 7.3 tothe development of product reaization processes. 7.2 Customerrelated processes 7.24. Determination’ot requirements related to the product “The organization shallidetermine 2) requirements spoctied by the customer, including the requirements for delivery and post-delvery activities, >). requitememts not stated by the customer but necessary for specified or intended use, where known, ©) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. 7.2.2 Review of requirements related to the product ‘The organization shall review the requirements related to the product. This review shall be conducted prior to the ‘organization's committhent to supply a product to the customer (0.9. submission of tenders, acceptance of contracts of orders, acceptance [af changes to contracts or orders) and shall ensure that 8) product requiremeits are defined, 1b) contract or order: Fequirements differing trom those previously expressed are resolved, and ©} the organization héis the ability to meet the defined requirements. Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4). Where the customer jprovides no documented statement of secuirement, the customer requirements shall be trae, caine bron o crore Where product requireinents are changed. the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the chenged requirements, NOTE. 1 some stustonp, such as inwrnat sles, & formal revi Is treat Or eich err. stead the review can cover ‘relevant product information such as Catalogues or advertising materia 7.2.3 Customer cominunieatian ‘The organization shall determine and implement effective arrangements for commuricating with customers in relation to 2) product information, b) enquiries, contracts or order handling, including amendments, and ©) customer feedback! including customer complaints. 26 LID D “2180 2000 Ang reseed Liv. PROCESS &180 9001:2000(E) 7.3. Design and dyvelopment 7.3.1. Design and divelopment planning ‘The organization shalt plan and control the design and development of product, During the design and development planning, the organization shall determine a) the design and deysiopment stages, b) the review, verificetion 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 interfaces between different groups involved in design ard development to ensure effective communicatijn an clear assignment ct responsiblity. Planning output shell he updated, as appropriate, as the design and development progresses. 7.3.2 Design and development inputs Inputs relating to prodijet requirements shall be determined and records maintained (se 4.2.4). These inputs shall inclode 3} functiona’ and perfprmance requirements, ») applicable statutony end regulatory requirements, ©) where applicable, information derived from previous similar designs, and 4) other requirements) essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in contict with each other. 7.33 Design and Sevetopment outputs “The outputs of design bid development snal be provided in a form that enables verification against the design and development input and shall be approved prior to release, Design and development outputs shat @} meet the input requirements for design and development, >) provide appropriate information for purchasing, production and for service provision, €}_ contain or reference product acveptance erteria, and @) specity the characttiristics of the product that are essential for its sate and proper use. 7.3.4 Design and devplopment review At suitable stages, systzmatic reviews of design and development shall be performed In accordance with planned arrangements (See 7.3.1) @) 10 evaluate the abilty of the results of design and development to meet requirements, and. )_ to entity any probiiims and propose necessary actions. Participants in such reviews shail include representatives of functions concemed wih the design and development ‘¢age() being reviewed, Records ofthe resus of he reviews and any necessary actos shall be maintained (see 2.4). 8 © 190 2000 - allright regorved1SO 9001:2000(E) 7.3.5. Design and development verification Verification shall be piyrormod in aecordance with planned arrangements (see 7.3.1) to ensure that the design and evelopment outputs have met the design and development input requirements. Records cf the results of the verification and any necessary actions shall be maintained (see 4.2.4). 7.36 Design and development valldatton Design and developmiant validation shall be performed in accordance with planned arrangements (see 7.3.1) 10 ensure thatthe resutirig product is capable of meeting the requiremants for the specified application or intended use, where known, Whersier practicable, valklation shall be completed prior to the delivery or implementation of the product. Records of the resutts of validation and any necessary actions shall be maintained (see 4.2.4) 7.3.7 Control of design and development changes Design and devetopmipnt changes shall be identified and records maintained. The changes shall be reviewed. verified end validated, as appropriate, and approved before implementation. The review of design and development ‘changes shall include valuation of the effect of the changes on constituent parts and product already delivered. Records of the resuits pf the teview of changes and any necessary actions shall be maintained (see 4.2.4). 7.4 Purchasing 7.4.1 Purchasing precess ‘The organization shall ensure thet purchased product conforms to specified purchase requirements. The type and ‘extent of contro! appligd to the supplier and the purchased product shall be dependent upon the effect of the purchased product on 9 ubsequent product realization or the final product. ‘The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirert.ents. Criteria for selection, evaluation arid re-evaluation shal! be established. Records of the results of evaluations dnd any necessary actions arising from the evaluation shall be maintained (see 4.2.4) +k 7.42 Purchasing information Furchasing information shall describe the product to be purchased, including where appropriats 2) requirements for approval of product, procedures, processes and equipment, ) requirements for quplification of personnel, and ©) qualty managemest system requirements ‘The organization shail bnsure the adequacy of specified purchase requirements prior to their sommurtication to the supplier. 7.4.3 Verification of purchased product ‘The omganization shall establish and implement the inspection or other activities necessary for ensuring that purchased product med}s spectied purchase requirements Where the organizationior its customer intends to perform verification at the supplier's premises, the organization shall state the intended vertication arrangements and method of product release In the purchasing information. ‘B50 2000 = At gh reserved en, #RQcESS WHCESEENINE LTD 9 Lt180 9001:2000(E) 7.5. Production and service provision 75.1 Control of prtjduction and service provision “The organization shall plan and carty out production and service provision under controvied conditions, Controlled conditions shall incluije, as applicable 4) the mcaiabity of information that describes the characteristics of the product, ) the avatabilty of work instructions, as necessary. the use of sadly equipment, 8) the emalatilty ant use of monitoring and measuring devices, @) the implernentatin of monitoring and measurement, and 4) 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 ot measurement. This inchides any processes where deficiencies become ‘apparent only after the! product is in use or the service has been delivered. Validation shall demonptrate the ability of these processes te achieve planned results. ‘The orgenization shall establish arrangements for these processes including, as applicable 8). detined criteria fr heview and approval ofthe processes, ») approval of equipmpnt and qualification of personnel, 0} use of specific methods and procedures, ee een ©) revalidation. ; 7.5.3 Wentifiestion and traceability ‘Where appropriate, the: prganization shall identify the product by Suitable means throughout product realization. ‘The organization shal klentify the product status with respect to monitoring and measurement requirements. Ware Waceabiy i ryqukoment the organization shat control and record the unique identification cf the product (see 4.2.4). NOTE in some industy sijetore, configuration management is # means by whlch iorifcaion and tracoabilty are maintained. { 7.54 Customer property The organization shall eiercise care with customer property whie lis under the organization's contro! or being used 2y the Organization. The prganization shall identify, verity, protect and safeguard customer property provided for use 2¢ Inoorporation into the product, I! any customer property is lost, damaged ot otherwise found to be unsuitable for 4se, ths shall be reported! to the customer and records maintained (see 4.2.4). NOTE. Custorner property jan include intelectual property. ° \ 8180 7000 _ an etnnne,1SO 9001:2000(E) 7.5.5 Preservation o} product ‘The organization shallipreserve the conformity of product during internal processing and delivery to the intended destination. This presejvation shall include identification, handling, packaging, storage and protection. Preservation shal elso apply to the fonstituent parts of a product. 7.6 Control of moritoring and measuring devices ‘The organization shall determine the monitoring and measurement to be undertaken and the motitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.*) ‘The organization shallinstablish processes to ensure that monitoring and measurement can be carried out and are carried out in a manne} that's consistent withthe monitoring and measurement requirements. ‘Where necessary to erisure valid results, measuring equipment shall a) be calibrated oF vitifed at speciied intervals, or prior to use, against measurement standards traceable to ‘international or national measurement standards; where no such standards exist, the basis used for calityration or verification shall be recorded; b) be adjusted oF re-ajusted as necessary: c) de identified to: enable ‘the calibration status to be determined; 6) be safeguarded froin adjustments that would invalidate the measurement result ©) be protected from damage and deterioration during handiing, maintenance and storage, In adn. te omirgason shat sasees end reco the vay ofthe previous measuring ests when fe rent is found not fo conform to requirements. The organization shall take appropriate action on the equipment and any product ad. Records of the results of calfbration and verification shall be maintained (see 4.2.4). When used in the monijoring anti measurement of spectfied requirements, the abllty of computer software to satisfy the intended applicaticn shall De confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. ‘ NOTE See180 100:2"jpnd1S0 10012.2 or guidance 8 Measurement, jinalysis and improvement 8.1 General Tre organization shal lan and implement the monitoring, measurement, analysis and improvement processes neede a) fo demonstrate conipiity ofthe product 'b) to ensure conformity of the quality management system, and ©) te continual improve the effectiveness of the quality management system. ‘This shall include deteriiination of applicable methods, Inclucing statistical techniques, and the extent of their use. 8.2 Monitoring anc measurement ! 82.1 Customer satistpction ‘As on of the measure‘nents cf the performance of the quality management system, the organization shall monitor ‘formation relating to customer perception as to whether the organization has met customer requirements, The ‘methods for obtaining and using this information shal be determined. 130 2000 Atte rserps Lad "1SO 9901:2000(E) 8.22 Internal audi ‘The organization shiyl conduct internal audits at planned Intervals to determine wnether the quality management system 2) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quailty management system requirements establishes by the organization, and ) is effectively implemented and maintained. ‘An audit programms} shail be planned, taking into consideration the status and Importance of the processes and areas to be audited, ps well as te results of previcus audits. The aucit criteria, scope, frequency and methods shall be defined. Selectioy of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not auijt thelr own work. ‘The responsibiliies gnd requirements for planning and conducting audits, 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 ncnconformities and their causes. Follow-up activities shall include the verification of the actions: taken and the reporting of venifeation resums (see 8.5.2). NOTE See 60 10017, 180 10011-2.and iSO 10011-3f6 guidarce. 8.2.3. Monitoring and measurement of processes The organization shill apply sultable methods for monitoring and, where applicable, measuroment of the quality management system processes. These methods shall demonstrate the abifty of the processes to achieve planned results, ‘When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of fre product. 8.2.4 Monitoring end measurement of product The organization shail monitor and measure the characteristics of the product to verify that product requirements have been met. This thall be carried out at appropriate stages of the product realization process in accordance with the planned arangerrjents (6ee 7.1). Evidence of conformity with the acceptance criteria shall be maintained. Records shal indicate the person(s) authorizing release of|product (see 4.2.4). Product release and) service delivery shall not proceed unti the planned erangements (see 7.1) have been satisfactory completed, unless otherwise approved by a relevant authority and, where applicatte, by the customer. 83. Control of nonconforming product ‘The organization shaji ensure that product which does not conform to product requirements is identified and controtied to prevent its unintended use or delivery, The controls and related responsibilities and authorities tor dealing with nonconfojiming product shall be defined In a documented procedure. ‘The organization shall deal with nonconforming product by one or more of ths ‘olowing ways: 8) ‘by taking action toleliminate the detectsd nonconformity; b) by authorizing its use, release ot scceptance under concession by a relevant authority and, where applicable, by the customer, | 5) by taking action to precude ts origina intended use or appizaton Records of the nature of noneonfarmities and any subsequent actions taken, including concessions obtained, stall be maintained (see 4.2.4). 12 ©1S0 2000 - All Hahte renerwedt1SO 9001:2000(E) When nonconforming jjroduct is corrected it shall be subject to re-verification to demonstrate conformity 10 the requirements, ‘When nonconforming jiroduct is detected after delivery or use has started, the organization shall take action appropriate to the eflees, or potential effects, of the nonconformity. 8.4 Analysis of dath ‘The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of ‘he qualty managemeit system can be made. This shall include data generated as a result of monitoring and Measurement and from|other relevant sources. ‘The analysis of data shill provide information relating to @) customer satistactioh (see 8.2.1), ©) conformity to produit requirements (see 7.2.1), ©) characteristics end tfends of processes and products including opportunities for preventive action, and ©) suppliers. 85 Improvement 85.1 Continual improvement ‘The organization shall continually improve the effectiveness of the qualtly Mangement system through the use of the qualty policy, quality objectives, audit resutts, analysis of data, corrective and preventive actions and management review. 852 Correctiveaction The organization shail take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall ine appropriate to the effects of the nonconformities encountered. ‘A decumentes procedurp shall be established to define requirements for 2) reviewing noneantor}ties (mehuding customer complaints), b). determining the causes of nonconformities, ¢). evaluating the need Yor action to ensure that nonconformities do not recur, d) determining and impjementing action needed, €) records of the resulty of action taken (see 4.2.4), and reviewing comective qction taken, 8.5.3 Preventive action The organization shall dgtermine action 10 eliminate the causes of potentia! nonconformities in order to prevent their Seourrence. Preventive artions shai! be appropriate to the effects of the potential problems. L.T.A. PROCESS ENSIICERING LTD 150 2000 ~ Al righ reserva 13ISO 9001:2000(E) Adocumented procedure Shall be established to define requirements for a). determining potenial nonconformities and their causes, >) evaluating the neeld for action to prevent occurrence of noncontormities, ©} determining and itnplementing action needed. 6) records of resultsipf action taken (see 4.2.4), anc: ©) reviewing preventi}e action taken, 48 © 180 2000 - AN rights reserved1S 9001:2000(E) Annex A (informative) Correspondence between ISO 9001:2000 and ISO 14001:1996 AA ondence between ISO $091:2000 and ISO 14001:1996. 1 ap OTR 150 T4007 7096 reaction ftroduction General 01 Process approach o2 Relations with 180 sto os | i [Compaubtity with other management aystems _|0.4 jSeape R oy Scope Jconorat Application . ke Normative referenee [2 [Normative retorencas Fees cena er |Guaity management system [a Environmental management system requirements Gererel requirements at at Trequiromenis [Documentation requirerijents: 42 ~ |General J421 [44.6 |ervronmental management system documentation lowety manvat 14522 [a4 _ |Ervroomental management system dosumentation Contra! of documents 1423 [44s [Document conto! [Control of records. Jaze 4.5.3 [Records Management reaporaihiiy IS [eat [Stocture and reapensibity [Manedemen connie PT [Ex [Stvctoe and responstotty [Customer focus Y 5.2 3.1 |Environmertal aspects ~ 4.3.2 [Legal and other requirements [Quatiy pokey _ 63 [82 __feAtrormental policy 1 Pranring Isa [23 Planning [Qualty objeewves a1 [43S [Odjectives and targets [Quaily management sysjam Sanning 542 [4.3.4 | Environmental management programmo(s) | [Respenstomy, avthorty nd communication [55 [1 |General requiremerta Responsioity and authoiity is51 jaar ~ [Seekers and respendiiy Management representalve Iss2 fiternal communication | [353 _[#a3 [Communication 1 Management review 156 —|e6 —~ |Maragement review General ‘s61 i Review input Iss2 | | Review output ssa | Resource management Is [asa [Stature and responsiby Provision of resources 81 Human resources sz |General : (6.2.1 [Gompetence, awareness and trang ;2.2_|ado Waring, awareness and Competence infrastructure 6.3 Loa |Structure and responsibility. Work environment lea © 180.2000 A ights reser L.T.A. PROCESS ENGIN|Operatonal control [Pianring of product realgjation - [71 [48 Operational eontret |Customer-related procespes 72 eternination of requierpertsreafodte he |72.7 |@3.1 | Ervronmerial aspects —— product ! | J¢32 |Legal and other requirements 144.8 [Operational control jReview of requirements (platedTo the proaudt [722 [4.4.6 |Operationel control 143.1 _|Environmental aspects [Gustomer communicate 723 _|se (Communications [Design and development 73 | ~ ~ Design and development planning 73.1 |44.8 Operational control 1 IDesgn anc devetopment inputs 32 | Design and devetepmentioutputs v3.9 [Design and development review 3.4 Dealgn and developmentvericaton ras . Design and development vaidation ras | [Control of design and daeiopmant changes [7.3.7 | | Purchasing 74 [4.48 — |Operationat contro! | Purchasing process | rar | | [Purchasing information | ira2 \Vertication of purchased product 743 Production and service pjovision 75 |446 [Operational contro [Contr of production andservice provision [7.6.1 Naidaton ot processes flr procuction and i752 | lservice provision ldectfcation and traceabstity [Customer property Preservation of product | [Conti of monforing and|measuring devices [Monitoring and measurement |Measurement, analysis jind Improvement [Checking and corrective scion |General Mentoring and rreasurerent IMonitering and measurernort [Customer satistaction Pretrial aot t [k22 [45.4 |Emvronmental rianagement system audit Mentoring and measurafiental processes 1803 [415.1 —|Monfiorng and measurement 1 Monitoring and measuretaent of product | Corre! of nonconforming proguct [5.53 |Noveonformance and corrective and preventive acon ; [4.47 _ [Emergency preparedness and response 4 [anaes of cata 7 [<1 |Manttoring and meesurement [improvernent ica —erornei policy a a [Sorecive action ‘Noreonformance and Sonrectve and preventive acon Preventive action 16 ‘© 180 2000 — All ights reserved1SO 9001:2000(E) ‘Tebje A.2— Correspondence between ISO 14001:1986 and ISO 9001:2000 160 14001-1906 150 9001-2000 introavetion -o introdvetion lor [General 102 | Piocess approach Jos | Relationship with 1$0 9008 10.4 __|Compasioaty with cthor management systems [Scope ; o i [Scope 1 |General 1:2 [Appication Normative references 2 z [Normative reference [Definitions 5 3 ____ |Terms and definttions _| [Environmental menaggment system la ia JQuaity management system [requirements Generel requivomerts a1 [1 [General requirements - 155 |Responsibity, autrorty and communicator : [S5.1_|Responsioitty and authonty Environmental poly | a2 [51 [Management commitment : 53 founty porey [85 |Improvement Fanning [aa [s@ Planning ~ Emvironmental aspects aay [52 [Customer focus [7.21 [Determination of quirements related to the product [7.22 _ [Review of requirements related tothe product Lagal and other reauronjenis 332/52 |Gustomerfoous 17.2.1 |Determination of equcemerts related tothe product [Sbjectives ane targets [833 ]84.1|Ovalty objectives Ervironmental rianagenjont programmels) [484 [5.42 — [Quality management system planning 1351 [Continual improvement implementation and opejation aa I? |Product realization aaa i be fPianning of product roatzation [Structure and responsiblity [44.1 [5 [Management responsibiity | 5.1 | Management commitment i | [551 | Responsiety and authonty I552 | Management representative s [Resource management 8.1 |Provsion of resources : ls2 [Human resources | 162.1 |General ' 62 |nraseuct | i6.¢__ [Work envircament Hea, avarenese and porpatoroe leaa [623 —[Somoerence,avarenees and Baan [Communication i 643 [553 limemal communication Customer cormmurication Environmental manageripnt systems Gocurventaton [44.4 Documentation requroments General fouanny manval © 180 2000~ AN eights reserved ’ LA. PROCESS ENGINEERIEG LTD 71$0 9001:2000(E) Table A.3 — Correspondence between ISO 14001:1996 and ISO 9001:2000 (continued) 50 140011956 Bed [Document contol [e425 [423 [Control of documents : {Operational control bas (7 [Product realization I71 | Planning of product realization 17.2 | Customer-related processes \2.21 —[Detormination of requirements related to the product [7.2.2 [Review of requirements reisted to the product [73 |pesign and devetopment | 173.3 |Design and dovolopment planning | : 173.2 [Design and development inpuis \ 17.3.3 [Design and development outputs 17.3% {Design and development review 173.5 | Design and development vertiostion 1735 [Design and development validation 73.7 |Contol of design and davoloprnent changes . 174 | Purchasing 74.1 {Purchasing process 7.4.2 {Purchasing information 17.4.3 | vertication of purchased product 175 | Production ane service provision 7.5.1 |Gontrol of production and service provision [758 |igontiieation ane raceabiPty 75.4 | Customer property 175.5 Preservation of reduct [752 |Vateation of processes for oroduction and service zai [provision Emergency preparecndps and response Z&7__ [83 |Corirol ot nonconior a [Checking and corectvy) action as |e Measurement. analysis ang improvement |Montoring and measurymnent [65.1 [78 |Control of monitoring and measuring devices Ja1—|senerat [2.2 [Monitoring and measurement Is2.1 [customer satstacton 18.23 [Monitoring and measurement of processos | j2.2.4 — |Monttoring and measurement of product | le __lAnaysic of data INanconformance and Cprroctve and [452 [83 \Contret ctnoncantorming product Preventive ation las.2 |Coreatve acon | [853 __|Preventive action | Records r 453 [&24 [Control of records | Ervirorenental managelpot tem aude 454 [822 fletoral aval [Management roview | ae (58 i Ise 1562 Review input ) 5.63 [Review output | 18 6190 2000~ All rights reservedCorrespondence between ISO 9001:2000 and ISO 9001:1994 $S0 9001:2000(E} Annex B (informative) Table B.1 — Correspondence between ISO 9001:1994 and ISO 9001:2000 r 150 9007-1504 150 3001:2000 a i [2 Normative raferepce 2 Ig Definitions | x [¢ Guathy system epquirerments [ie oni) i: [4.1 Management réyponstofiy Nile ont] > 4.3.9 Quality potiey Jot 534541 4.1.2 Organtzation {ye ony] \ { 2.1.2.1 Responsibility and authority a 651 | |s.1.22 Resources le se21 | [4.1.2.3 Managemen} representative 552 | 6.1.3 Management tpview Is6.1 +851 | [422 Chatty system fhe ony) ” 42) Gere | lar saz2 4.2.2 duality systers| procedures a2 2.2.3 Quatty plannifg ba2+74 \4.3 Contract review jitie only) | | 14.3.1 General | } |4.3.2 Review ls2er2r-722+729 4.3.3 Amendment toia contract 72.2 | [63.4 Records 722 [2 Design control ite oA] ~ a 4.4.1 General j 4.4.2 Design and development planning 34 . 4.6.3 Organizational pnd technica! iteraces nas 4.4.4 Design input 7244732 4.4.5 Design ovtput a3 14.2.6 Design review 734 [47 Design verticalton 738 4.4.8 Design validation 736 2.4.9 Design changes 73.7 [25 Document and dia control ite ori] 14.54 General | ls23 [+52 Document andifata approval ard issue la2s 14 53 Document andijata changes a23 _| 6 Purchasing Title Caiyd J46.1 Goreral | 4.6.2 Evaluation of subcontractors ina 14.8.3 Purctasing data, 7.42 4.6.4 Vertication of pijchased product ras © 180.2000 - an sights reserjed (L.LA. PROCESS ENGINEERING LTD 191S0 9001:2000(E) ‘Table B.| — Correspondence between ISO 9001:1994 and ISO 9001:2000 (continued) 5 0011054 750 8007:2000, [&7 Control of custotber-suppied product 734 [£8 Product dertftction and tracesbilty 753 [49 Process contol | jasrear751 i750 F.70 Inspection and eating (ile only] 4.10.1 General 71484 4.10.2 Reseiving inspection and testing 74a0are 4.10.3 In-process inspection and testing p24 4.10.4 Final Inspectijn and testing 24 4.10.5 inspection an test records, rsasaee [4.11 Cont! of inspection, measuring and test equipment [ile only} ~ Ja.17.1 Goreral ns 6.12.2 Control procopire 78 2.72 inspection andijest suis rsa 14.13 Contal of ronepriorwing product [te only) ~ Ja 12.1 General 8s 4.18.2 Review and ajspesiion of nonconforming product 83 [4.14 Corrective and reventive action [ti’e on) 7 Jara Gone | Bs2-a53 4.14.2 Comoctive action las2 [4.14.9 Preventive acjon sss J4.15 Handling, storaye, packaging, preservation & delivery [ttle ony) | er 4.15.1 General [4.15.2 Handing 78s 4.15.3 Storage 755 6.15.4 Packaging 755 4.155 Preservation rss 4.15. Delivery Inst [4.18 Control of quality records __ jana la. 17 Intornal qualy dite B22 +828 [a8 Taning la2z _ [a7 Serving 754 ~ 1420 Statitical techn gues ft only] ~ 4.20.1 ersfeation «if need. a1 +023+824484 2.20.2 Procedures 8.1 +8.2.3+9.24484 7 (© ISO 2000 Al rights reserved:ISO 9001:2000() Table B.2 — Correspondence between ISO 9001:2000 and ISO 9001:1994 fo 7 __$80.800%:2000 150 90011594 Scope ie 7.9 Genera - F2 Application ~ [2 Normative referenire iz | [a Terme and defintinns ~ 3 [¢ Guaiky managemdnt system [ite oni] [2.1 Gerona requrempres a2 |¢.2 Documentation requrerients [ite ori] - |e.2.1 General 422 1622 Quality mamet lant 4.233 Contrt ot docurnents 45144524453 4.2.4 Contra of reco fase IS Mangement respansibility (We ony] _ 5.1 Maneyerrent comnirnent aa = [52 Gustomer focus [ae _ 5.3 Quality pofey fas ~ 5a Paring (ihe ony) 7 a 15.4.1 Quaity objectivos and 5.4.2 Quality managerront system pianniog 623 - 55 Responsibiy, eutiorty and communication file ony) 155.1 Responsibly arr authority ans | _ {582 Management rerosertatwo 14123 | 15.5.3 Internal commuo)cation [56 Management ro ” ~ 15.8.1 Generat ats [5.8.2 Review input | 5.8.3 Review out Z |S Resource managenjent [ite ony = 8.1 Provision of resourzes lanae [6.2 Human resourees jit only] 7 se Genet Janae 6.2.2 Competents, awyreness and training i618 [6.3 Wrastucrue ao [B:4 Work envronment” aa ~ [7 Product reafization lite oni) [7.4 Panning of produc} realization 42344104 7-2 Customer-reated processes Ite only] 4 7.21 Determination of jequirerners related to te product laa2e4ae 17.2.2 Review of requreinents related tothe product 4a2+43g4434 7.2 Custorner sommyication 4a2 [73 Besign and development five Oni] - 17.3.1 Design and develypment planning lsa2eass [7.3.2 Design ane devetypmont inputs ans 180.2000 Ad rights rovers 21ISO 9001:2000(E) Table 5.2 — Correspondence between ISO 9001:2000 and ISO 9001:1994 (continued) 150 9001-2000 150 5001-1984 7.33 Desigh and development outputs eas 7.3.4 Decign and dowilopment review 448 17.3.5 Design and devglopment verification 447 7.6 Design and devylopment vation 448 17.9.7 Contrt of desigh and development changos 449 7.2 Purchasing fide vy) 17.4.1 Purchasing rogers 1462 7.4.2 Purchasing information lao 7.4.3 Verification of purchased product |46.4 44102 |7.5 Production ang se}vice provision [ttle only] 17.8.1 Control of produrtion and service provision 7.5.2 Validation of proresses for production and service previslon [4.9 17.5.3 teentfcation ang traceabity a+ 4108+412 17.5.4 Customer prope:ty lar - [7.5.5 Preservation of jroduct 49441564419 [75 Contral ct monltoring and measuring devices 15244159 +4.15.444.155 ands ante ~ 7 [S Measurement, analysis and improvernent [ile 079) [8:1 General i at01 + 4204+ 4208 2 Mentoring and meacuremont fe oni 8.2.1 Custornor satsta.ction 5.2.2 irtoral aut [5.23 Mentoring and creasurement of processes 2.4 Monitoring and rheasurement of prochct lear la7 4420.14 4202 i [4102+ 4.10.3 +410.4+4.105+4.20.1 + 6202 [83 Control of nonconlsrming product [erste aige [at Analysis of data [e207 +4202 18.5 Improvement {litle pnty} t 2.8. coventry las | 3:2 Coveciv acon laner sasea | 18.5.3 Preventive actior) 4.14.1 +4.14.3 reBibliography {tj 180 9000-3:1997, Quality management and quality assurance standards — Part3: Guideiines tor the Application of 1S(9 9001:1894 to the development, supply, Installation and maintenance of computer software. 12] 150 9004:2000, uaiity management systems — Guidelines for performance improvements 18) 1SO 10005:1995, Quality management — Guidelines for quality plans. 4] !S0 10008:1997, Qualty management — Guidelines to quality in project management. {5} 1S0 10007:1998, Quality management — Guidelines for configuration management 16) 1SO 10011-1:1980, Guidelines for auditing quality systems — Part 1: Auditing”. 1] 180 10011-2:1981, Guidetnes for auctting quality systems — Part2: Qualifcation criteria for quality systoms auditors"). [8] 1S 10011-3:1991, Guidelines for auditing quality systems — Part 3: Management of audit programmes". 19} 180 10012-1:1992, Quality assurance requirements for measuring equipment — Part 1: Metrological contrmation for measuring equioment. [t0} 180 190032-2:1997. Quality assurance for measuring equipment Part2: Guidelines for contol of ‘measurement processes. 111] ISO 10013:1995) Guidelines for developing quality manuals. [12J ISOYTR 10014:1988, Guidelines for managing the economics af quailty. {13} 1S 10015:1999,/Quaiity management -- Guidelines for training. [14] 1SO/TR 10017:1889, Guidance on statistical techniques for ISO 9061:1994. 115] ISO 14001:1996, Environmental management systems — Specification with guidance for use. [18] 1EC 60300-1:—*), Dependability management — Part 1: Dependability programme management. 117) Quatity ses ela Principles Brochure”), 118} !S0 9000 + Iso tooo |News (a bimonthiy publication which provides comprehensive coverage of international developments ralpting to ISO's management system standards, including news of their implementation by diverse organizations around the world) [39] Reference websites: nttpy/Avww.iso.ch http:imww.bsi org.uk/iso-te176-sc2 1) To be revised as 80 |9011, Guldetines on qualty andior environmental management systems audting. 2) To be published. (Revgion of 1S0 9000-4:1883) 2) Avalabie trom websits)hite:/Mwwwsa.ch 4), Avadoble fom 180 Central Secretariat (sales@iso.ch. sats pts 1560 2000 ase reseried LATA. PROCESS CHBIRERGNS Lp 8