INTERNATIONAL. Iso STANDARD 10005 ‘Second edtion 200806-01 management systems — Guidelines for quality plans Systémes de management dela qualité — Lignes directrices pour les plans qualité WOUD snruto scion 0 noruauzacion Eota es una copia fel del original. Venta suterizade por ISO ai Instituto Nacional de Normalizacién de Chile (|NN) bajo el Acuerdo de POCOSA (Nov. 1992), Releronce number 180 ro0082005(€), ©180 2005180 10005:2005(E) ‘ne POF le may conte embodied ypetaces. In acarance wth Ate’ ons ai, is ray ba rtd or vowed it ha fete ested ures he Npshene when ae onbedded are lcenzd io and nts on Be conuter orming he drain ‘Bntateg thf porioa secant aaa te vespansty oft moi Mao's tering pe The FSO Cena Secreta | Seep obi in sro ets of he sofware pods Lt o cea Me POF fl can be fund the Goel nf aah he fe he POF teen Dares et opted ping Every sars ha eon akon crs that De sn aut Uo 80 meer Doses. hay evan a's paso lingo sen, seo he Catal Seceart te ade gen below © 50.2005 [A his reconmeUnes oferta speci no pat fh pubtcaton maybe reproduced or cod any em oy ny mans ‘Shoko r mecca nud photocopying snd racoan, wiht persion wing fom oe SO ote ease blow ee 1S0s moet inka county afte eres Is0 copra tice aus ponte 5 CH-1211 Gone 20 Foo saa r9 0087 Ermat copaeo 9 Viah varesoord utara in Stzesand A (21502005 — Anis ecored180 10005:2005(E) Contents ag 1 Scope : 2 Normative references .. 3 Terms and definitions 4. Development ofa quality PlaM eovnnnn 441 Identifying the need for the quality plan 4.2 Inputs to the quality plan 4.3 Scope of the quality plan ~ 444 Proparation of the quality plan 5 Content ofthe quality plan 5.4. General 52 Scope 5.3. Quality plan inputs... 54 Quality objectives 5.5. Management responsibil 5.6 Control of documents and data 527 Control of records 5.8 Resources 5.8 Requirements. 5.10 Customer communication .. 5414. Design and development .. AZ Purchasing nnonnnnnnnn 5.13. Production and service provision 5.14 Identification and traceability 10 5.18 Customer property .. 10 5.16 Preservation of product se 10 5.17 Control of nonconforming product. 1" ‘5.18 Monitoring and measurement .. " 519. Audis . : ve 6 Review, acceptance, implementation and revision of the quality plan 6.1 Review and acceptance of the quality plan 6.2 Implementation of the quality plan . 6.3. Revision of the quality plan 64 Feedback and improvement 7 : Annex A (informative) Simplified examples of formats for the presentation of quality plans 1“ ‘Annex B (informative) Correspondence between ISO 10005:2005 and ISO 9001:200 2 2 Bibliography180 10005:2005(E) Foreword {180 (the international Organization for Standardization) is @ workiwide federation of national standards bodies (50 member bocies). The work of preparing Intemational Standards is normally cated out tough ISO technical committees, Each member body interesied in a subject for which a technical committee has been teladlshed has the right fo be represented on that committee Internatonal organizations, governmental and ‘on-governmental,inlaison with ISO, also take part inthe work 1SO colaborates cose wih the international Electrotechnical Commission (IEC) on all mattrs of elecrotechnical standardization International Standards are drafted in accordance withthe rules given in the ISOIIEC Directives, Part 2 ‘The main task of technical commitees is lo prepare International Standards. Draft International Standards edopted by the technical committees are circulated to the member bodies for voing. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. “Attention is drawn to the possibility that some ofthe elements ofthis document may be the subject of patent Fights. 1S0 shall not be held responsible fr ideniying any or all such patent rights, 180 10005 was prepared by Technical Committee ISO/TC 176, Qualiy management and ually assurance, Subcommittee SC 2, Quay systems “This second edtion cancels and replaces the fst elton (1SO 10005:1995). It constitutes a technical revision of that ection, taking into account 80 9000:2000, ISO 6001:2000 and ISO 8004-2000. (91802005 — Ais ecard180 10005:2005(€) Introduction This International Standard was prepared to address the need for guidance on quality plans, ether in the ‘context of an established quality management system o¢ as an independent management actly In sithor ‘case, qually plans provide a means of relating specific requirements of the process, produc, projector contract to work methods and practices that support product realization. The quality plan should be compatible with other associated plans that may be prepared ‘Among the benefits of estabishing a qualty plan are the increased confidence thal requirements will be met, (greater assurance thal processes are in convo and the motivation it can give to those involved. t may also give insight into opportunites for improvement “This international Standard does not replace the guidance gven in 1SO 9004 or in industry- specific documents Where quay plans are required for project applications te guidance provided inthis International Standart is Intended to bo complementary to the guidance provided in ISO 10006, In terms ofthe process model shown in Figure 1, quality management system planring applies tothe whole model. Qualiy plans, however, apply primarly to the path from customer requirements, through product realization and product, to customer satisfaction Continual improvement of the quality management system key eval acing seis === tration to Figure 1 —Model of a process-based quality management systemINTERNATIONAL STANDARD 1S0 10005:2005(E) Quality management systems — Guidelines for quality plans 4 Scope ‘This Intemational Standerd provides guidelines for the development, review, acceptance, application and revision of qualty plans Ris applicable whether or not the organization has a management system in conformity with ISO 9001 This International Standard I applicable to quality plans fora process, product, projec or contrat, any product calegory (hardware, sofware, processed materials and services) and any industy. Its focused primarily on product realization and is not a guide to organizational qually management system planning ‘This Intemational Standard is 9 guidance document and is not intended to be used for certification or registration purposes NOTE. To avoid undue repetiton of “process, product, project or contact’, this Intemational Standard uses the term ‘specie case" (eee'3 10), 2. Normative references “The folowing referenced documents are indispensable for the application of this document. For dated ‘ferences, only the edition cited applies. For undated references, the latest edn ofthe referenced document {Including any amendments) applies 180 9000:2000, Quality management systems — Fundamentals and vocabulary 3. Terms and definitions For the purposes ofthis document, the terms and definitions given in ISO 9000 and the following apply. Some of the defnitons below are quoted directly from ISO 9000, but notes are in some cases omitted oF supplemented. 3a objective evidence data supporting he existence or verity of something NOTE Objctve evidence may be cbained trough obcervaton, measurement, est, o other msn {180 8000:2000, defintion 3.8.1) 32 Procedure specified way to carry out an activity or process (3.3) NOTE 1 Procedwes canbe documented or not NOTE 2. Whon a procedure Is documeniod, ho form "wrtton procedure" or “documented procadur' Is aque used The document tal contains procesue can be cao a “procedure document” [10 9000;2000, defntion 3 4 5} 180 2005- Aaa ened 1180 10008:2005(E) 33 process Set of interrelated or interacting activites which transforms inputs into outputs NOTE Adopted from ISO 9000:2000, dfnton 3.41 (he Nos have not been included) 34 product Fesultof a process (3.3) NOTE 1 There aro four geno product categories as follows = seniees ( 9. transport, — sofware (eg computer program. dictonary) — hardware (29 engine mechanical pat = processed materials (09 lubricant) Many products comprise elements belonging f front generic preductcatgoros. Whother he producti then called er, sofas, hardware or focessad mater depends on the dona element For skampla the ofleed product “uomabil’ consist of arduate (eg tyres), processed materials (fue, cooing Haul), sofware (eg. engine conor ‘Software, civer's manual), nd sores (eg, operting explanations gan byte slesvan) NOTE 2 Service isthe est of atleast one actly nevessadly performed atthe intraco betwoon tho Suppian and {ustomer and is generally intangible Provision ofa sence can Inve or exam, the alow: — sn acvty perormad on a custemor-supplied angle product ( 9 automobile oe rea) — en sctvty performed on a customersuppied inlangitie prod (¢9. he income statement nosded to propa @ tax retin — tho dovery oan intangible produc (eg the davery of formation inthe conta of knowledge transmission: — ne cretion af ambience fr the customer (2m holes and ostaurants) Software consiste of infrmation and i generally intangible and can be in the form of approaches, transactions oF procedures (32) Howat is general tangible andi amount a countable charactrate Procasted mers ae general tangle and thal amouni a contnuous charatenste Hardware and processed malas ofan a eforad to a5 goods, [180 9000:2000, definition 3.4.2) 35 project nique process (23) consisting of a set of coordinated and controlled actos with start and finish dates, Undertaken fo achieve an objective canforming to specic requirements, including the constraints of tine, cost and resources NOTE 1 An insvidual project can form prt of» larger projet structure NOTE 2 tn some projects, the objectives are refined and the product charactrstes deine progressively asthe project proceeds NOTES The outcome of a project maybe one or sever! unis of product (34) {180 9000:2000, defriton 3.4.3} 36 ‘quality management system ‘management system to ciret and contol an organization wih regard to quay [180 8000-2000, defntion 32:31 2 (180 2005 Atronerorenes180 10005:2005(E) 37 quality objective something sought, or aimed for, related to qualty NOTE 1 Quality ebyctnes ae goneraty based onthe organizations quality pokey NOTE 2 Qualtycbjctives ae generally specie for relevant uetion and leven the organization {180 9000:2000, definition 3.25] 38 ‘quality plan document speclying which processes (33), procedures (3 2) and associated resources will be applied by whom and when, to meet the requirements ofa specific project (3 5), product (3.4), process or contract NOTE 1. These procedures oneraty include those fering to qualtly management processes and to predict reakzaton processes NOTE 2 A qually pan often makes reference to parts of he ually manus! oto procedure documents NOTE 3. qual plan's generat one ofthe resus of quality planning 39 record document stating results achieved or proving evidence of activities performed NOTE. Adapted om 1S0 9000:2000, ofniion 376 (the Notes have nat been inctued). 3.10 specific case subject of the quality plan (3.8) NOTE This term suse to avoid repotin o process, prot, projet or contract” within this International Standard 4 Development of a quality plan 4.4. Identifying the need for the quality plan ‘The organization should identify what need there may be for quality plans. There are a number of situations ‘where quaity plans may be useful or necessary, for example: 2) to show how the orgenization’s quality management system apples toa specific case; ) to mest statutory, regulatory or customer requirements ©} In developing and validating new products or processes; 4) 10 demonstrate, internally andlor externally, how quality requirements wil be met ©) to organize and manage activ to meet quality requirements ané quality objectives; 1) to optimize the use of resources in meeting quality objectives: 9) 10 minimize the risk of not meeting quality requirements; h) to use as a basis for monitoring and assessing compliance with the requirements for quality 1) inthe absence of a documented quay management system. NOTE There mayor may ol be a need to prepare = quay plan fra specife cate. An orgarization wih an estabishod ‘aly management system maybe 2.0 of of te neds for quay plans under existing aye he rpaniaton ‘ay then deci that there sno need to prepare separate quality pane (2160 2005 ihsrseried 3180 10005:2005(E) 42 Inputs to the qu ity plan ‘Once the organization has decided to develop @ quality plan, the organization should Kentify the inputs for preparation of the quality pian, for example: 4) the requirements of the specif case; 1) the requirements for the quality plan, Including those in customer, statutory, roguatory and industry specifications; ©) the qualty management system requirements ofthe organization; €) risk assessments on the specific case €@) the requirement for and availabilty of resources; 4) information onthe needs of those engaged in carying out activities covered by the quality plan: {9) information onthe needs of other interested parties who will use the quality plan; fh) other olevant quality plans: |) other relevant plane, such as other project plans, environmental, health and safety, securiy and information ‘management plans 43. Scope of the quality plan ‘The organization should determine what i to be covered by the quality plan and what is covered or to be covered by her documents, Unnecessary dupicalion should be avoided “The scope of the quality plan will depend on several factors, including the following: 4) the processes and quality characteristics that are particular to the specific case, and will therefore need to be included; ») the requirements of customers or other interested partis Interal or external) for inclusion of processes not paticlar to the specie case, but necessary for them to have confidence that their requirements vail be ©) the extent to which the quality plan is supported by a documented quality management system \where quality management procedures have not been established, they may need to be developed to support ‘the quality plan “There may be benefits rom reviewing the scope ofthe quay plan with the customer or other interested partis, {or example in order to facta their use of the qualty plan for monitoring and measurement. 44. Preparation of the quality plan 444 Initiation ‘Te person responsible for preparing the quality plan should be clearly identified. The quality plan should be prepared with the palicipation of people who are involve i the specific case, both within the cganization and, \where appropriate, external parties. |when preparing a quality plan, ually management actives applicable to the specific case should be defined and, where necessary, documented 442. Documenting the quality plan “The qualiy plan should indicate how the required actives wil be caried cut, ether drecly or by reference to appropriate documented procedures of other documents (e.g. project plan, work instruction, checklist, 4 (0180 2005 Abie setened180 10005:2005(€) computer applcaton). Where a requirement resus in @ deviation ftom the organization's management systems, this deviation should be justified and authorized Much of the generic documentation needed may already be contained in the organization's quality management system documentation, including its qually manual and documented procedures. This ‘documentation may need tobe selected, adapted andior supplemented. The qual plan should show how the ‘organization's generic documented procedures are applied, or alteratvely modified or overridden by procedures in the quay plan, ‘A quality plan may be included as part of another dacument or documents, for example project quality plans are often included in project management plans (see ISO 10006), 443 Responsibilities In preparing the quality plan, the organization should agree and dafine the respective oles responsibltes and ‘obligations both within the organization and withthe customer, regulatory authorities or other interested parties ‘Those administering the qualty plan should ensure thatthe persons it refers to are aware of the quay ‘objectives and any specific qualy Issues or controls required by the qually plan 444 Consistency and compatibility “The contents and format ofthe quality plan should be consistent with the scope of the quality plan, the inputs to the plan and the needs ofthe intended users. The level of detain the quality plan should be eoneisten with any ‘agreed customer requirement, the organization's method of operation and the complety of the actives to be Performed. The need for compatiilty with other plans should also be considered. 4.45. Presentation and structure ‘The presentation ofthe quay plan may have any of several forms, for example a simple textual description, @ table, a document matrix a process map, a work Now chart or @ manual. Ary oF alla these may be presented In electronic ar hard-copy formats NOTE Examples of quality pans are provided in Annex A ‘The quality plan may be broken up into several documents, each of which represents a plan for a distinct ‘aspect Control of the interfaces between the different documents needs to be cleary defined. Examples of these aspects include design, purchasing, production, process contol or particular activites (such as ‘acceptance testing) ‘An organization may wish to propare quality plan that conforms to applicable requirements of ISO 9001 ‘A cross teference matrix is provided in Annex B for guidance, 5. Content of the quality plan 5.4 General ‘The examples and lists provided in his clause should not be considered comprehensive or limiting in any wa. ‘The quality plan for a specific case should cover the topics examined below as appropriate. Some tops in this guidance may not be applicable, for example where design and development are not involved. (© 1902005 ~ Aig ssn 5180 10005:2005(E) 52 Scope ‘The scope should be clearly stated in the qualy plan. This should include: 2) a simple statement of the purpose and expected outcome of the specific case: ) the aspacts ofthe specie case to which it willbe applied, incluting particular imitations to its applica: ) the conditions ofits vality (e.g. dimensions, temperature r ‘quality management systems certification status) 19, markot conditions, resource avaiailty oF 5.3. Quality plan inputs Itmay be nevessary to lit or deseribe the input to the quality plan (see 4.2, to facitate, for example, — ‘olerence to input documents by users ofthe quatty plan, — enecking consiztency with input documents during maintenance ofthe quality plan, and — identification of changes to input documents that may necessitate a review ofthe quay plan. 5.4 Quality objectives “The quality plan should state yhe quality objectives fr the specific case and how they willbe achieved. Quality objectives may be established, for example, in relation to. — quality characteristics forthe specific case, — important istes for satisfaction ofthe cuslomer or other interested parties, and = opportunities for improvement of work practices. “These qualty objectives shouldbe expressed in measurable terms, 8.5 Managoment responsibilities “The quality plan should identify individuals within the organization who are responsible, in the specific case, for the lowing: 8) ensuring that the activites requted for the quality management system or contract are planned, implemented and controlled, and thei progress monitored; b)- determining the sequence and interaction ofthe processes applicable tothe specie case; ©) communicating equirements to al alfected departments and functions, subcontractors and customers, and resolving problems that arise atthe interfaces between such groups: 4) reviewing the results of any audits conducted; ©) authorizing requests for exemption from the ganizations quality management system requirements; 4) controling corrective and preventive actions; 19) ‘reviewing and authorizing changes to, o deviations from, the quality plan. Reporting lines of those valved in implementing the quality plan may be presented in the form ofa flow chart. 5.6 Control of documents and data For documents and data applicable to the specific case, the qually plan should state: 8) how the documents and data willbe identi ) by whom the documents and data wil be reviewed and approved 6 (2180 2005 Ateghsacered180 10005:2005(E) ©) 10 whom the documents will be distributed, or thelr availabilty notified 1) how access tothe documents and data can be obtained, 8.7 Control of records ‘The quality plan should state what records should be established and how they will be maintained. Such records might include design review records, inspection and test records, process measurements, work orders, ‘rawings, minutes of meetings. Matters to be considered include the following 8) how, where and for how long records will be kept 5 ©) on what media the records will be kept (such as hard copy or electric media) What the contractual, statutory and regulatory requirements are, and how they will be satisfied 4) how leqiilty, storage, retrievabilty, disposition and confidentially requirements will be defined and salsied ©) what methods wal be used to ensure that records are avalabie when required 1) what records wil be supplied to the customer, when and by what means: 1) where applicable, in wnat language textual records wil be provided h) the esposal of records. 5.8 Resources 5.1 Provision of resources ‘The quality plan should define the type and amount of resources neaded forthe successful execution of the plan. These resources may include materials, unan resources, nfastriclue and work environment ‘Where a particular resource has limited avalabily, the quality plan may need to identity how demand from a ‘number of concurrent products, projects, processes or contracts willbe Satisfied 5.82 Materials Whore thore are specific characteristics for required materials (raw materials andlor components). the spectficalions or standards to which tha materials have to Conform should be stated or referred toi the quality plan 5.83. Human resources ‘The quality plan should specity, where needed, the particular competences required for defined roles or activities within th specific case. The qual plan should define any specie training or other actions required for personnel ‘This should incude: 4) the need for, and Waning of, new personnel; ) the training of existing personne! in new or revised operating methods. ‘The need or applicabilty of team development and motivational strategies chould algo be considered NOTE The quaifcation ofporsonno is addressed in 513, and ining into ue of quay plan is adores in 6.2 12180 2005 Anais esos 7180 10005:2005(E) 5.84 Infrastructure and work environment ‘The quality plan should stat the particular requicements ofthe specific case wit regard to the manufecturing or sorvice facity, workspace, tools and equipment, information and communication technology, support Services and transport facies necessary forts successful completion \Wmere the work environment has a dcect effect on product or process quality, the qualty plan may need to spect the particular environmental characteristics, for example: 2) the aicborne particle content fora clean room; b) electrostatic sensitive device protection: ©) biological hazard protection; 4), the temperature profile of an oven, 2) ambient light and ventilation 5.9 Requirements “The quality plan should include or make reference to the requirements to be met forthe spect case. A simple vervow ofthe requirements may be included to help users to understand tho context oftheir work, fr example ‘noutine of project in other cases, there may be a need for a comprehensive Ist of requirements, developed ‘rom input documents “The quality plan should state when, how and ty wham the requirements specifed forthe speciic case wil be reviewed The quality plan shoul! also etate how the results of tis review wil be recorded and how conficts or Ambiguities inthe requirements wil be resolved 8.10 Customer communication ‘The qualiy plan should state the folowing: 1) who is responsible for customer communication in patoular cases; b) the means tobe used for customer communication: ©) where applicable, communication pathways and contact point for specie customers or functions; 4) the records to be kept of customer communication; €@) the process tobe followed when a customer compliment or complaints receved, 5.11 Design and development 5.1.1 Design and development process “The quality pian should include or make reference tothe pla(s) for design and development ‘The quality plan should take account of applicable codes, standards, specifications, qualty characteristics and fegulatory requirements, 28 appropriate It should identiy the criteria by which the design and development inguls and outputs should be accepted, and how, at whel stago(s), and by whom, the outputs should be reviewed, vetlied and validated Design and development is a complex process and guidance should be sought ftom appropriate sources, Including the organization's design and development procedures, NOTE 150 9008 provides general guidance on the design and development process, ISOMEC 80003 provides specie ‘uldance fr tho software sector 8 12180 2005 Als resared180 10005:2005(E) 5.14.2. Control of design and development changes The quality plan should state the flowing: 8) how requests for changes to the design willbe controlled ) who is authorized to initiate a change request: €) how changes willbe reviewed in terms of their impact; 4) who is authorized to approve or reject changes 2) how the implementation of changes willbe verified In some cases there may be no requirement for design and development. However, there may sill be a need to manage changes to existing designs 5.42 Purchasing ‘The quality plan should define the folowing: 8) the critical characteristics of purchased products that affect the quality ofthe organization's produc how those characteristics will be communicated to suppliers, to enable adequate controt throughout the product oF service lifecycle; €)_ the methods to be used to evaluate, select and contol suppliers 4) requirements for, and reference to, supplier qual plans or other plans, where appropriate: ©) the methods to bo used to salisty the relevant qualty assurance requirements, inchiding statutory and regulatory requirements tat apply to purchased products; 1) how the organization intends to verily purchased product conformity to specified requirements; 9) the facies and services that wll be outsourced NOTE See webste wseiso orgie 7682 for guidance on “outsourced 5.13 Produetion and service provision Production and service provision, together with the relevant monitoring and measurement processes, ‘commonly orm the main part ofthe qualty plan. The processes involved wil vary. depending on the nature of the work, For example, a contact may involve manufacturing, istaliaton and other postdelvery processes ‘The inlerrelatonship between the various processes Involved may be efectvely expressed through the preparation of process maps or flow charts Production and service processes may need to be checked, to ensure they are capable of delivering the Fequired output; such a check should always be undertaken i the output of a process cannot be verifies by subsequent monitoring or measurement “The quality plan should identily the Inputs, realization activites and outputs required for carrying out production andor service delivery. Where appropriate the quali plan should include or refer to the folowing: 1) the process steps; b) ‘relevant documented procedures and work instructions; ©) the tools, techniques, equipment and methods to be used to achieve the specified requirements including details of any necessary material, product or process certification; 6) required controlled conditions to meet planned arrangements 2) mechanisms fer determining compliance with such conditions, incicing any specified statistical or other process controls; 4) details of any necessary qualification andlor certification of personnel 12150 2005 -abnoneesaved a180 10005:2005(E) 9) criteria fr workmanship 0 service delivery: 1). applicable statutory and regulatory requirements 1) industry codes and practices \Where installation or commissioning is a requirement, the qualty plan should state how the product will be installed and wich characterises have fo be verifed and validated at that ime, Where the specie case includes post delivery actviies (2. maintenance, support or taining services), the {ually plan should state how the organization intends to assure conformance to applicable requirements, such fa) statutes and regulations: 'b) industry codes and practices: ©) the competence of personnel, including rainees; 4) the availabilty of intial and on-going technical support during the agreed time period NOTE. Guidance on projec! processes tobe managed under ns clase is provided in ISO 10006, 5.14 Identification and traceability Where product identification is appropriate, the quality plan should define the methods to be used. Where ‘raceabityis.a requirement, the quality plan should define is scope and exten, including how the affected products wil be identified “The quality plan should state 18) how contractual, statutory and regulatory traceabilty requirements are identiied and incorporated into working documents what records relating o such traceability requirements willbe generated and how they will be controled and distributed: 1) speci requirements and methods forthe identification ofthe inspection and test status of products NOTE tdentfcaion ant traceabity 12 part of configuration management. For futher guidance on confgwation ‘management, 30 150 10007 5.45. Customer property ‘The quality plan should stato 2) how products provided by the customer (auch as material, tooling, test equipment, software, date, information, intellectual property or services) are identified and controled, ») the methods to be used to very that customer supplied products moet specified requirements, (6) how nonconforming customer-supplied products will be contrlled, and 4) how damaged, lost or unsuitable product willbe controlled NOTE Guidance on information security it enn SOMIEC 17798 5.16 Preservation of product “The quality plan should state 4) requirements for handling, storage, packaging and delivery, and how these requirements willbe met, ) the organization is tobe responsible for delivery) how the product willbe delivered tothe specitied site, in ‘manner thal wil ensure thats aquired characteristics aro not degraded 10 12160 2005 ations resend180 10005:2005(E) 5.7 Control of nonconforming product ‘The quality plan should define how nonconforming product will be identifed and controled to prevent misuse, Lunt proper disposal or acceptance by concession is completed. The quality plan may need to define specific limitations, such as the degree or type of rework or repair alowed, and how euch rework or repair wil ba ‘authorized 5.48 Monitor 1g and measurement ‘Moritoring and measurement processes provide the means by which objective evidence of conformity will be jbiained. In some instances, customers request submission of montring and measurement plans (comnmonly referred to as inspection and test plans") alone, without other qualily plan information, as a basis fr monitoring Conformity with specified requirements, ‘Tho qualty plan should doi the folowing: 2) process and product monitoring and measurements to be applied ) the stages at which they should be appiod: ) the quality characteristics to be monitored and measured at each stage 6 the procedures and acceptance criteria to be used: ‘any statistical process control procedures to be applied: 1) where inspections or tests are required to be witnessed or performed by regulatory authories andor customers, for example, — 8 test, or series of tests (sometimes refered to as “ype tests"), directed towards the approval of a Gesign and conducted to determine ithe design is capable of meeting ie requirements of te product specification, = site testing including acceptance, — product verification, and — product vation; 19) where, when and how the organization intends, or is required by the customer, statutory or regulatory authorities, to use third partis to perform inspections or tests; 1) the teria for product release. ‘The quality plan should identity the contol to be used for monitoring and measuring equipment intended for Use for the specific caso, including its calibration confirmation status NOTE 1 Guidance on the management of measurement systems canbe found in $0 10012 NOTE 2 Guidance on he selection of statistical methods can be founda ‘SOVTR 10017 549 Audits ‘Aucits may be used for several purposes, such as to monitor the implementation and effectiveness of quality plans b) tomanitor and verity conformity wth speciied requirements; ©) for survelance of supplies to the organization; 4) 10 provide independent objective assessment, when required, to meet the needs of customers or other interested partes. 150-205 aan scree "180 10005:2005(E) ‘The quality plan should identi the audits to be performed fr the specie case, the nature and extent of such auits and how the resulls ofthe audits should be used. NOTE Furterguldanes for austing i given la ISO 10041 6 Review, acceptance, implementation and revision of the quality plan 641 Review and acceptance of the quality plan “The quality pan should be reviewed for adequacy and effectiveness, and should be formally approved by an authorized person or a group that includes representatives from relevant functions within te organization In contractual stations, a quality plan may need to be submited tothe customer by the organization for review and acceplance, ether as part of a pre-conact consultation process or after a contract has been awarded ‘Once a contract is awarded the quay plan chould be reviewes and, where appropriate, revised to reflect any ‘changes in requiements that may havo occurred as a result of te pre-conlractconsuiation where a projector contrac is conducted in stages, the organization may be expected to submit a qualy plan to ‘the customer for each stage, prio tothe start of Hat stage 6.2 Implementation of the quality plan In the implementation ofthe quay plan, the organization should give consideration to the following issues, 2) Distbution ofthe quality plan ‘The quality plan should be distributed to all relevant poople Gare should be taken to distinguish between copes that ave disinbuted under document contra provisions (tobe updated as appropriate), and those that ‘re supplied for information only 1) Training in the use of quay plans Insome organizations, for example those engaged in project management, quaity plans may be used as a foutine part of the quality management system. However in others, qualty plans may be used only ‘occasionally In this tase, special traning may be needed 10 assist users in applying the qualy plan comet ©), Monitoring confoemty with quality plans “The organization fs responsible for monitoring conformity with each quality plan that t operates. This may inoude — operational supervision of he plannes arrangements, — milestone reviews, and = aus Where many short-term quality plans are used, aults are generally undertaken on a sampling basis, Where quality plans are submitted 10 customers or other extemal parties, these parties may establish provisions for monitoring conformity withthe qualty plans. ‘Whether carried out by internal or external parties, such monitoring can assist in 1) assessing the commitment ofthe organization tothe effective implementation of the quai pian, 2) evaluating the practical implementation of the quality plan, 3) determining where risks may arise in relation tothe requitemens ofthe specie case, 4) taking corective or preventive action where appropriate, and 5) identifying opportunites for improvement in the quality plan and associated actives 2 (21502005 —Aihsracercs180 10005:2005(E) 6.3 Revision of the quality plan ‘The organization should revise the quality plan 4) to reflect any changes to quality pian inputs, inctding — the specie case for which the qualty plans established, — the processes forthe realization ofthe product, — the organization's quality management system, and — statutory oF regulatory requirements; ) 10 incorporate agreed improvements tothe qualty plan ‘An authorized person or persons should review changes to the quality plan for impact, adequacy and effectiveness. Revisions to the quality plan should be made known to all those involved in ts use. Any ‘documents that are affected by changes inthe quality plan should be revised as necessary The organization should consider how and under what circumstances the organization would authorize a {deviation fom the quality plan, including ‘who will have the authority to request such deviations, — how such a request willbe made, — what information wil be provided and in what form, and — who wil be identiied as having the responsibilty and authority to acceptor raject such deviations ‘A qualiy plan shouldbe treated as a configuration item and should be subject to configuration management. 6.4 Feodback and improvement Where appropriate, experience gained from the application of a quality plan should be reviewed and the information used to Improve future plans or the qualty management system isell (© 1902006 —Am sered 13180 10005:2005(E) Annex A (informative) Simplified examples of formats for the presentation of quality plans AA General “This annex provides examples of some ofthe formats in which quality plans may be presented ‘The examples shown should not Be taken a being complete as regards the quality plan contont dafined in Clause 5. Actual quality plans may be more complex. It would normally be expected that al the processes for product realization would be covered, unless they do not apply fo the specific case. Presentation of quality plans may be in any format deemed sultable for mesting the agreed requirements. A textual presentation rather than a ciagrammatic one may be more appropriate in certain circumstances Similar a diagrammatic format may be supplemented with text. Other formats better suited toa specific case may be used. Where the quality plan is available electronically, dacuments referred to, such as procedures, could be ‘accessible va hyperlinks Examples 1 and 2 are different presentations ofthe same case, in order to ilusrate tha thee is no particular ‘tgnment ofa given presentation for a specific case. As examples of presentation, the contents of Examples 1 {04 ae llusrave and do not represent recommendations. “The examples include — Example 1: Table (Processed materials qualy pan), — Example 2: Flow chart (Processed materials quality plan) — Example 3: Form (Manufacturing quality plan), and — Example 4: Text (Software development qualty plan) 1“ 12150 2008s reared'S0 10005:2005(€) (2150 2005 — ign eens A2 Examples 2A Example 1: A “table” type quality plan (fr processed materials) ‘aPc 00s | Produetvoduct tine Speciation | Grcmwa ty: | approved bye e509 aatvy Deseton pee aan = TRG_qaty pen & SORGDS & fe poses a oan we Gao core [ipa oe Sees eee sy oes [Our uy ech ae Hh ew way CFT Ta) fo ansponane” [5 Gero ard rio chan th sprite of perl ainda] ger ore mE, [tyrone cng nementebases cscs cn) Sana hers no sal dst er vga Cabal eae i we ont rear sme te yrs. nee rte ad ese mr wi aid hh eters oS Records _|srecing quay Reso wie retained ors mriarn oh ae GS [te rearenens soma, pce ard varporion of vy WaRAaN oll cae age T uma [Sepa a sacein Wsthrat eo fesucen [als we ited hve sly cogil TOG He Faso] cop aia wee sec rascal Snaios Sr [ston gr ane ar epecteton and er vod wl rave reguerents sor-ivo | mcr aso asconncs womretite arena me perey sre elie review! Customer solved, and fhe company has th 10 meet tne roquiraments| SOP” J vi sca ed ony hw na py cesromaa| S0R- 188 | aa Costas [oupune nebo ceca aby vag Ba ato kgm SOFT) op aay con ttian [sede sessed Wrote messy owen Be ester sl comes] $9859 | ar \rrepanet tm tab Denna [Ase cot ers a i, pat on gen sons | agg development | rottypa appv, and roses veriiation ard vakietion hontiiend tea psc phan ye con we ae va ape od] SOR b feng sated he caret ov eked a toys covets ba puns Java rote. oonnd um ok Taare sf coos comes nurs eroasorng mao mayon sopovs Oy encase, dopcsdel eure] SORc are Inspr fon aso Prediction | Sanne pS ORR 30-6 | wre enneaon 04 |sunaar operating procedures a irs traceability awe. sop-540 | MEG [Gor snccatons and any Ta waits al poened an rnd we [up be tat sector yun panos tty nd afece ba] sono | ME? canoer rope shies olen nas ee Sse poeta to peal aga ah wav Bl ua arcade, Darian a Ried pos wa bo seed pe] Jnana, tuts ad wane ns Carla hang mando br eo [prevent damage, deterioration or contamination of the product Buk products will bel mar 15180 10008:2005(E) ‘ety Derrton ae aac iyi pass Fol at tales Reval wi bo Se a a nencontrnin rte sous arth rtenconcasin tome cstome wie ued ei eaves |Seee sync pecan shed io | itontorng ed JSrten and tsrg plas nt owl be preps 0 cove a pedo akan] a [The compony ravage of measuring a tg oqupmon oer as Inapecion and |rRipe oft develop poaicon abd contol aches Al ruc earacon | SOP-610 | GA wing eoupmen [theme rty he east nance pet] teins may ecstacy ava sora FSP: Guay SyenProcte; SOP: Sands Opertrg Prosrdire + ss: aman Resouces; MAT: Matis Cork MKT: Maraing and Sls; MEG: Manfactring, QA: Cully Assurore: PUR: Jpsensang; WOT: Top Management TSS. Tesi Sermon oe A22 Example 2: A “flow-chart” type of quality plan (lor processed materials) -Afulkpage example folows. A23. Example 3: A “form” type of quality plan (lor a manufacturing fait) ‘Afulkpage example flows, 16 ‘©1902006 Aran rarened180 10005:2005(E) sword get ump to] 1 sus uewornte rg vores 9 pmo] uouaineroug Gann | wa | wn] ee Hapmadey | 4 paeatg ekinsere-uopeypodg sn emp sence vedi BRET stureyoede Tae “Flow chart” type of quality plan 7 (61802005 — A hts sereseems 0 Gan evonesey © SunoemueN © 10H \xemeeme] Fenn, gucieedg | jeoys eu | LOK famssaug) | to | woes tamyeecun) ax Soren ywer | amin | sues 0 wsts] eee] om ams] Qu egos stood 0, =o Powoujonues essa steooig | moutnsoong | sue sen 150 10005:2005(E) ‘eid Ayjenb jo 2d uO, 2190 2005 argh reernd 18150 10005:2005(E) A24 Example sisplay unit) “toxt” typo of quality plan (for the development of software, fora pedestal mounted 7 Scope The purpose of ts quaty plan to dently the quality management methods being applied to te contract botmeen the compony ands elon for a garment dstabtion system 2) Inetsions ris quay plan apptes to the development and supply of the dsbtuton, concession management and marking suveystoms The tharcial management syeoms aro the subject of 9 subeoivat wth the swbeontaor and 0 the ual plans coneornad sity wih tne subeonvact management aspects ofthat part ofthe pojact, Jp) Exclusions [Tho dovloomont work bsing undertaken by the subcontractor Is covered by the purchase order and isnot included in detain hs plan 12 Quality objectives re ctent has made no specie domands in terms of quanti quay objectives Accordingly. the company standard of releasing sofware wih no known catagory A defects, no known category B defects, and category C dacs oy wih cin saroomant sal apply A dof is defined a system behaiour showing evidence of nanconformy against tne agreed a aston, ne cmgny cet of cnmisiring sstams win 85% maga fhe cova ate tad nt contacts elapoed te forthe projec shat alo opp [3 Responsibiities |e Projct Manager has overall responsbity for the succesful execution ofthe project, Including conformity wth te company’s OMS and maating the abow objectives. Tre Qualty Manager is responsbe or projet ute and fe folowing through any conetve actors frm them Any required davation rom to GMS i fo bo approved by th Qual Manager beter tha deviation takes place, 4 Documentation Some documents used inthis projet havo references that donot confor tothe nest QMS requirements Tha extn teens shall be relsined. In aller respects, te OMS appbes, 5 Records The project le and associate records aro be roland fora peri not as han thee years ale the warranty period es expired Dispostion that ine shal bey agreement wth te cont In accordance wah the company pa, he eo may view any canractolated records at ary reaccnabie te. A conot spect compiter flee shal be backed up a east weekly Js Resources Tho ctontis to supply asamp of OCR fos atleast 2.00) fr use in testing he document read being suppl! a prt ot tho system The subconvactor shal obtain and commission the documont reader a pat of ter supply ofthe franca management system Alc ne development tsam shall bs employees of the company Appropriately qualia individuals wil be made avaiable bythe Human Resources Manager to meat he noods ofthe project The Project Managar shal be Sh 17 Projectinputs [re primary inputs the Requirements Speciation KLOB-0-001 propared ty the cients advisors. Same marketing documents ond Aanual Reports ret be pried bythe company fe feminization purposes. (© 1502005 Ags sored 9180 10005:2005(€) [a Customer communications ny queries with the specication are tobe raised wit ho lent through the Project Manager at project meetings. Thi decison’ final The cent does ct havea software technical capably so technical queries shout be adresse tough the Projet Manager aris delegate Minutes of project mectngs wil be prepared by the Project Manager Sinn, eommunicatone for he stoma queries complains compliments} shou be routed trough the Project Manager J Design and development the peooct sche wil be presented using an approved echodung too. The rca dates are customer acceptance ests by end October) and syst ob-out (otro Al next year) tof he company standards in ho Sofware Development Manual shal apply Review and approvals shal be as inthe company’s Guay Manual change requests that affect he fectionlty 38 26en by the sors must be approved bythe company Detaled design [changes af the subcontracor and to company must be approved by the Project Manager before work in them tse approach to testing shal be the companys Qualty Manual. The document data capture testing wil requ the doceront reader ‘Tha fal ests ol he marking subeylom vst need te pedestal mountod display unl, test customer eacion The dstibuton system ae a whole eto be tested at ho company eofore shipment nd customer acceptance at tei premises| 0 Purchasing ax eauipment s beng purenased by the cent (computers through the subcontractor, ciher tems cect). Any oer purchases must be Pandod oto company’s procedures 11 Installation and commissioning tne document reader wil be devered to the clants HO The pedestals wil borate ou! by the lento thee programe ater fed ras Suppot may be needed forthe fest instalation who castomer stall are gaining familary withthe systems 12 Special processes: tere are no special processes in his project 113 Configuration management oocament deniers shot eontoe tothe version of he Qualty Manu document rosy nied beforehand curent company approved configuration management tos shal be used. In place a the tart ofthe projet, excopt thos 114 Customer property hy equipment belonging to the clant must be so identi while inthe company oF ts subcontraces’ possession [Customer property of akin must be rocorded inte project og, 115 Product handling Sottace wil be devered on GO-ROM Al|CDS willbe vius checked 118 Nonconformities ho sofas shal be delivered wih know noncanfornts other than ensmetc ones without a writen concession fom th Chen The process wllbo a gen mths company Mand SOM 20 (2190 2005 Atnignasarernd180 10005:2005(E) 17 Monitoring and measurement The project progress wi be corded on time shoots and repsterad on he Project Schedule on a weekly basis. report shal be prepared ‘or and presented wo te progress mootings wih te cont. The subeonrato wil be ried to Slee mcetngs Records shal be kept bythe prosamming loam lear of any problems isantied wth the sta a secon and bial level esting. Catagorzaton of problems i problem eign: Reutemont Spee. (missing arincarec). Desgn| essing orincorect, coding (missing, icons: lg, nlrtce er, dala handing eer) shal be poked 18 Internal audit An aust of he implementation and effectiveness oft quay pan shal ake place at the onc of the design stage tie qutty pan nas been prepare bythe projet manager of be cents Dstrbuton Poel and apples to al war Author: Quay anager: Document No: KLOB-F008 arson 1 Wa {OI wst1TuT0 AACIORAL DE NORMALIZACION | Esta es una copia fie! del original. Venta autorizada por ISO al Instituto Nacional de Normalizacién de Chile (INN) bajo el ‘Acuerdo de POCOSA (Nov. 1992) (2180 2005- Algae a180 10005:2005(E) 2 Correspondence between ISO 1000! Annex B (informative) 1005 and ISO 900° 1000 ‘Table B.1 — Corresponclence between ISO 10005:2005 and ISO 9001:2000, 0 te00s20es Meadra 190 9001000 i [Dawent ofa quail pn ma is orn ofthe quay an im [seneat a rm —_ |Seane a 74 [Quality plan inputs: _ 7a [vas aiectes ~ irae [Management responsibilities - [5 1,551,583,652 [Control of documents and data _ 423 Conor ofa aaa Resources is [Provision of resources: 7 ler teas it [Human resources _ [62 [infrastructure and work environment : 6364 = [Requirements - _ 21722 [Customer communication __ 723,824 Desi and development _ fa [Dein and devon proaess ira16736 [Genii desgn and devoupnant changes a7 [Purniing Ta ‘TProduction and service provision [751752 Identification and traceability 753 [Customer property 7 754 Presenaton of poi i755 [Control of nonconforming product ~ [es [Monitoring and measurement ~~ [r6.823,824,84 | [Aut | e [B22 fe Review acoplana glemereaion ard rvs te ally Ban [71 ex Revi and acopiance of he qu an Th lez plementation ofthe quay lan i les [Revision of the quality plan 7 [ea ~ [Feedback and improvernent [Bs [NOTE Covacanerc bere cues ons ty TAN (© 1802006 — a resertro) m 12) 113) 180 10005:2005(E) Bibliography 180 9001:2000, Quality management systoms — Requiements 180 8008:2000, Qualty management systems — Guidelines for performance improvements 150 10006:2008, Quality management systoms — Guideines fr quality management in projects 180 10007:2008, Quality management systems — Guidelines for configuration management 180 100122008, Measurement management systems — Requirements for measurement processes and measuring equipment ISO/TR 10013:2001, Guidelines for quality management system documentation 180 10015:1999, Quay management — Guidelines for training ISOITR 10017:2009, Guidance on statistical techniques fr ISO 9001-2000 ISOMEC 17798:--"), Information technology — Security techniques — Code of practice for information security management 180 19011:2002, Guidelines for quality andlor environmental management systems auditing ISO/IEC 80003:2004, Software engineering — Guidelines for the application of ISO 9001:2000 to ‘computer software 150 8001 for Small Businesses — What to do. Advice from ISO/TC 176, ISO Handbook, 2°4 edition, 2002 Reference websites: www iso org — win e176 org — viv iso argite176/5¢2 1) Tobe published (Revision of SOMEC 17790-2000) (21902005 — Ah reserved a180 10005:2005(E) a ies 03,120.10