auisAerosoace = AEROSPACE | aa cosoae PPMP HE eomatonl cep STANDARD : - r Tasied TT Revised . 2000-01 ‘ ‘Superseding ASS100B, __ Quality Management Systems - Requirements for Aviation, ‘Space and Defense Organizations RATIONALE S ments, slakeholgor eS oe defintions and notes have been revised and addtional requirements have been included in resp ‘This standard has been revised to incorporate the requirements of ISO 9001:2008. In addition, cf needs, . TABLE OF CONTENTS ». is), FOREWORD ou” MANAGEMENT SYSTEMS — REQUIRI SCOPE. gece 44 General... 12 Application. : 4“ a 34 32, 33 34 4. 4A 42 10 424 40 422 10 423 Control of Documents 10 424 Control of Records. 1 Sl Sa bye une pong mc pad SAE wea No ae Giana nual oases Ye Ne eet sy Ease nase sys a ee es se, 5 ines cepts jn sah eee esl hoes ete ee Qeervsc see stctercine 1 ema pt hs tts ay epi, ea el ni, ayo yey et, Sen ahi, photocapying, recording, or atherwisa, without the prior written permlasion of SAL a Tortagen ocimanronset: ier eran. oats cond 3 RAras ease ponent ‘HF wee aDDRESs:54 82 53 54 544 542 55 55.4 552 553 58 564 582 56.3 _ Design ang Development Validation “Pur AS91006 Page 2 of 33 MANAGEMENT RESPONSIBILITY. ‘Management Commitment. Customer FOCUS ..n.nmen Quality Policy . Planning... Quality Objectives Quality Management System Plannin Responsibility, Authority and Communi Responsibility and Authority. ‘Management Representative. Internal Communication. ‘Management Review General RESOURCE MANAGEMENT wn Provision of Resources. Training Infrastructure... Work Environment... PRODUCT REALIZATION. Planning of Product Beatle Project Management’... Risk Management; Configuration Management, Control of Work Transfers, Custoiner-Relaiéd Processes. Determination of Requirements Related to the Product Review of Requirements Related to the Product. Customer Communication Design and Development... Design and Development Planning . Design and Development Input Design and Development Outputs, Design and Development Review. Design and Development Vericatio Design and Development Verification and Validation Testing... Design and Development Verification and Validation Documentation Contfol of Design and Development Changos vasing Purchasing Process... Purchasing informati s Verification of Purchased Product Production and Service Provision... Control of Production and Service Provision Production Process Verification... Control of Production Process Changes... Control of Production Equipment, Toots and 5: Post-Delivery Support. f : Validation of Processes \entifcation and TraceabilityAS9100C. Page 3 of 33 54 Customer Property. 78S Preservation of Produ : 76 Control of Monitoring and Measuring Equipm: 25 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT.. General enn Monitoring and Measurement, ‘Customer Satisfaction Internal Audit Monitoring nk Monitoring and Measurement of Product.. Control of Nonconforming Product. Analysis of Data Improvement Continual improvement. Corrective Action.. Preventive Action. BIBLIOGRAPHY...SAE AS91000 _ Page 4 of 33 To assure customer satisfaction, aviation, space and dofonse organizations must produce, and continually improve, safe, reliable products that meet or exceed customer and applicable statutory and regulatory requirements. The globalization of the industry and thé resulting diversity of regional and national requirements and expectations have complicated this objective. Organizations have the challenge of purchasing products from ‘suppliers throughout the world and at all levels of the supply chain. Suppliers hnva the challenge of delivering Products to multiple customers having varying quality requirements and expectations. FOREWORD Industry has established the international Aerospace Quality Group (IAQG), with representatives frbin Companies in the Americas, Asia/Pacific and Europe, to implement initiatives that meke significant Improvements in quality and reductions in cost throughout the value stream. This standard has been ‘Prepared by the JAQG..~ 4 This document standardizes quality management system requirements t the greatest:éxten! possible’end can ‘be used at all levels of the supply chain by organizations eround.the World, its use.should resull ia improved quality, schedule and cost performance by the reduction or elimination of organteation-unigtie requirarnents ond wider application of good practice. While primarly developed for the aviation, space and defense industry, this ‘standard can also be used in other industry sectors where. quailty maragemieiit systent with addtional ‘requirements over an ISO 9001 system is needed, Eee Ce} REVISION SUMMMARYIRATIONALE This standard has been revised to inoomorate: the: requirements GF ISO $00%:2008. In adation, industry requirements, definitions and notes have bean revised and, additional roquirsivents have been included in response to stakeholder needs. e es ¢SAE AS91006 Page 5 of 33 ) 0.4 General INTRODUCTION ‘The adoption of @ quality management system should be a strategic decision of an organization. The design and implementation of an organization's quailly management system Ie influenced by 4) its organizational environment, changes in that environment, and the risks associated with that environment, b) its varying needs, ©) its particular objectives, )_ the products it provides, 2) the processes it employs, ) its size and organizational structure, “ It is not the intent of this Intemational Stafdard to imply unitony | uniformity of documentation, ee, oe The quality management system requirements specifiai in {his Intemnatjofial Standard are, boriplementary to requirements for products. Information marked "NOTE" ie for guidance in undorstanding’orclviying the eesocisted requirement. his-ntemational Standard can be used by interrat ard eerl’paties, includ catication bodes, to assess the organization's ability to meet customer statutory andtegulatory requirements’ applicable to the product, and the organization's own requirements. ede ; “The quality management principles slated it 1S0 $009 and ISO 9004 have been taken into consideration during the development of this International Standard. Shoo = 0.2 Process Approach A ‘This Intemational Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness ofa quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effestivey, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, cen be considered as a process. Often the output frem one process directly forms the input to the next. ‘The application of a system of processes within an organization, together with the identification and interactions of these processes, and thelr management fo procuce the desired outcome, can be referred to as the “process approach’. ‘An advantage oi the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over thair combination and interaction. When used within a qually management system,.such an approach emphasizes the Importance of )_ understanding and meeting requirements, )_ the nead to consider processes in terms of added value, Jp obtaining resuts of process perfomance ond efectvensse, and 4) continual improvement of processes based on objective measurement,SAE AS91000 Page 6 of 33 The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented In Clauses 4 to 8 This illustration shows that customers play a significant role in defining requirements es inputs, Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level, NOTE in addition, the methodology known es “Plan-Do-Check-Act" (PDCA) can be applied to all processes, POCA can be briefly described as follows. Plan: establish the objectives end processes necessary to deliver results In accordance with customer re@uirements and the organization's polices. ; Do: implement the processes. Check: monitor and measure processes and product against poticies, abjotlives and reQiramenis Tor the.pibdlict and report the results. = » ‘Act: fake actions to continually improve process performanca, + Continual improvement of the quality management sysian == TE i Sea a ee a Koy Se vat sting ectios rato we FIGURE 1 - MODEL OF A PROGESS-BASED QUALITY MANAGEMENT SYSTEME AS91000 Page 7 of 33 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 1. SCOPE ' 14 General This standard includes 180 9004:2008' quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic toxt. It Is emphasized that tho requirements specified in this standard are’ complementary {not altermitive) t0 contractual and applicable statutory and regulatory requirements. Should there be 2 conflict botweon the requirements of this standard and applicable statutory or regulatory requirements, the: latter. shall take Precedence. Soy . ‘This international Standard specifies requirements for a quelity management syslém where'anorganization >, 8) needs to demonstrate its ability to consistently provide produgt that mssls customer and applicable: statutory and regulatory requirements, and DO ee ») aims to enhance customer satisfaction through the effective application of thé Systerm,inclding ‘processes for continual improvement of the system and the assurance’ of canformy 416 customer and applicable statutory and regulatory requirements. &, < NOTE 1 In his international Standard, the term ‘prodct’ only applesto. cp ‘product intended for, or required by, a customer, 0) sy tended ouput rnuting toms ol rectal ibeaen OF NOTE 2 Statutory and regultory requirement can be dxpresssd as log roquroments. 4.2. Application 4 7 . All requirements of thi Inlrnalionel Starderd are generic and are inlended to be: applicable to.all organizations; regardless of type, size and product provided Where any requirement(s) of this Inteinational Stendard cannot be applied due to the nature of an organization and its product, this can be considered for @xclusion. Whore @xclusions aré:mede, claims of conformity fo this International Standard are not acceptable unless these exclusions are limited fo requiromonts within Clavee 7, and such exclusions do not affect the organization's ability, or responsibilty, to brovide product that meets customer and applicable statutory and regulatory requirements. This standard ig intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, ‘spare parts or materials for their own products, Organizations whose primary business Is providing maintenance, repair and overhaul services for-aviation ‘commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operats autonomously, or that are substantially different from their manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography). "Wh the permission ofthe International Organization for Standareization (180). The complete standard can be oblained from any ISO ‘amber of from the ISO Central Secrotarat: 1, ch. de 1a Voio-Creuse, Case postale 66, CH-1211 Geneva 20, SWITZERLAND, or visit ‘www.is0.079. Copyright remains wilh ISO.AE. AS91006. Page 8 of 33 Organizations that procure parts, materials and assemblies and resell these products to a customer in the() aviation, space and defense industries, including organizations that procure products and spit them Into smaller {quantities for resale, should use the IAQG-developed 8120 standard (see B/blography). 2. NORMATIVE REFERENCES ‘The folowing referenced documents are indispensable foF'the aplication ofthis document. For dated references, only the ediion ited applies. For undated references, the latest edlion of the referenced. docurnont (eluding any amendments) applies. 180 9000-2008, Quaity management systems — Fundamentals and vocabulary 3. TERMS AND DEFINITIONS For the purposes ofthis document, the terms and definitions given in SO 9000 apy. scouts, ean alag mean “sefvide. 34 Risk An undesirable situation or circumstance that has both’ likelihood . consequence. EN re 3.2 Special Requirements Thoso requirements Identified by the customer, or determified bythe oryentzation, which have high risks to being achieved, thus requiring their incluston in the tisk management process; Factors used in the etorminaton Of special requirements include product.or process. complexity, past experionce and product or process ®.” ‘maturity. Examples of special requirements include performance requirements Imposed by the customer that are at the limit of the industry's capability, or Fequicements, determined by tho organization to be at the limit of Its technical or process capabilites. So 3.3 Critical Items . Those items (e.9., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product, including safety, performance, form, fit, function, producibility, service life, ete.; that require specific actions to ensure they are adequately managed. Examples of critical items Inclucio safety critical items, fracture critical items, mission critical ems, key characteristics, ete. 34 Key Characteristic An atéribute’ or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires specific actions for the purpose of controlling variation. NOTE Spécial requirements and critical items are new terms and, along with key characteristics, are interrelated. Special requirements.are identified when determining and reviewing requirements related to the product (see 7.2.4 and 7.2.2). Special requirements can require the identification of critical items. Design output (see 7.3.3) can include identification of critical itoms that require specific actions to ensure they are adequately managed. Some eritical items will he further classified as key. characteristics because their variation neads to be controlled, OyE AS91006 Page 9 of 33 QUALITY MANAGEMENT SYSTEM 4.1 General Requirements 7 The organization shall establish, document, implement and maintain a quality management ‘system and continually improve its effectiveness in accordance with the requirements of this Intemational Standard The organization's quality management system shall also address customer and applicable statutory and regulatory quality managemont system requirements, . ‘The organization shall 8) determine the processes needed for the quality management systeri and their application throughoulthe organization (se 12), . 4 3 5) determine the sequence and interaction of these processes, ©) determine criteria and methods needed to ensure that both the opératioinand contig of these prooésses are effective, @) ensure the availablity of resources and information nevegsary to support tha operation-and thonitoring of these provesses, aur ¢ SS 2) monitor, measure where applicable, and analyse'thiiSe otbtesses, afd! 1) npement atone necessary oeciove planed eulsind cdi oroveriit those processes ese processes shal be managed by’ titi orsenizaiy insorordance wih the requirements ofthis Intemational Standard, Where an organization chooses: to outsource any ‘process that 424 Control of Records Records established to provide evidence of conformity to requirements and of. the effective operation of the, guality management system shall be controlled, % 4 - The organization shell estsblish @ documented procedure to define the contro's need for the identification, storage, protection, retrieval, retention and dispostion of records. "on te as Tecords that ate created by afiil/or retained by 5. MANAGEMENT RESPONSIBILITY or ‘Management Commitment ‘Top’ management shall provide evicénee of its commitment t6'the development and implementation of the quality management system and continually improving ts effestvenaes by , a) communicating to the requirements, ce of meaing customer as: well as slatulory end regulatory 2) estabshing the quality potcy, ©) ensuring that quailty objettives are established, ) ensiting the availability of resources. ‘Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1), Top management shall ensure that product conformity and on-time delivery porformance are measured and that eppropriate action is fekon if planned results are not, or will not be, achieved.SAE AS9100C Page 12 of 33 on 5.3 Quality Policy ‘Top management shall enure that the quality policy ~ . © 2) is appropriate to the purpose of the organization, b) includes @ commitment to comply with requirements and continually Improve the effectiveness of the qually management system, ©) provides a framework for establishing and reviewing quality objectives, 4d) is communicated and understood within the organization, and ©) is reviewed for continuing sultabilly, 54 Planning 541 Quality Objectives Top management shall onsuré that quliy objectives, inlusisg those needed ‘@ reel requirements for product [see 7.1 a} fe eslblehed a eleven! uncons and eves whine Chialion. The quay . 1. gs @) the acceptance criteria are met. 7.8.6.2 Design and Development Verification and Validation ocumientation results, efc., demonstrate that the product dedinition ‘operational conditions. * 7.3.7 Control of Design and Development Chatiges “at the completion of design and/or development, the-organization stall elisure that Taports, calculations, test ‘meets the: Specification requironrents for all identified Design and development changes shall-be identified afd records maintsinéd:sThe changes shall be reviewed, verifed|)})s and validated, as appropriate, and approved before implementation. The review ‘of design and development changes shall ~ include evaluation of the effect of the changes on constituent parts and preduct already delivered. Records of the results of the review of changes and any necessary actions shell b> Design and development changes shal! be controlied in (see 7.1.3). Ly, TE, % 7A Purchasing: oe fae Ft TAA Purchasing Process ‘maintained (a0 4.2.4). accordance with the configuration management process “The organiation shall ensue that purchased product conforms to speciied purchase requirements. The type and extent cf control applied to he supplier and the purchased product ‘on subsequent produc! realization or the final product shall be dependent upon the effect of the purchased product The organization shall be responsible for the conformity of all products purchased from suppliers, including product fr ‘The organization shall evaluate and select suppliers baser yn sources defined by the customer. 1d on their abilly to supply product in accordance with the organization's ‘requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4), NOTE One factor that can be used during supplier objective and reliable external sources, as evaluated selection and evaluation is ‘supplier quality data from by the organization (e.g., information from accredited ‘quality management system or process certification bodies, organization approvals from governnent Juthorities). Use of such data would be only one component of an organization's supplier control process and the organization remains responsible for verifying requirements. that purchased product meets specified purchasey,, Bi}SAE 391000. Page 21 of 33 o The organization shall a) maintain a register of its suppliers that includes approval status (e.9., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family), b) periodically review supplier performance; the results of these reviews shall be used es a basis for establishing the level of controls to be Implemented, ¢) define the necessary actions to take when dealing with suppliers that do not moet requirements, @) ensure where required that both the organization and all suppliers tise ciistomer-approved $pocial process sources, aot ©) define the process, responsibilities and authority for the approval staius:decision, changes of the approval Status and conditions fora controlled use of suppliers depending on the supplier's approval situs, ant 1) determine and manage the risk when selecting and using suppliers (88 7.1.2}. 7.42. Purchasing Information Purchasing information shall describe the product to be purchéiged, includitig, witiere appropriate 8) requirements for approval of product, procedures! Bfocessés and equifinent} ‘ b) requirements for qualification of personnel, . 2) quality management system requirements; ) the identification and revision _statiis.. of ~ specifications, drawings, process requirements, Inepection/verification instructions and other relevant technical date, : ©) requirements for design test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organization, and as applicable critical items including Key charactoristics, ] requirements ‘Yor test Specimens (e.g. production method, number, storage conditions) for design approval, Inspection/verification, Investigation or auditing, ® requirément® regarding the need for the suppller to + notify the organization of nonconforming product, © + obtain organization approval for nonconforming product disposition, + notify the organization of changes in product and/or process, changes of suppliers, changes of manufacturing faciity location and, whore required, obtain organization approval, and + flow down to the supply chain the applicable requirements including customer requirements, h) records retention requirements, and 9) tight of access by the organization, their customer and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.SAE '$9100C_ Page 22 of 33 7.43. Verification of Purchased Product, ‘The organization shalt establish and implement the‘inspection or other activities necessary for ensuring that purchased product meets spectiod purchase requirements. NOTE 1 Customor verification activities performed at any level of the supply chain should not be used by the organization or the supplier as evidence of effective control of quality and does not absolve the organization of its responsibility to provide acceptable product and comply with all requirements. NOTE 2 Verification activites can include ss = obtaining objective evidence of the conformity of the product from the supplier (eg. accompanying dlocumentation, certificate of conformity, test records, statistical records, process: ; = _ Inspection and audit at the supplier's premises, + _ review of the required documentation, + inspection of products upon receipt, and Where the organization or fs « state the intended verficaton sranenat ae method of pregua release inthe erchasing infomation 7.5.4 Contfolof| Pre ksi and Serves Provision ‘Tho organization shall plan’and cory out production and service provision under controlled conditions, Controlled conatlons shal include, a8 eppetic, a) ihe aval of ffomtion thet describes the characterises ofthe product NOTE “This 2) theavaiabity cf work nstustions, as necessary, ration can Include drawings, parts lists, materials and process specifications. NOTE Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspection documents. ©). the use of suitable equipment, NOTE Suitabio equipment can include product specific tools (e.g., jigs, fixtures, molds) and software programs. 4) the availablity and use’of monitoring and measuring equipment, i €)- the implementation of monitoring and measurement,SAE AS91000 Page 23 of 33 0, @). accountability for all product during production (e.g, parts quantities, split orders, nonconforming product), the implementation of product release, delivery and post delivery activities, ‘h) evidence that al! production and inspection/verification operations. have beon comploted as planned, or as otherwise documented and authorized, 1) proviston for the prevention, detection and removal of foreign objects, J. monitoring and contro! of utilities and supplies (e.g, water, comipressid air, electricity, chomi the extent they affect conformity to product requirements, and 4 19 entra for workmenshi, speciied In the clearest precios! way {egy wniton standar samples, ilustrations). Planning shall consider, es appropriate é + establishing, implemanting and maintaining appropri: procebses to saitege”eritcat “és, Including process controls where key charactoristics have boon identified, = identifying in-process Inspection/veritication points when ” Porformed at later stages of realization, and GQ) Peete processes (2007.52) 7.8.11 Production Process Vevih tion The organization shall use a refresentative item from the fist prddliction run ofa new part or assembly to very that the production processes, production. document jd tooling are capable of producing parts and This process shail be repeated when changes occur that invalidate the original results (2.0, re ing changes; manufacturing process changes, tooling changes). The organization shail cofitrol and document changes affecting processes, production equipment, tools. or software programs, se The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product conformity. 7.8.4.3 Control of Production Equipment, Tools and Software Programs Production equipment, tools and software programs used to automate and control/monitor product realization processes, shall be validated prior to release for production and shall be maintained. Storage requirements, including periodic preservation/condition checks, shall be defined for production a or tooling in storage:SAE. AS91006 Page 24 of 33 75.1.4 Post-Delivery Support Post-delivery support shall provide as applicable for the 2) collection and analysis of in-service data, ) actions fo be taken, including investigation and reporting, when problems aro detected after delivery, ©) control and updating of technical documentation, ay 4) approval, control and use of repair schemes, and Se @) controls required for off-site work (e-g., organization's work undertaken at tho custornér's faci 7.5.2. Validation of Processes for Production and Service Provision’ ‘The organization shall validate any processes for producti ahd service provision Wt vetlfed by subsequent monitoring or measurement and, as a consequence, deficiencies becom product is in use or the service has been delivered. 4 a )_epproval of equamontnd a \iealion at personnel, ©) vse of spect methads and piocedires, dy requiremen or eons se0 424), ‘and @) revali 7.83, ldenieaton and Trsceabity {Where appropriate, the organization shall idontiy the product by sultable means throughout product realization. “The organization shall maintain the Identification of the configuration of the product in order to identify any lfferences between the actual configuration and the ogreed configuration. ‘The oradhization shall identily the product status with respect to monitoring and measurement requirements throughout product realization, When acceptance authority media are used shall establish appropriate controls for the media. ., Stamps, electronic signatures, passwords), the organization Where traceability is @ requirement, the organization shall control the unique identification of the product and maintain records (see 4.2.4).SAE 391000. Page 25 of 33, ® ‘NOTE Traceability requirements can include + identification to be maintained throughout the product life, = the ability to traco all products manufactured from the same batch of raw matorial, or from the same manufacturing batch, to the destination (e.g., delivery, scrap), + for an assembly, the ability to trace its components to the assembly andl then to the next higher assembly, and “ + for @ product, a sequential record of its production (manufacture, 2ssembly, inspection/varification) to be retrievablo. ‘ § NOTE In some industry sectors, configuration management Is a means by, Which identification and traceability “are maintained (see 7.1.3). = Pa 7.54 Customer Property The organization shall exercise core with customer property whit 6 Under the organization's conffal'of boing used by the organization. The organization shall identity, verify, protect nd eefequard usioiner propery provided for use of incorporation into the product. If any customer property is lost, damaged of otherwise found to:be uneultable for use, the organization shall repon this tothe customer and rinisin records (soe 4.24) 6.5 Preservation of Product Se . a The organization shall preserve the product during internal précessing and déivéry to the intended destination in order to maintain conformity to requirements. As applicable; preservation shall include Mentifcation, handling, packaging, storage and protection. Preservation shall also epply.t6 the constituent parts of a product. Preservation of product shalf-also include, where applicable in accordance with product specifications and ‘applicable statutory and fegulatory requiramerits, provisions for 4) cleaning, : ©) special handiling for sensitive products, ©) shelf life control and stock rotation, and 9) special handling for hazardous materials. ®SAE AS9100C. Page 26 of 33 7.6 Control of Monitoring and Wieasuring Equipment ‘The organization shall determine the monitoring ard measurement to bé undertaken an Ihe monitoring and measuring Tne pita needed to provide evidence of conformiy of produc to determined requirements The organization shall maintain a register of the monitoring and measuring equipment and define the process employed for thelr calibration/verification Including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. NOTE Monitoring and measuring equipment includes, but is not fimited fo: fest hardware, test software, Mo ated test equipment (ATE) and plotters used to produce Inspoction data. also includes petsonally owned a ee ee canplied equipment used to provide evidence of product conformity. © carved out and are cartied “The organization shall esteblish processes to ensure that monitoring atidmeasurem@nt can, ea i hats consistent wth the monitoring and measurement eqirements The organization shall ensure that environmental Zoaaitions are suitable for thescalibration, inspection, measurement and testing being carried out. eS oe Where necessary fo ensure valid resus, measuring eaupment shall ‘ 1) be calibrated or verfed, or both, at spectfiad infect, or proc fa'use, against measurement standards traceable to ‘ be callbrated oF vSfonal meesuroment stardaras; where to such standards exit, the basis used for ‘ealipration or ‘verification shall be recorded (802 4.2.4) oF oC : b) be adjusted or re-adjustes as fiévessary: ¢) have identification in oféer to determi 4) be eater om adrenal woulda hy measrement result ot @) be protected fem datiage and delflaration during hancing, maintenance and sorege. The orgatiization shall estabiish, implement and maintain a process for the recall of monitoring and measuring : ‘equipment requiring calibration or verification. 1n‘Gddition, the organization shall assess and record the validity of the previous measuring results when the equipment is Rane nat ia onforn to requirements. The organization shal fake appropriate action onthe ‘equipment and any product n ‘alfedteds Sa ‘Recordof te fests of calibration and verison shale zinigined (600 424). ! When used in the monitoring and meesurement of speciied requtements, the abity of computer software to satisty the intended application shall be confimed. This shall be undertaken proro inal use ‘and reconfirmed as necessary. NOTE Confimation of the ability of computer sofware to satisfy the intended application ‘would typically include its verification and configuration management to maintain its suitability for use.SAE AS91006 Page 27 of 33 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General “The organization shall plan and implement the monitoring, measurement, analysis and improvemmont processes needed 2) to demonstrate conformity to product requirements, b)_ to ensure conformity of the quality management system, and ©) to continually improve the effectiveness of the quality management system, This shall include determination of applicable methods, including statistical techniques, and the extiht Of hair use es; NOTE According to the nature of the product and depondingon the specified reqilremen techniques can be used to support ge Oe 5 5 - design verification (e.g, rellabitity, maintainability, safet + process controf, © selection and inspection of key characteristics, ‘* process capability measurements, — > @Q) + stetsscat process conto design of experimont, + inspection, and ~ failure mode, effect and ¢rlticatity analysis. 82 Monitoring and 82.1 Customer Satisfaction: As one of thé:-measurements of the performance of the qually management system, the ‘organization shall monitor piformation reeling to customer perception as to whether the organization has met customer requtements, The meihoos for obtaining and using this.information shall be detormined. Information to be: tnonitored and used for the evaluation of customer satisfaction shall include, but is not limited Or bradct conformity, on-time delivery performance, customer complaints and corrective action requests, Organizations: shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results. NOTE Monitoring customer perception can include obtaining input from sources euch as customer satisfaction surveys, SeeTomer data on delivered product qually, user opinion surveys, lot business analysis, compliments, warranty clang and dealer reports ®SAE AS91006 Page 28 of 33 i 82.2. Internat Audit : “The organization shall conduct internal audis at plerined intervals to determine whether the quality management system 2) conforms to the planned arrangements (see 7.1), tothe requirements of this Intemational Standard and to the quafity sorragoment system requirements established by the organization, end . NOTE Planned arrangements include eustomer contractual requirements. . b) is effectively implemented and maintained. i ‘An auatt programme shall be planned, taking into consideration the sai. and importance ofthe processes aiid areas to A aU OTe ie reulls of previous audi. The audit ceria, seape. enue ce methods shal. b8 defined. ie be avai, 2 we ore and conauct of aus shall ensure obj én Mpa of 2H process, Auditors shall not avd their own work. oe Oe ager ‘A documented procedure shall be established to define the rosponsibllies and't i ucts, establishing records and reporting results. . I Records of the audits and their results shall be mai « ‘The management responsible for the area being audites shatfYensite that anj‘tieeessary corrections and corrective Tefen are taken without undue delay 10 eliminate cetected nencontorrties and thelr causes. Follow-up activities shall actions ae tat eaton of the ations taken and the fepeting of erfeation robuts (862 9.52) NOTE. See ISO 19011 for guidanes: fF ‘The organization shall apply Suitable methods for monitoring and, where appliceble, measurement of the quality. i The organicnnte ploseseee. Tese fielnods shll demonstrate the aliy oft er ‘to achieve planned rs aa pried euler, pt astueyed, correction and corrective ection shat be fen ‘as appropriate. ' NOTE When deteirining siltable TrotRods, i is advisable that the, organizaior consider the type .and extent of : aoe ayn easurement appropriate o each of ts processes in relation fo thelr impact on the conformity to product requirements Mon fo offelvencse of the quay management system In the event of process noncontormity, the organization shall |g). take appropriate action to correct the nonconforming process, et b). evaluate whather the process nonconformity has resulted in product nonconformity, 6) deterring if the process nanconformity is limited fo @ specific case or whether it could have affected othe processes or products, and @) Identify and control any nonconforming product (90° 8-3)AE AS9100C_ Page 29 of 33 9 ‘8.2.4 Monitoring and Measurement of Product The organization shall monitor and measure the characteriétics of the product to verify that product requirements have: been met. This shall be carried out at appropriate stages of the product realization process in accordance with the. planned arrangements (see 7.1). Evidence of-conformity with the acceptance criteria shall be maintained, ‘Measuroment requirements for product acceptance shall be documented and shalt include ) criteria for acceptance andior rejection, 4) where in the sequence measurement and testing operations are to be performed, ©) required records of the measurement results (at a minimum, indication of acceptance orrejection), and. any specitic measurement instruments required and any specific Instructions assoelatsdwith theitiso. When critical items, including key characteristics, have been Jdehitiied the organization sholLeilétire they are controlled and monitored in accordance with the established processes: Q ¢ When the organtzation uses sampling inspection as a meats of product acceptance, tha Sampling plan shall be dustiied on the basis of recognized statistical principles andl appropriate for use (ie., matching the sempling plan to the criticality of the product and to the process capabilit/). ae ed Where product is. released for production use pending completion of ail requirétl measurement and monitoring activities, it shall be identified and recorded to allow rocall and replacement if it ls subsequently found that the roduct does not meet requirements, ” : ¢ Records shall indicate the porson(e) auforizing Where required to demonstrate iroduct qiialificati that the product meets the defined requirement a Jo tho organtzaton shall ensure tat records provide evidence The release of product and delivery of seivice tthe customer shall not proceed unl the planned arrangements (eee 7.1) have been satisfactory eainpleled, unless ottierwise approved by a relevant authority and, where applicable, by ‘he customer. ES The organization shail ensure that all documents required to accompany the product are present at delivery. 8.3 Gontial of Noneonforming Product hall e9SurS thet product which does not conform to product requirements is identied and controlled to The organizat Lise or delivery. A documented procedure shall be established to define the controls and related prevent its unlnten¢ Tesponsibilties and authorities for desting with nonconforming product. NOTE The term “nonconforming product” ineludes nonconforming product returned by a customer. The organtzaton’s documentod procedure shall define the responsibilty and authority for the review and disposition of nonconforming product, and the process for approving personnel making these devistone, ®SAE AS9100C. Page 30 of 33 7 Where applicable, the organization chal deal with nonconforming product BY one oF more ofthe following weys: 4) by taking action to eliminate the detected nonconformiN 'b) by authoring its use, release or acceptance under concession by @ relevant authority and, where applicable, by the customer, «)_ by taking ction to preclude Its original inionded use or application; 4) by teking action appropriate to the effects, oF potential effects, of the nonconformity when, ndngonférming product is detected after delivery or use has started gee = The organization's nonconforming product control provss, all provide for timely: reporting of dalivered nonconforming product; nn . NOTE Parties requiring notification of nonconforming product NO Tomers, distributors and regulatory authorities. >.» 2) by taking actions necessary to contain the etfotl of tie nonconférmity on other processes oF products. ispesitions of use-2s-ls or repair shail_onli,be “aod oifor-appioval by, an authorized representative of the Organization responsible for desian. on NOTE Authorized representative includes personnal flavingi delegates abthorily from the design organization. The organization shall not use dispositions of \ gécan ts or ropatitiploss specifically authorized by the customer The orgie oormity results i a depart from she contract requlremonts. Product dispositioned for sorap shall be ‘conspicuously and permanently marked, or positively controlied, until physically rendered unusable. . > ‘ig Srected 1 shall be subject 0 e-verfction 19 demonstrate conformity to the Records of the nature of noncanformities and ony subsequent actions taken, Including concessions obtained, shall be ganization Shel determine, collect and analyse appropriate data to demonstrate the sultabilty and effectiveness c lity Management system ‘and to evaluate where ‘continual improvement of the effectiveness of the quali ystom can be made. This ‘shall include data generated as & result of monitoring and ‘measurement an “Tha analysis of data shall provide information reating fo a) customer satisfaction (see 8.2.1), 1b) conformity to product requirements (see 8.2.4), ©) cheractristios and tends of processes and products, including opportunities for preventive action (see 6.2.8 a 824), and 4) suppliers (see 74).SAE AS91000 Page 31 of 33 QO - 8.5 Improvement 85.1 Continual Improvement ‘The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. The organization shall monitor the implementation of improvement activities and evaluate the effectiveness of the results. eee NOTE Cantina improvement opportunities can result from lessons loamed, problem reéelitions andthe benchmarking of best practices. : 85.2 Corrective Action Ly ‘The organization shell take action to eliminate the causes of nonconforities in order {o prevent recurenés. Corrective actions shall be appropriate tothe effects of the nonconformities encountered: eke ‘A documented procedure shal be established to define requreménis for @)_ reviewing nonconformitis (including customer complaints), b) determining the causes of nonconformities, Si) ©valuating the need for action to ensure that nonconformi 4) determining and implementing acto needed, ©) records of the results of action taken (6084 2.4), 4) reviewing the effectiveness sf.the conective: on taken, 9 towing down corféctive scionreqiirements to a supplier when it ts determined that the supplier to responsible for the nanconformity, 1) spociic actions where timely and/or etective corrective actions are not achieved, and 9) determining if aditional nonconforming product exists based on the causes of the nonconformities and toking further action when required. 85.8 Preventive Action ‘The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their cccurrence, Preventive actions shall be appropriate to the effects ofthe potential problems. ‘A documented procedure shal be established to define requirments for 2) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonsonformties, @ determining and implementing action needed,: 3 q i ! a 3 : i a | nb | un | it ! ra | Saks : fea 26 38SAE 391006 Page 33 of 33 © BIBLIOGRAPHY ASIEN 9110 Quality Management Systems ~ Requirements for Aviation Maintenance Organizations ASIEN 9120 Quality Management Systems — Requirements for Aviation, Space and Defense Distributors 1809000 Quality management systems ~ Fundamentals and vocabulary 480 9001 Quality management systems ~ Requirements 180 9004 Managing for the sustained success of an organization —A quality managément approach 180 10007 Quality management systems ~ Guidelines for configuration management 180 19011 ® * To be published. (Revision of $0 9004:2000)