【原】AS9100常见问题Series of Standards Frequently Asked Questions (FAQs)

AS9100D 2019-12-30

展开全文

In developingthislistofFrequently Asked Questions (FAQ's)for the9100:2016 Seriesrevisions, inputhas been obtained from experts and users of the standardfromaround the world. The list is reviewedand updated on a regular basis to maintainitsaccuracy,andtoinclude newquestions where appropriate.Itis intendedthat thislistwillalso provideagoodsource of information for new usersof thestandards.

在为9100:2016系列修订版开发这个常见问题列表(FAQ's)时，已经获得了来自世界各地标准的专家和用户的输入。我们在OASIS中数据库存中，收集清单定期审查和更新，以保持其准确性，并在适当时列入新的问题。本清单还将为标准的AS9100D新用户提供良好的信息来源。

1.Why has it been decided to issue a new version of ISO 9001 baseline text?

1.为什么决定发出新版本的以iso9001为基准文件?

Business needs and expectationshave changed significantly since thelastmajorrevisionofISO 9001 intheyear2000.Examples of these changes are evermoredemandingcustomers, the emergence of newtechnologies,increasingly more complexsupply chainsandamuchgreater awarenessof the need for sustainable development initiatives.

自2000年iso 9001最新修订以来，业务需求和期望发生了显著变化。这些变化的例子包括:对客户的需求越来越大，新技术的出现，供应链越来越复杂，以及人们对可持续发展举措的必要性有了更高的认识。

2.Does the 9100:2016 Series still apply to all organizations - big, small, different sectors and different items– products,services?

9100:2016系列是否仍然适用于所有组织——大的、小的、不同的部门和不同的项目——产品、服务?可持续发展倡议的需要。

Theconcept of the standard hasnot changed; it's applicableto anytypeoforganization, regardless ofthe size,type oritscorebusiness.

标准的含义没有改变;它适用于任何类型的人组织，无论大小，类型或它的业务。

3.How has the structure of the standardchanged?

标准的结构发生了怎样的变化?

The structurehasbeen changed to align with thecommon10clauseshigh-level structure developedby ISOto ensuregreaterharmonizationamongitsmanydifferentmanagement systemstandards.

The new10 clauseshigh-level structure will apply toall ISOmanagementsystemstandards, whichisbuiltaroundthe PDCA(Plan-Do-Check-Act)sequence.Thiswill makeiteasierfor organizations to addressthe requirements of more thanone ISOManagementSystemStandard withina single, integratedsystem.

它的结构已被改变，以配合国际标准化组织开发的高层结构，以确保它的许多不同的管理体系标准之间更大的协调。它的构建遵循PDCA(Plan-Do-Check-Act)序列。这将使组织更容易在一个单一的、集成的系统中满足不止一个异构代理系统标准的要求。

4.What are the main differences in content between the old and new version?

新旧版本在内容上的主要区别是什么?

·Theadoptionof the high level structure asset out in AnnexSLof ISO Directives Part1

·An explicitrequirementfor risk-based thinking to support and improvethe understanding andapplicationof theprocessapproach

·Fewerprescriptiverequirements

·Moreflexibilityregardingdocumentation

·Improvedapplicabilityforservices

·Arequirementto define the boundaries of theQMS

·Increasedemphasis onorganizationalcontext

·Increasedleadershiprequirements

·Greateremphasis onachievingdesired processresultsto improve customer satisfaction

5.How has documentation requirementschanged?

Specific documentedprocedures arenolongermentioned;itis theresponsibilityofthe organizationto maintain documented information to supportthe operation ofits processes and retain thedocumentedinformation necessary to haveconfidence that the processes are being carriedout as planned. Theextent of the documentation that is neededwilldependon the business context.

6.The standard does not mention a quality manual, is it still required?

A qualitymanualisnolongerspecifically required. The newstandardrequiresthe organization to maintaindocumented information necessary for theeffectivenessofthe qualitymanagement system(QMS).There aremanywaystodothisandaquality manualisjustone.Ifit is convenientand appropriate for anorganizationto continuetodescribe itsqualitymanagement systemin a quality manual then that isperfectlyacceptable. The 9100:2016 standardadded requirements inclause 4.4.2 that included the previous qualitymanualrequirements in addition to including additional information.Your organizationmustcomply ifyouhave statutory, regulatory, orcustomer requirements to maintainaquality manual.

7.Why has management review been moved to performance evaluation? (9.3)

The sequence of the newversionof9100:2016 isbasedon the Plan, Do, Check, Act cycleandso, in ordertoevaluate quality management systemperformance,itmakessensefor management review tofollow themeasurement of the system performance.

8.The title of management representative hasbeen removed from ISO9001:2016 and then added in9100:2016.

The ISOintent wasthat itis uptotopmanagement toensurethat the rolesandresponsibilities are assigned for reportingon the performance of the QMS.Some organizationsmightfindit convenienttomaintaintheircurrent structure, with a single personcarryingoutthis role.

Othersmight takeadvantageof the additionalflexibility to consider other structuresdepending on theirorganizationalcontext.

9.Why has product been changed to product andservice?

9100:2009 alreadymadeitclearthatthe term product in theprevious versionofthe standard also includes service, so thereisnoimpact inpractical terms.The term product and service is

nowusedthroughout the standard to reflect thefargreater useof the standardoutsideof the manufacturing sector,andtoemphasizeitsapplicabilityin theservice industries.

10.What is risk-based thinking and why has it been introduced into the standard?

The phrase risk-basedthinking isusedtodescribe theway inwhichthe ISO9001:2015baseline textaddressesthe question of risk. Theconcept of riskhasalwaysbeenimplicitin theISO9001 text,byrequiringtheorganizationto plan itsprocessesand manage itsbusinesstoavoid undesirableresults.Organizations have typicallydonethisbyputtinggreater emphasison planningand controllingprocessesthat have the biggest impacton the qualityofthe products and servicestheyprovide. The way in whichorganizationsmanageriskvaries dependingon their businesscontext(e.g. thecriticalityofthe products and services beingprovided, complexity of the processes,andthe potentialconsequencesof failure).Useof the phrase risk-based thinking is intendedtomakeitclearthatwhile an awareness of risk isimportant,formal risk- managementmethodologies and risk assessmentarenotnecessarilyappropriateforallbusiness situationsandorganizations.Forfurtherinformationabout risk-basedthinking, see ISOTC176 website athttp://isotc./livelink/livelink/open/tc176SC2publicandAnnex A.

Risk basedthinkinghasmerged verywellwiththe9100:2009 additionofriskmanagement, which was product focused and limitedto theProduct Realizationclause, nowOperations.See AnnexA.4 foradditional informationon thedifferences

11.What has been changed in terms ofplanning?

9100:2016 requires the organizationto addressrisksandopportunities,quality objectives and planning of changes throughout the organization.Asnewproducts,technologies,marketsand business opportunities arise,itis tobeexpected that organizations will wanttotake full advantageof these opportunities.This hastobedone ina controlled manner, and be balanced againstthepotentialrisks involved, which could leadto undesirableside effects.

12.Are organizations still allowed to exclude requirements of ISO 9001?

9100:2016 no longerrefers to “exclusions” in relation to the applicabilityofitsrequirementsto the organization’squality managementsystem.However,an organizationcan determinethe applicabilityofrequirements. All requirementsinthenewstandardare intendedtoapply. The organizationcan onlydecide that a requirementisnotapplicableifits decisionwill notaffectits abilityorresponsibilityto ensurethe conformity of products and servicesandthe enhancement of customersatisfaction.

13.What is the process approach and is it still applicable to 9100:2016?

The process approach isawayof obtaining a desiredresult,bymanaging activitiesandrelated resourcesasa process. Althoughthe clausestructure of9100:2016 followsthePlan-Do-Check- Act sequence, the processapproach isstill theunderlying concept for theQMS.Forfurther guidance,pleaserefer to theSupport Package module: Guidance on the Concept and Use of the Process Approach for managementsystems.

1.14 Whatare the benefits of the new version of9100:2016?

Lessprescriptive, but withgreater focuson achievingconformingproducts and services More userfriendlyfor service and knowledge-based organizations

·Greaterleadershipengagement·Morestructuredplanningforsettingobjectives·Managementreviewisalignedto organizational results·Theopportunity for moreflexibledocumentedinformation·Addressesorganizationalrisks andopportunities in a structured manner·Addressessupply chainmanagementmoreeffectively·Opportunityforanintegratedmanagementsystemthataddresses other elements such as environment,healthandsafety,businesscontinuity, etc.

1.15 What are the differences betweenperformance, effectivenessand efficiency ofthe QMS anditsprocesses?

·Performance:the capabilityofaprocesstoproduceitsdeliverables;this can beevaluated with“performanceindicators”(different from“managementindicators”usedtomanage the day to dayactivities).·Effectiveness:whentheobjectivesdefinedarereached·Efficiency:whenresourcesaffectedto carry outthe activitiesare optimized

16.What are the diferences between prEnversusEN?

In the European sector, ASD-STAN is publishing the IAQG9100 documents as ASD-STANprEN9100 and relateddocuments, to make the standardas the same time availableas it is published in the American and Asian-Pacificsectors. ASD- STANprEN means ASD-STAN projected EN and ASD-STANprENs are technically equal (with exactlythesamecontent)to thelaterENpublications by the CEN members.

TheASD-STAN prEN is an early publication ofthe CEN EN. The CENEN is a later re-distribution of the ASD-STAN publication with a CEN coversheet. ASD-STAN prEN publications canbe used for any training and certification activity. More information can be found at https://www.asd-stan.org/frequently-asked- questions/

17.Why is there such a short transitionperiod?

IAQGdecided to match the ISO9001:2015 transition period of September 2018 so organizations couldavoid two separate transition efforts and audits.

1.What is meant by the context of the organization?(4)

什么是组织环境？

This isthecombination of those internal andexternalfactors thataffectanorganization's approachtotheway inwhichitprovidesproducts and services thataredelivered to its customer.

Externalfactors can include, for example, cultural,social, political, legal, regulatory, financial, technological, economic,and competitive environment, at theinternational,national, regional orlocallevel.

Internalfactors typically include the organization’scorporateculture,governance, organizationalstructure, technologies, information systems, anddecision-making processes (both formalandinformal).

这是影响组织为顾客提供产品和服务的途径的内部和外部因素的综合。

外部因素可以包括，例如，文化、社会、政治、法律、监管、金融、技术、经济和竞争环境，在国际、国家、区域或地方各级。

内部因素通常包括组织的企业文化、治理、组织结构、技术、信息系统和决策过程(正式和非正式)。

2.What are the needs and expectations associated with interested parties? (4.2)

什么是理解相关方与需求与期望？

·The organization wi l l n ee d to determine the interested partiesthat are relevantto the quality management system and therequirements of those interested parties, as outlined in clause 4.2.does not extend past the quality managementsystem requirements and the scope of this International Standard

.·As stated in the scope,this International Standard is applicable wherean organizationneeds to demonstrate its ability to consistently provide products andservices that meet customer and applicable statutory and regulatory requirements,and aims to enhance customer satisfaction.

·组织将根据第4.2条的规定，确定与质量管理体系和相关方要求相关的利益方。这并不超出质量管理体系的要求和本国际标准的范围

·如范围所述，本国际标准适用于组织需要证明其始终如一地提供满足客户和适用法律法规要求的产品和服务的能力，并旨在提高客户满意度的地方。

2.3 What are expectations relating to HumanFactors?

与人为因素相关的期望是什么?

·In clause 7.1.4, the ISO text requires that the organization implements a suitable environmenttaking into consideration human factors and the note mentions examplesof socialfields (e.g., non-discriminatory, calm,non-confrontational) and psychological fields (e.g., stress-reducing, burnout prevention, emotionally protective). So, appropriate working conditions are expected for peopleworking within the organization in order to mitigate the risksof human factorseffects on the employees and performanceof the organization.

·In clause 8.5.1g, the focus is on preventing humanerror through mistake-proofing orPoke- A-Yoke techniques in how workisconducted.

·In clause 10.2.1.b.2, human factors may be at the origin of the nonconformities:a.The tool, the internal procedure relating to problem solving, the templates or checklists, thetraining material can be used by the organization to support the determination of the causes of the nonconformities that shouldinclude the consideration of human factors.b.The people involved in this process should be aware of the aspects of human factorson workperformed.

·在第7.1.4条中，ISO文本要求组织实施考虑人为因素的合适环境，说明中提到了社会领域(如非歧视性、冷静、非对抗性)和心理领域(如减压、预防倦怠、情感保护)的例子。因此，在组织内工作的人需要适当的工作条件，以减少人为因素对员工和组织绩效的影响。

·在第8.5.1g条中，重点是通过工作过程中的防错或防错技术来防止人为错误。

在条款10.2.1.b·。2、人为因素可能是不符合的根源:b.该工具、与解决问题有关的内部程序、模板或检查表、培训材料可由组织用于支持不符合原因的确定，这些不符合应包括考虑人为因素。参与此过程的人员应该了解所执行工作的人为因素的各个方面。

2.4 What ismeant by organizational knowledge?(7.1.6)

什么是组织知识?

Organizational knowledgeisknowledgespecificto theorganization;itis gainedby experience. It is informationthat isusedand sharedto achieve theorganization’sobjectives. Requirements regardingorganizational knowledge were introduced forthepurpose of safeguarding the

organizationfromlossofknowledge and encouraging the organizationto acquire new knowledgeasitsbusinesscontextchangesand sharetheknowledge with others.

Implementation considerationsinclude activities to benefit from lessonslearned, e.g., database, communications,incorporationoflessonslearned in processesand procedures; identification of experts ableto transfer knowledge; on jobtraining; tutorial sessions; documentedinformation on howtoperformtasks;competencymatrices;andsuccessionplanning activities.

5.What is expected for Awareness(7.3)?

Individuals shouldbe ableto explain their role (i.e. sales, engineering,procurement, operator, repairtechnician) and howtheycontributeto quality; quality basics such asfollowing instructions,reportingevents,maintainingrecords;andknow the use of the products and potentialimpactoffailures.

6.Documents and records have beenreplaced by documented information. What doesthis mean?(7.5)

Documentation, documents andrecords arenowcollectivelyreferred to as documented information.Wherethatdocumented information might be subjectto change(asin thecaseof procedures, work instructions,etc.), organizations are required toMAINTAINthe information up-to-date;wherethe information is notnormally subjectto change(forexamplerecords)the organizationisrequiredtoRETAINthatinformation.

7.What is the expectation for implementing and auditing escape prevention? (8.1)

This requirementwas re-enforced in thestandardsince theindustrycontinuestosee a high level ofescapes tothecustomer. The organization isrequiredtoshoweffectivecontrols to preventthe deliveryofnonconforming products and servicesto thecustomer and robust correctiveactions whenescapesareencountered.

8.Is there a guidance document or an ISO standard that I can obtain that defines a process for Risk Management(8.1.1)?

Yes. Thereareseveral goodresources forRisk Managementwhicharelisted below:

·ISO31000RiskManagement

·IAQGSupply Chain Management Handbookhas Chapter 7.3 onRiskManagementwhichcan be accessedat http://www./iaqg/handbook/scmhtermsofuse.htm

·IAQG9134 Supply Chain RiskManagement

·ISOGuide73 RiskManagementVocabulary

·ISO17666Space Systems - RiskManagement

·ISO16085Systems-Software Engineering -Risk Management

·ProjectManagementInstitute

·RiskManagementGuideforDoDAcquisition

There arenumerousriskmanagementresources and 9100 is notprescriptivein providing the “how” risk managementistobeperformed, only that certain aspects beestablished, implemented,and maintained as appropriate. Risk Managementforoperationalprocesses isasubsetof Risk-basedThinking (6.1) which transcends the entireQMS.See9100:2016 Annex A.4 foradditionalinformation.

2.9 Is therequirement relatingto product safety applicable for all the organizations; such as raw materialproviders, small organizations, lower tier, build to print, machine shops, as for complex organizations,equipment manufacturers? (8.1.3)

Therequirement relating to productsafetyisdirectlylinked to thefinaluseof the product. All theorganizationsshouldknow the finaluseof the product that they deliver. Theymaygetthis informationinternallyorfrom theircustomers(orfromthe customer of their customers).

According totheuse of theirproductand the potentialconsequenceof theirfailure, theyshould be ableto determine“criticalitems”asper9100 definition,andimplement appropriate actions to managethem.

Note:Someorganizations(e.g. thoseproviding COTS or raw materials) mayhavealowerlevel ofknowledge of the final useof theirproductsthan those producing by customer specification.

Reminder:

a)Theorganizationmustunderstand thedefinitions:

·Safety=aviation,space and/ordefensesafety

·Safetyofpeople onboard, around the aircraftorproduct,overflown

·Relatedtotheproduct operation (the useinservice oftheproduct)

Differentfrom:

·Peoplesafetyat work(HSE)

·Securityincluding fighting malicious actions(terrorism, sabotage, vandalism…)

·a)Theorganizationshouldbe aware of thefollowings:

·Achieving theproduct safetyobjective requirestoimplementsafetydedicated provisionsduringthe complete life cycleofthe product (development, production, operations, maintenance, disposition(scrapping orreuse of dismantled parts)

·Develop proactivity(risk management)inaddition to reactive methods (e.g.processing ofoccurrences)

·Identify risks potentially impactingthe safetyofthe products and address them before they generate adverseeffects

·Buildingtheproduct accordingto theengineering without deviations

·Everybodyhas arole toplay

·Safetyrisk management(systemandproduct analysisandhazardidentification for critical items,safety risk assessment and mitigation,non-conformitiescollection, analysis, reportingofoccurrences)

·Safetyassurance (safety performance monitoring andmeasurement, management of change of product and organization,continuous improvement)

·Safetypromotion(trainingandeducation and communication)

2.10 What are some methods to implement counterfeit part prevention (8.1.4)?

·Trainingin theawareness and prevention of counterfeit partsoProcurementpersonnel intrusted sourceselectionand requirementsoInspectionpersonnelforpreventionof counterfeititems (visual, test)oDesignpersonnelinobsolescencemanagement

·Obsolescencemonitoring of design decisions andpartsselections to be appropriate for service life ofproduct

·Controlsforacquiring parts from originalmanufacturers,authorized distributors,orother approvedsources

·Assuringtraceability of partsandcomponents totheir original manufacturers:oOriginalEquipmentManufacturer (OEM)oroAuthorizedmanufacturer (e.g., in case ofPMA,directdelivery authorizations)

·Verificationandtestmethodologiestodetectcounterfeit parts:oPartsidentification ormarkingoTestsorchemicalanalysis

·CounterfeitpartsreportingoMonitoring reporting from externalsources (access to databases, informationletters fromOEMs)oQuarantine and reporting of internalincidences in appropriate government and industry reportingsystems (determine the responsibilities in theescalationprocess, theprocess tofollow to reporttoauthorities andcustomers)

·Requirementregardingnonconformancecontrol:oSegregateandcontrolsuspected orknown counterfeit productsoEnsurethese products are notre-introducedinto thesupply chain

2.11How are the design and development (8.3) requirements applicable to services? (Examples forTraining organization, Designservice provider, Testing laboratories)

Theactivitiesoforganizationsprovidingservicesneedtobedeveloped before being proposed tocustomers,especiallyto studythe variouswaystoanswertocustomerrequirements. The

newversionofthe clause8.3 relating to design and development (D&D) allowsadaptingthe requirements toeachtypeofservice.

For example, aTraining providerD&Dactivitycan betostudyseveralwaystoproposetrainings (classroom, e-learning,). ForaDesign service provider or aTesting laboratory, a D&D activitycan be tostudyvariousmethodologiestoperformtheiractivity.

12.Why has Purchasing changed to ‘Control of externally provided processes, productsand services’?(8.4)

This changereflectsthefactthatnot allproducts,servicesorprocesses that an organization acquires are necessarily purchasedinthetraditionalsense. Somemay beacquired from other partsofacorporateentity,for example,aspart ofashared poolof resources,productsdonated by benefactors or servicesprovidedbyvolunteers.

13.Explain in detail the intent of section 8.4.3 m (a flow down requiring awareness of supplierpersonnel).

The intentofthisrequirementistoensureexternalproviderpersonnel understand the role they playin conformity,product safety,andethicalbehavioraspart offinalproductmeeting requirements. The intentofthe flowdowntoexternal providersof the awareness requirement istoensurethat the whole supply chain havethe same awareness on the topics listed

Theorganizationscan answerwith:

-ageneral requirementtoalltheirexternal providersor tokeyexternalproviders(reminding that they areworkingfortypesof aerospaceproducts)-specificrequirements(inPOsor inContracts) to relevant external providersreminding that they aresupplyingproducts having safety impactson the finalproducts.

14.What has happened to validation of processes or what used to be called special processes?(8.5)

ISO 9001:2015chose toremovethe standalone sub-clause onspecialprocesses, this requirementcontinues,andhas been incorporatedinto thesub-clausefoncontrolof production and serviceprovision (Ref. 8.5.1). This wasnot specificordetailedenoughfor Aviation, Space, andDefense so9100:2016added itasclause 8.5.1.2, Validation andControl of SpecialProcesses.

15.What is meant by post delivery activities and what is the extent of an organization’s responsibility?(8.5.5)

This meansthat based on customer agreements or other requirements, the organizationmaybe responsibleforprovidingsupport fortheir productor serviceafter delivery. This could include, for example,technicalsupport,routine maintenance, or in somecases recall.

16.What are examples of documentationrequired for Release of Product? (8.6)

Organizations are requiredtoretain documentedinformation of plan and9100 8.5.1Notes includesexamplesdocuments forverification of products and services.Asforrelease of product, organizationisrequiredtoretain thoseverificationdocumentedinformation includes theevidence of conformity with theacceptance criteriaandtraceabilityto theperson(s) authorizingtherelease.

17.What is the difference in the standard between improvementand continual improvement? (10)

9100:2016 used the term continualimprovementtoemphasizethe factthatthisisanongoing activity.However,itis importanttorecognize thatthere area numberofways inwhichan organizationmayimprove.Small stepcontinual improvementisonlyone of these. Others may includebreakthroughimprovements, re-engineering initiativesorinnovation.9100:2016 therefore uses the moregeneraltermimprovement, of which continual improvementisonebut not the onlycomponent.