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AS9100:2009 航空、航天和国防行业质量管理体系要求常见问题回答  发帖心情 Post By:2009-12-4 7:42:00 [只看该作者]

Forward 前言

To assist in the deployment and sustainment of 9100:2009, the International Aerospace Group (IAQG) 9100 Team has developed a collection of questions and clarifications for users of the standard. It is intended that these FAQ’s be updated as new questions are received.

为了帮助开发和维持9100:2009标准,国际航宇组(IAQG)的9100小组已经为标准的使用者编写了一份常见问题和说明(FAQ)文件。如果有新问题提出来的话,该文件会及时更新的。

General 9100:2009 Revision Registration
9100:2009总的修改情况

What is the purpose of the 9100 standard?
9100标准的用途是什么?

★The 9100 standard on quality management system requirements is intended to be used at all levels of the supply chain. Its use can result in improved quality, schedule and cost performance. This standard is primarily developed for the aviation, space and defense industry, but can also be used in other industries.
9100是关于质量管理体系要求的标准,它意向用于供应链中所有的层次。采用后可以提高质量、进度和成本绩效。该标准主要用于航空、航天和国防行业,但也可适用于其他行业。

★ Who is responsible for updating the 9100 standard?
谁负责及时更新9100:2009标准?

★The International Aerospace Quality Group (IAQG) is responsible for
the development and maintenance of the 9100 standard. For further
details contact 9100 team via the IAQG website.
国际航宇组(IAQG)负责开发和维持9100标准。详细情况可以通过IAQG网站联系。
Rev D 4/6/2009 2  

★ How can you tell the difference between the ISO 9001:2008 text and the 9100 text?
您是如何告诉我们ISO 9001:2008和9100标准之间不同内容的?

★The bold, italic text represents the aviation, space and defense
specific additions.
标准用黑体斜体文字来表示在ISO 9001:2008标准基础上为航空、航天和国防特定的附加要求。

★ Where can I find more information about the IAQG and the standards it has published?
我从哪里得到有关 IAQG和已经发布的各项标准更多的信息?

★The International Aerospace Quality Group website is located at
http://www.iaqg.sae.org/iaqg/.
IAQG的网站:http://www.iaqg.sae.org/iaqg/。

★ What are the benefits of implementing IAQG quality standards?
执行IAQG标准有什么好处?

★IAQG members agree to use standards internally and with suppliers
o One voice, minimize variation, shared resources, reduced
duplication and waste
IAQG成员一致同意在内部和供方一起都采用这些标准,这样有共同的声音、减少变差、分享资源、降低重复和浪费。

★Focus on the complete supply chain and stakeholders
关注整个供应链以及利益相关方。

★True global Aerospace cooperation and harmonization
真正的全球航空航天合作和协调一致。

★Higher quality products at reduced cost
以降低成本来得到更加高的质量。

★Fewer , customer-unique documents
较少的顾客特定文件。

★System for Third Party approval
为第三方批准的体系。

★Shared supplier approval database
分享供方批准的数据库。

★Recognition by Regulatory Authorities
得到法规当局的任可。

★Open sharing of “Best Practices” 公开分享“最佳操作”。

★Networking with Quality Directors / VPs in Primes and Suppliers
主制单位质量经理、副总裁和供方之间可以通过网络联系。

★Rapid consensus & deployment 快速达成一致和开发。

★ Why change the 9100 standard?
9100为什么要修改?

★9100 has been revised to address the following needs:
根据以下需要,9100已经做了修改:

★Incorporate ISO 9001:2008 changes
跟着ISO 9001:2008 修改。

★Expand scope to include land and sea based systems for defense applications 扩大使用范围,从原来航空、航天扩大包括陆和海上基础国防行业的应用。

★Ensure alignment with IAQG strategy (on-time, on-quality performance)
为了贯彻IAQG的战略方针(及时、质量业绩)。

★Adopt new requirements based on stakeholder needs
根据利益相关方的需求增加新的要求。

★ Improve existing requirements where stakeholders identified need for clarification, including when a documented procedure is required.
凡是利益相关方认为必须加以澄清的各项要求,其中包括要求文件化程序的要求有所改进。

★ Who provided input to the 9100 revision?
谁提供修改9100的输入?

★IAQG and its sector member companies, IAQG Strategy Streams and Teams, suppliers, civil airworthiness authorities, certification/registration bodies, defense industry and authorities, space industry companies, regulatory authorities and trade group associations.
IAQG组织本身和各个区域的成员公司,还有IAQG支流和团队、各个供方、民航适航当局、认证/注册机构、国防行业和国防当局、航天行业各个公司、法规当局和行业协会组织。
Rev D 4/6/2009 3

★ What process was used to determine the changes to 9100?
决定对9100做修改的程序是什么?

★The 9100 team used a project management approach to solicit input and manage the revision as follows:
9100团队利用项目管理方式收集需要更改的输入,再按照以下方式加以管理:

★Project Management 项目管理
Design Specification; IAQG Strategy; 9100 objectives; Stakeholder inputs; and Web survey inputs.
设计规范;IAQG的战略;9100的目标;利益相关方输入;以及通过互联网调查得到的输入。

★Data Mining and Consolidation 修改日期协调一致
MCRT (Master Comments Review Template) which was used to collect over 400 comments and proposals.
MCRT(主要意见评审模板)用来收集400多条意见和建议。

★Review Process  评审过程
Review of proposals by the IAQG 9100 team based on the Design Specification (approx. 40% acceptance).
9100团队根据设计规范对意见和建议加以评审(大约40%采纳了)。

★Draft coordination and voting  协调起草草案,投票通过
1st draft issue July 2007, 9100 team review October 2007, informal coordination draft issue November 2007, stakeholders comments review April 2008; formal ballot issue May 2008, vote October 2008; release January 2009.
第一份草案2007年7月发布,9100团队在2007年10月作了评审,11月发布了非正式的协调草案。2008年4月利益相关方评审,供投票用正式版本在2008年5月发出,2008年 10月投票通过,2009年1月正式颁布。

★ Where can I find more information on the changes to 9100:2009?  在哪里我能发现有关9100:2009版更改更多的信息?

★7.1.1 Project Management - New requirement for planning and managing product realization in a structured and controlled way.  
7.1.1 项目管理 - 新提出的要求,要求在结构和控制途径上加以策划和管理产品实现。

★7.1.2 Risk Management - New requirement of implementation of a risk management process applicable to the projects & products; responsibility, criteria, mitigation & acceptance.
7.1.2 风险管理 - 新提出的要求,要求执行一个风险管理过程,应用于项目和产品;包括风险的责任、准则、降低和接纳。

★7.1.3 Configuration Management - Moved from clause 4.3 to clause 7.1 and added details on the different activities to be covered.
7.1.3 技术状态管理 - 把原来4.3条移动到7.1条,增加了有关需要加以包括的不同活动的具体要求。

★7.1.4 Control of Work Transfer - Moved from clause 7.5 (Production) to clause 7.1 to add emphasis on having a process to plan and control of transfer activities.
7.1.4 转移工作的控制 - 把原来7.5条(生产)这条要求移动到7.1条来。强调要有一个过程来策划和控制各项转移工作活动。

★Product quality and on-time delivery performance - Added requirement for “product conformity” and “on-time delivery” to be measured, and appropriate actions taken if planned results are not achieved. The intent is to provide a linkage between the QMS and organization performance.
产品质量和及时交付绩效 - 新提出要求,要针对“产品符合性”和“及时交付”加以测量。而且提出,当策划结果没有达到的话,要求采取适当的措施。意图是在质量管理体系和组织的绩效之间提供一个链接。

★Process to be required to address control of Special Requirements, Critical Items and Key Characteristics - Key characteristic requirements remain unaltered, but the concept of identifying special requirements (either from the customer or by the organization) which  require additional controls (e.g. risk management), that translate into Critical Items, which then may flow to Key characteristics for variation
control is new.
凡是特殊要求、临界实体和关键特性要求有过程来加以控制 - 保留关键特性,没有变化,但是,提出新的概念,就是要识别特殊要求(无论是从顾客角度或者组织角度),针对特殊要求要采取附加的控制(也就是风险管理)。通过风险管理把特殊要求转化成各种临界实体,才可以再转化为关键特性,以便对其变差加以控制。

★Formal monitoring of customer satisfaction data - Added the requirement to monitor data and to develop improvement plans that address deficiencies. The intent is to promote continuous improvement of the product and customer satisfaction.
对顾客满意数据的正式监视 - 增加了这项要求,为了监视数据以及开发改进薄弱环节的计划。意图是促进持续改进产品和顾客满意。
Rev D 4/6/2009 4

★ Where can I find additional information on the primary changes? 我从哪里可以见到其他有关主要更改的信息?

★IAQG Website http://www.iaqg.sae.org/iaqg/
从AQG网站 http://www.iaqg.sae.org/iaqg/

★IAQG 9100 Deployment Material
http://www.iaqg.sae.org/iaqg/organization/requirements.htm#ipr 从IAQG 9100开发材料网站http://www.iaqg.sae.org/iaqg/organization/requirements.htm#ipr

★ What about the requirements from regulatory authorities, is there any
change?关于法规当局的要求,这方面有什么变化?

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  发帖心情 Post By:2009-12-4 7:42:00 [只看该作者]

A general requirement has been introduced (in 4.1) to address all the applicable statutory and regulatory QMS requirements in the organization's QMS, instead of keeping detailed requirements into chapters.
总的要求已经在第4.1条中提出了,要求组织的质量管理体系应当满足所有应当采用的各种法律和法规定中对质量管理体系提出的要求,不再在各个具体的章节中再规定详细的要求。

★ Why was First Article Inspection (FAI) moved to clause 7.5.1.1 and renamed? 为什么把首件检验移动到第7.5.1.1条,而且把名称也改了?

★Production process verification “FAI” is the requirement to validate the production processes, documentation and tooling and repeat the process when necessary (i.e. when engineering or manufacturing processes change). The requirement was moved from 8.2.4.2  (measurement) to 7.5.1.1 (production) because it is part of product
realization and is not intended to be a follow on activity.
生产过程的验证“FAI”是对生产各个过程、文件和工装工具加以确认的要求。而且,当有必要(也就是当工程或制造过程发生变更)的时候加以重复确认。因为,这是产品实现本身的一个组成部分,它的意图不是一种后续的活动,所以,把这个要求从8.2.4.2条(测量)移动到7.5.1.1条(生产)。

★ What is the difference between Key Characteristics, Special Requirements and Critical Items?
关键特性、特殊要求好临界实体之间有什么不同?

★Special Requirements are those requirements that have high risks to being achieved, hence requiring their inclusion in the risk management process. 特殊要求是指那些要想达到这些要求具有高风险的那些要求。因此,必须对这些要求包括在风险管理过程之中。

★Critical Items, including key characteristics, are those items that have significant effect on the product realization and use of the product, and hence require specific actions to assure they are adequately managed.
临界实体,关键特性也是临界实体之一,是指这些实体对产品实现以及产品的使用具有重大后果的影响,因此,要求对它们采取专门的措施,确保对它们有充分的管理。

★Key Characteristics includes an attribute 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.
关键特性包括某一种属性或者特征,它的变差对产品的配合、外形、功能、性能、服务寿命或可生产性具有重大后果的影响,因此,必须对它采取专门的措施,以便达到控制变差的目的。

★ ISO 10007 is referenced after Configuration Management, does this mean it is required?
ISO 10007是《技术状态管理》要求后面引用的标准,这是否意味这是一项要求?

★No, ISO 10007 is included in a Note for reference only where additional information on configuration management can be obtained.
不是要求。ISO 10007是放在“注”里的,仅供参考。告诉您从哪里可以得到有关技术状态管理的附加信息。

★ Do the ISO 9001:2008 changes affect 9100:2009?
ISO 9001:2008版的更改对9100:2009标准是否起作用?

★Yes. The 9100 standard has been updated to stay consistent with ISO 9001:2008, which will continue to be the baseline. The changes being incorporated into ISO 9001:2008 are considered an amendment and minor in nature.
是的。9100标准已经更新,其目的就是为了跟上ISO 9001:2008额更新。因为,ISO 9001:2008是9100标准的基础。ISO 9001:2008所作的更改已经考虑了,而且从本质上来说也是起码要做的更改。
Rev D 4/6/2009 5

★ How long will we have to transition to 9100:2009?
9100:2009标准必须在多长时间内过渡完成?

★30 months. Companies will be encouraged to upgrade during their scheduled audit cycle.
2009年1月起30个月内过渡完成。鼓励各个公司在他们计划的审核周期内完成。

★ Will auditor and registrar training be available?
审核员和注册培训是否可获得?

★Yes, the sanctioned auditor training is being developed and will consist of both 9100 and 9101 training.
是的。强制执行的审核员培训正在开发之中,9100和9101的培训将同时进行。

★ Are 9110, 9120 and 9101 going to be updated to continue alignment with
9100:2009?
9110、9120和9101是否持续更新,确保和9100:2009一致?

★Yes, the 9110 and 9120 standards will continue to use 9100 as their baseline and will follow the release of 9100 within a six month timeframe. 9101 will incorporate 9111 and 9121 and be published as one standard.
是的。9110和9120标准将继续用9100作为基础,将在六个月内跟随9100的发布。

★ Where can copies of new 9100, 9110, 9120 and 9101 standards be obtained?
我们可以从哪里得到9100、9110、9120和9101标准?

★There are numerous national and regional standards bodies. Each has their own publication schedule requirements. The sector standard bodies are as follows:
可以从很多国家和地区标准机构处得到。他们各自有自己的出版计划要求。地区标准机构包括以下:

Contact John on IAQG link 可以和IAQG的John联系
? 美国的SAE (Americas): http://.aerospace.sae.org/
? 欧洲的 ASD (Europe): http://www.asd-stan.org/
? 亚太SJAC (Asia/Pacific): http://www.sjac.or.jp/en_index.html

★ Our company is currently registered to 9100, but based on the new Scope statement we should be registered to 9110. Does this mean we will have to change our registration?
我们公司现在注册9100,但是,根据新标准的范围,我们应当注册9110。是否必需变更我们的注册?

★If an organization needs other QMS standards in addition to 9100, such as 9120 (Distributor) or 9110 (Maintenance) then the additional registration requirements should be determined by customer and regulatory requirements. More than one standard registration may be necessary if the products of the company meet several of the standards′ scopes (i.e. a company that manufactures products and also sell
maintenance services). Clause 1.2 Introduction outlines the new applicability statements for 9100, 9110 and 9120.
假如某组织的质量管理体系除了满足9100要求之外,还需要满足譬如9120(分配商)或9110(维修)要求,那么,附加的注册要求应当由顾客和法规当局来确定。假如公司的各种产品(也就是公司制造产品,同时也销售服务)符合若干标准范围的话,也许有必要按照一个以上的标准注册。标准第1.2条说明了9100、9110和9120新的应用范围。

★ Why was the text deleted from Clause 4.2.2 Quality Manual Relationships?
标准为什么把4.2.2条《质量手册》中要求对应条款号的要求取消了?

★The deletion of the requirement to create a document showing the relationship between 9100 requirements and the organizations documented procedures was seen as adding no value to assuring product quality above the existing ISO text. Users of 9100 will still need to identify appropriate documented procedures as an inherent part
of being audited. The rational is there other ways to show the relationships and we need to be flexible to other methods of achieving the same intended result.
9100原来要求文件化程序和标准要求之间的联系必须要用文件来说明,这条要求被消除了。因为,这样做法看来相对于现在的标准要求来说,对确保产品质量没有什么增值。因为,9100标准的使用者仍然必须识别适当的文件化程序作为被审核质量管理体系固有的部分。取消的理由是,还有其他的方法来显示相互关系,而我们必须灵活地采用其他方法来达到同样意向的结果。
Rev D 4/6/2009 6

★ Where do I find definitions of some of the terms used in 9100?
我从什么地方可以获得9100标准中所采用的某些术语?

★IAQG Dictionary has a wide range of definitions and includes definitions
from ISO 9000:2005. The 9100:2009 uses both of these sources in lieu
of adding definitions to the standard.
IAQG 字典具有广泛的定义,其中包括来自 ISO 9000:2005的定义。9100:2009标准采用以上两方面的来源,除此之外,再有的定义就在标准中规定了。




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