1.Special Processes特殊过程
当特殊过程(具体参考AS 9100/9110 条款 7.5.2)被确定存在时，需要对特殊过程评估及过程进行验证、监视和测量，并对此过程进行控制。
NOTE 1: 当组织内部存在特殊过程，在第一阶段就需要识别并针对这种特殊过程的管理审核是必须的
a) 特殊过程的验证
需审核每个特殊过程有关的记录，包括特殊过程的策划与实际结果之间的结果比较 (see 9100 clause 7.5.2).
b) 特殊过程的监视、测量和控制
审核组应确定特殊工艺的要求，包括客户的要求、选择一个标准过程或更多特殊过程，审核员须审核使用的监视和测量设备，比如：校准和精度。记录结果的方法。必要时，需验证过程和最终产品之前的可追溯性。
对外包的特殊过程，审核组需要核实在供应商管理过程中对于供方的特殊过程的管理，这也包括客户指定的供应商。
NOTE 2: Special processes are managed by using personnel qualified, as required by organization and/or customer requirements, and by controlling physical or chemical process characteristics [e.g.,
temperature, time (process duration), pressure, chemical composition of product or process
treatment material (surface treatment solution)].
NOTE 3: If an audit(s) has been performed by a customer or by a specialized independent 3rd party, the audit team can take the audit by these organizations into account.
2.Audit Reporting审核报告
3.Nonconformity Management不符合项的管理
4.Audit Records审核记录
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4.2 Documentation requirements文件控制
4.2.1 General总要求
12 a. Documented statement of a quality policy文件化的质量Quality policy ref.:
方针声明
13 Documented quality objectives文件化的质量目标Quality objectives ref.:
14 b. Documented quality manual文件化的质量手册Quality manual ref.:
15 c. Documented procedures required by 9100-series List of procedures ref.:
standards AS9100体系要求的形成文件的程序
16 Documented records required by 9100-series List of records ref.:
standardsAS9100体系要求的记录
17 d. Necessary documents and records as per clause
4.2.1.d文件管理 4.2.1.d条款中要求的文件和记录
18 Documented safety policy and safety objectives (9110 Safety policy/safety objectives ref:
only)文件化的安全方针和目标
19 Accessibility and awareness of personnel of relevant
QMS documentation and changes相关人员可以接触到
并知道相关 QMS文件和更改
4.2.2 Quality manual质量手册
20 Quality manual established, maintained and质量手册的建
立、维护和
21 a. Includes the scope of the QMS包括 QMS的范围
22 Includes justification of exclusions删除的理由List excluded clauses:
23 b. Includes QMS documented procedures or reference to
themQMS程序与参考
documented evidence24 c. Includes a description of the QMS processes and
interactions过程和相互作用的描述
d. Includes a description of the processes and
procedures used for: (9110 only)过程和程序的描述
25 proficiency of personnel人员的能力要求
26 rosters of certifying staff and personnel认证有关人
员和其它人员的名册
27 training program培训计划
28 current approved technical data目前已核定的技术数
据
29 performing preliminary inspection进行初步核查
30 acceptance of incoming articles
31 inspecting articles involved in an accident for hidden
damage before MRO activities (9110 only)
32 conducting maintenance in compliance with
customer, statutory and regulatory requirements
33 performing final inspection and 'return to service' of
maintained articles
34 governing work performed at another location
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4.2.3 Control of documents文件控制
35 Documents required by the QMS are controlledQMS 文件所
需的控制
36 Records are controlled in accordance with clause 4.2.4
4.2.4条记录控制
Documented PROCEDURE exist and includes: Procedure ref.:
文件化的程序，并包括：
37 a. approval process 审批程序
38 b. review, update, and re-approval process审查、批准和
重新批准过程
39 c. identification of changes and current revision status识
别变更和现行修订状态
40 d. documents are available where needed使用处可获得
有关最新版本
41 e. documents are legible and identifiable文件保持清晰和
易于识别
42 f. external documents are identified and controlled外来文
件控制与分发
43 g. obsolete documents are identified and controlled作废
文件的非预期使用（杨兴文注：含识别）
4.2.4 Control of records记录控制
44 Records (as required in 4.2.4) are established and controlled
建立和控制记录（在 4.2.4的要求）
A documented PROCEDURE exists that includes controls for:
Procedure ref.: 形成文件的控制程序存在，包括：
45 identification鉴定
46 storage存储
47 protection保护
48 retrieval检索
49 retention保留
50 disposition处置
51 supplier created and/or retained records供应商生成或产
生的记录
52 Records are legible, identifiable and retrievable记录都清晰可
Samples of records reviewed审查记录样本辨，识别和检索
53 Records of product origin, conformity and shipment are Samples of records reviewed审查记录样本
maintained (9120 only)
54 Back-up procedures are defined for records stored in an Procedure ref.:
electronic form (9120 only)
55 Electronic records are secured and cannot be corrupted
due to software or system changes (9120 only)
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Item # 8 Quality Management System Requirements 序号QMS要求9 C 10 NCR Objective Evidence/Comments客户证据
与意见 (e.g., observations, OFIs)
5. MANAGEMENT RESPONSIBILITY管理职责
5.1 Management commitment管理承诺
Evidence of top management commitment includes：最高管理
层的承诺证据包括：
Evidence ref.: 56 a. communicating importance of meeting customer,
statutory, and regulatory requirements传达满足顾客和法
律法规要求的重要性
57 b. establishing a quality policy制订质量方针
58 c. establishing quality objectives制订质量目标
59 d. conducting management reviews进行管理评审
60 e. ensuring availability of resources确保资源的获得和可用
61 f. establishing the safety policy建立安全方针 (9110
only)
62 g. ensuring safety objectives are established确保安全
目标的建立 (9110 only)
5.2 Customer focus顾客为关注点
Top management ensures：高层管理人员保证：
63 customer requirements are determined and met有决心满足
顾客要求
64 product conformity is measured产品符合的测量
65 on-time delivery (OTD) performance is measured准时交
付业绩的测量
66 actions are taken, if planned results are not or will not
be achieved策划的结果不能实现时，需采取行动（杨兴
文注：如果上述目标未达成时，需采取措施）
5.3 Quality policy质量方针
Top management ensures that the quality policy高层管理人员确保质量方针:
67 a. is appropriate是适当的
68 b. includes a commitment to comply with requirements and
continually improve the effectiveness of the QMS包括对满Commitment ref.承诺证据:
足要求和持续改进QMS有效性的承诺；
69 c. provides a framework to establish and review its quality
objectives提供建立和检讨质量目标的框架
70 d. is communicated and understood在组织内部得到沟通与
理解
71 e. is reviewed for suitability持续适宜性的评审
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Item # 8 Quality Management System Requirements 序号QMS要求9 C 10 NCR Objective Evidence/Comments客户证据
与意见 (e.g., observations, OFIs)
5.4 Planning策划
5.4.1 Quality objectives 质量目标
Top management ensures that quality objectives are最高管理者确保质量目标:
72 established建立
73 measurable可测量
74 consistent with the quality policy与质量方针一致
5.4.2 Quality management system planningQMS策划
Top management ensures最高管理者确保:
75 a. QMS planning is carried out to meet the requirements
defined in clause 4.1 and the quality objectives最高管理者
对QMS策划，确保满足质量目标及4.1要求
76 b. QMS integrity is maintained when changes occur发生变
更时，需保持QMS的完整性
5.4.3 Safety objectives安全目标 (9110 only)
Top management ensures safety objectives are:
77 Established建立
78 Measurable可测量
79 consistent with the safety policy与安全方针一致
5.5 Responsibility, authority and communication职责、权限和沟通
5.5.1 Responsibility and authority职责和权限
Top management ensures that responsibilities and authorities最高管理者需确保职责和权限:
80 are defined定义
81 communicated沟通
5.5.1.1 Accountable executive manager责任部门经理人(9110 only) 82 A
manager has been appointed by top management with
authority to ensure that all necessary resources are
obtained最高管理者需任命一名经理人，鹕保其权限及资源
5.5.1.2 Maintenance manager(s) 维修经理(9110 only)
83 Top management appointed a manager(s) responsible for
assuring that all maintenance required is performed in
accordance with all requirements
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