正在进行的基本供应管理和监控
h) supplier selection criteria, 供应商选择标准
i) supplier re-evaluation, and 供应商再评估,和
j) feedback to key suppliers based on data analysis
of supplier performance. [10] 根据供应商绩效的数据分析反馈给关键供应商
7.4.1.C.1-NOTE 1: The documented procedure(s) should be
applicable to off-the-shelf product. This typically
includes original equipment manufacturer (OEM) products
used in manufacturing and commercial off-the-shelf
(COTS) products used in software systems.
7.4.1.C.1-注
1:程序文件应适用于现有产品。这特别包括用于制造的原有设备制造商(OEM)产品和用于软件系统的商业性现有(COTS)产品。
7.4.2 Purchasing information 采购信息
采购信息应表述拟采购的产品,适当时包括:
a) 产品、程序、过程和设备批准的要求;
b) 人员资格的要求;
c) 质量管理体系的要求。
在与供方沟通前,组织应确保规定的采购要求是充分与适宜的。
7.4.3 Verification of purchased products 采购产品的验证
组织应确定并实施检验或其他必要的活动,以确保采购的产品满足规定的采购要求。
当组织或其顾客拟在供方的现场实施验证时,组织应在采购信息中对拟验证的安排和产品放行的方法作出规定。
7.5 Production and service provision 产品和服务提供
7.5.1 Control of production and service provision
产品和服务提供的控制
组织应策划并在受控条件下进行生产和服务提供,适用时,受控条件应包括:
a) 获得表述产品特性的信息;
b) 获得作业指导书;
c) 使用适宜的设备;
d) 获得和使用监视和测量装置;
e) 实施监视和测量;
f) 放行、交付和交付后活动的实施。
7.5.1.C.1 Organization’s Support Program – The
organization shall ensure that customers are provided
support to resolve product related problems. [5]
7.5.1.C.1 组织的支持计划-组织应确保向客户提供解决相关问题产品的支持。〔5〕
7.5.1.C.2 Service Resources – The organization shall
provide customer contact employees with
appropriate tools, training, and resources necessary to
provide effective and timely customer service. [4]
7.5.1.C.2
服务资源-组织应提供客户联系员工,这些员工具有对提供有效的和即时的客户服务的必要的适当的工具,技能和资源。
7.5.1.HS.1 Emergency Service – The organization shall
ensure that services and resources are
available to support recovery from emergency failures of
product in the field throughout its expected life. [4]
7.5.1.HS.1 紧急服务-组织应确保服务和资源能支持产品从整个期望生命中紧急故障恢复。〔4〕
7.5.1.HS.2 Installation Plan – The organization shall
establish and maintain a documented installation plan.
The installation plan shall identify the resources, the
information required, and list the sequence of events.
The results associated with the installation sequence
shall be documented. [10]
7.5.1.HS.2
安装计划-组织应建立和维持一个文件性的安装计划。安装计划应鉴别资源,所需信息和列出事情的次序。和安装次序有关的结果写在文件中。〔10〕
7.5.1.S.1 Patching Procedure(s) – The organization shall
establish and maintain a documented
procedure(s) that guide the decision to solve problems
by patching.
a) The documented procedure(s) shall address patch
development procedures, propagation (forward and
backward), and resolution.
b) The documented procedure(s) shall be consistent
with customer needs or contractual requirements for
maintenance support.
c) The organization shall provide the customer with a
statement of impact on the customer's operation for each
patch. [11]
7.5.1.S.1 修补程序-组织应建立和维持一个程序文件指导通过修补解决问题的决定
第 7 楼:7a) 程序文件应写出修补发展程序,发展(向前和向后),和解决方案b)
程序文件应和用于维护支持的客户需求或合同需求一致。c)
组织应提供客户每个修补对客户的操作影响的阐述。7.5.1.S.2 Patch Documentation –
The organization shall establish and maintain methods to
ensure that all documentation required to describe,
test, install, and apply a patch has been verified and
delivered with the patch. [11]7.5.1.S.2
修补文件-组织应建立和维持一些方法,这些方法确保需要描述、试验、安装和使用修补的文件已被修改并分发。7.5.1.S.3
Replication – The organization shall establish and
maintain a documented procedure(s) for replication,
which should include the following:
复制-组织将建立和维持一个用于复制的程序文件,应包括如下:a) identification of master
copy, 原版的鉴定b) identification of replicate copies for
delivery, 传递的副本的鉴定c) quantity of replicates to deliver,
传递副本的数量d) type of media, 媒体类型e) labeling, 标签f)
identification of required documentation such as user
guides, 被要求文件如用户指南的鉴定g) packaging of documentation,
and文件包装,和h) control of environment to ensure repeatable
replication. [9] 确保可重复的复制的环境控制7.5.1.V.1 Software Used in
Service Delivery – Organizations shall document and
implement processes for the maintenance and control of
software used in service delivery to ensure continued
process capability and integrity.7.5.1.V.1
用于服务传递的软件-组织应编制和实施用于软件控制和维护的过程,这些软件用在服务传递,以确保持续的制程容量和完整性。7.5.1.V.2
Tool Changes – The organization shall have a documented
procedure(s) in place to ensure that substitutions or
changes to tools used in performing the service do not
adversely affect the quality of the service.7.5.1.V.2
工具变更-组织应适当地有一个程序文件去确保用在服务上的工具的替代或变更不反过来影响服务的质量。7.5.2
Validation of processes for production and service
provision
产品和服务提供的制程的确认当生产和服务提供过程的输出不能由后续的监视或测量加以验证时,组织应对任何这样的过程实施确认。这包括仅在产品使用或服务已交付之后问题才显现的过程。确认应证实这些过程实现所策划的结果的能力。组织应规定确认这些过程的安排,适用时包括:a)
为过程的评审和批准所规定的准则;b) 设备的认可和人员资格的鉴定;c) 使用特定的方法和程序;d)
记录的要求(见4.2.4);e) 再确认。7.5.2.HV.1 Operational Changes –
Each time a significant change is made in the
established operation (e.g., a new operator, new
machine, or new technique), a critical examination shall
be made of the first unit(s)/service(s) processed after
the change. [5]7.5.2.HV.1 操作变更-每次一个主要的变更发生在已建立的操作(如:
一个新的操作者,新设备,或新技术),变化之后的第一个元件/服务需经过严格的检验。7.5.3
Identification and traceability
鉴定和可追溯性适当时,组织应在产品实现的全过程中使用适宜的方法识别产品。组织应针对监视和测量要求识别产品的状态。在有可追溯性要求的场合,组织应控制并记录产品的唯一性标识(见4.2.4)。注:在某些行业,技术状态管理是保持标识和可追溯性的一种方法。7.5.3.HS.1
Product Identification – The organization shall
establish and maintain a process for the identification
of each product and the level of required control. For
each product and its versions, the following shall be
identified where they exist:
产品鉴定-组织需建立和维持一个每个产品的鉴定方法和所需的控制水平。每个产品及其副本,下面在他们存在处将被鉴定:a)
product documentation, 产品文件b) development or production
tools essential to repeat product creation,
对于重述产品创造必要的开发偶尔生产的工具c) interfaces to other products,
and与其它产品的接口,和d) software and hardware environment. [9]
软硬件环境7.5.3.H.1 Traceability for Recall – Field
Replaceable Units (FRU) shall be traceable throughout
the product life cycle in a way that helps organizations
and their customers to identify products being recalled,
needing to be replaced, or modified.7.5.3.H.1
用于退还的可追溯性-域可替代的单位(FRU)在产品生命周期内应是可追溯的,运用可帮助组织和客户鉴定退还的,需替换或修复的产品的方法。7.5.3.H.2
Traceability of Design Changes – The organization shall
establish and maintain adocumented procedure(s) which
provides traceability of design changes to identifiable
manufacturing dates, lots, or serial numbers.7.5.3.H.2
设计变更的可追溯性-组织应建立和维持一个程序文件,提供设计变更可追溯性,象制造日期,份额或系列号。7.5.4
Customer property 顾客财产The organization shall exercise
care with customer property while it is under the
organization's control or being used by the
organization. The organization shall identify, verify,
protect and safeguard customer property provided for use
or incorporation into the product. If any customer
property is lost, damaged or otherwise found to be
unsuitable for use, this shall be reported to the
customer and records maintained (see
4.2.4).组织应爱护在组织控制下或组织使用的顾客财产。组织应识别、验证、保护和维护供其使用或构成产品一部分的顾客财产。若顾客财产发生丢失、损坏或发现不适用的情况时,应报告顾客,并保持记录(见4.2.4)。NOTE
Customer property can include intellectual
property.注:顾客财产可包括知识产权。7.5.5 Preservation of product
产品防护在内部处理和交付到预定的地点其间,组织应针对产品的符合性提供防护,这种防护应包括标识、搬运、包装、贮存和保护。防护也应适用于产品的组成部分。7.5.5.C.1
Anti-Static Protection – Anti-static protection shall be
employed, where applicable, forcomponents and products
susceptible to electrostatic discharge (ESD) damage.
Consider components and products such as: integrated
circuits, printed wiring board assemblies, magnetic
tapes and/or disks, and other media used for software or
data storage. [5]7.5.5.C.1
反静态保护-反静态保护适用于易受静电释放(ESD)的影响的成分和产品。这些成分和产品如:集成电路,印刷线路集成板,磁带和/或磁盘和其它的用于软件和数据储存的媒体。〔5〕7.5.5.HS.1
Packaging and Labeling Audit – The organization shall
include a packaging and labeling audit in the quality
plan or documented procedure(s). This may include, for
example, marking, labeling, kitting, documentation,
customer-specific marking, and correct
quantities.7.5.5.HS.1
包装和标签审核-组织应在质量计划或程序文件中包括包装和标签。可包括,如:标记,标签,用具,文件,客户要求的标记和正确的数量。7.5.5.HS.1-NOTE
1: This audit is normally done on products ready to
ship.7.5.5.HS.1-注 1:审核一般对准备发货的产品进行。7.5.5.H.1
Deterioration – Where the possibility of deterioration
exists, materials in storage shall be controlled (e.g.,
date stamped/coded) and materials with expired dates
shall be deemed non-conforming. [5]7.5.5.HS.1
变化-存在变化的可能性的地方,存的料要严格控制(如:印字/编码的日期),到期的材料被认为是不合格的。〔5〕7.5.5.S.1
Software Virus Protection – The organization shall
establish and maintain methods for software virus
prevention, detection, and removal from the deliverable
product. [9]7.5.5.S.1
软件病毒保护-组织应建立和维持可传软件病毒防护,检查和排除的。〔9〕7.6 Control of
monitoring and measuring devices 监控和测量设备的控制
组织应确定需实施的监视和测量以及所需的监视和测量装置,提供证据,为产品符合确定的要求(见7.2.1)。
组织应建立过程,以确保监视和测量活动可行并以与监视和测量的要求相一致的方式实施。
当有必要确保结果有效的场合时,测量设备应:
a)
对照能溯源到国际或国家标准的测量标准,按照规定的时间间隔或在使用前进行校准或检定。当不存在上述标准时,应记录校准或检定的依据;
b) 必要时进行调整或再调整;
c) 得到识别,以确定其校准状态;
d) 防止可能使测量结果失效的调整;
e) 在搬运、维护和贮存期间防止损坏或失效;
此外,当发现设备不符合要求时,组织应对以往测量结果的有效性进行评价和记录。组织应对该设备和任何受影响的产品采取适当的措施。校准和验证结果的记录应予保持(见4.2.4)。
当用于规定要求的监视和测量时,计算机软年满足预期用途的能力应予以确认,确认应在初次使用前进行,并在必要时予以重新确认。
7.6.H.1 Identified Equipment – Monitoring and measuring
devices that are either inactive or unsuitable for use
shall be visibly identified and not used. All monitoring
and measuring devices that do not require calibration
shall be identified. [5]