-
Quality management systems
—
Requirements
质量管理体系
要求
GB/T 19001
—
201X/
ISO 9001:2015
代替
GB/T
19001
—
2008
ISO
9001:2015(E)
(ISO
9001:2015
，
IDT)
引
言
Introduction
........
1
范围
1
Scope
....
2
规范性引用文件
2 Normative
references
.....
3
术语和定义
3 Terms and
definitions
.......
4
组织环境
4 Context of
the organization
.....
4.1
理解组织及其环境
4.1 Understanding the organization and
its context
.
4.2
Understanding
the
needs
and
expectations
of
interested
4.2
理解相关方的需求和期望
parties
4.3
确定质量管理体系的范围
4.3
Determining the scope of the quality management
system
....
4.4
质量管理体系及其过程
4.4
Quality management system and its
processes
..
5
领导作用
5
Leadership
.........
5.1
领导作用和承诺
5.1 Leadership and
commitment
..
5.1.1
总则
5.1.1
General
........
5.1.2
以顾客为关注焦点
5.1.2 Customer
focus
...........
5.2
方针
5.2
Policy
........
5.2.1
制定质量方针
5.2.1 Establishing the quality
policy
......
5.2.2
沟通质量方针
5.2.2 Communicating the quality
policy
......
5.3
组织内的角色、职责和权限
5.3
Organizational roles, responsibilities and
authorities
6
策划
6
Planning
........
6.1
应对风险和机遇的措施
6.1 Actions to address risks and
opportunities
........
6.2
质量目标及其实现的策划
6.2 Quality objectives and planning to
achieve them
..
6.3
变更的策划
6.3 Planning of
changes
...........
7
支持
7
Support
............
7.1
资源
7.1 Resources
....
7.1.1
总则
7.1.1 General
....
7.1.2
人员
7.1.2 People
...
7.1.3
基础设施
7.1.3
Infrastructure
.......
7.1.4
过程运行环境
7.1.4 Environment for the operation of
processes
.
7.1.5
监视和测量资源
7.1.5 Monitoring and measuring
resources
..
7.1.6
组织的知识
7.1.6 Organizational
knowledge
......
7.2
能力
7.2
Competence
....
7.3
意识
7.3 Awareness
...
7.4
沟通
7.4
Communication
.....
7.5
成文信息
7.5 Documented
information
.............
7.5.1
总则
7.5.1
General
......
7.5.2
创建和更新
7.5.2 Creating and
updating
...........
7.5.3
成文信息的控制
7.5.3 Control of documented information
1
/
34
8
Operation
.....
8.1 Operational planning and
control
...........
8.2 Requirements for products and
services
....
8.2.1 Customer
communication
.....
8.2.2 Determining the requirements for
products and services
....
8.2.3 Review of the requirements for
products and services
..
8.2.4 Changes to requirements for
products and services
......
8.3 Design and development of products
and services
....
8.3.1
General
......
8.3.2 Design and development
planning
...
8.3.3
Design and development
inputs
....
8.3.4
Design and development
controls
.......
8.3.5 Design and development
outputs
........
8.3.6 Design and development
changes
....
8.4
Control
of
externally
provided
processes,
products
and
services
..
8.4.1
General
......
8.4.2 Type and extent of
control
.......
8.4.3 Information for external
providers
.............
8.5 Production and service
provision
.....
8.5.1 Control of production and service
provision
...
8.5.2 Identification and
traceability
.......
8.5.3 Property belonging to customers
or external providers
8.5.4
Preservation
......
8.5.5 Post-delivery
activities
........
8.5.6 Control of
changes
..................
8.6 Release of products and
services
...
8.7
Control of nonconforming
outputs
......
9
Performance evaluation
....
9.1 Monitoring, measurement, analysis
and evaluation
....
9.1.1 General
..
9.1.2 Customer
satisfaction
..
9.1.3 Analysis and
evaluation
.....
9.2 Internal
audit
.......
9.3
Management review
..
9.3.1
General
......
9.3.2 Management review
inputs
.
9.3.3
Management review
outputs
......
10
Improvement
.......
10.1
General
........
10.2 Nonconformity and corrective
action
.....
10.3
Continual improvement
.....
Annex
A
(informative)
Clarification
of
new
structure,
terminology and
concepts
..
Annex
B
(informative)
Other
International
Standards
on
quality
management
and
quality
management
systems
developed by ISO/TC
176
..
Bibliography
.....
2
/
34
8
运行
8.1
运行策划和控制
8.2
产品和服务的要求
8.2.1
顾客沟通
8.2.2
产品和服务要求的确定
8.2.3
产品和服务要求的评审
8.2.4
产品和服务要求的更改
8.3
产品和服务的设计和开发
8.3.1
总则
8.3.2
设计和开发策划
8.3.3
设计和开发输入
8.3.4
设计和开发控制
8.3.5
设计和开发输出
8.3.6
设计和开发更改
8.4
外部提供的过程、产品和服务的控制
8.4.1
总则
8.4.2
控制类型和程度
8.4.3
提供给外部供方的信息
8.5
生产和服务提供
8.5.1
生产和服务提供的控制
8.5.2
标识和可追溯性
8.5.3
顾客或外部供方的财产
8.5.4
防护
8.5.5
交付后的活动
8.5.6
更改控制
8.6
产品和服务的放行
8.7
不合格输出的控制
9
绩效评价
9.1
监视、测量、分析和评价
9.1.1
总则
9.1.2
顾客满意
9.1.3
分析与评价
9.2
内部审核
9.3
管理评审
9.3.1
总则
9.3.2
管理评审输入
9.3.3
管理评审输出
10
改进
10.1
总则
10.2
不合格和纠正措施
10.3
持续改进
附录
A
（资料性附录）新结构、术语和概念说
明
附录
B
（资料性附录）
SAC/TC151
制定的其他<
/p>
质量管理和质量管理体系标准
参
考
文
献
Introduction
0.1 General
The
adoption
of
a
quality
management
system
is
a
strategic
decision for an organization that can
help to improve its overall
performance
and
provide
a
sound
basis
for
sustainable
development
initiatives.
The
potential
benefits
to
an
organization
of
implementing
a
quality management system based on this
International Standard
are:
a) the ability to consistently provide
products and services that
meet
customer
and
applicable
statutory
and
regulatory
requirements;
b)
facilitating opportunities to enhance customer
satisfaction;
c) addressing risks and
opportunities associated with its context
and objectives;
d)
the
ability
to
demonstrate
conformity
to
specified
quality
management system
requirements.
This International
Standard can be used by internal and external
parties.
It
is
not
the
intent
of
this
International
Standard
to
imply
the
need for:
—
uniformity
in
the
structure
of
different
quality
management
systems;
—
alignment
of
documentation
to
the
clause
structure
of
this
International Standard;
—
the
use
of
the
specific
terminology
of
this
International
Standard
within the organization.
The
quality
management
system
requirements
specified
in
this
International
Standard
are
complementary
to
requirements
for
products and services.
This
International
Standard
employs
the
process
approach,
which
incorporates
the
Plan-Do-Check-Act
(PDCA)
cycle
and
risk-
based thinking.
The
process
approach
enables
an
organization
to
plan
its
processes and their interactions.
The
PDCA
cycle
enables
an
organization
to
ensure
that
its
processes
are
adequately
resourced
and
managed,
and
that
opportunities for
improvement are determined and acted on.
Risk-based
thinking
enables
an
organization
to
determine
the
factors that could cause its processes
and its quality management
system
to
deviate
from
the
planned
results,
to
put
in
place
preventive
controls
to
minimize
negative
effects
and
to
make
3
/
34
引
言
0.1
总则
采用质量管理体系是组织的一项战略决策，
能
够帮助其提高整
体绩效，
为推动可持续发展奠
定良好基础。
组织根据本标准实施质量管理体系的潜在益
处是：
a
）
稳定提
供满足顾客要求以及适用的法律
法规要求的产品和服务的能力；
b
）
促成增强顾客满意的机会；
c
）
应对与
组织环境和目标相关的风险和机
遇；
d
）
证实符
合规定的质量管理体系要求的能
力。
本标准可用于内部和外部各方。
实施本标准并非需要：
——统一不同质量管理体系的架构；
——形成与本标准条款结构相一致的文
件；
——在组织内使用本标准的特定术语。
本标准规定的质量管理体系要求是对产品和
< br>服务要求的补充。
本标准采
用过程方法，
该方法结合了
“策划—
实
施—检查—处置”
（
PDCA
）循环和
基于风险
的思维。
过程方
法使组织能够策划过程及其相互
作用。
PDCA
循环使组织能够确保其过程得到充
分的资源和管理，确定改进机会并采取行动。
基于风险的思维
使组织能够确定可能导致其
过程和质量管理体系偏离策划结果的各种因
< br>素，
采取预防控制，
最大限度地降低不利影响，
并最大限度地利用出现的机遇（见附录
A.4
）
。
maximum use of opportunities as they
arise (see
Clause A.4
).
Consistently meeting requirements and
addressing future needs
and
expectations
poses
a
challenge
for
organizations
in
an
increasingly dynamic and
complex environment. To achieve this
objective,
the
organization
might
find
it
necessary
to
adopt
various
forms
of
improvement
in
addition
to
correction
and
continual
improvement,
such
as
breakthrough
change,
innovation and re-organization.
In
this
International
Standard,
the
following
verbal
forms
are
used:
—
“shall” indicates a
requirement;
—
“should” indicates a
recommendation;
—
“may” indicates a
permission;
—
“can” indicates a possibility or a
capability.
Information
marked as “NOTE” is for guidance in
underst
anding
or clarifying
the associated requirement.
0.2 Quality
management principles
This
International Standard is based on the quality
management
principles
described
in
ISO
9000.
The
descriptions
include
a
statement
of
each
principle,
a
rationale
of
why
the
principle
is
important
for
the
organization,
some
examples
of
benefits
associated with the
principle and examples of typical actions to
improve
the
organization’s
performance
when
applying
the
principle.
The quality
management principles are:
—
customer focus;
—
leadership;
—
engagement of
people;
—
process approach;
—
improvement;
—
evidence-based decision
making;
—
relationship
management.
0.3 Process approach
0.3.1 General
This
International Standard promotes the adoption of a
process
approach
when
developing,
implementing
and
improving
the
effectiveness
of
a
quality
management
system,
to
enhance
customer
satisfaction
by
meeting
customer
requirements.
Specific
requirements
considered
essential
to
the
adoption
of
a
process
approach are included in
4.4
.
Understanding and managing interrelated
processes as a system
contributes
to
the
organization’s
effectiveness
and
efficiency
in
achieving
its
intended
results.
This
approach
enables
the
organization
to
control
the
interrelationships
and
interdependencies
among
the
processes
of
the
system,
so
that
the overall performance
of the organization can be enhanced.
The
process
approach
involves
the
systematic
definition
and
management of processes, and their
interactions, so as to achieve
the
intended
results
in
accordance
with
the
quality
policy
and
4
/
34
在日益复杂的动态环境中持续满足要求，
并针对未来需求和期望
采取适当行动，
这无疑
是组织面临的一项挑战。为了实现这一目
标，
组织可能会发现，
除了纠正和持续改进，
< br>还有
必要采取各种形式的改进，
如突破性变革、
创
新和重组。
在本标准中使用如下助动词：
“应”表示要求；
“宜”表示建议；
“可”表示允许；
“能”表示可能或能够。
“注”的内容是理解和说明有关要求的
指南。
0.2
质量管理原则
本标准是在
GB/T
19000
所阐述的质量管
理原则基础上制定的。
每项
原则的介绍均包含
概述、
该原则对组织的重要性的依据、
应用该
原则的主要益处示例以及应用该原则提高组
织绩效的典型措施示例。
质量管理原则是：
——以顾客为关注焦点；
——领导作用；
——全员积极参与；
——过程方法；
——改进；
——循证决策；
——关系管理。
0.3
过程方法
0.3.1
总则
本标准倡导在建立、
实施质量管理体系以
及提高其有效性时
采用过程方法，
通过满足顾
客要求增强顾客满意。
采用过程方法所需考虑
的具体要求见
4.4
。
将相互关联的过程作为一个体系加以理
解和管理，
有
助于组织有效和高效地实现其预
期结果。
这种方法使组织能够对
其体系的过程
之间相互关联和相互依赖的关系进行有效控
制，以
提高组织整体绩效。
过程方法包括
按照组织的质量方针和战
略方向，
对各过程及其相互作用进行系
统的规
定和管理，从而实现预期结果。可通过采用
PDCA
循环（见
0.3.2
）以及始终基于风险的
思
strategic
direction
of
the
organization.
Management
of
the
processes
and the system as a whole can be achieved using
the
PDCA
cycle
(see
0.3.2)
with
an
overall
focus
on
risk-based
thinking
(see
0.3.3)
aimed
at
taking
advantage
of opportunities
and
preventing undesirable results.
The
application of the process approach in a quality
management
system enables:
a) understanding and consistency in
meeting requirements;
b) the
consideration of processes in terms of added
value;
c) the achievement of effective
process performance;
d)
improvement
of
processes
based
on
evaluation
of
data
and
information.
Figure
1
gives
a
schematic
representation
of
any
process
and
shows
the
interaction
of
its
elements.
The
monitoring
and
measuring
check
points,
which
are
necessary
for
control,
are
specific to each process and will vary
depending on the related
risks.
维（见
0.3.3
）对过程和整个体系进行管理，
旨在有效利用机遇并防止发生不良结果。
在质量管理体系中应用过程方法能够：
a
）
理解并持续满足要求；
b
）
从增值的角度考虑过程；
c
）
获得有效的过程绩效；
d
）
在评价数据和信息的基础上改进过程。
单一过程的各要素及其相互作用如图
1
所示。
每一过程均有特定的监视和测量检查点，
以用
于控制，这些检查点根据相关的风险有所不
同。
图
1
单一过程要素示意图
Figure
1
—
Schematic representation
of the elements of a
0.3.2
PDCA
循环
single process
PDCA
循环能够应用于所有过程以及整个质量
0.3.2 Plan-Do-Check-
Act cycle
The PDCA cycle can be applied
to all processes and to the quality
管理体
系。图
2
表明了本标准第
4
章至第
10
management system
as a whole.
Figure 2
illustrates how
Clauses
章是如何构成
PDCA
循环的。
4
to
10
can be grouped in
relation to the PDCA cycle.
注：括号中的数字表示本标准的相应章节。
NOTE
Numbers
in
brackets
refer
to
the
clauses
in
this
International
5
/
34
Standard.
图
2
本标准的结构在
PDCA
循环中的展示
Figure
2
—
Representation
of
the
structure
of
this
International Standard in
the PDCA cycle
PDCA
循环可以简要描述如下：
——策划（
Plan
）
：根据顾客的要求和组织的
The PDCA
cycle can be briefly described as follows:
—
Plan
: establish the
objectives of the system and its processes,
方针，
建立体系的目标及其过程，
确定实现结
and
the
resources
needed
to
deliver
results in
accordance
with
果所需的资源，并识别和应对风险和机遇。
customers’
requirements
and
the
organization’s
policies,
and
——实施（
Do
）
：执行所做的策划；
identify and address risks and
opportunities;
——检查（
Check
）
：根据方针、目标、要求和
—
Do
: implement what was
planned;
对过程以及形成的产品和服务
—
Check
:
monitor
and
(where
applicable)
measure
processes
所策划的活动，
，并报告结果；
and
the
resulting
products
and
services
against
policies,
进行监视和测量（适用时）
objectives,
requirements
and
planned
activities,
and
report
the
——处置
（
Act
）
：
必要时，
< br>采取措施提高绩效。
results;
0.3.3
基于风险的思维
—
Act
:
take actions to improve performance, as necessary.
基于风险的思维（见附录
A.4
）是实
现质量管
0.3.3 Risk-based thinking
本标准以前的版本已经
Risk-based
thinking (see
Clause A.4
) is
essential for achieving an
理体系有效性的基础。
effective quality
management system. The concept of risk-based
隐含基于风险思维的概念，
例如：
采取预防措
对发生的不合格进行分
thinking
has
been
implicit
in
previous
editions
of
this
施消除潜在的不合格，
International
Standard
including,
for
example,
carrying
out
析，
并采取与不合格的影响相适应的措施，
防
p
reventive
action
to
eliminate
potential
nonconformities,
止其再发生。
analyzing
any
nonconformities
that
do
occur,
and
taking
action
to
prevent
recurrence
that
is
appropriate
for
the
effects
of
the
为了满足本标准的要求，
组织需策划和实施应
noncon
formity.
To
conform
to
the
requirements
of
this
International
Standard,
对风险和机遇的措施。
< br>应对风险和机遇，
为提
获得改进结果以及防
an organization needs to plan and implement
actions to address
高质量管理体系有效性、
risks and
opportunities. Addressing both risks and
opportunities
止不利影响奠定了基础。
establishes a basis for increasing the
effectiveness of the quality
management system, achieving improved
results and preventing
某些有利于实现预期结果的情况可能导致机
negative
effects.
Opportunities
can
arise
as
a
result
of
a
situation
favourable
to
遇的出现，
例如：
有利于组织吸引顾客、
开发
减少浪费或提高生产率的
一系
achieving an intended result, for
example, a set of circumstances
新产品和服务、
利用机遇所采取的措施也可能包括考
that
allow
the
organization
to
attract
customers,
develop
new
列情形。
products
and
services,
reduce
waste
or
improve
productivity.
虑相关风险。
< br>风险是不确定性的影响，
不确定
Actions to
address opportunities can also include
consideration
性可能有正面的影响，也可能有负面的影响。
但并非所有的
of associated risks. Risk
is the effect of uncertainty and any such
风险的正面影响可能提供机遇，
uncertainty
can
have
positive
or
negative
effects.
A
positive
正面影响均可提供机遇。
deviation arising from a risk can
provide an opportunity, but not
0.4
与其他管理体系标准的关系
all positive effects of risk result in
opportunities.
以
0.4
Relationship with other management system
standards
本标准采用
ISO
制定的管理体系标准框架，
（见附
This
International Standard applies the framework
developed by
提高与其他管理体系标准的协调一致性
。
ISO to improve alignment
among its International Standards for
录
A.1
）
本标准使组织能够使用过程方
法，并结合
management systems (see
Clause A.1
).
This
International
Standard
enables
an
organization
to
use
the
PDCA
循环和基于风险的思维，将其质量管理
process
approach,
coupled
with
the
PDCA
cycle
and
risk-
based
体系与其他管理体系标准要求进行协调或整
thinking,
to
align
or
integrate
its
quality
management
system
合。
本标准与
GB/T
19000
和
GB/T
19004
存在如下
with the
requirements of other management system standards.
This International Standard relates to
ISO 9000 and ISO 9004 as
关系：
——
GB/T
19000
《质量管理体系
基础和术语》
follows:
6
/
34
—
ISO
9000
Quality
management
systems
—
Fundamentals
and
vocabulary
provides
essential
background
for
the
proper
understanding
and
implementation
of
this
International
Standard;
—
ISO
9004
Managing for the sustained success
of an organization
—
A
quality
management
approach
provides
guidance
for
organizations that
choose to progress beyond the requirements
of this International Standard.
Annex
B
provides
details
of
other
International
Standards
on
quality management and
quality management systems that have
been developed by ISO/TC 176.
This
International
Standard
does
not
include
requirements
specific
to
other
management
systems,
such
as
those
for
environmental
management,
occupational
health
and
safety
management,
or
financial
management.
Sector-specific
quality
management system standards based on
the requirements of this
International
Standard
have
been
developed
for
a
number
of
sectors.
Some
of
these
standards
specify
additional
quality
management
system
requirements,
while
others
are
limited
to
providing
guidance
to
the
application
of
this
International
Standard
within
the
particular
sector.
A
matrix
showing
the
correlation
between
the
clauses
of
this
edition
of
this
International Standard
and the previous edition (ISO 9001:2008)
can be found on the ISO/TC 176/SC 2
open access web site at:
/tc176/sc02/public
.
为正确理解和实施本标准提供必要基础；
——
GB/T 19004
《追求组织的持续成功
质量
管理方法》
为选择超出本标准要求的组织提供
指
南。
附录
B
给出了
SAC/TC
151
制定的其他质量管
理和质量管理体系标准
（等
同采用
ISO/TC 176
质量管理和质量保证技术委员会制
定的国际
标准）的详细信息。
本标准
不包括针对环境管理、
职业健康和安全
管理或财务管理等其他管
理体系的特定要求。
在本标准的基础上，
已经制定了若干行业特定
要求的质量管理体系标准。
其中的
某些标准规
定了质量管理体系的附加要求，
而另一些标准
则仅限于提供在特定行业应用本标准的指南。
本标准的章节内容与之前版本
（
GB/T
19001
—
2008/ISO
90
01:2008
）章节内容之间的对应关
系见
< br>ISO/TC176/SC2
（国际标准化组织
/
质量管
理和质量保证技术委员会
/
质量体系分委员
会
）
的<
/p>
公
开
网
站
：
…
…
…
..
/tc176/sc02/public
。
质量管理体系
要求
1.
范围
本标准为下列组织规定了质量管理体系
要求：
a
）需要证实其具有稳定提供满足顾客要求及
适用法律法规要求的产品和服务的能力；
b
）通过体系的有效应用，包括体系改进的过
程，
以及保证符合顾客要求和适用的法律法规
要求，旨在增强顾
客满意。
本标准规定的所有要求是
通用的，
旨在适用于
各种类型、
不同规
模和提供不同产品和服务的
组织。
注
1
：
本标准中的术语
“产品”
或
“服务”
仅适用于预期提供给顾客或顾客所要求的产
品
和服务。
注
2
：法律法规要求可称作法定要求。
Quality
management
systems
—
Requirements
1 Scope
This International
Standard specifies requirements for a quality
management system when an organization:
a)
needs
to
demonstrate
its
ability
to
consistently
provide
products
and
services
that
meet
customer
and
applicable
statutory and
regulatory requirements, and
b)
aims
to
enhance
customer
satisfaction
through
the
effective
application of the
system, including processes for improvement
of the system and the assurance of
conformity to customer and
applicable
statutory and regulatory requirements.
All
the
requirements
of
this
International
Standard
are
generic
and are intended to
be applicable to any organization, regardless
of its type or size, or the products
and services it provides.
NOTE 1 In
this International Standard, the terms “product”
or “service”
only
apply
to
products
and
services
intended
for,
or
required
by,
a
customer.
7
/
34
NOTE
2
Statutory
and
regulatory
requirements
can
be
expressed
as
legal requirements.
2 Normative references
The
following
documents,
in
whole
or
in
part,
are
normatively
referenced
in
this
document
and
are
indispensable
for
its
application. For dated
references, only the edition cited applies.
For
undated
references,
the
latest
edition
of
the
referenced
document (including any amendments)
applies.
ISO 9000:2015,
Quality management systems
—
Fundamentals and
vocabulary
2.
规范性引用文件
下列文件对于本文件的应用是必不可少的。
< br>凡是注日期的引用文件，
仅注日期的版本适用
于本文件。
凡是不注日期的引用文件，
其最新
版本
（包括所有的修改单）适用于本文件。
GB/T
19000
—
2015
质量管理体系
基础和术
语
(ISO
9000:2015
，
IDT)
3.
术语和定义
GB/T
19000
—
2015
界定的术语和定义适用于
本文件。
4.
组织环境
4.1
理解组织及其环境
组织应确定与其宗旨和战略方向相关并影响
其实现质量管理体系预期结果的能力
的各种
外部和内部因素。
组织应对这些外部和内部因素的相关信息进
行监视和评审。
注
1
：
< br>这些因素可能包括需要考虑的正面和负
面要素或条件。
注
2
：考虑来自于国际、国内、地区或
当地的
各种法律法规、技术、竞争、市场、文化、社
会和经济环
境的因素，有助于理解外部环境。
注
3
：考虑与组织的价值观、文化、知识和绩
< br>效等有关的因素，有助于理解内部环境。
4.2
理解相关方的需求和期望
由于相关方对组织稳定提供符合顾客要求及
适用法律法规要求的产品和服
务的能力具有
影响或潜在影响，因此，组织应确定：
a
）与质量管理体系有关的相关方；
b
）与质量管理体系有关的相关方的
要求。
组织应监视和评审这些相关
方的信息及其相
关要求。
4.3
确定质量管理体系的范围组
织应确定质量管理体系的边界和适用性，
以确
定其范围。
3 Terms and definitions
For
the
purposes
of
this
document,
the
terms
and
definitions
given in ISO
9000:2015 apply.
4 Context of the
organization
4.1 Understanding the
organization and its context
The
organization
shall
determine
external
and
internal
issues
that
are
relevant
to
its
purpose
and
its
strategic
direction
and
that
affect
its
ability
to
achieve
the
intended
result(s)
of
its
quality
management system.
The
organization
shall
monitor
and
review
information
about
these external and
internal issues.
NOTE 1 Issues can
include positive and negative factors or
conditions
for consideration.
NOTE
2
Understanding
the
external
context
can
be
facilitated
by
considering
issues
arising
from
legal,
technological,
competitive,
market,
cultural,
social
and
economic
environments,
whether
international, national, regional or
local.
NOTE
3
Understanding
the
internal
context
can
be
facilitated
by
considering
issues
related
to
values,
culture,
knowledge
and
performance of the organization.
4.2
Understanding
the
needs
and
expectations
of
interested parties
Due to
their effect or potential effect on
the
organization’s ability
to
consistently
provide
products
and
services
that
meet
customer and applicable
statutory and regulatory requirements,
the organization shall determine:
a)
the
interested
parties
that
are
relevant
to
the
quality
management system;
b) the requirements of these interested
parties that are relevant
to the
quality management system.
The
organization
shall
monitor
and
review
information
about
these interested
parties and their relevant requirements.
4.3 Determining the scope of the
quality management
system
The
organization
shall
determine
the
boundaries
and
applicability
of
the
quality
management
system
to
establish
its
8
/
34
scope.
When determining this scope, the
organization shall consider:
a) the
external and internal issues referred to in
4.1
;
b) the
requirements of relevant interested parties
referred to in
4.2
;
c) the products and services of the
organization.
The
organization
shall
apply
all
the
requirements
of
this
International
Standard
if
they
are
applicable
within
the
determined scope of its quality
management system.
The scope of the
organization’s quality management system shall
be available and be maintained as
documented information. The
scope shall
state the types of products and services covered,
and
provide
justification
for
any
requirement
of
this
International
Standard
that
the
organization
determines
is
not
applicable
to
the scope of its quality
management system.
Conformity to this
International Standard may only be claimed if
the
requirements
determined
as
not
being
applicable
do
not
affect
the
organization’s
ability
or
responsibility
to
ensure
the
conformity of its products and services
and the enhancement of
customer
satisfaction.
在确定范围时，组织应考虑：
a
）
4.1
中提及的各种外部和内部因素；
b
）
4.2
中
提及的相关方的要求；
c
）组织的产品和服务。
如果本标准的全部要求适用于组织确定的质
量管理体系范围，
组织应实施本标准的全部要
求。
< br>组织的质量管理体系范围应作为成文信息，
可
获得并得到
保持。
该范围应描述所覆盖的产品
和服务类型，
如果组织确定本标准的某些要求
不适用于其质量管理体系范围，应说明理由。<
/p>
只有所确
定的不适用的要求不影响组织确保
其产品和服务合格的能力或责任，
对增强顾客
满意也不会产生影响，
方可声称符合本标准的<
/p>
要求。
4.4
质量管理体系及其过程
4.4.1
组织应按照本标准的要求，
建立、
实施
、
保持和持续改进质量管理体系，
包括所需过程
及其相互作用。
组织应确
定质量管理体系所需的过程及其在
整个组织中的应用，且应：
a
）确定这些过程所需的输入和期望
的输出；
b
）确定这些过程的顺序和相互作用；
c
）
确定和应用所需的准则和方法
（包括监视、
测量和相关绩效指标）
，以确
保这些过程的有
效运行和控制；
<
/p>
d
）
确定这些过程所需的资源并确保其可
获得；
e
）分配这些过程的职责和权限；
<
/p>
f
）按照
6.1
的要求应对风险和机遇；
g
）评价这些过程，实施所需的变更，以确保
实现这些过程的预期结果；
h
）改进过程和质量管理体系。
4.4.2
在必要的范围和程度上，组织应：
a
）保持成文信息以支持过程运行；
b
）保留成文信息以确信其过程按策
划进行。
5.
领导作用
4.4 Quality management system and its
processes
4.4.1
The
organization shall establish, implement, maintain
and
continually improve a quality
management system, including the
processes needed and their
interactions, in accordance with the
requirements of this International
Standard.
The
organization
shall
determine
the
processes
needed
for
the
quality management system and their
application throughout the
organization, and shall:
a)
determine the inputs required and the outputs
expected from
these processes;
b) determine the sequence and
interaction of these processes;
c)
determine
and
apply
the
criteria
and
methods
(including
monitoring, measurements and related
performance indicators)
needed
to
ensure
the
effective
operation
and
control
of
these
processes;
d)
determine
the
resources
needed
for
these
processes
and
ensure their availability;
e) assign the responsibilities and
authorities for these processes;
f)
address
the
risks
and
opportunities
as
determined
in
accordance with the requirements of
6.1
;
g) evaluate
these processes and implement any changes needed
to ensure that these processes achieve
their intended results;
h) improve the
processes and the quality management system.
4.4.2
To the extent
necessary, the organization shall:
a)
maintain documented information to support the
operation of
its processes;
b)
retain
documented
information
to
have
confidence
that
the
processes are being
carried out as planned.
9
/
34
5 Leadership
5.1 Leadership
and commitment
5.1.1 General
Top management shall demonstrate
leadership and commitment
with respect
to the quality management system by:
a)
taking
accountability
for
the
effectiveness
of
the
quality
management system;
b)
ensuring
that
the
quality
policy
and
quality
objectives
are
established
for
the
quality
management
system
and
are
compatible
with
the
context
and
strategic
direction
of
the
organization;
c)
ensuring
the
integration
of
the
quality
management
system
requirements into the
organization’s
business processes;
d)
promoting
the
use
of
the
process
approach
and
risk-based
thinking;
e)
ensuring
that
the
resources
needed
for
the
quality
management system are available;
f)
communicating
the
importance
of
effective
quality
management
and
of
conforming
to
the
quality
management
system requirements;
g)
ensuring
that
the
quality
management
system
achieves
its
intended results;
h)
engaging,
directing
and
supporting
persons
to
contribute
to
the effectiveness of the quality
management system;
i) promoting
improvement;
j)
supporting
other
relevant
management
roles
to
demonstrate
their leadership as it applies to there
are as of responsibility.
5.1
领导作用和承诺
5.1.1
总则
< br>最高管理者应通过以下方面，
证实其对质量管
理体系的领
导作用和承诺：
a
）对质量管理体系的有效性负责；
b
）确保制定质量管理体系的质量方
针和质量
目标，
并与组织环境相适应，
与战略方向相一
致；
c
）确保质量管理体系要求融入组织的业务过
程；<
/p>
d
）促进使用过程方法和基于风险的思
维；
e
）
确保质量管理体系所需的资源是可获得的；
f
）沟通有效的质量管理和符合质量
管理体系
要求的重要性；
g
）确保质量管理体系实现其预期结果；
h
）促使人员积极参与，指导和支持
他们为质
量管理体系的有效性作出贡献；
i
）推动改进；
j
）支持其他相关管理者在其职责范围内发挥
领导作用。<
/p>
注：
本标准使用的
“业务”
一词可广义地理解
为涉及组织存在目的的核心活动
，无论是公
NOTE
Referenc
e
to
“business”
in
this
International
Standard
can
be
有、私有、营利或非营利组织。
interpreted
broadly
to
mean
those
activities
that
are
core
to
the
purposes
of
the
organization’s
existence,
whether
the
organization
is
5.1.2
public, private, for
profit or not for profit.
5.1.2
Customer focus
Top management shall
demonstrate leadership and commitment
with respect to customer focus by
ensuring that:
a)
customer
and
applicable
statutory
and
regulatory
requirements are
determined, understood and consistently met;
b)
the
risks
and
opportunities
that
can
affect
conformity
of
products
and
services
and
the
ability
to
enhance
customer
satisfaction are determined and
addressed;
c) the focus on enhancing
customer satisfaction is maintained.
5.2 Policy
5.2.1
Establishing the quality policy
Top
management
shall
establish,
implement
and
maintain
a
quality policy that:
a) is
appropriate to the purpose and context of the
organization
and supports its strategic
direction;
b) provides a framework for
setting quality objectives;
c) includes
a commitment to satisfy applicable requirements;
10
/
34
以顾客为关注焦点
最高管理者应通过
确保以下方面，
证实其以顾
客为关注焦点的领导作用和承诺：<
/p>
a
）确定、理解并持续地满足顾客要求
以及适
用的法律法规要求；
b
）确定和应对风险和机遇，这些风险和机遇
可能影响产品和服务合格以
及增强顾客满意
的能力；
c
）始终致力于增强顾客满意。
5.2
方针
5.2.1
制定质量方针
最高管理者应制定、<
/p>
实施和保持质量方针，
质
量方针应：
a
）
适应组织的
宗旨和环境并支持其战略方向；
b
）为建立质量目标提供框架；
c
）包括满足适用要求的承诺；
d
）包括持续改进质量管理体系的承诺。
d)
includes
a
commitment
to
continual
improvement
of
the
quality
management system.
5.2.2 Communicating
the quality policy
The quality policy
shall:
a) be available and be
maintained as documented information;
b)
be
communicated,
understood
and
applied
within
the
organization;
c) be
available to relevant interested parties, as
appropriate.
5.3
Organizational
roles,
responsibilities
and
authorities
Top
management
shall
ensure
that
the
responsibilities
and
authorities
for
relevant
roles
are
assigned,
communicated
and
understood within the organization.
Top
management
shall
assign
the
responsibility
and
authority
for:
a)
ensuring that the quality management system
conforms to the
requirements of this
International Standard;
b)
ensuring
that
the
processes
are
delivering
their
intended
outputs;
c)
reporting
on
the
performance
of
the
quality
management
system
and
on
opportunities
for
improvement
(see
10.1
),
in
particular to top management;
d)
ensuring
the
promotion
of
customer
focus
throughout
the
organization;
e) ensuring
that the integrity of the quality management
system
is maintained when changes to
the quality management system
are
planned and implemented.
5.2.2
沟通质量方针
质量方针应：
a
）可获取并保持成文信息；
b
）在组织内得到沟通、理解和应用；
c
）适宜时，可为有关相关方所获取。
5.3
组织内的角色、职责和权限
最高管理者应确保组织内相关角色的职责、
< br>权
限得到分配、沟通和理解。
最高管理者应分配职责和权限，以：
a
）确保质量管理体系符合本标准的要求；
b
）确保各过程获得其预期输出；
c
）
报告质
量管理体系的绩效以及改进机会
（见
10.1
< br>）
，特别是向最高管理者报告；
d
）确保在整个组织推动以顾客为关
注焦点；
e
）
确保在
策划和实施质量管理体系变更时
保持其完整性。
6.
策划
6.1
应对风险和机遇的措施
6 Planning
6.1.1
在
策划质量管理体系时，组织应考虑到
4.1
所提及的因素和
4.2
所提及的要求，并确
6.1
Actions to address risks and opportunities
6.1.1
When
planning
for
the
quality
management
system,
the
定需要应对的风险和机遇，以：
organization shall consider the issues
referred to in
4.1
and the
requirements
referred
to
in
4.2
and
determine
the
risks
and
a
）确保质量管理体系能够实现其预期结果；
opportunities that need to
be addressed to:
a)
give
assurance
that
the
quality
management
system
can
b
）增强有利影响；
c
）预防或减少不利影响；
achieve its intended result(s);
d
）实现改进。
b) enhance desirable effects;
6.1.2
组织应策划：
c) prevent, or reduce, undesired
effects;
a
）应对这些风险和机遇的措施；
d) achieve improvement.
b
）如何：
6.1.2
The organization shall
plan:
1
）在质量管理体系过程中整合并实施这些措
a) actions to address these risks and
opportunities;
施（见
4.4
）
；
b) how to:
1)
integrate
and
implement
the
actions
into
its
quality
2
）评价这些措施的有效性。
应对措施应与风险和机遇对产品和服务符合
management
system processes (see
4.4
);
性的潜在影响相适应。
2)
evaluate the effectiveness of these actions.
Actions
taken
to
address
risks
and
opportunities
shall
be
proportionate
to
the
potential
impact
on
the
conformity
of
注
1
：通过信息充分的决策，应对风险可选择
规避风险，
为寻求机遇承担风险，
消除风险源，
products and services.
NOTE 1
Options to address risks can include avoiding
risk, taking risk
改变风险的可能性或后果，
分担风险，
或保留
11
/
34
in order to
pursue an opportunity, eliminating the risk
source, changing
风险。
the
likelihood
or
consequences,
sharing
the
risk,
or
retaining
risk
by
注
2
：
机遇可
能导致采用新实践，
推出新产品，
informed
decision.
NOTE
2
Opportunities
can
lead
to
the
adoption
of
new
practices,
launching
new
products,
opening
new
markets,
addressing
new
customers,
building
partnerships,
using
new
technology
and
other
desirable
and
viable
possibilities
to
address
the
organization
’s
or
its
customers’
needs.
6.2 Quality
objectives and planning to achieve them
6.2.1
The
organization
shall
establish
quality
objectives
at
relevant
functions,
levels
and
processes
needed
for
the
quality
management system.
The
quality objectives shall:
a) be
consistent with the quality policy;
b)
be measurable;
c) take into account
applicable requirements;
d)
be
relevant
to
conformity
of
products
and
services
and
to
enhancement of customer satisfaction;
e) be monitored;
f) be
communicated;
g) be updated as
appropriate.
The organization shall
maintain documented information on the
quality objectives.
6.2.2
When planning how to achieve its
quality objectives, the
organization
shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated. <
/p>
开辟新市场，
赢得新顾客，
建立合作伙伴
关系，
利用新技术和其他可行之处，
以应对组织或其
顾客的需求。
6.2
质量目标及其实现的策划
6.2.1
组织应针对相关职能、层次和质量管理
体系所需的过程建立质量目标。
质量目标应：
a
）与质量方针保持一致；
b
）可测量；
c
）考虑适用的要求；
d
）
与产品和服务合格以及增强顾客满意相关；
e
）予以监视；
f
）予以沟通；
g
）适时更新。
组织应保持有关质量目标的成文信息。
6.2.2
策划如何实现质量目标
时，
组织应确定：
a
）要做什么；
b
）需要什么资源；
c
）由谁负责；
d
）何时完成；
e
）如何评价结果。
6.3
变更的策划
< br>当组织确定需要对质量管理体系进行变更时，
变更应按所策划的方式实施（见
4.4
）
。
6.3 Planning of changes
When
the
organization
determines
the
need
for
changes
to
the
quality management system, the changes
shall be carried out in a
组织应考虑：
a
）变更目的及其潜在后果；
planned manner (see
4.4
).
b
）质量管理体系的完整性；
The organization shall consider:
a) the purpose of the changes and their
potential consequences;
c
）资源的可获得性；
d
）职责和权限的分配或再分配。
b)
the integrity of the quality management system;
c) the availability of
resources;
d)
the
allocation
or
reallocation
of
responsibilities
and
7.
支持
authorities.
7.1
资源
7 Support
7.1.1
总则
组织应确定并提供所需的资源，以建立、
7.1
Resources
实施、保持和持续改进质量管理体系。
7.1.1 General
The
organization
shall
determine
and
provide
the
resources
needed for the
establishment, implementation, maintenance and
组织应考虑：
a)
现有内部资源的能力和局限；
continual improvement of the quality
management system.
The
organization shall consider:
a)
the
capabilities
of,
and
constraints
on,
existing
internal
b)
需要从外部供方获得的资源。
12
/
34
resources;
b) what needs to be obtained from
external providers.
7.1.2 People
The
organization
shall
determine
and
provide
the
persons
necessary
for
the
effective
implementation
of
its
quality
management
system
and
for
the
operation
and
control
of
its
processes.
7.1.3
Infrastructure
The
organization
shall
determine,
provide
and
maintain
the
infrastructure necessary for the
operation of its processes and to
achieve conformity of products and
services.
7.1.2
人员
组织应确定并配备所需的人员，
以有效实施质
量管理体系，并运行和控制其过程。
7.1.3
基础设施
组织应确定、
提供并维护所需的基础设施，
以
< br>运行过程，并获得合格产品和服务。
注：基础设施可包括：
a
）建筑物和相关设施；
NOTE Infrastructure can include:
b
）设备，包括硬件和软件；
a) buildings and associated utilities;
c
）运输资源；
b) equipment, including hardware and
software;
d
）信息和通讯技术。
c) transportation resources;
7.1.4
过程运行环境
d)
information and communication technology.
组织应确定、
提供并维护所需的环境，
以<
/p>
运行过程，并获得合格产品和服务。
7.1.4 Environment for the operation of
processes
The
organization
shall
determine,
provide
and
maintain
the
适宜的过程运行环境可能是人为因素与物
environment
necessary for the operation of its processes and
to
注：
理因素的结合，例如：
achieve conformity of products and
services.
NOTE
A
suitable
environment
can
be
a
combination
of
human
and
a
）社会因素（如非歧视、安定、非对抗）
；
physical factors, such as:
b
）心理因素（如减压、预防过度疲劳、保证
a) social
(e.g. non-discriminatory, calm, non-
confrontational);
情绪稳定）
；
b) psychological (e.g. stress-reducing,
burnout prevention, emotionally
c
）物理因素（如温度、热量、湿度、照明、
protective);
空气流通、卫生、噪声）
。
c)
physical
(e.g.
temperature,
heat,
humidity,
light,
airflow,
hygiene,
由于所提供的产品和服务不同，
这些因素可能
noise).
存在显著差异。
These
factors
can
differ
substantially
depending
on
the
products
and
7.1.5
监视和测量资源
services
provided.
7.1.5.1
总则
当利用监视或测量来验证产品和服务符合
7.1.5
Monitoring and measuring resources
要求时，
组织应确定并提供所需的资源，
以确
7
.1.5.1 General
The
organization
shall
determine
and
provide
the
resources
保结果有效和可靠。
needed
to ensure valid and reliable results when
monitoring or
measuring
is
used
to
verify
the
conformity
of
products
and
组织应确保所提供的资源：
a
）
适合所开展的监视和测量活动的特定类型；
services to requirements.
The organization shall
ensure that the resources provided:
a)
are
suitable
for
the
specific
type
of
monitoring
and
b
）得到维护，以确保持续适合其用途。
measurement activities
being undertaken;
作为监视和测量
b)
are
maintained
to
ensure
their
continuing
fitness
for
their
组织应保留适当
的成文信息，
资源适合其用途的证据。
purpose.
The
organization
shall
retain
appropriate
documented
information as evidence of fitness for
purpose of the monitoring
7.1.5.2
测量溯源
当要求测量溯源时，
或组织认为测量溯源是信
and measurement
resources.
任测量结果有效的基础时，测量设备应：
7.1.5.2 Measurement traceability
When
measurement
traceability
is
a
requirement,
or
is
considered
by
the
organization
to
be
an
essential
part
of
对照能溯源到国际或国家标准的测量标准，
providing
confidence
in
the
validity
of
measurement
results,
a
）
按照规定的时间间隔或在使用前进行校准和
measuring equipment shall be:
a) calibrated or verified, or both, at
specified intervals, or prior to
（或）
检定，
当不存在上述标准时，
应保留作
13
/
34
use, against
measurement standards traceable to international
or
national measurement standards; when
no such standards exist,
the basis used
for calibration or verification shall be retained
as
documented information;
b) identified in order to determine
their status;
c)
safeguarded
from
adjustments,
damage
or
deterioration
that
would
invalidate
the
calibration
status
and
subsequent
measurement
results.
The
organization
shall
determine
if
the
validity
of
previous
measurement
results
has
been
adversely
affected
when
measuring
equipment
is
found
to
be
unfit
for
its
intended
purpose, and shall
take appropriate action as necessary.
7.1.6 Organizational knowledge
The
organization
shall
determine
the
knowledge
necessary
for
the
operation
of
its
processes
and
to
achieve
conformity
of
products and services.
This knowledge shall be maintained and
be made available to the
extent
necessary.
When
addressing
changing
needs
and
trends,
the
organization
shall
consider
its
current
knowledge
and
determine
how
to
acquire
or
access
any
necessary
additional
knowledge
and
required updates.
NOTE
1
Organizational
knowledge
is
knowledge
specific
to
the
organization; it is generally gained by
experience. It is information that
is
used and shared to achieve the
organization’s objectives.
NOTE 2 Organizational knowledge can be
based on:
a)
internal
sources
(e.g.
intellectual
property;
knowledge
gained
from
experience;
lessons
learned
from
failures
and
successful
projects;
capturing
and
sharing
undocumented
knowledge
and
experience;
the
results of improvements in processes,
products and services);
b)
external
sources
(
e.g.
standards;
academia;
conferences;
gathering
knowledge from
customers or external providers).
为校准或验证依据的成文信息；
b
）予以识别，以确定其状态；
c
）予以保护，防止由于调整、损坏或衰减所
导致的校准状态和随后的测量结果的失效。
当发现测量设备不符合预期用途时，
组织应确
定以往
测量结果的有效性是否受到不利影响，
必要时应采取适当的措施。
7.1.6
组织的知识
组织应确定必要的知识，
以运行过程，
并获得
合格产品和服务。
这些知识应予以保持，
并能在所需的范围内得
到。
为应对不断变化的需求和发展趋势，
组织应审
视现有的知识
，
确定如何获取或接触更多必要
的知识和知识更新。
注
1
：组织的知识是组织特有的知识，通常从
其经验中获得，
是为实现组织目标所使用和共
享的信息。
注
2
：组织
的知识可基于：
a
）内部来源（如知
识产权，从经验获得的知
识，
从失败和成功项目吸取的经验和教
训，
获
取和分享未成文的知识和经验，
过程、
产品和
服务的改进结果）
；
b
）外部来源（如标准、学术交流、专业
会议、
从顾客或外部供方收集的知识）
。
7.2
能力
组织应：
a
）确定
在其控制下工作的人员所需具备
的能力，
这些人员从事的工作影
响质量管理体
系绩效和有效性；
b
）基于适当的教育、培训或经验，确保
这些人员是胜任的；
c
）适用时，采取措施以获得所需的能力，并
评价措施的有效性；
d
）保留适当的成文信息，作为人员能力的证
据。
<
/p>
注：
适当措施可包括对在职人员进行培训、
辅
导或重新分配工作，
或者聘用、
外
包胜任的人
员。
7.3
意识
组织应确保在其控制下工作的人员知晓：
a
）质量方针；
b
）相关的质量目标；
7.2 Competence
The
organization shall:
a) determine the
necessary competence of person(s) doing work
under its control that affects the
performance and effectiveness
of the
quality management system;
b)
ensure
that
these
persons
are
competent
on
the
basis
of
appropriate education, training, or
experience;
c)
where
applicable,
take
actions
to
acquire
the
necessary
competence, and
evaluate the effectiveness of the actions taken;
d)
retain
appropriate
documented
information
as
evidence
of
competence.
NOTE
Applicable
actions
can
include,
for
example,
the
provision
of
training
to,
the
mentoring
of,
or
the
reassignment
of
currently
employed persons; or the hiring or
contracting of competent persons.
7.3
Awareness
The organization shall ensure
that persons doing work under the
organization’s control are aware
of:
14
/
34
a) the quality
policy;
b) relevant quality objectives;
c)
their
contribution
to
the
effectiveness
of
the
quality
management
system,
including
the
benefits
of
improved
performance;
d)
the
implications
of
not
conforming
with
the
quality
management system requirements.
c
）他们对质量管理体系有效性的贡献，包括
改进绩效
的益处；
d
）不符合质量管理体系要求的后果。
7.4
沟通
组织应确定与质量管理体系相关的内部
和外部沟通，包括：
7.4 Communication
The
organization
shall
determine
the
internal
and
external
communications
relevant
to
the
quality
management
system,
a
）沟通什么；
b
）何时沟通；
including:
c
）与谁沟通；
a) on what it will communicate;
d
）如何沟通；
b) when to communicate;
e
）谁来沟通。
c) with whom to communicate;
7.5
成文信息
d) how to communicate;
7.5.1
总则
e)
who communicates.
组织的质量管理体系应包括：
7.5
Documented information
a)
本标准要求的成文信息；
7.5.1
General
The organization’s
quality management system shall
include:
a)
documented
information
required
by
this
International
b)
组织确定的为确保质量管理体系有效性所
需的成文信息；
Standard;
b)
documented
information
determined
by
the
organization
as
being necessary for the effectiveness
of the quality management
注：
对于
不同组织，
质量管理体系成文信
息的多少与详略程度可以不同，
取决于：
system.
NOTE
The extent of documented information for a quality
management
——组织的规模，
以及活动、
过程、
产品和服
system can
differ from one organization to another due to:
务的类型；
—
the size of organization
and its type of activities, processes, products
——过程及其相互作用的复杂程度；
and services;
——人员的能力。
—
the complexity of
processes and their interactions;
7.5.2
创建和更新
—
the competence of persons.
在创建和更新成文信息时，
组织应确保适
当
的：
7.5.2 Creating and
updating
When
creating
and
updating
documented
information,
the
a
）标识和说明（如标题、日
期、作者、索引
编号）
；
organization shall ensure appropriate:
a)
identification
and
description
(e.g.
a
title,
date,
author,
or
b)
形式（如语言、软件版本、图表）和载体
（如纸质的、电子的）
；
reference number);
b) format
(e.g. language, software version, graphics) and
media
c)
评审和批准，以保持适宜性和充分性。
7.5.3
成文信息的控制
(e.g.
paper, electronic);
7.5.3.1
应控制质量管理体系和本标准所要
c) review and
approval for suitability and adequacy.
求的成文信息，以确保：
7.5.3
Control of documented information
7.5.3.1
Documented
information
required
by
the
quality
management system and by
this International Standard shall be
a<
/p>
）在需要的场合和时机，均可获得并适用；
controlled to ensure:
a)
it
is
available
and
suitable
for
use,
where
and
when
it
is
b
）予以妥善保护（如防止泄密、不当使用或
缺失）
。
needed;
b)
it
is
adequately
protected
(e.g.
from
loss
of
confidentiality,
7.5.3.2
为控制成文信息，适用时，组织应进
行下列活动：
improper use, or loss of integrity).
7.5.3.2
For
the
control
of
documented
information,
the
a
）分发、访问、检索和使用；
organization shall address the
following activities, as applicable:
b
）存储和防护，包括保持可读性；
c
）更改控制（如版本控制）
；
a) distribution, access,
retrieval and use;
15
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34
b) storage and
preservation, including preservation of
legibility;
c) control of changes (e.g.
version control);
d) retention and
disposition.
Documented
information
of
external
origin
determined
by
the
organization
to
be
necessary
for
the
planning
and
operation
of
the
quality
management
system
shall
be
identified
as
appropriate, and be controlled.
Documented
information
retained
as
evidence
of
conformity
shall be
protected from unintended alterations.
NOTE Access can imply a decision
regarding the permission to view the
documented information only, or the
permission and authority to view
and
change the documented information.
8
Operation
8.1 Operational planning and
control
The organization shall plan,
implement and control the processes
(see
4.4
)
needed
to meet
the
requirements
for
the
provision
of
products and services,
and to implement the actions determined
in
Clause 6
, by:
a) determining the requirements for the
products and services;
b) establishing
criteria for:
1) the processes;
2) the acceptance of products and
services;
c)
determining
the
resources
needed
to
achieve
conformity
to
the
product and service requirements;
d)
implementing control of the processes in
accordance with the
criteria;
e)
determining,
maintaining
and
retaining
documented
information to the extent necessary:
1) to have confidence that the
processes have been carried out as
planned;
2)
to
demonstrate
the
conformity
of
products
and
services
to
their
requirements.
The
output
of
this
planning
shall
be
suitable
for
the
organization’s operations.
The
organization
shall
control
planned
changes
and
review
the
consequences
of
unintended
changes,
taking
action
to
mitigate
any adverse
effects, as necessary.
The
organization
shall
ensure
that
outsourced
processes
are
controlled (see
8.4
).
d
）保留和处置。
< br>对于组织确定的策划和运行质量管理体系所
必需的来自外部的成文信息，
组织应进行适当
识别，并予以控制。
对所保留的、
作为符合性证据的成文
信息应予
以保护，防止非预期的更改。
注：
对成文信息的
“访问”
可能意味
着仅允许
查阅，或者意味着允许查阅并授权修改。
8.
运行
8.1
运行的策划和控制
为满足产品和服务提供的要求，并实施第
6
章所确
定的措施，
组织应通过以下措施对所需
的过程（见
4.4
）进行策划、实施和控制：
a
）确定产品和服务的要求；
b
）建立下列内容的准则：
1
）过程；
2
）产品和服务的接收。
c
）
确定所需的资源以使产品和服务符合要求；<
/p>
d
）按照准则实施过程控制；
e
）在必要的范围和程度上，确定并
保持、保
留成文信息，以：
1
）确信过程已经按策划进行；
2
）证实产品和服务符合要求。
策划的输出应适于组织的运行。
组织应控制策划的变更，
评审非预期
变更
的后果，必要时，采取措施减轻不利影响。
组织应确保外包过程受控（见
8.4
）
。
8.2
产品和服务的要求
8.2.1
顾客沟通
与顾客沟通的内容应包括：
8.2
Requirements for products and services
a
）提供有关产品和服务的信息；
8.2.1 Customer communication
b
）处理问询、合同或订单，包括更改；
Communication with customers shall
include:
c
）获取有关产品和服务的顾客反馈，包括
顾
a) providing information relating to
products and services;
客投诉；
b) handling enquiries, contracts or
orders, including changes;
c) obtaining
customer feedback relating to products and
services,
d
）处置或控制顾客财产；
e
）关系重大时，制定应急措施的特定要求。
including customer complaints;
d) handling or controlling
customer property;
e)
establishing
specific
requirements
for
contingency
actions,
8.2.2
产品和服务要求的确定
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34
when relevant.
8.2.2
Determining
the
requirements
for
products
and
services
When
determining
the
requirements
for
the
products
and
services to be offered to customers,
the organization shall ensure
that:
a)
the
requirements
for
the
products
and
services
are
defined,
including:
1) any applicable statutory and
regulatory requirements;
2) those
considered necessary by the organization;
b)
the
organization
can
meet
the
claims
for
the
products
and
services it offers.
8.2.3
Review
of
the
requirements
for
products
and
services
8.2.3.1
The organization shall ensure that it
has the ability to
meet the
requirements for products and services to be
offered to
customers.
The
organization
shall
conduct
a
review
before
committing
to
supply
products
and
services
to
a
customer,
to
include:
a)
requirements
specified
by
the
customer,
including
the
requirements for delivery and post
deliveryactivities;
b)
requirements
not
stated
by
the
customer,
but
necessary
for
the
specified or intended use, when known;
c) requirements specified by the
organization;
d)
statutory
and
regulatory
requirements
applicable
to
the
products
and services;
e)
contract
or
order
requirements
differing
from
those
previously expressed.
The
organization
shall
ensure
that
contract
or
order
requirements
differing
from
those
previously
defined
are
resolved.
The
customer’s
requirements
shall
be
confirmed
by
th
e
organization
before
acceptance,
when
the
customer
does
not
provide
a documented statement of their requirements.
NOTE
In
some
situations,
such
as
internet
sales,
a
formal
review
is
impractical
for
each
order.
Instead,
the
review
can
cover
relevant
product
information, such as catalogues.
在确定向顾客提供的产品和服务的要求时，
组
织应
确保：
a
）产品和服务的要求得到规定，包括：
1
）适用的法律法规要求；
2
）组织认为的必要要求。
b
）
提供的产品和服务能够满足所声明的要求。
8.2.3
产品和服务要求的评审
8.2.3.1
组织应确保有能力向顾客提供满足要
求的产品和服务。
在承诺向顾客提供产品和服
务
之前，组织应对如下各项要求进行评审：
a
）顾客规定的要求，包括对交付及
交付后活
动的要求；
b
）顾客虽然没有明示，但规定的用途或已知
的预期用途所必需的要求；
c
）组织规定的要求；
d
）适用于产品和服务的法律法规要求；
e
）与以前表述不一致的合同或订单
要求。
组织应确保与以前规定不一
致的合同或订单
要求已得到解决。
若顾客没有提供成文的要求，
组织在接受顾客
< br>要求前应对顾客要求进行确认。
注：
在某些情况下，
如网上销售，
对每一个订
单进行正式的评审可能是不实际的，
作为替代
方法，可评审有关的产品信息，如产品目录。
8.2.3.2
适用时，
组织应保留
与下列方面有关
的成文信息：
a
）评审结果；
b
）产品和服务的新要求。
8.2.4
产品和服务要求的更改
若产品和服务
要求发生更改，
组织应确保相关
的成文信息得到修改，
并确保相关人员知道已
更改的要求。
8.3
产品和服务的设计和开发
8.3.1
总则
组织应建立、
< br>实施和保持适当的设计和开发过
程，以确保后续的产品和服务的提供。
8.3.2
设计和开发策划
8.2.3.2
The organization shall retain
documented information,
as applicable:
a) on the results of the review;
b) on any new requirements for the
products and services.
8.2.4 Changes to
requirements for products and services
The
organization
shall
ensure
that
relevant
documented
information
is
amended,
and
that
relevant
persons
are
made
aware of
the changed requirements, when the requirements
for
products and services are changed.
8.3 Design and development of products
and services
8.3.1 General
The
organization
shall
establish,
implement
and
maintain
a
design
and
development
process
that
is
appropriate
to
ensure
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