ISO 9004-2018：2018年版持续成功质量管理指南

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ISO 9004-2018是国际标准化组织（International Organization for Standardization, ISO）发布的第四版质量管理指南，重点关注组织的质量管理以实现可持续的成功。这份标准于2018年4月发布，其核心内容围绕着质量管理体系的持续改进和性能提升，旨在帮助组织建立和维持高质量的操作模式。该标准的标题“Quality management – Quality of an organization – Guidance to achieve sustained success”明确指出，它不仅关注产品质量，而且涵盖了组织的整体质量战略，目的是确保组织在竞争激烈的市场环境中保持长期的稳定和成功。ISO 9004强调了以下几个关键知识点： 1. **指导原则**：ISO 9004提供了实施质量管理的指导原则，如领导作用、全员参与、过程方法、系统方法、持续改进和基于事实的决策等，这些原则旨在促进组织文化转型和战略目标的实现。 2. **绩效与可持续性**：标准着重于如何通过有效的质量管理系统来衡量和提升组织的绩效，确保其在经济、社会和环境三个维度上的可持续发展。这包括设定SMART目标（具体、可测量、可达成、相关和有时间限制），以及定期评估和调整策略以适应内外部环境的变化。 3. **领导力与决策**：领导者在推动质量管理体系的实施过程中扮演重要角色。他们需要展示对质量的承诺，并通过透明的沟通和决策，激发员工的积极性和创新精神。 4. **风险管理与机遇利用**：ISO 9004强调识别和管理风险，同时把握和利用内外部机会，以增强组织的竞争力和抵御不确定性的能力。 5. **社会责任**：标准鼓励组织将社会责任融入其质量管理实践，包括环境保护、公平交易和社会福祉，以实现多方共赢。 6. **版权与授权**：文档本身受到ISO的版权保护，未经许可不得复制或在网络上使用。任何想要复制或利用该文件的个人或机构需事先获得ISO的书面许可，联系地址和联系方式已给出。 ISO 9004-2018是一个全面的质量管理框架，为组织提供了一套工具和方法，帮助它们提升效率、优化服务和产品，以及在全球化市场中实现长期的可持续成功。通过遵循该标准，企业可以提升内部流程的有效性，增强客户满意度，同时履行其社会责任，从而在日益竞争的商业环境中取得竞争优势。

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ISO 9004:2018(E)

5.3

External and internal issues

5.3.1

External

issues are factors

that

exist outside of the organization

that

can affect the organization's

ability

achieve sustained success, such as:

a) statutory and regulatory requirements;

b) sector-specific requirements and agreements;

competition;

d) globalization;

e) social, economic, political and cultural factors;

f) innovations and advances in technology;

g) natural environment.

5.3.2 Internal issues

are

factors that exist within the organization itself that can

affect

the organization's

ability to achieve sustained success, such as:

a) size and complexity;

b) activities and associated processes;

c) strategy;

d) type of products and services;

performance;

f) resources;

g) levels of competence and organizational knowledge;

h) maturity;

i) innovation.

5.3.3 When considering external and

internal issues, the organization should take into account

relevf nt information from the past,

its

current situation and

its strategic

direction.

The organization should determine which external and internal issues could result in risks to its

sustained success or opportunities to enhance its sustained success.

Based on the determination of these issues, top management should decide which of these risks and

opportunities should be addressed and initiate the establishment, implementation and maintenance of

the necessary processes.

The organization should consider how

establish, implement and maintain a process for monitoring,

reviewing and evaluating external and internal issues, with consideration of any consequences to be

acted on (see 22.).

6 Identity of an organization

6.1 General

An organization

defined

its identity and context. The identity of an organization is

determined by

its

characteristics, based on its mission,

vision,

values and culture.

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ISO 9004:2018(E)

Mission, vision, values and culture are interdependent and the relationship between them

should

recognized as dynamic.

6.2 Mission, vision, values and culture

The identity of an organization includes its:

a) mission:

the

organization's purpose for existing;

vision: aspiration of what an organization

would

like to become;

c) values: principles and/or thinking patterns intended to play a role in shaping the organization's '.

culture and to determine what is important to the organization, in support of the mission and vision;

culture: beliefs,

history,

ethics, observed behaviour and

attitudes that

are

interrelated with the

identity

the organization.

It is essential that the organization's culture aligns with its mission, vision, and values. Top management

should ensure that the context

the organization is considered when determining its mission, vision

and values. This should include an understanding of its existing culture and assessing the need

change the culture. The strategic direction of

the

organization and

its policy should be aligned

with

these identity elements.

Top

management should review the mission, vision, values

and

culture at planned intervals

and

whenever

the

context of the organization changes. This review should consider external and internal

issues that

can

have an effect on tihe organization's ability to achieve sustained success. When changes

are made to any of the identity elements, they should be communicated within the organization and to

interested parties, as appropriate.

7 Leadership

7.1 General

7.1.1

Top management, through its leadership, should:

promote the adoption of the mission, vision, values and culture in

way that is concise and easy to

understand, to achieve unity

purpose;

create

an internal

environment in

which people

are engaged

and

committed

the

achievement of

the organization's objectives;

c) encourage and support managers at appropriate levels to promote and maintain the unity of

purpose

and

direction

established by the top management.

7.1.2

achieve sustained success,

top

management should demonstrate leadership and commitment

within the organization, by:

a) establishing the organization's identity

(see

Clause 6);

b) promoting a culture of trust and integrity;

c) establishing and maintaining teamwork;

providing people with the necessary resources, training and

authority

to act with accountability;

e) promoting shared values, fairness and ethical behaviour so that these are sustained at all levels of

the organization;

f) establishing and maintaining an organizational structure to enhance competitiveness, where

applicable;

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ISO 9004:2018(E)

g) individually and collectively reinforcing the organization's

values;

communicating

achieved

successes externally and

internally, as

appropriate;

i) establishing

basis for

effective

communication

with

people in

the

organization, discussing issues

that have general impact, including financial impact, where

applicable;

supporting leadership development at

all levels

the

organization.

7 .2 Policy and strategy

Top management should set out the organization's intentions and direction in the form of the

organization's policy, to address aspects such as compliance, quality, environment, energy, employment,

occupational health and

safety,

quality of work life, innovation, security, privacy,

data

protection

and customer experience. Policy statements

should

include commitments to satisfy the needs and

expectations of interested parties and

promote improvement.

When establishing the strategy, top management should either apply a recognized and appropriate

model available in the market, or design or implement an organization-specific customized model.

Once chosen, it is crucial

maintain

the

stability of the model as

the

solid foundation

and

reference for

managing

the

organization.

Strategy should reflect the identity of the organization, its context and long-term perspective. All short-

and medium-term objectives should be aligned accordingly (see 1..3.).

Top management should make strategic decisions regarding competitive factors

(see Table 1).

These policy and strategy decisions should be reviewed for continued suitability. Any changes to the

external

and

internal issues, as

well

as any new risks

and

opportunities, should be addressed.

The organization's policies and strategy constitute the basis to establish process management (see

Clause 8).

Table 1 - Examples of actions to consider when addressing competitive factors

Competitive

factors

A Products and

services

People

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Actions to consider

focusing on current and potential customers and potential markets for products

and services

offering standard

products and

services or

designs

specific to

customer

requirements

realizing the advantages of being first to market or being a follower

scaling production from one-off to mass production, as appropriate

dealing with short

innovation cycles

or a stable long-term

customer demand

managing quality requirements

recognizing demographic development and changing values

considering

diversity

cultivating an image as an attractive employer

determining the desired competence and experience of people to hire

considering appropriate approaches

recruitment, competence development,

retention,

and

!eave

management

addressing capacity flexibility by considering permanent versus fixed-term

contracts

considering fuEI time versus part time or temporary employment, as well as the

balance between them

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