ISO 9001可以归纳为五项保证要求
The basic assurancerequirements
基本的保证要求
We can also condense the requirements of ISO 9001into five assurance requirements:
我们也可以将ISO 9001的要求浓缩为五个保证要求：
1
The organization shall demonstrate its commitment to the achievement of quality. This is addressed by clause 5.2.
组织应证实其对实现质量的承诺。这一点在5.2条款中有所陈述。
2
The organization shall demonstrate that it has effective policies for creating an environment that will motivate its personnel into satisfying the needs and expectations of its customers and applicable statutory and regulatory requirements. This is addressed by clause 5.1.
组织应证明它有有效的方针来营造一个环境，以激励其人员满足顾客的需求和期望以及适用的法律和法规要求。这一点在5.1条款有所陈述。
3
The organization shall demonstrate that it has effectively translated the needs and expectations of its customers and applicable statutory and regulatory requirements into measurable and attainable objectives. This is addressed by clause 6.2.
组织应证实其已将顾客的需求和期望以及适用的法律和法规要求有效地转化为可测量和可实现的目标。这一点在6.2条款中有所陈述。
4
The organization shall demonstrate that it has a network of processes for enabling the organization to meet these objectives in the most efficient way. This is addressed by clauses 7.1 and 8.1.
组织应证实其拥有一个过程网络，使组织能够以最有效的方式实现这些目标。这一点在7.1和8.1条款中有所陈述。
5
The organization shall demonstrate that it is achieving these objectives as measured, that they are being achieved in the best way and that they remain consistent with the needs and expectations of its stakeholders. This is addressed by clause 9.
组织应证实其正在实现所测量的这些目标，以最佳方式实现这些目标，并与相关方的需求和期望保持一致。这一点在第9章中有所陈述。
ISO 9001也可以归纳为8项基本管理要求：
The basic managementrequirements
基本管理要求
Further on in this bookwe comment on the structure of ISO 9001 and the 300+ requirements in moredetail, but we can condense these into the following eight managementrequirements:
在本书的后面，我们将更详细地评论ISO9001的结构和300多项要求，但我们可以将这些要求浓缩为以下八项管理要求：
1
Purpose – review the organization’s purpose and the needs and expectations of the stakeholders relative to this purpose. This is addressed by clause 4.2.
目的 − 评审组织的目的以及相关方相对于此目的的需求和期望。这一点在4.2条款中有所陈述。
2
Context – scan the environment to determine the factors affecting the ability of the organization to fulfill its purpose, decide priorities for action and set the strategic direction. This is addressed by clause 4.1.
环境 − 扫视环境，以确定影响组织实现其目的的能力的因素，决定行动的优先级，并确定战略方向。这一点在4.1条款中有所陈述。
3
Policy – define the overall intentions, principles and guiding values related to quality commensurate with the organization’s purpose and strategic direction. This is addressed by clause 5.2.
方针 − 定义与组织的宗旨和战略方向相适应的与质量有关的总体意图、原则和指导价值。这一点在5.2条款有所陈述。
4
Planning – establish objectives, measures and targets for fulfilling the organization’s purpose and its policies; assess risks and develop plans and processes; and determine the resources needed for achieving the objectives that take due account of these risks. This is addressed by clauses 4.4, 6.1, 6.2 and 7.1.
策划−为实现组织的宗旨和方针确定目标、措施和指标；评估风险并制定方案和程序；确定实现目标所需的资源，并适当考虑到这些风险。在4.4、6.1、6.2和7.1等条款有所陈述。
5
Implementation – resource, operate and manage the plans and processes to deliver outputs that achieve the planned results. This is addressed by clauses 7.1 to 7.5 and clause 8.
实施 − 为计划和过程提供资源、操作和管理，以提供输出，实现策划的结果。在7.1至7.5条款和第8章中有所陈述。
6
Measurement – monitor, measure and audit processes; the achievement of objectives; and adherence to policies and the satisfaction of stakeholders. This is addressed by clauses 8, 9.1.1, 9.1.2 and 9.2.
测量 − 监视、衡量和审核过程；目标的实现；以及对方针的遵守和相关方的满意度。这一点在第8章、9.1.1、9.1.2和9.2条款中有所陈述。
7
Review – analyse and evaluate the results of measurement, determine performance against objectives and determine changes needed in policies, objectives, measures, targets and processes for the continuing suitability, adequacy and effectiveness of the system. This is addressed by clauses 9.1.3 and 9.3.
评审 − 分析和评价测量的结果，根据目标确定绩效，并确定方针、目标、措施、指标和程序所需的变更，以保证体系的持续适宜性、充分性和有效性。这一点在9.1.3和9.3条款中有所陈述。
8
Improvement – undertake action to bring about improvement by better control, better utilization of resources and better understanding of stakeholder needs. This might include innovation and learning. This is addressed by clauses 6.3 and 10.
改进 − 采取措施，通过更好地控制、更好地利用资源和更好地了解相关方的需求来实现改进。这可能包括创新和学习。这一点在6.3条款和第10章中有所陈述。
The basic assurancerequirements
基本的保证要求
We can also condense the requirements of ISO 9001into five assurance requirements:
我们也可以将ISO 9001的要求浓缩为五个保证要求：
1
The organization shall demonstrate its commitment to the achievement of quality. This is addressed by clause 5.2.
组织应证实其对实现质量的承诺。这一点在5.2条款中有所陈述。
2
The organization shall demonstrate that it has effective policies for creating an environment that will motivate its personnel into satisfying the needs and expectations of its customers and applicable statutory and regulatory requirements. This is addressed by clause 5.1.
组织应证明它有有效的方针来营造一个环境，以激励其人员满足顾客的需求和期望以及适用的法律和法规要求。这一点在5.1条款有所陈述。
3
The organization shall demonstrate that it has effectively translated the needs and expectations of its customers and applicable statutory and regulatory requirements into measurable and attainable objectives. This is addressed by clause 6.2.
组织应证实其已将顾客的需求和期望以及适用的法律和法规要求有效地转化为可测量和可实现的目标。这一点在6.2条款中有所陈述。
4
The organization shall demonstrate that it has a network of processes for enabling the organization to meet these objectives in the most efficient way. This is addressed by clauses 7.1 and 8.1.
组织应证实其拥有一个过程网络，使组织能够以最有效的方式实现这些目标。这一点在7.1和8.1条款中有所陈述。
5
The organization shall demonstrate that it is achieving these objectives as measured, that they are being achieved in the best way and that they remain consistent with the needs and expectations of its stakeholders. This is addressed by clause 9.
组织应证实其正在实现所测量的这些目标，以最佳方式实现这些目标，并与相关方的需求和期望保持一致。这一点在第9章中有所陈述。
ISO 9001也可以归纳为8项基本管理要求：
The basic managementrequirements
基本管理要求
Further on in this bookwe comment on the structure of ISO 9001 and the 300+ requirements in moredetail, but we can condense these into the following eight managementrequirements:
在本书的后面，我们将更详细地评论ISO9001的结构和300多项要求，但我们可以将这些要求浓缩为以下八项管理要求：
1
Purpose – review the organization’s purpose and the needs and expectations of the stakeholders relative to this purpose. This is addressed by clause 4.2.
目的 − 评审组织的目的以及相关方相对于此目的的需求和期望。这一点在4.2条款中有所陈述。
2
Context – scan the environment to determine the factors affecting the ability of the organization to fulfill its purpose, decide priorities for action and set the strategic direction. This is addressed by clause 4.1.
环境 − 扫视环境，以确定影响组织实现其目的的能力的因素，决定行动的优先级，并确定战略方向。这一点在4.1条款中有所陈述。
3
Policy – define the overall intentions, principles and guiding values related to quality commensurate with the organization’s purpose and strategic direction. This is addressed by clause 5.2.
方针 − 定义与组织的宗旨和战略方向相适应的与质量有关的总体意图、原则和指导价值。这一点在5.2条款有所陈述。
4
Planning – establish objectives, measures and targets for fulfilling the organization’s purpose and its policies; assess risks and develop plans and processes; and determine the resources needed for achieving the objectives that take due account of these risks. This is addressed by clauses 4.4, 6.1, 6.2 and 7.1.
策划−为实现组织的宗旨和方针确定目标、措施和指标；评估风险并制定方案和程序；确定实现目标所需的资源，并适当考虑到这些风险。在4.4、6.1、6.2和7.1等条款有所陈述。
5
Implementation – resource, operate and manage the plans and processes to deliver outputs that achieve the planned results. This is addressed by clauses 7.1 to 7.5 and clause 8.
实施 − 为计划和过程提供资源、操作和管理，以提供输出，实现策划的结果。在7.1至7.5条款和第8章中有所陈述。
6
Measurement – monitor, measure and audit processes; the achievement of objectives; and adherence to policies and the satisfaction of stakeholders. This is addressed by clauses 8, 9.1.1, 9.1.2 and 9.2.
测量 − 监视、衡量和审核过程；目标的实现；以及对方针的遵守和相关方的满意度。这一点在第8章、9.1.1、9.1.2和9.2条款中有所陈述。
7
Review – analyse and evaluate the results of measurement, determine performance against objectives and determine changes needed in policies, objectives, measures, targets and processes for the continuing suitability, adequacy and effectiveness of the system. This is addressed by clauses 9.1.3 and 9.3.
评审 − 分析和评价测量的结果，根据目标确定绩效，并确定方针、目标、措施、指标和程序所需的变更，以保证体系的持续适宜性、充分性和有效性。这一点在9.1.3和9.3条款中有所陈述。
8
Improvement – undertake action to bring about improvement by better control, better utilization of resources and better understanding of stakeholder needs. This might include innovation and learning. This is addressed by clauses 6.3 and 10.
改进 − 采取措施，通过更好地控制、更好地利用资源和更好地了解相关方的需求来实现改进。这可能包括创新和学习。这一点在6.3条款和第10章中有所陈述。
