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Benefits, Aims & Key Changes to ISO 9001
ISO9001的益处，目标及关键变化
Permissible Exclusions
允许的排除
Quality Management Principles
品质管理原则
Documentation Requirements
文件要求
Management Responsibility
管理职责
content (cont.)
Resource Management
资源管理
Product Realization
产品实现
Measurement, Analysis & Improvement
测量，分析和改进
Process Based Auditing
以过程为基础的审核
BENEFITS, AIMS & KEY CHANGES TO ISO 9001
ISO9001的益处，目的及关键变化
Key Benefits of ISO 9001:2000
ISO9001:2000的主要益处
More emphasis on reliability and meeting customer requirements
更加强调可靠性及满足顾客要求
Continual improvement
持续改进
Based in internationally accepted good management practices
基于国际上接受的优良管理惯例
Due diligence
勤奋
BENEFITS, AIMS & KEY CHANGES TO ISO 9001
ISO9001的益处，目的及关键变化
Aims of ISO 9001:2000
ISO9001:2000的目的
To be more relevant to normal management practices
更适合于标准管理惯例
More relevant to Service Providers
更适合于服务供应商
Increase standard consistency
增强了标准的一致性
Reduce the complexity of the Standard
减少了标准的复杂性
BENEFITS, AIMS & KEY CHANGES TO ISO 9001
ISO9001的益处，目的及关键变化
Understanding ISO 9001:2000
ISO9001:2000的理解
Auditors must fully understand ISO 9001:2000 in order to audit against it
审核员必须充分地理解ISO9001:2000以便以其为依据进行审核
Auditors must also fully understand the application of ISO 9001A:2000 to the particular organisations they are auditing
审核员还必须充分理解ISO9001:2000在其审核的特定组织上应用
BENEFITS, AIMS & KEY CHANGES TO ISO 9001
ISO9001的益处，目的及关键变化
Key Changes to ISO 9001:2000
ISO9001:2000的关键变化
Internal communications
内部沟通
Quality objectives
品质目标
Continual improvement
持续改进
Competency and awareness
能力和意识
Process approach
过程方法
Pro-active customer satisfaction
专业、主动的客户满意度
Internal quality audits
内部品质审核
Understand product intended use
了解产品的预期用途
ISO 9001 = COMMONSENSE BUSINESS PRINCIPLES
常识性经营原则
Focus on your customer
以顾客为关注焦点
Know your customers
了解顾客
Continually improve everything you do
持续改进所做的每件事
Provide adequate staff training
提供充分的员工培训
Provide support from the top
从高层提供支持
Provide means for two-way communication
提供双向沟通的方法
Encourage teamwork and empowerment
鼓励团队工作及授权
Make work pleasurable
使工作愉快
Welcome complaints
欢迎抱怨
Remember the customer is always right - well nearly always!
记住顾客总是对的
PERMISSIBLE EXCLUSIONS
允许的排除
Planning of product
产品的策划
Customer processes
顾客过程
Design
设计
Purchasing
采购
Product/service provision
生产/服务提供
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
A quality management principle is a comprehensive and fundamental rule or belief for leading and operating an organisation.
品质管理原则是领导和运作一个组织的广泛的、基本的准则和信念，
Customer Focus
以顾客为关注焦点
Leadership
领导作用
Involvement of People
全员参与
4. Process Approach
过程方法
Systems Approach to Management
管理的系统方法
Continual Improvement
持续改进
Factual Approach to Decision Making
基于事实的决策方法
Mutually Beneficial Supplier Relationships
与供方互利的关系
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 1 - Customer Focus
原则1-以顾客为关注焦点
Organisations depend on their customers and therefore should understand current and future customer needs, meet these requirements and strive to exceed customer expectations.
组织依存于顾客，因此组织应当理解顾客当前和未来的需求，满足顾客要求并争取超越顾客期望。
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 2 – Leadership
原则2-领导作用
Leaders establish unity of purpose and direction of the organisation.
领导者应确立组织统一的宗旨及方向。
They should create and maintain the internal environment in which people can become fully involved in achieving the organisations objectives.
他们应当创造并保持使员工能充分参与实现组织目标的内部环境。
“Top Management shall ensure…….”
最高管理者应确保
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 3 - Involvement of People
原则3-全员参与
People at all levels are the essence of an organisation and their full involvement enable their abilities to be used for the organisations objectives.
各级人员都是组织之本，只有他们的充分参与，才能使他们的才干用于实现组织的目标。
Communications between management and employees on matters related to quality.
管理者与雇员关于品质问题的沟通。
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 4 - The Process Approach
原则4-过程方法
A desired result is achieved more efficiently when related resources and activities are managed as a process.
将活动和相关的资源作为过程进行管理，可以更高效地得到期望的结果。
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 5 - Systems Approach to Management
原则5-管理的系统方法
Identifying, understanding and managing a system of interrelated processes for a given objective improves the organisations effectiveness and efficiency.
为了一个指定的目标，识别、理解和管理一个系统的相关过程，可以提高组织的有效性和效率。
Particularly those processes with the greatest potential risk.
尤其是那些具有及高潜在风险的过程。
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 6 - Continual Improvement
原则6-持续改进
Continual improvement should be a permanent objective of the organisation.
持续改进应当是组织的一个永恒目标。
PDCA Cycle:
PDCA循环：
P – Plan计划
D – Do实施
C – Check检查
A – Act处置
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 7 - Factual Approach to Decision Making
原则7-基于事实的决策方法
Effective decisions are based on the analysis of data and information.
有效决策是建立在数据和信息分析的基础上。
Base decisions on reliable data.
把决定建立在可靠的数据上。
If you measure it, record it.
如果你测量它，就记录它。
If you record it, analyse it.
如果你记录它，就分析它。
If you analyse it, act on the results.
如果你分析它，就根据结果采取措施。
QUALITY MANAGEMENT PRINCIPLES
品质管理原则
Principle 8 - Mutually Beneficial Supplier Relationships
原则8-与供方互利的关系
An organisation and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.
组织与供方是相互依存的，互利的关系可增强双方创造价值的能力。
You need your suppliers and they need you.
你需要你的供应商，他们也需要你。
DOCUMENTATION REQUIREMENTS
文件要求
ISO 9001:2000 Clause
ISO9001:2000条款
– General
总则
- Quality Manual
质量手册
- Control of Documents
文件控制
- Control of records
记录控制
DOCUMENTATION REQUIREMENTS
文件要求
Clauses requiring procedures:
条款要求的程序文件:
- Control of Documents
文件控制
- Control of Records
记录控制
- Internal Audits
内部审核
- Control of Nonconforming Product
不合格品控制
- Corrective Action and Preventive Action
纠正措施和预防措施
MANAGEMENT RESPONSIBILITY
管理职责
Management commitment
管理承诺
Customer focus
以顾客为关注焦点
Quality Policy
质量方针
Planning
策划
Responsibility, authority and communication
职责,权限和沟通
Management review
管理评审
MANAGEMENT RESPONSIBILITY
管理职责
Management commitment
管理承诺
MANAGEMENT RESPONSIBILITY
管理职责
Customer focus - What is it?
以顾客为关注焦点-这是什么？
Realising that the customer is:
应意识到顾客是：
the most important person we come in contact with
我们接触到的最重要的人
not necessarily dependent on us
不必依靠我们
not an interruption to our work, but the purpose of it
不是对我们工作的打扰，而是工作的宗旨
doing us a favour by giving us the opportunity to serve their needs
通过给我们向他们提供所需服务/产品的机会来帮助我们
not an outsider to our business, but very much part of it - the real person that pays our salaries
不是我们经营上的局外人，而是经营上非常重要的一部分-又是真正向我们提供工资的人
MANAGEMENT RESPONSIBILITY
管理职责
Customer Statistics
顾客统计
For every customer who protests about poor customer service, there are 26 dissatisfied customers who do not complain but tell 20 others of their experience.
对于每个抗议不良服务的顾客来说，已有26个不满意的顾客并没有抱怨，但已将他们的看法转告另外20个人。
By comparison, less than 10% are lost through issues related to product/service cost.
通过比较，低于10%的顾客是由于产品/服务价格的问题失去的。
Research shows that it is 6 times more costly to win a new customer than to maintain an existing one.
调查显示赢得一个新顾客的花费是维持一个现有顾客花费的6倍。
Statistics indicate that 91% of dissatisfied customers slip away quietly, never to return.
统计表明有91%不满意的顾客安静地离开，再也不会回来。
MANAGEMENT RESPONSIBILITY
管理职责
Quality policy
质量方针
MANAGEMENT RESPONSIBILITY
管理职责
Planning
策划
MANAGEMENT RESPONSIBILITY
管理职责
Responsibility, authority and communication
职责、权限与沟通
MANAGEMENT RESPONSIBILITY
管理职责
Management review
管理评审
RESOURCE MANAGEMENT
资源管理
Provision of resources
资源提供
Human resources
人力资源
Infrastructure
基础设施
Work environment
工作环境
RESOURCE MANAGEMENT
资源管理
Provision of resources
资源提供
RESOURCE MANAGEMENT
资源管理
Human resources
人力资源
Competence requirements determined
确定能力要求
Training provided to ensure competence
提供培训以保证能力要求
Monitoring the effectiveness of training
监控培训的有效性
Consider current and future needs
考虑当前的和未来的需求
Consider statutory requirements
考虑法令要求
Personnel aware of the relevance of their activities
人员应意识到其从事活动的相关性
RESOURCE MANAGEMENT
资源管理
Infrastructure
基础设施
RESOURCE MANAGEMENT
资源管理
Work environment
工作环境
PRODUCT REALIZATION
产品实现
Planning of product realization
产品实现的策划
Customer-related processes
与顾客有关的过程
Design and development
设计和开发
Purchasing
采购
Production and service provision
生产和服务提供
Control of monitoring and measuring devices
监视和测量装置的控制
Planning of product realization
产品实现的策划
PRODUCT REALIZATION
产品实现
Customer-related processes
与顾客有关的过程
PRODUCT REALIZATION
产品实现
Design and development
设计和开发
Planning
策划
Inputs
输入
Outputs
输出
Review
评审
Verification
验证
Validation
确认
Control of design/development change
设计和开发更改的控制
PRODUCT REALIZATION
产品实现
Purchasing
采购
Purchasing process
采购过程
Purchasing information
采购信息
Verification of purchased product
采购产品的验证
PRODUCT REALIZATION
产品实现
Production and service provision
生产和服务提供
Control of production and service provision
生产和服务提供的控制
Validation of processes for production and service provision
生产和服务提供过程的确认
Identification and traceability
标识和可追溯性
Customer property
顾客财产
Preservation of product
产品防护
Control of monitoring and measuring devices
监视和测量装置的控制
PRODUCT REALIZATION
产品实现
Control of monitoring and measuring devices
监视和测量装置的控制
PRODUCT REALIZATION
产品实现
MEASUREMENT, ANALYSIS & IMPROVEMENT
测量、分析和改进
General
总则
Monitoring and measurement
监视和测量
Control of nonconforming data
不合格品控制
Analysis of data
数据分析
Improvement
改进
MEASUREMENT, ANALYSIS
& IMPROVEMENT
测量、分析和改进
General
总则
Monitoring and measurement
监视和测量
MEASUREMENT, ANALYSIS & IMPROVEMENT
测量、分析和改进
Control of nonconforming product
不合格品控制
MEASUREMENT, ANALYSIS & IMPROVEMENT
测量、分析和改进
Analysis of data
数据分析
MEASUREMENT, ANALYSIS & IMPROVEMENT
测量、分析和改进
Continual Improvement
持续改进
Plan - establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organisation’s policies.
计划-根据顾客的要求和组织的方针，为提供结果建立必要的目标和过程
Do - implement the process.
实施-实施过程
Check - monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
检查-根据方针、目标和产品要求，对过程和产品进行监视和测量，并报告结果
Act - take actions to continually improve process performance.
处置-采取措施，以持续改进过程业绩
MEASUREMENT, ANALYSIS & IMPROVEMENT
测量、分析和改进
Demonstrating Improvement
演示改进
Continual Improvement
持续改进
Establishing Improvement Objectives
建立改进的目标
Collection of Data
收集数据
Analysis of Data ()
分析数据
Monitoring Improvement
监视改进
MEASUREMENT, ANALYSIS & IMPROVEMENT
测量、分析和改进
PROCESS BASED AUDITING
以过程为基础的审核
Auditors examine the business processes of the organisation linking them to the requirements of the Standard and to the organisation’s procedures and instructions.
审核员根据标准的要求，根据组织的程序和指南检查组织的经营过程。
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