ISO9000 Standards
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ISO
TC/176
ISO9000 QMS
ISO14000 EMS
OHSMS 18000
Integrated Management System
ISO 9000:2000
• Quality system standards adopted by
International Organization for Standardization
in 1987; revised in 1994 and 2000
• Technical specifications and criteria to be used
as rules, guidelines, or definitions of
characteristics to ensure that materials,
products, processes, and services are fit for
their purpose.
2
Objectives of ISO Standards (1 of 2)
• Achieve, maintain, and continuously improve
product quality
• Improve quality of operations to continually
meet customers’ and stakeholders’ needs
• Provide confidence to internal management
and other employees that quality
requirements are being fulfilled
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Objectives of ISO Standards (2 of 2)
• Provide confidence to customers and other
stakeholders that quality requirements are
being achieved
• Provide confidence that quality system
requirements are fulfilled
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ISO 9000:2000 Quality
Management Principles
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6.
7.
8.
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
BENEFITS OF ISO 9000
• better understanding of customer needs;
• consistent performance;
• provision of a framework for measuring performance
and improving processes;
• continuous improvement in efficiency and
effectiveness;
• enhancement of the ability to deal with a changing
business environment;
• establishment of a unified, purposeful system
composed of interrelated business processes.
A survey result
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clarify responsibilities,
reduce errors,
improve the flow of information,
identify management issues early,
reduce the time needed for routine matters,
and
• improve production.
U.S. Companies
The ISO 9000 family
• ISO 9000:2000 Quality management
systems — Fundamentals and
vocabulary
• ISO 9001:2000 Quality management
systems — Requirements
• ISO 9004:2000 Quality management
systems — Guidelines for performance
improvements
The ISO 9000 family
• Standards and guidelines
– ISO 9000:2000, Quality management systems Fundamentals and vocabulary
• Purpose
–
Establishes a starting point for understanding
the standards and defines the fundamental terms
and definitions used in the ISO 9000 family
which you need to avoid misunderstandings in
their use.
The ISO 9000 family
• ISO 9001:2000, Quality management
systems - Requirements
– This is the requirement standard you use to
assess your ability to meet customer and
applicable regulatory requirements and thereby
address customer satisfaction.
– It is now the only standard in the ISO 9000
family against which third-party certification
can be carried.
The ISO 9000 family
• ISO 9004:2000, Quality management
systems - Guidelines for performance
improvements
– This guideline standard provides guidance for
continual improvement of your quality
management system to benefit all parties
through sustained customer satisfaction.
The ISO 9000 family
• ISO 19011, Guidelines on Quality and/or
Environmental Management Systems
Auditing
– Provides you with guidelines for verifying the
system's ability to achieve defined quality
objectives. You can use this standard internally
or for auditing your suppliers.
Examples of the ISO 9000 standards
in use
• A metal parts fabricating company used ISO
9000:2000 to develop a plan to implement their
quality management system. When they were ready,
they prepared a quality manual and quality system
procedures as required by ISO 9001:2000,
excluding the requirements covering product design
and development because their products are made to
designs prepared by their customers. Later, in order
to bid on the supply of parts to a major automotive
company, they adapted their quality system to meet
the sector specific requirements of ISO/TS 16949.
Examples of the ISO 9000 standards
in use (II)
• A welfare agency decided to establish a quality
improvement strategy. It adopted ISO 9004:2000 as
the basis for planning and implementing its system.
The agency found that ISO 9000:2000 provided
very useful additional guidance and plans to seek
certification to ISO 9001:2000 to gain more
credibility.
Examples of the ISO 9000 standards
in use (III)
• A washing machine manufacturer had a wellestablished company culture of continual
improvement and effective production control. The
management decided to improve the company's
development processes and to implement ISO
9001:2000 to obtain certification for commercial
purposes. The company used ISO 9004:2000 to
guide its improvement processes and ISO
10006:1997 to develop a project management plan.
Examples of the ISO 9000 standards
in use (IV)
• A large chemical processing company was required by its
major customers to gain registration/certification to ISO
9001:2000. In order to obtain additional benefits, company
leadership planned a comprehensive management strategy
based on ISO 9000:2000 and ISO 9004:2000. A thorough
review of their business processes indicated that all elements
of ISO 9001:2000 were applicable to their quality
management system. The company used ISO 10013:1999 to
guide the development of quality documentation in its
various production divisions and ISO 10015:1999 for
guidance in the preparation of training plans for their
employees.
Examples of the ISO 9000 standards
in use (V)
• A firm of international lawyers wanted to improve their
client management processes and to achieve
registration/certification to ISO 9001:2000. Their quality
management system provides for the design and
development of new services such as international tax
planning and modifying traditional services to meet the
requirements of new or amended legislation. They included
purchasing control to cover the selection of computer
hardware and software, as well as purchasing the services of
specialist lawyers as needed. After successfully
implementing ISO 9001:2000, they used the self-assessment
guidelines of ISO 9004:2000 to monitor their progress as
they improved their quality management system
Examples of the ISO 9000 standards
in use (VI)
• A computer software developer serving a niche market
recognized that as their user base expanded they would be
faced with issues concerning product management and
configuration control. Changes to base products, user
hardware and regulatory requirements were compounding
customer service issues. ISO 9004:2000 provided the guidance
they needed to establish documented procedures to control
process change and improvement. ISO 10006:1997 and ISO
10007:1995 provided additional assistance as they managed
the project and prepared procedures for configuration
management. They later acquired another software developer
and were able to use their quality management system to
integrate the acquisition into their own structure very quickly
with a minimum of disruption to customers.
Examples of the ISO 9000 standards
in use (VII)
• A bank decided to implement a quality management system
for its on-line Internet banking services. They ensured that
their quality manual made clear that their other conventional
banking services were not included in their quality
management system. While adopting the requirements of ISO
9001:2000, the bank obtained guidance from ISO 9000:2000
to interpret words and phrases used in the standard for their
application. They applied all the requirements of Clause 7,
recognizing that design and development is an important part
of creating new service processes. The bank used ISO
10013:1995 to prepare their documentation, which they posted
on their internal computer network to ensure current
procedures are available to their staff.
The ISO 9001-2000 Standard
Schematic representation of a
Process
Model of a process-based quality
management system (Taken from
ISO 9000:2000)
Quality Management system PDCA
Schematic representation of typical
quality management system
Chain of interrelated processes
Typical network of interacting
processes
Structure of ISO 9001 Standard
• 21 elements organized into four major
sections:
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Management Responsibility
Resource Management
Product Realization
Measurement, Analysis, and improvement
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0 Introduction
0.1 General
The standard specifies requirements for a
quality management system that can
"address customer satisfaction, by meeting
customer and applicable regulatory
requirements....used by internal and external
parties including certification bodies..."
0 Introduction
0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other
management systems
1 Scope
• The standard requires a quality management
system to be able to:
A) demonstrate provision of consistent
"product that meets customer...requirements“
B) "address customer satisfaction" through
"processes for continual improvement"
1 Scope
• In addition, it refers to the need to
monitor customer satisfaction by
"evaluation of information relating to
customer perceptions of whether or not
the organization has met the customer
requirements".
1 Scope
• It also states areas of permissible
scope exclusions from product
realization (section 7) where the
elements do not affect A) above.
2 Normative reference
3 Terms and definitions
4 Quality Management System
Requirements
• general system requirements
• documentation requirements
– 4.2.1
– 4.2.2
– 4.2.3
– 4.2.4
General
Quality Manual
Control of Documents
Control of Records
5 Management responsibility (I)
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5.1 Management commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
– 5.4.1 Quality Objectives
– 5.4.2 Quality management System
Planning
Management responsibility (II)
• 5.5 Administration
– 5.5.1
– 5.5.2
Responsibility and Authority
Management Representative
– 5.5.3
Internal Communication
• 5.6 Management Review
– 5.6.1 General
– 5.6.2 Review Input
– 5.6.3 Review Output
6 RESOURCE MANAGEMENT
• 6.1 Provision of Resources
• 6.2 Human Resources
– 6.2.1
– 6.2.2
General
Competence, Awareness and Training
• 6.3 Infrastructure
• 6.4 Work Environment
7 PRODUCT REALIZATION
(I)
• 7.1 Planning of Product Realization
• 7.2 Customer Related Processes
– 7.2.1 Determination of Requirements Related
to the Product
– 7.2.2 Customer Request for Quote
– 7.2.3 Review of Quotes
– 7.2.4 Amendment to Contract
– 7.2.5 Records
7 PRODUCT REALIZATION
(II)
• 7.3 Design and Development
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7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
Design and Development Planning
Design and Development Inputs
Design and Development Outputs
Design and Development Review
Design and Development Verification
Design and Development Validation
Control of Design and Development Changes
7 PRODUCT REALIZATION
(III)
• 7.4 Purchasing
– 7.4.1 Purchasing Process
– 7.4.2 Purchasing Information
– 7.4.3 Verification of Purchased
Product
7 PRODUCT REALIZATION
(IV)
• 7.5
Production and Service Provision
– 7.5.1 Control of Production and Service
Provision
– 7.5.2 Validation of Processes for
Production and Service Provision
– 7.5.3 Identification and Traceability
– 7.5.4 Customer Property
– 7.5.5 Preservation of Product
7 PRODUCT REALIZATION
(V)
• 7.6 Control of Monitoring and
measuring Devices
8. MEASUREMENT, ANALYSIS
AND IMPROVEMENT (I)
• 8.1 General
• 8.2 Monitoring and Measurement
– 8.2.1 Customer Satisfaction
– 8.2.2 Internal Audits
– 8.2.3 Monitoring and Measurement of
Processes
– 8.2.4 Monitoring and Measurement of Product
8. MEASUREMENT, ANALYSIS
AND IMPROVEMENT (II)
• 8.3 Control of Nonconforming Product
• 8.4 Analysis of Data
• 8.5 Improvement
– 8.5.1
– 8.5.2
– 8.5.3
Continual Improvement
Corrective Action
Preventative Action
Implement your QMS
• 14 steps (processes)
• Methodology
• Problem solving
1. Identify the goals you want to
achieve
Typical goals may be:
• Be more efficient and profitable
• Produce products and services that consistently meet
customer requirements
• Achieve customer satisfaction
• Increase market share
• Maintain market share
• Improve communications and morale 士气 in the
organization
• Reduce costs and liabilities 债务
• Increase confidence in the production system
2. Identify what others expect of
you
• These are the expectations of interested
parties (stakeholders) such as:
Customers and end users
Employees
Suppliers
Shareholders
Society
3. Obtain information about the
ISO 9000 family
• For more detailed information, see ISO 9000:2000,
ISO 9001:2000 and ISO 9004:2000
• For supporting information, refer to the ISO Web
site
• For implementation case studies and news of ISO
9000 developments worldwide, read the ISO
publication ISO Management Systems.
4.Apply the ISO 9000 family of
standards in your management
system.
• Decide if you are seeking certification that your
quality management system is in conformance
with ISO 9001:2000 or if you are preparing to
apply for a national quality award.
• Use ISO 9001:2000 as the basis for certification
• Use ISO 9004:2000 in conjunction with your
national quality award criteria to prepare for a
national quality award
5. Obtain guidance on specific topics
within the quality management system
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These topic-specific standards are:
ISO 10006 for project management
ISO 10007 for configuration management
ISO 10012 for measurement systems
ISO 10013 for quality documentation
ISO/TR 10014 for managing the economics of
quality
• ISO 10015 for training
• ISO/TS 16949 for automotive suppliers
• ISO 19011 for auditing
6. Establish your current status, determine the gaps
between your quality management system and the
requirements of ISO 9001:2000
• You may use one or more of the following:
• Self assessment
• Assessment by an external organization
7. Determine the processes that
are needed to supply products to
your customers
• Review the requirements of the ISO 9001:2000
section on Product Realization to determine how
they apply or do not apply to your quality
management system including;
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Customer related processes
Design and/or development
Purchasing
Production and service operations
Control of measuring and monitoring devices
8. Develop a plan to close the
gaps in step 6 and to develop the
processes in step 7
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Identify actions needed to close the gaps, allocate
resources to perform these actions, assign
responsibilities and establish a schedule to
complete the needed actions. ISO 9001:2000
Paragraphs 4.1 and 7.1 provide the information
you will need to consider when developing the
plan.
9. Carry out your plan
• Proceed to implement the identified actions and
track progress to your schedule
10. Undergo periodic internal
assessment
• Use ISO 19011 for guidance in auditing, auditor
qualification and managing audit programmes
11. Do you need to demonstrate
conformance?
• If yes, go to step 12 . If no, go to step 13
• You may need or wish to show conformance
(certification/registration) for various purposes, for
example:
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Contractual requirements
Market reasons or customer preference
Regulatory requirements
Risk management
To set a clear goal for your internal quality development
(motivation)
12. Undergo independant audit
• Engage an accredited registration/certification
body to perform an audit and certify that your
quality management system complies with the
requirements of ISO 9001:2000.
13. Continue to improve your
business
• Review the effectiveness and suitability of your
quality management system. ISO 9004:2000
provides a methodology for improvement.
14.Maintaining the benefits and
continual improvement
• Most new users obtain measurable benefits early
in the process of deploying the standard
requirements in their operations. These initial
benefits are generally due to improvements in
their organization and internal communication.
The benefits must be strengthened through
effective internal auditing and management review
of system performance. Like all systems, it either
improves or becomes less effective. It does not
remain static for long. l
TQM –European model for self
appraisal
People
satisfaction
People
management
leadershi
p
Policy & Strategy
Resources
Enables
processes
Customer
satisfaction
Impact on society
Results
Business
Results
Baridrige award criteria framework
System
Management
Of process
Quality
5.0
Driver
Senior
Executive
Leadership
1.0
Human
Resource
Development
Management
4.0
Customer
Focus &
Satisfaction
7.0
Goal
•Customer satisfaction
•Customer satisfaction relative to
competitors
Strategic
Quality
Planning
3.0
Information
& Analysis
2.0
•Customer retention
Quality &
Operational
Results
6.0
•Market share gain
Measure of progress
•Product &service quality
•Productivity improvement
•Waste reduction/elimination
•Supplier quality
Baridrige award criteria
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1.0 Leadership (110 points)
2.0 Strategic Planning (80 points)
3.0 Customer and Market Focus (80 points)
4.0 Information and Analysis (80 points)
5.0 Human Resource Development and
Management (100 Points)
6.0 Process Management (100 points)
7.0 Business Results (450 points)
TOTAL POINTS = 1000
总点数 = 1000
Basic Steps in Problem Solving
• Define the problem and establish an improvement goal
明确问题并建立改进目标
• Collect data 收集数据
• Analyze the problem 分析问题
• Generate potential solutions 产生潜在解决方案
• Choose a solution 选择一个方案
• Implement the solution 实施方案
• Monitor the solution to see if it accomplishes the goal
监督方案以观察它是否完成目标
ISO 14000
• ISO 14000 - A set of international standards for
assessing a company’s environmental performance
ISO 14000：一系列评估公司环境绩效的国际标准
• Standards in three major areas 标准的三大主要区域
• Management system 管理系统
• Operation 运作
• Environmental systems 环境系统
ISO 14000
• Management systems
– development and integration of environmental
responsibilities into business planning
• Operations
– Consumption of natural resources and energy
• Environmental systems
– Measuring, assessing and managing emissions,
effluents, and other waste