ISO 9001:2008 Quality Management
ISO 9001:2008 is part of the ISO 9000 family of standards. This family is comprised
of the following:
- ISO 9000: Quality management systems - Fundamentals and vocabulary
- ISO 9001: Quality management systems - Requirements
- ISO 9004: Quality management systems - Guidance for performance improvement
- ISO 19011: Guidelines on quality and/or environmental management systems auditing
ISO 9001:2008 Requirements
ISO 9001:2008 specifies the requirements for a quality management system where an
- Needs to demonstrate its ability to consistently provide product that meets customer
and applicable regulatory requirements, and
- Aims to enhance customer satisfaction through the effective application of the system,
including processes for continual improvement of the system and the assurance of
conformity to customer and applicable regulatory requirements.
It is now the only standard in the ISO 9000 family against whose requirements your
quality system can be certified by an external agency. The ISO 9001:2008 certification
signifies a global benchmark in customer satisfaction, product quality, and leads
to significant reduction in defect levels. The standard recognizes that the word
"product" applies to services, processed material, hardware and software intended
for, or required by your customer.
ISO 9001:2008 Sections
There are four sections in ISO 9001:2008 that specify the key activities while implementing
1. Management Responsibility
2. Resource Management
There must be a commitment to the establishment of quality policy, planning and
objectives as well as meeting customer requirements. There should be measurable
and quantifiable improvement targets and supporting data.
This is required with specific attention to resource availability and resources
such as information, communication, facilities and work environment. The training
effectiveness must be evaluated.
3. Product/Service Realization
4. Measurement, Analysis and Improvement
Product Realization is an important element of the ISO 9001 Process model. It addresses the processes within an organization involved in the development and delivery of new products and services, from concept to delivery to the customer. As Omnex explains to our customers, in innovative organizations this where an â€œideaâ€ is turned into a new product, which is then manufactured and sold to the customer. In the standard, Product realization begins with a customer enquiry or order, the solution for which is then designed or developed, along with the processes required for its provision, and then delivered to the customer. After sales services and warranty processes are also included in this process. These processes are the focus of the entire QMS process model.
These are required for 'continual improvement' as it is an explicit requirement
of ISO 9000:2000. Customer satisfaction must be measured. Measurements are also
extended to the system, processes, and product or services. Improvement actions
have to be initiated as and when necessary.
The standard is designed to look at all of the important processes affecting quality,
from the initial review of contracts from customers, to the delivery of the finished
product/service. The intent of the standard is to provide a universal baseline for
quality management, which can be used by companies from various industry segments
and around the world.
ISO 9001:2008 and its 8 Principles
Principles contain greater scope requirements than ISO 9001:1994, but have less
specific documentation requirements.
Principle 1 - Customer focus
Organizations depend on their customers, and therefore should understand current
and future customer needs. They should meet customer requirements and strive to
exceed customer expectations.
- Increased revenue and market share obtained through flexible and fast responses
to market opportunities.
- Increased effectiveness in the use of the organization's resources to enhance customer
- Improved customer loyalty leading to repeat business.
Applying the principle of customer focus means:
- Researching and understanding customer needs and expectations.
- Ensuring that the objectives of the organization are linked to customer needs and
- Communicating customer needs and expectations throughout the organization.
- Measuring customer satisfaction and acting on the results.
- Systematically managing customer relationships.
- Ensuring a balanced approach between satisfying customers and other interested parties
(such as owners, employees, suppliers, financiers, local communities and society
as a whole).
Principle 2 - Leadership
Leaders establish unity of purpose and direction in the organization. They should
create and maintain the internal environment in which people can become fully involved
in achieving the organization's objectives.
- People will understand and be motivated to achieve the organization's goals and
- Activities are evaluated, aligned and implemented in a unified way.
- Bad communication within the organizational levels will be minimized.
Applying the principle of leadership means:
- Establishing a clear vision of the organization's future.
- Setting challenging goals and targets.
- Creating and sustaining shared values, fairness and ethical role models at all levels
of the organization.
- Establishing trust.
- Providing people with the required resources, training and freedom to act with responsibility
- Inspiring, encouraging and recognizing people's contributions.
Principle 3 - Involvement of people
The involvement of people at all levels in an organization is essential to the success
of a Quality Management System implementation.
- Motivated, committed and involved people within the organization.
- Innovation and creativity in furthering the organization's objectives.
- People accountable for their own performance.
- People eager to participate in and contribute to continual improvement.
Applying the principle of involvement of people means:
- People understanding the importance of their contribution and role in the organization.
- People identifying constraints to their performance.
- People accepting ownership of problems and their responsibility for solving them.
- People evaluating their performance against their personal goals and objectives.
- People actively seeking opportunities to enhance their competence, knowledge and
- People freely sharing knowledge and experience.
- People openly discussing problems and issues.
Principle 4 - Process approach
Quality is achieved more efficiently when activities and related resources are managed
- Lower costs and shorter cycle times through effective use of resources.
- Improved, consistent and predictable results.
- Focused and prioritized improvement opportunities.
Applying the principle of the process approach means:
- Systematically defining the activities necessary to obtain a desired result.
- Analyzing and measuring the capability of key activities.
- Identifying the interfaces of key activities within and between the functions of
- Focusing on factors such as resources, methods, and materials that will improve
the key activities of the organization.
- Evaluating risks, consequences and impact of activities on customers, suppliers
and other interested parties
Principle 5 - System approach to management
Identifying, understanding and managing interrelated processes as a system contribute
to the organization's effectiveness and efficiency in achieving its objectives.
- Integration and alignment of the processes that will best achieve the desired results.
- Ability to focus effort on the key processes.
- Providing confidence to interested parties regarding the consistency, effectiveness
and efficiency of the organization.
Applying the principle of system approach to management means:
- Structuring a system to achieve the organization's objectives in the most effective
and efficient way.
- Understanding the interdependencies between the processes of the system.
- Structured approaches that harmonize and integrate processes.
- Providing a better understanding of the roles and responsibilities necessary for
achieving common objectives and thereby reducing cross-functional barriers.
- Understanding organizational capabilities and establishing resource constraints
prior to action.
- Targeting and defining how specific activities within a system should operate.
- Continually improving the system through measurement and evaluation.
Principle 6 - Continual improvement
The continual improvement of the organization's overall performance should be a
permanent objective of the organization.
- Performance advantage through improved organizational capabilities.
- Alignment of improvement activities at all levels of the organization's strategic
- Flexibility to react quickly to opportunities.
Applying the principle of continual improvement means:
- Employing a consistent organization-wide approach to the organization's performance.
- Providing people with training in the methods and tools of continual improvement.
- Making continual improvement of products, processes and systems an objective for
every individual in the organization.
- Establishing goals to guide, and measures to track continual improvement.
- Recognizing and acknowledging improvements.
Principle 7 - Factual approach to decision
Effective decisions are based on the analysis of data and information.
- Informed decisions.
- An increased ability to demonstrate the effectiveness of past decisions through
reference to factual records.
- Increased ability to review, challenge and change opinions and decisions.
Applying the principle of factual approach to decision making means:
- Ensuring that data and information are sufficiently accurate and reliable.
- Making data accessible to those who need it.
- Analyzing data and information using valid methods.
- Making decisions and taking action based on factual analysis, balanced with experience
Principle 8 - Mutually beneficial supplier
An organization and its suppliers are interdependent, and a mutually beneficial
relationship enhances the ability of both to create value.
- Increased ability to create value for both parties.
- Flexibility and speed of joint responses to changing market or customer needs and
- Optimization of costs and resources.
Applying the principles of mutually beneficial supplier relationships means:
- Establishing relationships that balance short-term gains with long-term considerations.
- Pooling of expertise and resources with partners.
- Identifying and selecting key suppliers.
- Clear and open communication.
- Sharing information and future plans.
- Establishing joint development and improvement activities.
- Inspiring, encouraging and recognizing improvements and achievements by suppliers.
Thus the revised ISO 9001 standard was developed on a simple process-based structure.
This is a departure from the previous 20-element structure used in the 1994 revision
of ISO 9001. The new process-based structure is more generic and adopts the process-management
approach already widely used in business today. Also, the process-based structure
is consistent with the Plan-Do-Check-Act improvement cycle used in the ISO 14000
standards (on environmental management systems).
ISO 9001:2008's Areas of Focus
Some of the changes reflected in the current standard are:
There is a logical sequence of requirements and guidelines due to process orientation
of the new standards.
A great deal of emphasis has been placed on the role of top management, which includes
its commitment to the development and improvement of quality management systems,
responding to customer needs, consideration of legal and regulatory requirements,
and the establishment of measurable objectives at relevant functions and levels.
An enhanced requirement for "continual improvement" has been introduced, defining
a complete cycle to improve the effectiveness of the quality management system
The concept of "permissible exclusions" to the requirements of ISO 9001:2008 has
been introduced to tackle the wide spectrum of organizations and activities that
use the standard.
There is an organizational requirement to monitor information on customer satisfaction
and/or dissatisfaction as a measure of system performance.
The ISO 9000 Resources
It is considered the responsibility of the top management to provide the necessary
resources. Requirements now include evaluation of the effectiveness of training,
provision of relevant information, internal and external communication, facility
needs, and human and physical factors of the work environment.
A few notable changes have also manifested in terminology. The most important changes
concern the use of the term "organization" instead of "supplier" and the use of
the term "supplier" instead of "subcontractor". These changes respond to the need
to be more consistent with the normal use and meaning of the words.
The number of requirements for documented procedures has been reduced in ISO 9001:2008,
and the emphasis is placed on the organization to display effective operation.
Further detailed changes of less strategic impact are also studied wherever possible
with the intention to simplify or clarify the requirements of the existing standards,
and to make them more "user-friendly".
Continual improvement is a process of increasing the effectiveness of your organization
to fulfill your quality objectives. ISO 9001:2008 requires that you plan and manage
the processes necessary for the continual improvement. ISO 9004:2000 provides information
that will be helpful in going beyond ISO 9001:2008 to improve the efficiency of
your operation. It is recommended that you obtain data from various sources, both
internal and external, to assess the merit of your quality system goals. This information
can also be used to improve process function. Organizations can also expand their
management systems by extending the ISO 9001:2008 structure to comprise the requirements
of the ISO 14001 Environmental management systems. The structural and organizational
requirements of the two management systems have been designed to be compatible.
Impact of ISO 9001:2008 on
QS-9000 was the first automotive management standard that affected the corporate
management and design function of the global automotive supply base. However QS-9000:1998
was a plant-focused management systems standard -standardizing and improving the
product and processes on the plant floor. ISO 9001:2008, which is a quality management
process model will affect the entire enterprise and business processes. ISO 9001:2008
links quality objectives, key processes and continuous improvement. Though the automotive
standard heavily influenced ISO 9001:2008, it doesn't embody all the current scope
of ISO 9001:2008 Requirements. In essence QS-9000-registered companies will lose
their ISO certification if their quality systems are not upgraded accordingly.