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ISO 9000:2008 Quality management
ISO 9001:2008 Quality Management Systems

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Background

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 organization:

  • 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 a system.

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 “idea” 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.

Key benefits:

  • 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 satisfaction.
  • 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 expectations.
  • 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.

Key benefits:

  • People will understand and be motivated to achieve the organization's goals and objectives.
  • 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 and accountability.
  • 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.

Key benefits:

  • 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 experience.
  • 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 as processes.

Key benefits:

  • 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 the organization.
  • 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.

Key benefits:

  • 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.

Key benefits:

  • Performance advantage through improved organizational capabilities.
  • Alignment of improvement activities at all levels of the organization's strategic intent.
  • 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 making

Effective decisions are based on the analysis of data and information.

Key benefits:

  • 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 and intuition.

Principle 8 - Mutually beneficial supplier relationships

An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

Key benefits:

  • Increased ability to create value for both parties.
  • Flexibility and speed of joint responses to changing market or customer needs and expectations.
  • 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:

Sequence

There is a logical sequence of requirements and guidelines due to process orientation of the new standards.

top Management

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.

Continual Improvement

An enhanced requirement for "continual improvement" has been introduced, defining a complete cycle to improve the effectiveness of the quality management system

Permissible Exclusions

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.

Customer Satisfaction

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.

Terminology

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.

Documentation

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.

Other Changes

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

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-9000:1998

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.

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