ISO 9001 is an International Standard containing requirements for establishing and maintaining a company's quality management system.

A quality management system is set up by a company to:

This standard can be applied to almost any company - from product manufacturers to service providers. It is not specific to any product or industry.

Rather than specify requirements for your final product - what you produce - ISO 9001 focuses further "upstream" on the processes - or how you produce, ISO 9001 requires systems for controlling the processes you use to develop and produce your products and/or deliver your services. This standard is based on the idea that there are certain elements every quality management system must have in place in order to ensure that quality products and services are consistently provided to the customer on time.

ISO 9001 Quality Management Systems - Fundamentals and Vocabulary defines a process as a "set of interrelated or interacting activities which transforms inputs into outputs".

By identifying and managing the "processes" in your company, your company is embracing the "Process Approach" to management.

ISO 9001 is divided into four main sections that state requirements for the primary process "categories"in your company:

• Management processes, including planning and management review.
• Resource management processes, including human resources, infrastructure, and the work environment.
• Product realization processes, including sales order review, product design, purchasing, calibration, and the actual "production" of your product or service.
• Measurement, analysis and improvement processes, including internal auditing, inspection, testing, and corrective/preventive action.

You can see how these main sections relate to each other in the following diagram:

In this diagram:

• Management defines requirements and objectives for both the organization and the quality management system and identifies the resources needed to achieve them.
• Once you understand what the customer wants, you produce it.
• You measure customer satisfaction and other factors affecting the performance of the system.
• Management reviews the results of the measurements and takes action to improve.

Focusing on the customers' needs and continually improvement is the goal.

Customer Focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. Your company should understand what the customer expects from your products and services, including price, delivery, warranty, etc. Management should focus on managing customer relationships by 'measuring customer satisfaction and taking action on the results.

Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. Your company's management and leaders should: Establish a quality policy / mission statement and quality objectives; Provide the human resources, facilities, and work environment to make a quality product; Demonstrate a commitment to education and training; Provide a stimulating work environment by establishing goals and targets and recognizing individual and organizational accomplishments.

Involvement of People

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. People should be empowered and held responsible to: Solve problems; Seek opportunities for personal and organizational improvement; Focus on the customer's needs.

Process Approach

A desired result is achieved more efficiently when activities and related resources are managed as a process. Managing a process includes: Defining the desired result, such as an assembled component (manufacturing process) or a completed part specification (design process); Identifying and measuring process inputs and outputs; Identifying and managing handoffs and relationships with other processes; Responsibilities for managing the process; Identifying, providing, and supporting the resources required by the process.

System Approach to Management

Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives. To apply this principle, your company should: Identify and develop the system of processes that affect a particular objective; Understand how processes relate to each other in the system; Establish measures to drive continual improvement.

Continual Improvement

Continual improvement of the organizations overall performance should be a permanent objective of the organization. Continual improvement includes actions to improve: Product features and characteristics (making a better product); Process effectiveness and efficiency (to do it with fewer resources, quicker, and "make it right the first time").

Factual Approach to Decision Making

Effective decisions are based on she analysis of data and information. Decisions should not be made based on guesses, hearsay, or personal opinion, but on hard data. As it is often said, "In God we trust, all others bring data".

Mutually Beneficial Supplier Relationships

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. Your company is dependent upon its suppliers to provide a quality product or service to your customers. Developing relationships with key suppliers helps to ensure and improve supplier quality, reliability, and timeliness.

Companies may be "registered" (or "receive certification") to ISO 9001 by applying to a registrar and paying a registration fee. The registrar is a company that will audit your company's quality management system to see if it is meeting all the necessary requirements.

Unlike the 1994 revision of the standard, all companies will now be registered to ISO 9001 - not ISO 9002 or ISO 9003. If certain aspects of ISO 9001 do not apply to your company (for example, if your company doesn't develop its own product designs), your company would exclude those requirements from the scope of its registration.