What Is ISO 9000?
ISO 9000 is a set of standards for quality management, developed as an internationally-acceptable baseline for performance by businesses and other organizations. It was created by the International Organization for Standardization (ISO) with input from standards professionals from many nations.
Quality management is the act of overseeing all of the processes that go into achieving and maintaining the desired level of excellence in the creation and delivery of a product or service. This includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and improvement. It is also referred to as total quality management (TQM).
- ISO 9000 is a set of internationally recognized standards for quality assurance and management.
- Published by the International Organization for Standardization, it aims to encourage the production of goods and services that meet a globally-acceptable level of quality.
- ISO 9000 lays out best practices, guidelines, and a standard vocabulary for quality management systems.
- ISO 9001 is the portion of ISO 9000 that consists of action items for a business or other organization that seeks ISO certification.
Understanding ISO 9000
ISO 9000 standards were developed to help manufacturers effectively document the quality system elements that need to be implemented to maintain an efficient quality system. They are increasingly being applied to any organization or industry.
ISO 9001 is now being used as a basis for quality management—in the service sector, education, and government—to help organizations satisfy their customers, meet regulatory requirements, and achieve continual improvement.
The ISO 9000 series, or family of standards, was originally published in 1987 by the International Organization for Standardization (ISO). They first gained popularity in Europe, and then spread to the U.S. in the 1990s. As the world’s view of quality assurance has evolved, the standards have been revised.
Current versions of ISO 9000 and ISO 9001 were published in September 2015.
ISO 9000 lays out best practices, guidelines, and a standard vocabulary for quality management systems.
ISO 9000 Standards
ISO 9000 lays out in detail the fundamentals and vocabulary of quality management systems.
The actionable portion of ISO 9000 is ISO 9001. Organizations that receive certification are being recognized as meeting ISO 9001. Obtaining that certification is a process that takes over a year and requires substantial documentation to demonstrate conformity with the standards.
The ISO 9000 family contains these standards:
- ISO 9001:2015: Quality Management Systems—Requirements
- ISO 9000:2015: Quality Management Systems—Fundamentals and Vocabulary (definitions)
- ISO 9004:2009: Quality Management Systems—Managing for the Sustained Success of an Organization (continuous improvement)
- ISO 19011:2011: Guidelines for Auditing Management Systems
How to Become ISO 9001 Certified
ISO certification is provided by third-party organizations, not by the ISO itself.
A company or other organization seeking certification would first implement the quality management recommendations contained in ISO 9000. It would then conduct an internal audit or obtain the services of an external auditor to evaluate its compliance with the standards. It would then call in an organization that is authorized to review its compliance and issue certification.
The ISO website has information on selecting a certification body.
In the U.S., the ANSI National Accreditation Board (ANAB) provides information about companies that it has accredited to conduct certification services for compliance with ISO and other quality standards.
About one million organizations around the world have received ISO 9001 certification.
Benefits of ISO 9000
Adoption of ISO standards is strictly voluntary. Gaining certification can be a time-consuming and expensive undertaking. Nevertheless, there are a number of benefits to meeting ISO standards.
The organization cites several benefits to gaining certification, including increased confidence from consumers and stakeholders, holding a competitive edge, and obtaining greater ease in meeting government-mandated regulations in any jurisdiction in which the company does business.
For example, the Toro Company has a section on its website devoted to the ISO 9001 certification it has received for the management practices used to produce its commercial products and irrigation systems.
It is among about one million companies globally that have been certified as meeting ISO 9000 standards. An online database offers access to most certified organizations.
History of ISO 9000
ISO 9000 is perhaps the best known and most widely adopted set of standards produced by the International Organization for Standardization.
Established in 1947, ISO is an independent, non-governmental body that develops and publishes technical, industrial, and commercial standards based on input from 160 member nations.
Its standards aim to establish management practices that produce safe, reliable, and high-quality products and services at a globally acceptable level.
The organization has published more than 24,000 standards that it recommends. Most notably, it publishes a set of environmental standards, ISO 14001, for companies and organizations that want to adopt an effective environmental management system.
Other standards fall into a number of categories, including health and safety, energy management, food safety, and information technology security.
What Is Quality Management?
In general, quality management focuses on long-term goals through the implementation of short-term initiatives.
Quality control (QC) is a key part of quality management and assurance, through which a business seeks to ensure that product quality is maintained or improved with reduced or zero errors.
Quality control requires the business to create an environment in which both management and employees strive for perfection. This is done by training personnel, creating benchmarks for product quality, and testing products to check for statistically significant variations.
A major aspect of quality control is the establishment of well-defined controls. These controls help standardize both production and reactions to quality issues. Limiting room for error by specifying which production activities are to be completed by which personnel reduces the chance that employees will be involved in tasks for which they do not have adequate training.
What Are the ISO 9000 Requirements?
The ISO 9000 requirements address the fundamentals of quality management in any organization. They specify in detail the standards that must be met throughout the process of planning, producing, and delivering a product or service.
Major subject areas included in ISO 9000 include manufacturing processes, equipment maintenance, record-keeping, employee training, and customer relations.
The organization behind ISO 9000 was formed to meet the demands of international commerce and the standards are based on input from regulators from many countries. The intent is to encourage the production of products and services that meet the standards of any country in which they may be purchased.
What Is the Difference Between ISO 9000 and ISO 9001?
The titles are often used interchangeably. ISO 9001 is a section of ISO 9000 and consists of the primary action items for reaching ISO 9000 compliance.
What Is the Difference Between ISO 9000 and ISO 14000?
ISO 9000 and ISO 14000 are both sets of standards created and published by the International Organization for Standardization.
- ISO 9000 is devoted to quality management. It is designed to help companies and other organizations ensure that the products and services they create and the processes they use to create them meet a high standard of quality and integrity.
- IDO 14000 is a set of standards for companies and other organizations that want the processes they use and the products they create to have a minimal adverse impact on the environment.
What Are the Costs of ISO 9000?
A small organization seeking ISO 9000 certification might spend $10,000 to $15,000 preparing for and obtaining certification. The costs include the ISO 9000 manual (about $240) and auditor fees (about $1,300 per day).
The costs depend on the size and complexity of the organization and the degree to which they already have a quality management system in place.