ISO 9000 is a series of standards that has been deemed to represent good quality management practices by international consensus, consisting of a set of standards and guidelines related to quality management systems.
It is designed to help businesses ensure that they are meeting the needs of their customers and shareholders. The system is published by the International Organization of Standards (ISO), and deals with the fundamentals of quality management as well as the eight management principles on which they are based.
ISO 9000 was first published in 1987, although its roots go back to the MIL-Q-9858 United States Department of Defense standard that was published in 1959. ISO 9000 is based on the standards put forth by the British Standards Institution (BSI) that were presented to the ISO committee in 1979. MIL-Q-985 was revised into a NATO AQAP standard in 1969, which were then revised into the BS 5179 standard in 1974, which were once again revised to become the BS 5750 standard submitted to ISO to become ISO 9000.
The ISO 9000 series consists of the following standards: ISO 9000, ISO 9001, and ISO 9004. They are used when necessary with the ISO 10000 series of guidelines, as well as ISO 16949 and ISO 19011, specific guidelines for the automotive and environmental industries respectively. In its latest edition, ISO 9000 is ISO 9000:2005, and provides the fundamentals and establishes the vocabulary used in the remainder of the ISO 9000 series.
The main standard, ISO 9001:2008, lists the requirements for a QMS, and is the basis for all of the other ISO standards and guidelines in the 9000 and 10000 series. It is the only auditable standard in the series. ISO 9004:2000, the latest edition of that standard, provides guidelines for performance improvements in a wider spectrum than does ISO 9001 for sustained success in quality systems.
The ISO 9001:2008 standard consists of eight sections, with the last five being specific to the establishment of a quality management system that is sustainable and auditable. Specifically, they are:
- Chapter 4: Overview of Systemic Requirements – This is a general introduction to the requirements of Chapters 5 through 8, and establishes the baseline for developing a quality management system based on ISO 9000:2008. This section requires a business to develop and maintain a quality manual, control quality documents, and maintain all records related to quality. It states that your procedures manual and documents must reflect what the business is doing and the manner in which it is to be accomplished.
- Chapter 5: Overview of Management Requirements – This section defines the six sets of requirements that the management of a business must follow. It states that management must satisfy customers, support quality requirements, establish the policy for quality within an organization, perform periodic reviews, carry out the quality policy laid out, and control the quality system.
- Chapter 6: Overview of Resource Requirements – Chapter 6 requires the recognition and establishment of quality resources within the business, including personnel, work environments, and infrastructure. Personnel placed in quality roles must be competent. Work environments must be fit to ensure a quality product is built. Infrastructure to fit the needs of the quality program must exist and maintained.
- Chapter 7: Overview of Realization Requirements – This section of ISO 9001:2008 requires a business to recognize the processes that bring a product or service into being. A business must control customer processes, planning processes, and production processes. The quality aspects of the business’s product must be identified and controlled, and customer communication processes must be developed and controlled. Product design and development outputs must be controlled, and must be approved prior to implementation. These outputs must then be used to control product quality. Chapter 7 also establishes the need for validation, review, and design of a process, as well as the need to manage changes required of the product.
- Chapter 8: Overview of Remedial Requirements – This final section requires that a business execute remedial actions as necessary based on a plan devised and provided by the organization. This includes the measurement and monitoring of processes used to demonstrate conformance with the ISO standard, and improve the quality of the processes and product. Chapter 8 sets forth requirements for the control of non-conforming products, including records establishment and maintenance, controlling their use, and verifying that the non-conformances have been corrected. This chapter also lays out the requirements of a continuous quality improvement process to prevent future non-conformities from occurring.
Presently, there are over 350,000 companies in over 100 different countries that are certified in the ISO 9000 process.
Organizations who invest the time and effort to become certified under the ISO 9000 process demonstrate to the business community that they are committed to creating their product based on a set of internationally-accepted standards.
Certification involves creating a QMS based on the criteria set forth in ISO 9001:2008, and then agreeing to commit to audits, both internal and external to the organization, to ensure that they are maintaining those standards.
ISO 9000 certification helps a business not only helps the organization develop and maintain an actionable QMS, but can also help it market that quality commitment to other businesses and consumers to expand its presence in its market niche.