ISO 9001

Quality management systems

"All improvement happens project by project and in no other way", Joseph Juran

ISO 9001 is certainly the best known management system standard and probably one of the most popular standards ever published in the world.

First publication of ISO 9001 was in 1987. That edition was based on a British Standard (BS 5750) but the history of quality assurance and control goes back to the MIL-Q-9858 specification that was developed in 1966 by the American Department of Defense as a program to assure adequate quality of products and services contracted by the United States army.

Since the first publication, ISO 9001 has been revised four times - in 1994, 2000, 2008 with the last revision in 2015. Standards are being revised periodically in order to keep them relevant for the market and respond to the changes in technology, business diversity and global commerce.

ISO 9001 is applicable to all types of organizations, regardless of size and activity and has been adopted all around the world with more than 1.000.000 certifications globally according to the ISO Survey.

ISO 9001 is part of a family of standards that also includes ISO 9000 (covering basic concepts and language), ISO 9004 (that focuses on how to make a quality management system more efficient and effective) and ISO 19011 (which sets out guidance on audits of quality management systems). Out of them only ISO 9001 includes the requirements for a quality management system and can be used for certification.

Starting from the requirements of ISO 9001 other quality management system standards have been developed for different industries. These standards usually include the requirements of ISO 9001 with particular elements specific to the industry. Some examples are ISO/TS 16949 applicable for the development, production and, when relevant, installation and service of automotive-related products; AS 9100 for companies that build aircraft, spacecraft or related parts and assemblies; ISO 13485 that specifies the requirements for design and development, production, storage and distribution, installation, or service of medical devices or ISO/TS 29001 which defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.

A quality management system is a set of processes, policies and procedures needed by an organization to plan and perform its activities (regardless whether its production or service provision).

ISO 9001 certification is the process through which a third-party (usually called certification body or registrar) audits an organization's quality management system conformity with the requirements of the standard and if the results are positive issues a confirmation (usually a certificate of conformity).

The certification is valid for 3 years from the date of the certification decision as long as the conformity of the quality management system is maintained by the certified organization and this is confirmed through yearly surveillance audits.

An organization may choose to implement ISO 9001 together with other management system standard (like ISO 14001, ISO/IEC 27001, ISO 50001 or OHSAS 18001, among others) in what is called an integrated management system and the evaluation for certification can be done simultaneously in an integrated audit.

 

Interested in an online course on ISO 9001:2015 requirements and auditing?

Follow this link: ISO 9001:2015 Quality Management Systems Auditor.