What is ISO 9000?

ISO 9000 Definition

ISO 9000 is a series of quality management system standards that have been created to help organizations ensure that they meet the needs of their stakeholders, such as customers, shareholders, personnel, etc., while at the same time complying with statutory and regulatory requirements.

The ISO 9000 series consists of the following standards:

  • ISO 9000:2015 – defines the specifics of quality management systems, which form the basis of the ISO 9000 family, while also stipulating the terms used in these standards.
  • ISO 9001:2015 – this is the requirement standard which provides directions on how to achieve quality requirements, meet the relevant regulatory requirements, improve satisfaction for all stakeholders and have a method of identifying and implementing improvements.
  • ISO 9004:2018 – offers guidance for sustained success according to the eight quality management principles. It lays out the principles that senior management should use to improve performance while taking into account the requirements of all stakeholders.
  • ISO 19011:2018 – sets out guidance on internal audits, which are used to confirm and improve the effectiveness of a quality management system, and external audits, which are generally audits of suppliers but can also be done by any interested third parties.

ISO 9001 is the only auditable standard for which third party certification and auditing organizations provide independent confirmation that the requirements of that standard are met.

ISO 9000 was introduced in 1987 and was based on the BS 5750 series of standards as presented by the British Standard Institute (BSI) to the International Organization for Standardization (ISO) in 1979. Before that it can trace its roots to the MIL-Q-9858 US Department of Defense standard that was published in 1959.

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Manage compliance for ISO 9001/13485/14001/17025/22000/45001 & IATF 16949.

 

Contains document control, training, complaints, audit, non-conformance, risk & CAPA modules.