ISO 9000
ISO 9000 is a set of standards on quality management accepted, and used internationally. ISO 9000 standards are designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product.[1]
ISO 9000 standards help companies effectively document the quality system elements to be implemented to maintain an efficient quality system. ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement. However, it should be considered to be a first step, the base level of a quality system, not a complete guarantee of quality. They are not specific to any one industry and can be applied to organizations of any size. [2]
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.[3]
Standards in the ISO 9000 family include:
- ISO 9001:2015 - sets out the requirements of a quality management system
- ISO 9000:2015 - covers the basic concepts and language
- ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective
- ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.
ISO 9000 vs. 9001
ISO 9000 is a series, or family, of standards. ISO 9001 is a standard within the family. The ISO 9000 family of standards also contains an individual standard named ISO 9000. This standard lays out the fundamentals and vocabulary of quality management systems (QMS).[4]