Standards
ISO 9001
ISO 9001 is the ISO standard for quality management systems (QMS): its requirements define how an organisation establishes, implements, maintains and continually improves a QMS, and ISO states that it is the only standard in the ISO 9000 family that can be certified to.
The current edition is ISO 9001:2026 (edition 6, published in September 2026); ISO lists ISO 9001:2015 and its Amendment 1:2024 as withdrawn. ISO says organisations certified to ISO 9001:2015 will have to transition to the new version within the timeframe set by their certification cycle, and should contact their certification body.
ISO calls it the most widely used quality management standard in the world, with more than one million certificates issued to organisations in 189 countries. Certification is not mandatory; ISO describes it as one way to show stakeholders and customers the commitment and ability to consistently deliver high quality products or services.
ISO describes ISO 13485:2016 as the standard for quality management systems in the design and manufacture of medical devices. Ultra Controlo is certified to ISO 9001:2015 and ISO 13485:2016, and to ISO 14001.
Sources
- ISO 9001:2026 Quality management systems, Requirements (iso.org page and FAQ)
- ISO 13485:2016 (iso.org summary)
- Ultra Controlo, Medical gas answers
- ISO 9001:2015 (withdrawn), iso.org page and life cycle
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.