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ISO 10993-7:2026 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

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ISO 9000:2026

ISO 9000:2026 Quality management — Fundamentals and vocabulary

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This publication was last reviewed and confirmed in 2026.

Quality management — Fundamentals and vocabulary

Description

This document establishes the fundamental concepts and principles of quality management which are universally applicable to the following:

  • organizations seeking sustained success through the implementation of a quality management system (QMS);
  • customers seeking confidence in an organization’s ability to consistently provide products and services conforming to their requirements;
  • organizations seeking confidence in their supply chain that product and service requirements will be met;
  • organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management;
  • organizations performing conformity assessments against the requirements of ISO 9001;
  • providers of training, assessment or advice in quality management;
  • developers of related standards.

This document defines terms that apply to all quality management documents and QMS standards developed by ISO/TC 176.

This document is applicable to all organizations, regardless of size, complexity or business model.

Edition

5

Published Date

2026-06-19

Status

PUBLISHED

Pages

53

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

This document establishes the fundamental concepts and principles of quality management which are universally applicable to the following:

  • organizations seeking sustained success through the implementation of a quality management system (QMS);
  • customers seeking confidence in an organization’s ability to consistently provide products and services conforming to their requirements;
  • organizations seeking confidence in their supply chain that product and service requirements will be met;
  • organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management;
  • organizations performing conformity assessments against the requirements of ISO 9001;
  • providers of training, assessment or advice in quality management;
  • developers of related standards.

This document defines terms that apply to all quality management documents and QMS standards developed by ISO/TC 176.

This document is applicable to all organizations, regardless of size, complexity or business model.

Previous Editions

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