Definitions #
A set of rules and processes a company follows to ensure its products are safe and effective, especially for medical devices.
Technical A formalized framework of policies, procedures, and records to ensure a medical device consistently meets customer and regulatory requirements, as per ISO 13485 or 21 CFR Part 820.
Example The manufacturer's QMS must include design controls, risk management, and corrective action procedures for every medical device class.
Etymology #
Quality (from Latin qualitas, 'of what kind') + management (from manage, 'to handle or control') + system (from Greek systēma, 'an organized whole'). The term gained wide use in manufacturing in the 20th century, later applied to medical devices.
Collocations #
- QMS documentation QMS 文档体系，包括质量手册、程序文件、作业指导书和记录
- QMS audit QMS 审核，检查体系有效性
- CAPA process 纠正和预防措施流程
Real Business Examples #
- The QA manager conducted an internal QMS audit ahead of the ISO 13485 re-certification visit.
- ALL medical devices must be designed and manufactured under a compliant QMS to receive CE marking.
Register & Variants #
- Register: formal
- BrE/AmE: 全球通用，但美式常称 QMS 与 21 CFR 820
Synonyms & Antonyms #
- Synonyms: Quality System, QMS
Common Errors #
- Believing ISO 13485 is the same as ISO 9001 ISO 13485 adds specific requirements for regulatory compliance and risk management in medical devices, while ISO 9001 is general.
- Documenting but not following the QMS The QMS must be actually implemented and continuously improved; documentation alone is insufficient during audits.
Confusable Terms #
- Quality Assurance (QA) vs Quality Management System
- QA is a subset of QMS focused on planning and preventing defects; QMS is the whole system including QA and QC.
Frequently Asked Questions
Is ISO 13485 mandatory for medical device manufacturers??
In many jurisdictions, yes, or an equivalent QMS is required for regulatory approval (e.g., FDA does not certify to ISO 13485 but requires a QMS under 21 CFR 820).
What are the main QMS components??
Typical components include document control, management responsibility, resource management, product realization, measurement, analysis, and improvement (CAPA).
Published: 2026-09-23 Category: Medical Devices