What ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes requires
ISO 13485:2016 specifies requirements for a quality management system (QMS) for organizations involved in the lifecycle of a medical device. It requires organizations to demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, as mandated by Clause 4.1 for establishing and maintaining an effective QMS.
Pillar: Medical & Healthcare · Authority: International Organization for Standardization (ISO) · Version: 1.0.0 · Last updated:
Primary source: https://www.iso.org/standard/59752.html
SHA-256 integrity: 5106e2143daf82a5ac7b78f14f0acd87d525ea4e69613e0dfa88c22761b179fb
Primary Citations — 7 traced to source
- ISO 13485:2016, Clause 4: Quality management system
- ISO 13485:2016, Clause 5: Management responsibility
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