Quality Management System
What is Quality Management System?
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
Terms that appear alongside quality management system
Each of these is named in at least one of the same controls as quality management system. The number is how many controls name both.
- management system 35 shared controls
- quality management 35 shared controls
- audit 9 shared controls
- compliance 9 shared controls
- policy 5 shared controls
- accountability 4 shared controls
- baseline 4 shared controls
- change management 3 shared controls
Frameworks that govern quality management system
What the standards actually require on quality management system
Requirements naming quality management system across 6 standards, quoted from the control text.
Providers must put in place a quality management system that ensures compliance with the Regulation, documented systematically in written policies, procedures and instructions, covering at least: a regulatory compliance strategy including conformity assessment...
EUAI-Art.17 · Quality management system →Requirement defined in ISO 9001:2015, clause 4.4 (Quality management system and its processes). See licensed source for normative text.
iso-9001-2015::4.4 · Quality management system and its processes →Establish, implement, maintain, and continually improve the QMS and its processes
AS9100D-4.4 · Quality Management System and Its Processes →Section 820.10 establishes the substantive QMS requirements by incorporating ISO 13485:2016 SECTIONS 4 THROUGH 8 in full. Manufacturers must implement: ISO 13485:2016 SECTION 4 General QMS requirements + documentation (Quality Manual + Medical Device File + co...
QMSR-820.10 · Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10) →Section 5 establishes sponsor responsibilities and quality management. Sponsor must implement a Quality Management System (QMS) per R3 covering: risk identification + assessment + mitigation + acceptance + monitoring + review;
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-Vendor · ICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight →The manufacturer shall apply a quality management system to the processes covered by this standard. If the manufacturer does not have such a system, at minimum risk management, configuration management, and problem resolution processes shall be established.
IEC62304-4.1 · Quality Management System →Questions people ask about quality management system
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