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.
Top management makes sure the quality management system is planned so that it satisfies the general requirements in 4.1 and the quality objectives, and that the system stays intact when changes to it are planned and made.
iso-13485-2016::5.4.2 · Quality management system planning →Management review takes place at least once a year. It is held more often where risk to meeting customer requirements rises, whether from internal or external changes that touch the QMS or from problems with performance.
iatf-16949-2016-quality-management-system-for-automotive-production::9.3.1.1 · 9.3.1.1 Quality management system performance →The enterprise sets up and maintains a quality management system that provides a standard, formal and ongoing way of managing the quality of information, so that its enabling technology and its business processes stay in line with business requirements and wit...
cobit-2019::APO11.01 · APO11.01 Establish a quality management system (QMS) →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 →Every computerized system is managed through a defined life cycle within the quality management system, covering the concept, project, operation and retirement phases, with activities that are systematic, planned, defined in procedures and scaled to the system...
gamp-5-good-automated-manufacturing-practice::2.1.2 · 2.1.2 Life Cycle Approach within a Quality Management System →The organization shall have a quality management system that supports the achievement of functional safety and complies with a quality management standard such as IATF 16949, ISO 9001 or an equivalent, since functional safety builds on the quality processes fo...
iso-26262-2018-functional-safety-for-road-vehicles::2:5.4.5 · 5.4.5 Quality management system →Questions people ask about quality management system
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