Quality management system (QMS)
A quality management system (QMS) is the set of processes, responsibilities and records an organisation uses to deliver products or services that consistently meet customer and regulatory requirements. ISO 9001 sets the general requirements for one. ISO 13485 sets the medical-device version, which device regulators rely on.
- Short form
- QMS
- Clauses
- ISO 9001:2015 4.4 · ISO 13485:2016 4.1 · ISO 13485:2016 4.2.2
Where the term appears
ISO 9001:2015 4.4 asks you to establish, implement, maintain and continually improve a QMS, and to define the processes it needs: their inputs and outputs, order, criteria, resources, owners and risks. ISO 13485:2016 4.1 asks you to document the QMS and maintain its effectiveness against the standard and the regulations that apply to you, to record the regulatory role you play (manufacturer, importer or distributor, for example), and to control outsourced processes. The ISO 9001 and ISO 13485 pages cover each standard.
Improve or maintain
ISO 9001 expects continual improvement. ISO 13485 puts the weight on keeping the system effective and changes controlled, because a device’s safety depends on processes staying validated. ISO 13485:2016 4.2.2 also still requires a quality manual, which ISO 9001:2015 dropped, so an auditor moving between the two will ask for it.
How Sted uses it
- Sted’s knowledge base holds 64 policies and procedures, 3 notices and charters, and 168 record templates, each tagged to the clauses it serves.
- For ISO 9001 Sted’s knowledge base carries 17 policies and procedures and 41 record templates tagged to its clauses, and for ISO 13485 23 policies and procedures and 60 record templates.
Related terms
- ISMS: the information security counterpart, on the same clause structure as ISO 9001.
- Documented information: the documents and records a QMS keeps.
- CAPA: the improvement process at the heart of a device QMS.
- Management review: where top management checks the QMS still works.