What is a Quality Management System (QMS)?
The system of organisational structures, procedures, responsibilities and evaluation mechanisms which ensure an organisation is capable of delivering the service to specific standards.
Who is responsible for the QMS?
An assigned quality manager is responsible for ensuring the QMS functions correctly but overall responsibility falls to the head of the laboratory. All members of staff have responsibility to be aware of QMS.
What are the 9 main components of a QMS?
1) Quality Manual
2) QMS Documentation
3) Quality Assurance
4) Internal Quality Control
5) Quality Improvement - Audits, non conformance, KPI etc
6) Continual Improvement
7) Quality assessment e.g. EQA
8) Audit
9) Accreditation
What is included in the quality manual?
It documents the quality policy, describes the QMS, outlines how an organisation seeks to comply with standards (i.e. UKAS), outlines a commitment to good professional practice and health and safety and must be read by all members of staff.
What are some examples of QMS documentation?
Quality Manual, COSHH & Risk assessment, SOPs, Health & Safety, Meeting records & minutes, Job descriptions, staff training records, reagent batch records etc.
