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Laboratory Quality Management System (LQMS)

Laboratory Quality Management System (LQMS)

by Bruna De Lucca Caetano | Jul 14, 2023 | Laboratory, QMS

A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and practices implemented in a laboratory to ensure consistent quality and accuracy in its operations. Various standards and regulations outline specific requirements for...
What is ISO 15189? A Detailed Introduction (and Role of eQMS)

What is ISO 15189? A Detailed Introduction (and Role of eQMS)

by Allan Murphy Bruun | Feb 7, 2023 | Laboratory, QMS, Regulations

The ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical laboratories. The medical laboratory is essential to patient care since decisions on patient treatment are made based on laboratory results. The...
Laboratory Document Control: A Simple (But Complete) Guide

Laboratory Document Control: A Simple (But Complete) Guide

by Allan Murphy Bruun | Nov 4, 2022 | Document Control, Laboratory

An efficient laboratory document control system is essential for the lab manager to keep records of all processes in place and documents always up-to-date. Medical laboratories and testing companies must have complete control over their documents and protocols to...
Laboratory Audits: Overview, Guide, and Tips

Laboratory Audits: Overview, Guide, and Tips

by Germans Frolovs | Feb 25, 2022 | Audits, Laboratory

Regulatory bodies such as the ISO and the FDA frequently evaluate laboratory operations to check compliance. Because laboratories guarantee quality in medical device and pharmaceutical companies’ operations, any non-conformance in the laboratory can mean...

Recent Posts

  • Quality Management System Documentation
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  • FDA 21 CFR Part 11 vs EU Annex 11: What is the Difference?
  • Laboratory Quality Management System (LQMS)
  • ICH Q10 Pharmaceutical Quality System (and Role of an eQMS)

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