Understand your lab’s current practices and how closely they align with minimum QMS requirements!
CLSI’s new Gap Analysis Tool can help personnel quickly and easily assess whether their laboratory is in compliance with QMS requirements and can track progress toward achieving complete compliance.
More About Gap Analysis
Close Your Gaps
When your laboratory already has adequate policies, processes, procedures, and practices, no gaps exist. Gaps are the areas in which your laboratory does not perform activities that support the QSEs. Gaps occur when the QSE processes followed by managers to meet the laboratory or organization’s needs and procedure instructions for an individual’s actions are not documented. When specific elements of any quality policy, process, or procedure are incomplete, missing, or unclear, your laboratory should close the gap by completing, developing, clarifying, or unifying these documents.
Align With Minimum QMS Requirements
Performing a gap analysis of laboratory quality activities helps your laboratory recognize existing quality activities compared with minimum QMS requirements. Analyze your laboratory’s unique situation and provide a defined starting point for improvement activities. Provide information for creating a customized implementation plan and determining necessary resources.