CLSI QMS15
Laboratory Internal Audit Program
CLSI QMS15-Ed2 offers expert guidance on a robust laboratory internal audit program designed to drive continual quality improvement. This guideline outlines the essential components of an effective program, defining responsibilities, scope, timing, procedures, and execution to help labs meet regulatory and quality requirements with confidence.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline QMS15—Laboratory Internal Audit Program provides recommendations for establishing an internal audit program and related processes for enhanced quality and continual improvement in the laboratory. The audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, and the audit process describes the details of conducting an audit. Committed laboratory leadership and individuals willing to share their expertise and experience enable a successful internal audit program.
This guideline replaces the previous edition of the approved guideline, QMS15-A, published in 2013. Several changes were made in this edition, including:
• Reorganizing the justification for the internal audit program
• Adding a subchapter on auditor training and competence assessment
• Revising the responsibilities of the functional roles
• Revising the audit process flow chart
• Adding a subchapter on audit criteria
• Reorganizing the audit process chapter
• Adding more appendixes
This guideline is intended for use by laboratory leaders, such as directors, managers, and supervisors, as well as other laboratorians who perform laboratory testing. This guideline focuses on using an internal audit program to actualize the laboratory’s commitment to quality, good professional practice, and continual improvement by identifying problematic processes. The audit program described in this guideline can be used in laboratories worldwide. This guideline is intended for use primarily by:
• Medical laboratories
• Blood gas laboratories
• Blood donor and pretransfusion testing laboratories
• Public health laboratories
• Research laboratories
The examples provided are applicable to laboratories of any size and functional complexity. This guideline is not intended for use by laboratories involved in examinations for clinical trials, because the requirements applied to those laboratories are more stringent. This guideline does not include audit program details available in published materials on auditing.
Clinical and Laboratory Standards Institute guideline QMS15—Laboratory Internal Audit Program provides recommendations for establishing an internal audit program and related processes for enhanced quality and continual improvement in the laboratory. The audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, and the audit process describes the details of conducting an audit. Committed laboratory leadership and individuals willing to share their expertise and experience enable a successful internal audit program.
This guideline replaces the previous edition of the approved guideline, QMS15-A, published in 2013. Several changes were made in this edition, including:
• Reorganizing the justification for the internal audit program
• Adding a subchapter on auditor training and competence assessment
• Revising the responsibilities of the functional roles
• Revising the audit process flow chart
• Adding a subchapter on audit criteria
• Reorganizing the audit process chapter
• Adding more appendixes
This guideline is intended for use by laboratory leaders, such as directors, managers, and supervisors, as well as other laboratorians who perform laboratory testing. This guideline focuses on using an internal audit program to actualize the laboratory’s commitment to quality, good professional practice, and continual improvement by identifying problematic processes. The audit program described in this guideline can be used in laboratories worldwide. This guideline is intended for use primarily by:
• Medical laboratories
• Blood gas laboratories
• Blood donor and pretransfusion testing laboratories
• Public health laboratories
• Research laboratories
The examples provided are applicable to laboratories of any size and functional complexity. This guideline is not intended for use by laboratories involved in examinations for clinical trials, because the requirements applied to those laboratories are more stringent. This guideline does not include audit program details available in published materials on auditing.