CLSI QMS02
Developing and Managing Laboratory Documents
CLSI QMS02 Ed7 offers thorough guidance on designing and implementing a strategic laboratory documents management system. his guide includes an effective approach to creating, controlling, changing, and retiring a laboratory's policy, process, procedure, and form documents in both paper and electronic environments.
Use with QMS02 Ed 7 Ten Rules for Laboratory Document Management Quick Guide.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document QMS02—Developing and Managing Laboratory Documents presents the important components of a program for documents management, including creating, reviewing, approving, maintaining, assessing, changing, and retiring documents used in the laboratory environment. This guideline describes the components of a documents management program, whether paper-based or electronic, and the related processes for creating and managing laboratory documents. Key features of electronic document management systems are also described. Several examples of process and procedure documents for quality management and preexamination, examination, and postexamination laboratory activities are included.
This guideline was revised in 2024 under the Limited Revision Process and replaces the 6th edition of the guideline, which was published in 2013. Several changes were made in this edition, including:
• Aligning QMS02 chapters and subchapters with CLSI document QMS26 to first discuss the components of a documents management program, followed by the processes for creating and managing individual documents.
• Aligning QMS02 with the updated CLSI document template.
• Updating information about electronic document management systems to provide additional guidance for use in medical laboratories.
This guideline presents the elements of a program for managing laboratory documents. In addition, an evidence-based process is described for preparing different types of laboratory documents from the time a need is recognized for a new or revised document, through the document’s use and control, until the time it is retired. The information presented applies to both paper-based and electronic document management systems.
This guideline is applicable to documents used by medical laboratories of any size, complexity, or specialty, including point-of-care testing.
QMS02 is intended for use by the following:
• Administrative and technical personnel who develop laboratory documents
• Manufacturers
• Educators
• Regulatory and accreditation organizations
CLSI QMS02QG
Free
Clinical and Laboratory Standards Institute document QMS02—Developing and Managing Laboratory Documents presents the important components of a program for documents management, including creating, reviewing, approving, maintaining, assessing, changing, and retiring documents used in the laboratory environment. This guideline describes the components of a documents management program, whether paper-based or electronic, and the related processes for creating and managing laboratory documents. Key features of electronic document management systems are also described. Several examples of process and procedure documents for quality management and preexamination, examination, and postexamination laboratory activities are included.
This guideline was revised in 2024 under the Limited Revision Process and replaces the 6th edition of the guideline, which was published in 2013. Several changes were made in this edition, including:
• Aligning QMS02 chapters and subchapters with CLSI document QMS26 to first discuss the components of a documents management program, followed by the processes for creating and managing individual documents.
• Aligning QMS02 with the updated CLSI document template.
• Updating information about electronic document management systems to provide additional guidance for use in medical laboratories.
This guideline presents the elements of a program for managing laboratory documents. In addition, an evidence-based process is described for preparing different types of laboratory documents from the time a need is recognized for a new or revised document, through the document’s use and control, until the time it is retired. The information presented applies to both paper-based and electronic document management systems.
This guideline is applicable to documents used by medical laboratories of any size, complexity, or specialty, including point-of-care testing.
QMS02 is intended for use by the following:
• Administrative and technical personnel who develop laboratory documents
• Manufacturers
• Educators
• Regulatory and accreditation organizations