CLSI QMS14
Quality Management System: Leadership and Management Roles and Responsibilities
CLSI QMS14-Ed2 enhances your lab's leadership skills, helping meet quality management system requirements. This guide enables leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory that are essential for managing and sustaining quality.
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Free
{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute QMS14-Ed2—Quality Management System: Leadership and Management Roles and Responsibilities assists laboratories in meeting the leadership-based requirements for a QMS, as represented by quality system essential Organization and Leadership. It presents a conceptual framework of three organizational dimensions (ie, cultural, structural, and functional) and provides content for managing laboratory quality.
This guideline was revised in 2024 under the limited revision process and replaces the 1st edition of the guideline, which was published in 2012. Several changes were made in this edition, including:
• Aligning content to the content in the current edition of CLSI QMS01
• Eliminating content now covered in CLSI documents that did not exist when this guideline was published in 2012.
• Aligning CLSI QMS14 to the updated CLSI document template.
This guideline can be used by organizations and individuals involved in managing or operating preexamination, examination, and postexamination laboratory processes. It is applicable to:
• Medical laboratories
• Blood gas laboratories
• Blood donor and pretransfusion testing laboratories
• Public health laboratories
• Clinical research laboratories
This guideline does not describe, in detail, topics and content covered in other CLSI documents. In addition, it does not reference requirements specific to any regulatory agency or accreditation organization. It is suggestive and not prescriptive in approach. It is not a comprehensive instructional manual for applying the concepts discussed, and it does not include detailed instructions or plans for how to design an organizational structure, implement a QMS, allocate resources, or create quality policies, processes, or procedures.
The concepts, descriptions, and examples provided apply to laboratories of any size, functional complexity, scope of service, and organizational structure. This guideline is applicable to any laboratory’s QMS, regardless of its comprehensiveness and stage of development. This guideline is also applicable regardless of the regulations or accreditation program followed by a laboratory. Laboratories can use this guideline to assist in justifying the need for a QMS, designing or implementing a QMS, and/or maintaining and improving an established QMS.
Free
Clinical and Laboratory Standards Institute QMS14-Ed2—Quality Management System: Leadership and Management Roles and Responsibilities assists laboratories in meeting the leadership-based requirements for a QMS, as represented by quality system essential Organization and Leadership. It presents a conceptual framework of three organizational dimensions (ie, cultural, structural, and functional) and provides content for managing laboratory quality.
This guideline was revised in 2024 under the limited revision process and replaces the 1st edition of the guideline, which was published in 2012. Several changes were made in this edition, including:
• Aligning content to the content in the current edition of CLSI QMS01
• Eliminating content now covered in CLSI documents that did not exist when this guideline was published in 2012.
• Aligning CLSI QMS14 to the updated CLSI document template.
This guideline can be used by organizations and individuals involved in managing or operating preexamination, examination, and postexamination laboratory processes. It is applicable to:
• Medical laboratories
• Blood gas laboratories
• Blood donor and pretransfusion testing laboratories
• Public health laboratories
• Clinical research laboratories
This guideline does not describe, in detail, topics and content covered in other CLSI documents. In addition, it does not reference requirements specific to any regulatory agency or accreditation organization. It is suggestive and not prescriptive in approach. It is not a comprehensive instructional manual for applying the concepts discussed, and it does not include detailed instructions or plans for how to design an organizational structure, implement a QMS, allocate resources, or create quality policies, processes, or procedures.
The concepts, descriptions, and examples provided apply to laboratories of any size, functional complexity, scope of service, and organizational structure. This guideline is applicable to any laboratory’s QMS, regardless of its comprehensiveness and stage of development. This guideline is also applicable regardless of the regulations or accreditation program followed by a laboratory. Laboratories can use this guideline to assist in justifying the need for a QMS, designing or implementing a QMS, and/or maintaining and improving an established QMS.