CLSI QMS06 PDF
CLSI QMS06 includes written and graphic descriptions of the fundamental processes and common supporting elements in a continual improvement (CI) program. It provides the user with definitions, concepts, methods, and tools for implementing an effective program and meeting applicable requirements. The CI fundamental processes include:
• Identifying opportunities for improvement (OFIs)
• Selecting an opportunity
• Generating solution(s)
• Implementing solution(s)
• Evaluating the effect of the solution(s)
• Integrating and sustaining improvement(s)
The CI common supporting elements include but are not limited to:
• Management review
• Teamwork
• Improvement models and tools
• Documents and records
• Change management
• Risk management
• Communication
Although quality professionals might differ on various CI definitions, concepts, models, and tools, CLSI QMS06 attempts to consolidate the vast amount of information available while remaining nonprescriptive. CLSI QMS06 encourages using an organized systematic approach to CI, so that optimal outcomes are achieved for the efforts expended.
CLSI QMS06 is intended for use by all organizations and individuals involved in the management or implementation of preexamination, examination, and postexamination phases of medical laboratory examinations. CLSI QMS06 may also be applicable to other laboratories and nonlaboratory settings.
CLSI QMS06 is not meant to be prescriptive, nor a comprehensive instructional manual for using the tools described. It does not cover content and detail covered in other CLSI documents or requirements specific to any regulatory or accreditation organization.
