scope:

QMS17 provides guidance for establishing and maintaining a process to assist the laboratory in achieving a continuous state of readiness for assessment by an external assessment organization. It provides general guidance for:

• Seeking an assessment for the first time
• Considering whether to use a new external assessment organization
• Improving laboratory processes to achieve and sustain positive assessment outcomes

This guideline is intended for use by individuals responsible for the laboratory's external assessment activities. These individuals may include laboratory leadership and management, quality coordinators, compliance officers, clinical research coordinators, and administrative and technical personnel, as well as individuals who want to increase their knowledge in this area. This guideline may be applied to laboratories of any size and functional complexity, including but not limited to:

• Medical laboratories
• Public health laboratories
• Research laboratories
• Cell therapy and tissue processing laboratories
• Veterinary laboratories
• Food laboratories
• Environmental laboratories

This guideline may also have some application in laboratory industry settings, such as manufacturing of blood products, kits, and reagents.

This guideline does not include details specific to the operations and processes of the external accreditation organizations and is intended to cover the laboratory perspective only.

This guideline does not cover proficiency testing (PT) or internal assessments (ie, developing an internal audit program or processes for conducting internal audits, or establishing a program to identify and monitor quality indicators). Refer to CLSI documents QMS24,15 QMS12,16 and QMS1517 for information on PT.