Clinical and Laboratory Standards Institute guideline QMS17—External Assessments, Audits, and Inspections of the Laboratory outlines the process of selecting an assessment organization, preparing the laboratory for assessment, undergoing the assessment, responding to any deficiencies, and sustaining the state of readiness in a logical, ongoing cycle. This guideline provides expert information from laboratory professionals, industry, and accreditation organization perspectives to assist laboratories in planning for and attaining successful external assessments. External assessments include on-site and virtual audits, inspections, site visits, and surveys of laboratories and can also apply to some laboratory industry settings.

This guideline was revised in 2023 under the Limited Revision Process and replaces the first edition of the guideline, which was published in 2017. Several changes were made in this edition, including: 

• Adding information on virtual external assessment 

• Aligning QMS17 with the updated CLSI document template

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 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 can 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 can 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 only the laboratory perspective.

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 QMS24,14 QMS12,15 and QMS1516 for information on PT, quality indicators, and internal auditing, respectively.