Personal tools
You are here: Home / Resources / Accreditation and Assessment
Disclaimer

All of the web links and documents that are available on this site undergo a scheduled review for accuracy and relevance. The current documents and links were last reviewed in May 2020.

All documents are intended as examples and must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications.

Please feel free to contact us at smile@jhmi.edu with suggestions, comments, and items for submission; or if there are any issues with links or documents.

Plone Help

 

 

Accreditation and Assessment

Related Items Stored in Other Folders
Accreditation Organizations
Impact of Laboratory Accreditation on Patient Care and the Health System
Acc00-13
PBMC Laboratory Readiness Guide and Resources
Audit Reference - Weblink on HANC for PBMC Laboratory Readiness Guide Acc00-15
Requirements for Laboratories Performing Testing for DAIDS-Supported and/or Sponsored Clinical Trials
Weblink to DAIDS requirements for Clinical Trails. Acc00-17
Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trails Requirements for U.S. Laboratories
Weblink to DAIDS requirements for Clinical Trails- Acc00-18
Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials Requirements for Non-U.S Laboratories
Weblink to DAIDS requirements for Clinical Trails - Non U.S. Lab - Acc00-19
DCLOT Algorithm for Determining Level of Validation Required for Endpoints Assays
Weblink to DAIDS requirements for Clinical Trails Add III - Acc0020
Code of Federal Regulations for Good Laboratory Practice for Non-Clinical Studies
21 CFR Part 58 Acc00-ND
Code of Federal Regulations for Clinical Laboratories
42 CFR Part 493 Acc00-ND
SIVCO Inspection Management Software
Software to manage internal audit and accreditation inspection requirements Acc00-ND
GLI Quality Tool for Laboratory Accreditation
Audit Reference - Organization and Personnel - Website with step-by-step instruction on getting accreditation for your TB laboratory - Acc-ND
File Microsoft Word Document DAIDS Audit Preparation Guideline.doc
File Microsoft Word Document Lab Self Inspection Worksheet - Microbiology
SMILE created Worksheet for self inspection of microbiology laboratory.
File Study Plan Used for a Specific Laboratory Endpoint Assay Example
Audit Reference - Introduction - An example of a Study Plan for Laboratory Endpoint Assay

Document Actions