What You Need To Know About Development and Control of Laboratory Documents
September 18, 2013 at 2:00 PM EDT (60 minutes)
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Document control remains a frequently cited deficiency in many laboratory inspections. The first half of this webinar will illustrate how a hospital-based transfusion medicine laboratory uses CLSI document GP02-A5—Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition to address this issue. The second half of this webinar will showcase the document’s recently published replacement: CLSI document QMS02-A6—Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition. Four key features that help laboratories meet published regulations, accreditation requirements, and international standards for documents and document management will be featured. Suggestions on how to meet these requirements will also be discussed.


Learner Level: Intermediate

At the conclusion of this program, the participant will be able to:

  • Discuss issues to consider for document control, including standardization, review and approval, archiving, and storage.
  • Compare and contrast manual vs electronic document control systems.
  • Describe the changes included in the new QMS02-A6 and how these changes can help laboratories meet regulatory and accreditation requirements.


Related Document:

QMS02-A6 (Replaces GP02-A5)Quality Management System: Development and Management of Laboratory Documents; Approved Guideline—Sixth Edition


Continuing Education Credit:
Each webinar participant will receive 1.0 Continuing Education Credit. CLSI is an approved provider of continuing education programs in the clinical laboratory sciences by the American Society for Clinical Laboratory Science (ASCLS) P.A.C.E.® Program.


Each registration is for one computer connection to the program. Additional participants who wish to view from their own computer must register separately. If additional connections are used from your registration, a registration fee for each connection will be billed to you.


CLSI member discounts apply. Please call CLSI customer service (610.688.0100) to obtain the correct code so that you can receive your member discount.

Geralyn M. Meny, MD, MS
Director of Transfusion Medicine, University Hospital and Clinical Professor
University of Texas Health Science Center at San Antonio
San Antonio, TX


Sherrie Warner, MT(ASCP)
Manager of Transfusion Medicine
University Hospital
San Antonio, TX



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