Technical and Operational Best Practices

Quality Management

Formalized QA/QC policies are developed by biospecimen resources to minimize errors that could adversely affect scientific results. QA/QC policies are customized for the intended and potential uses of biospecimens in a given biospecimen resource.

B.3.1. Quality Management System

Biospecimen collection, processing, management, and distribution should be carried out within a quality management system (QMS) that contains formalized quality assurance/quality control (QA/QC) policies and written SOPs. Where feasible, the QMS should be managed by individuals who are not involved in repository operations, although this might not be possible for smaller or less established biospecimen resources. The QMS describes the biospecimen resource's QA/QC policies and approaches for ensuring that program requirements are met. Each biospecimen resource should either establish a written QMS or adhere to a QMS published by the organization with which the biospecimen resource is associated. There are several common quality management programs available upon which to pattern individual biospecimen resource QMS policies. No particular approach is recommended, but several are mentioned below to help design the appropriate QMS for the biospecimen resource. The following Web sites are relevant to the development of a QMS:

• ISBER
  http://www.isber.org
• Good Laboratory Practices
  http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_1,00.html
• Clinical Laboratory Improvement Amendment
  http://wwwn.cdc.gov/clia/
• International Organization for Standardization (ISO9000)
  http://www.iso.org
• U.S. Food and Drug Administration (FDA) Quality System Regulation, 21 CFR 820
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820