Quality

OPTIMA Label

Optimization of the Quality Management System

The OPTIMA Label allows your biobank to establish a QMS with proper documentation management and implementation of Quality Indicators to monitor and optimize your operational processes. This ultimate step will help you implement a strategy which will support your biobank’s long term activities. These developments are in alignment with the requirements by international standards, such as ISO 9001 and 20387.

Apply for an OPTIMA Label

OPTIMA labels
awarded

support documents provided

SOPs, FORMS AND TEMPLATES

OTHER DOCUMENTS

Scope

QUALITY ASSURANCE
MANAGEMENT

POLICIES

  • Quality policy
  • Service Level Agreement
  • Internal communication

DOCUMENTATION MANAGEMENT SYSTEM

  • Documentation management
  • Document list

PROFESSIONAL DEVELOPMENT

  • Management reviews
  • Satisfaction surveys
  • Internal audits
  • Internal audit reports
  • Management of nonconformities
  • List of non-conformities

RISK MANAGEMENT

  • Risk-biosafety management
  • Business model and cost recovery (sustainability)
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