Quality

OPTIMA Label

Optimization of the Quality Management System

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

SBP contributes concretely to the optimization of the following biobanking aspects in order to enhance your Biobanks’ quality with this Label:
– Documentation management
– Continual improvement including internal audits and management of non-conformities
– Risk management

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)

support
documents
provided

  • Non-conformity management 
  • Documentation management
  • Internal audit
  • Improvement Management
  • Quality Policy
  • Non-Conformity Report
  • Non-Conformity Log
  • Management Review Report
0
OPTIMA labels
awarded
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