Quality

NORMA Label

Standardization of the operational processes of a Biobank

The Norma Label guarantees the quality of the operational processes and the harmonization of practices at the Swiss level. In difference to the VITA Label, SBP examines the practices and processes of your Biobank during an on-site visit.

We recommend that our partner Biobanks aim for at least the Norma Label
Efficient sample management is indeed a prerequisite to enable researchers to perform reliable and high-quality research.

Scope
RESSOURCE MANAGEMENT

IT

  • IT security
  • Traceability

EQUIPMENT

  • Equipment calibration
  • Maintenance and repair
  • Equipment inventory
  • Critical consumable inventory

PERSONNEL

  • Roles
  • Job descriptions
  • Training

PROCESS MANAGEMENT

COLLECTION PROCESS

TRANSPORT PROCESS

RECEPTION PROCESS

PROCESSING PROCESS

STORAGE PROCESS

DISTRIBUTION PROCESS

METHODS

  • Quality control methods
  • Quality control results
  • Validation of methods
0
NORMA
labels
awarded

support
documents
provided

  • Data Protection
  • Data and sample traceability
  • Equipment Management
  • Personnel management
  • Biological Material Management
  • Validation of methods
  • Quality control strategy implementation
  • Participant iD log template
  • Sample tracking form template
  • Equipment calibration record
  • Equipment maintenance record
  • Expiring Consumables / Equipment Inventory
  • Personnel File
  • Sample Acceptance Criteria
  • Shipping Log
  • Quality Control results
  • Validation method record
  • Method List
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