Roadmap Phase 2

Set up the basis Set up an equipment system Ensure appropriate personnel and management Validate primary process Ensure proper equipment repair Ensure proper equipment use Ensure proper equipment maintenance Finalize organization Set up a proper management information system Ensure proper laboratory facilities Ensure proper inventory control system Ensure proper customer care

Determine which organizational positions are authorized and responsible for use of each piece of equipment.

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Add this, in the form of a table, to the SOPs for operation of equipment as developed in phase 1.

* Example: Equipment Authorization Table
ISO 15189 reference:
  • 4.1.5f
  • 4.2.1
  • 5.1.7
  • 5.1.8
  • 5.3.5
  • 5.3.11
  • 5.5.3
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