4.1.3 External assessment

​​​​​​​​A. Background & Definitions​

External Assessment: Evaluation of a research unit performed by an external party to judge whether the EQIPD QS is implemented appropriately

B. Guidance & Expectations​

Depending on the resources, the External Assessment is performed by:

• Contractor with formal training as auditor
• Peers

The aim of the External Assessment is to:

• Examine the compliance of structures and procedures of an organization with the EQIPD QS

The External Assessment is performed with checklists and in two different steps, where the first is mandatory and the second by chance:

• Remote Assessment
• On-site visits

Examples for a potential assessment:

• Reconstruct data and check critical items (checklist) by selecting a sample and track it back to the methods, equipment and freezer storage
• Validation of a method: who and how to use the SOP => Comparison of the individual steps => description of where problems occurred => compare how to document and evaluate them

Update cycle

• ​​Once per year
• When needed

PLEASE DO NOT FORGET​

• ​Make sure that the External Assessment is performed by qualified personnel
• Ensure that the external personnel has no conflict of interest

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C. Resources

to be added

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​Next item: 4.2.1 Installation of solutions, actions and mitigation strategies​

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