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

The External Assessment is performed by partners who are eligible to perform the assessments, meaning that they must have the formal training as auditors.

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 steps, whereas 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

The process for the External Assessment is described as follows:

1. You can get in contact with EQIPD via Email (info@eqipd.online) to initiate your certification
2. EQIPD will
   1. Provide you with additional information about the assessment and answer your questions
   2. Clarify costs, NDA and contracting
   3. Ask for several relevant documents to be assessed, e.g.:
      1. Study plans
      2. SOPs / Method protocols
      3. Publications
      4. EQIPD stand-alone documents (more information here: Documentation in EQIPD)
3. Remote assessment performed with an in-depth questionnaire focused on the relevant EQIPD core requirements and quality measures + assessment of provided documents.
4. Random selection of research units for onsite visit
5. Provisional assessment report providing feedback and detailing any recommendations to be addressed or implemented (if any) to be shared with you for review
6. Final Assessment Report submitted to you
7. Award of the Quality Certificate to demonstrate compliance with the EQIPD requirements

​PLEASE NOTE

The certification will be assigned for three years with a short remote assessment after 1 and 2 years.

C. Resources

to be added

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