1.5.5 Sustainability

Revision as of 20:07, 23 March 2021 by Bjoerngerlach (talk | contribs)
Jump to: navigation, search

​​​​​​​​A. Background & Definitions

This item refers to one of the Core Requirements (Core Requirement 18 - "Resources for sustaining the EQIPD Quality System must be available") and is, therefore, considered as essential.

This is likely to be the last core requirement to be implemented (Implementation Strategy​).

B. Guidance & Expectations

During the implementation, Process Owner and her/his team get an idea how much resources will be required to maintain the system.

It is up to a Process Owner how this resource estimation and allocation is done and whether this exercise is documented (by default, no extra paperwork such as a written declaration by a process owner is required).

The key criterion is that lack of time or resources is not used as a justification for not following the most appropriate practices.

It is expected that Process Owner will: ​* Calculate cost for maintaining Quality System (personnel and resources)

  • Assess the availability of resources (including finances) to support maintenance of the Quality System for the next three years


​​​​To consider the positive impact of maintaining higher research rigor standards under the Quality System

​C. Resources

Cost-benefit analysis - to be added

back to Toolbox

Next item: 2.1.1 Study protocol