Difference between revisions of "1.5.5 Sustainability"
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It is expected that Process Owner will: | It is expected that Process Owner will: | ||
| − | * Calculate cost for maintaining Quality System (personnel and resources) | + | ** 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 | * Assess the availability of resources (including finances) to support maintenance of the Quality System for the next three years | ||
Revision as of 12:26, 26 October 2021
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
PLEASE DO NOT FORGET
To consider the positive impact of maintaining higher research rigor standards under the Quality System
C. Resources
Cost-benefit analysis - to be added
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Next item: 2.1.1 Study protocol
