To conform to a Profile:
- Obtain the document containing “shall” statements
- Confirm you meet each “shall”
Most "shalls" can be confirmed using any reasonable procedure, e.g.:
- Technologist shall position the patient in a supine position
- Image Analysis Tool shall be able to present the reader with both timepoints side-by-side
Other "shalls" must be assessed using a specified procedure, e.g.:
- Physicist shall validate that the protocol achieves a standard deviation < 60HU. See 4.2. Assessment Procedure: Voxel Noise
One approach is to use the Profile document directly:
- The "shalls" are all contained in Chapter 3 organized in specification tables for each activity
- The assessment procedures are all contained in Chapter 4
A second approach some have found simpler is to use extracted checklists.
- The "shalls" are copied from Chapter 3 and sorted into a separate checklist for each actor
- The assessment procedures are copied from Chapter 4 into the bottom of the checklist document or provided separately
Note: actors using checklists can still reference the corresponding sections in the Profile document to see rationales or clarifications for some requirements (in the Discussion subsections) or to understand how their requirements support/interact with those on other collaborating actors.
After conformance has been successfully tested, vendors or sites prepare and publish documents called QIBA Conformance Statements to describe conformance to one or more QIBA Profiles by their products, staff or institution.
QIBA Conformance Statement documents are required to conform to the QIBA Conformance Statement Template April 2015
Conformance Statements can be used to determine whether staff and products are expected to deliver the biomarker performance described in the Profile Claim. Achieving the performance claim depends on all Actors described in the Profile conforming.
IMPORTANT: Vendors and sites are solely responsible for the accuracy and validity of their QIBA Conformance Statements. Unless QIBA Certified, QIBA and its sponsoring organizations have not evaluated or approved any QIBA Conformance Statement or any related product, site or staff, and QIBA and its sponsoring organizations shall have no liability or responsibility to any party for any claims or damages, whether direct, indirect, incidental or consequential, including but not limited to business interruption and loss of revenue, arising from any use of, or reliance upon, any QIBA Conformance Statement. A QIBA Conformance Statement is not intended to promote or advertise aspects of a product or site not directly related to its implementation of QIBA capabilities.
Conformity Assessment Pilot Projects
QIBA is currently running a number of Conformity Assessment Pilot Projects to explore different approaches:
A second simplification is to build software that automates evaluation of some of the shalls. That simplifies confirmation, potentially to the point that actors don’t even have to know that those automated shalls exist (if they are lucky enough to be doing them already). It’s hard to imagine that we will be able to automate all the shall checking, but the more the better.
Per ISO Committee on Conformity Assessment (CASCO): "Conformity assessment is the demonstration that ‘specified requirements’ are fulfilled (see ISO/IEC 17000:2004). Specified requirements can be for a product, service, process, management system, personnel, or an organization."