- 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
Other "shalls" must be assessed using a specified procedure, e.g.:
One approach is to use the Profile Document directly:
- Chapter 3 contains all the "shalls", organized in specification tables for each activity
A second approach some have found simpler is to use the extracted checklists.
in tables for
In QIBA, we’ve been trying to think about how to make that simpler, but for now, our profile documents are the formal list of “shalls” (in section 3) and section 5 (“Conformance”) in the profile template basically restates the above two bullets. So for now, the link beside the list profiles should probably point to the Profiles page.
One way we tried to simplify is to re-sort the shalls into actor checklists. Those can be found in several of the profiles on the Profiles page. The advantage is that it is FAR easier for actors to skip over the things the other actors have to do, and skip the discussion sections.
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.
Conformance requirements are specified in the QIBA Profile document for each Actor in the Profile. For some requirements, the Profile document also defines assessment procedures.
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 following template:
- QIBA Conformance Statement Template April 2015
Users can use Conformance Statements to determine whether their staff and products can be expected to deliver the biomarker performance described in the Profile Claim. Achieving the performance claim depends on all Actors described in the Profile being present at the site and conforming to the requirements.
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.
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.
Conformity Assessment Pilot Projects
QIBA is currently running a number of Conformity Assessment Pilot Projects to explore different approaches:
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."