QIBA Conformance Statements are documents prepared and published by vendors or sites to describe the intended conformance of their products, staff or institution to one or more QIBA Profiles.
QIBA Conformance Statement documents are required to conform to the following template:
- QIBA Conformance Statement Template April 2015
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.
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 NOTE: Vendors and sites are solely responsible for the accuracy and validity of their QIBA Conformance Statements. 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.
As QIBA refines its conformance process, the template will be revised.
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."