Difference between revisions of "Profile Conformance"

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{{TOCright}}
 
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'''To conform:'''
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'''To conform to a [[Profiles|Profile]]:'''
 
* '''Obtain the document containing “shall” statements'''
 
* '''Obtain the document containing “shall” statements'''
 
* '''Confirm you meet each “shall”'''
 
* '''Confirm you meet each “shall”'''
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Most "shalls" can be confirmed using any reasonable procedure, e.g.:
 
Most "shalls" can be confirmed using any reasonable procedure, e.g.:
* Technologist shall position the patient in a supine position
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:* ''Technologist shall position the patient in a supine position''
*  
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:* ''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.:
 
Other "shalls" must be assessed using a specified procedure, e.g.:
 
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:* ''Physicist shall validate that the protocol achieves a standard deviation < 60HU. See 4.2. Assessment Procedure: Voxel Noise''
  
 
==Conformance Testing==
 
==Conformance Testing==
One approach is to use the Profile Document directly:
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One approach is to use the Profile document directly:
* Chapter 3 contains all the "shalls", organized in specification tables for each activity
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:* The "shalls" are all contained in Chapter 3 organized in specification tables for each activity
*  
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:* The assessment procedures are all contained in Chapter 4
  
A second approach some have found simpler is to use the extracted checklists.
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A second approach some have found simpler is to use extracted checklists.  
in tables for
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:* The "shalls" are copied from Chapter 3 and sorted into a separate checklist for each actor
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.
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:* The assessment procedures are copied from Chapter 4 into the bottom of the checklist document or provided separately
 
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+
 
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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. 
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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.
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Conformance requirements are specified in the [[Profiles|QIBA Profile document]] for each Actor in the Profile.  For some requirements, the Profile document also defines assessment procedures.
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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.
  
 
==Conformance Statements==
 
==Conformance Statements==
 
After conformance has been successfully tested, vendors or sites prepare and publish documents called QIBA Conformance Statements to describe conformance to one or more '''[[Profiles|QIBA Profiles]]''' by their products, staff or institution.
 
After conformance has been successfully tested, vendors or sites prepare and publish documents called QIBA Conformance Statements to describe conformance to one or more '''[[Profiles|QIBA Profiles]]''' by their products, staff or institution.
  
QIBA Conformance Statement documents are required to conform to the following template:
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QIBA Conformance Statement documents are required to conform to the [[Media:QIBA_Conformance_Statement-2015.04.26.docx|QIBA Conformance Statement Template]] ''April 2015''
*[[Media:QIBA_Conformance_Statement-2015.04.26.docx|QIBA Conformance Statement Template]] ''April 2015''
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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.
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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.
  
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.
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'''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.
 
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'''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==
 
==Conformity Assessment Pilot Projects==
 
 
QIBA is currently running a number of Conformity Assessment Pilot Projects to explore different approaches:
 
QIBA is currently running a number of Conformity Assessment Pilot Projects to explore different approaches:
 
*'''[[Pilot Conformance Projects Under Development]]'''
 
*'''[[Pilot Conformance Projects Under Development]]'''
  
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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.
  
 
==See Also==
 
==See Also==
 
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."
 
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."

Revision as of 02:06, 20 November 2019

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

Conformance Testing

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.

Conformance Statements

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.

See Also

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."