Developed through an open, balanced, ANSI-accredited process — by the community the standards serve.
As an ANSI-accredited standards developer, HWASC develops American National Standards through a documented consensus process open to all directly and materially affected parties. Our accredited scope spans three connected areas: standards governing access, credentialing, and competency verification for non-hospital personnel; a cross-cutting conformity-assessment framework for the workflows those personnel participate in; and use-context conformity criteria for devices affected by diagnostic imaging and radiation therapy.
Healthcare facilities are responsible for ensuring that everyone who performs work inside their walls is competent to do it — including the non-hospital workforce: device and supply representatives, contracted biomedical and sterile-processing technicians, imaging service personnel, construction and MEP trades, and other professionals who enter facilities every day to perform job tasks.
For clinical personnel, that assurance rests on accredited national frameworks — licensure, certification, and credentials verification performed under recognized third-party oversight. For the non-hospital workforce, no equivalent exists. Today's model is facility-side credentialing: document verification keyed to presence and person-type, administered separately by each institution.
DuplicativeEvery facility re-verifies the same documents for the same person. A representative serving twenty hospitals is credentialed twenty times, at cost to everyone, with no added assurance.
Not a conformity-assessment functionDocument checking confirms paperwork is on file. No accredited third party attests that the individual is competent to perform the job tasks they are there to do.
Not portableCredentialing produces no attestation the professional can carry from one facility to the next. Nothing accumulates; everything is repeated.
InconsistentWith no national standard to reference, requirements change from institution to institution — so “credentialed” means something different at every door.
None of this is a criticism of credentialing organizations — without a national standard to reference, variation and duplication are inevitable. Standards give every party a common framework: facilities can align expectations to it, credentialing programs can build on it, and professionals can carry one accredited attestation wherever they work.
Competency verification of non-hospital personnel is not a new obligation — it is how healthcare facilities meet responsibilities they already carry under federal regulation and accreditation requirements:
Accredited, portable competency certification gives facilities a consistent, verifiable means of meeting these obligations for the non-hospital workforce — aligned with the verification models they already rely upon for clinical personnel.
The scope below is stated in three parts for readability; the verbatim accredited scope follows.
Voluntary consensus standards governing vendor credentialing, vendor-access controls, competency verification, certification requirements, and accreditation requirements for supplier organizations, Vendor Credentialing Organizations (VCOs), and non-hospital personnel who access healthcare facilities.
A framework establishing common competency, organizational-conformity, and verifiable identifier and chain-of-custody requirements for those personnel and supplier organizations across the healthcare workflows in which they participate — including procurement, value analysis, product-use documentation, and post-procedure billing — referencing the applicable process, data, and domain standards owned by other developers as normative inputs.
In support of those competency and conformity-assessment activities: conformity-assessment criteria and use-context performance qualification for implantable devices, markers, and related products used in, or intended for use in, patients undergoing diagnostic imaging or radiation therapy — including radiolucent and radiotherapy-compatible devices — addressing their radiological, imaging, and post-irradiation performance in the clinical use context, referencing existing material and test-method standards as normative inputs.
This scope excludes material composition and base material properties, which remain within the scope of other accredited developers.
The Healthcare Workforce Access Standards Commission develops voluntary consensus standards governing vendor credentialing, vendor-access controls, competency verification, certification requirements, and accreditation requirements for supplier organizations, Vendor Credentialing Organizations (VCOs), and non-hospital personnel who access healthcare facilities; and a cross-cutting conformity-assessment framework establishing common competency, organizational-conformity, and verifiable identifier and chain-of-custody requirements for those personnel and supplier organizations across the healthcare workflows in which they participate — including procurement, value analysis, product-use documentation, and post-procedure billing — referencing the applicable process, data, and domain standards owned by other developers as normative inputs; and, in support of those competency and conformity-assessment activities, conformity-assessment criteria and use-context performance qualification for implantable devices, markers, and related products used in, or intended for use in, patients undergoing diagnostic imaging or radiation therapy — including radiolucent and radiotherapy-compatible devices — addressing their radiological, imaging, and post-irradiation performance in the clinical use context, referencing existing material and test-method standards as normative inputs. This scope excludes material composition and base material properties, which remain within the scope of other accredited developers.
Every HWASC standard follows a documented consensus process consistent with ANSI's Essential Requirements.
A new standards project is announced publicly through ANSI's Project Initiation Notification System, giving all interested parties notice and the opportunity to participate.
A balanced technical committee is assembled — producers, users, and general-interest categories — so that no single interest dominates.
The committee drafts the standard, resolving comments and objections through documented due process.
Draft standards are announced for public comment through ANSI Standards Action. Every comment receives a documented response, and unresolved objectors are informed of their appeal rights.
Upon consensus and completion of due process, the standard is submitted to ANSI for approval as an American National Standard and published.
Published standards are periodically reaffirmed, revised, or withdrawn to keep them current.
Current projects announced through ANSI's Project Initiation Notification System (PINS), with active calls for consensus body members.
This standard establishes a two-part conformity-assessment scheme for non-hospital personnel who perform job tasks in healthcare provider facilities.
Under ISO/IEC 17024, an individual is certified for competency to perform job tasks in a healthcare environment and is issued a portable personal certification identifier. Under ISO/IEC 17065, the organization providing the products or services is certified — covering product competency, the direct-representative and distributor authorization relationship, and the requirements of ANSI/NEMA SC 1-2020 — and is issued an organizational certification identifier.
A job task is authorized only when a current individual certification operates under a current organizational certification whose scope covers the product. The standard does not apply to healthcare provider staff, or to persons who perform no job task (such as sales visits and patient or family visitors), who are governed by ordinary facility access control.
Existing practice administers non-hospital personnel through facility-side credentialing — document verification keyed to presence and person-type — which is duplicative across facilities, is not a conformity-assessment function, and produces no portable attestation of competence. No standard presently certifies, through accredited third parties, (1) an individual's competency to perform job tasks in a healthcare environment under ISO/IEC 17024, or (2) the conformity of the provider organization's service, product competency, and personnel-requirement obligations under ISO/IEC 17065. This standard establishes both, replacing repetitive per-facility credentialing with portable, accredited, registry-verifiable certifications, and aligning with the verification models healthcare facilities already rely upon for clinical personnel.
Directly and materially affected parties are invited to apply for membership on the consensus body in the following interest categories:
Healthcare provider organizations; medical device, equipment, and supply manufacturers and suppliers; direct representatives and distributor representatives; independent (1099) contractors and contracted service organizations, including biomedical, sterile processing, imaging, and construction/MEP personnel working in clinical space; vendor credentialing organizations; certification bodies and accreditation bodies operating under ISO/IEC 17011, 17024, and 17065; perioperative and infection-prevention professional associations; patient-safety advocates; and relevant regulatory and accreditation organizations.
Written comments in response to this PINS — including any assertion of conflict or duplication with an existing American National Standard — must be submitted by August 16, 2026. HWASC will consider and respond to comments consistent with the ANSI Essential Requirements.
To be notified of new projects and public review periods, contact info@hwasc.org.
Participation is open to all directly and materially affected parties — hospitals, suppliers, credentialing organizations, clinicians, and more.