Conformity Assessment

At a glance

The Code of Federal Regulations (CFR), Guidance on Federal Conformity Assessment Activities, 15 CFR Part 287 (2020), and https://www.iso.org/about-us.html define conformity assessment as checking that products, materials, services, systems, or people measure up to the specifications of a relevant standard.

Overview

In public health and health information technology (IT), conformity assessment is the practice of determining what meets the requirements of a particular standard for products (e.g., laboratory media, electronic health record [EHR] messaging implementation guide), services (e.g., standards that support the U.S. public health mission), and systems (e.g., assessing essential capabilities of public health labs, testing surveillance electronic system, certifying EHR).

The National Institute of Standards and Technology (NIST) "National Conformity Assessment Principles for the United States" (2007**) includes the following categories of conformance assessment activities that may be used by public health:

  1. sampling and testing,
  2. inspection,
  3. supplier's declaration of conformity,
  4. certification,
  5. management system assessment and registration,
  6. accreditation of the competence of those activities by a third party, and
  7. recognition (usually by a government agency) of an accreditation program's capability.

Test methods for health information technology developed by NIST are described here.

One tool that CDC offers for electronic message validation is the Message Evaluation and Testing Service (METS). This tool ensures that messages are adhering to HL7®standards defined in messaging guides. More details about METS may be found here.

More details on testing resources may be found at the Data Interchange Standards website, CA Resources tab.

* International Organization of Standardization (ISO). Conformity Assessment and Certification. URL: https://www.iso.org/conformity-assessment.html

** National Conformity Assessment Principles for the United States, NIST, 2007. At: https://share.ansi.org/Shared%20Documents/News%20and%20Publications/Brochures/NCAP%20second%20edition.pdf

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Content Source:
Office of Public Health Data, Surveillance, and Technology (OPHDST)