My Reading on ASQ CQA HB Part I-IA~IE-s

Part IA3
Certification Purposes
Companies in certain high- risk categories—such as toys, pressure vessels, elevators,
gas appliances, and electrical and medical devices—wanting to do business in Europe must comply with
Conformité Europeene Mark (CE Mark) requirements.
One way for organizations to comply is to have their management system certified by a third- party audit
organization to management system requirement criteria (such as ISO 9001). Customers may suggest or
require that their suppliers conform to ISO 9001, ISO 14001, or safety criteria. The U.S. Federal Acquisition
Regulations (FARs) 48 CFR 46.202-4 (48 CFR 46 - Quality Assurance) replaced references to government
specifications with higher- level contract quality requirements. Cited higher- level contract quality requirements
include ISO 9001, AS9100, ANSI/ASQC E4, and ANSI/ASME NQA-1. However, this does not preclude other
federal government entities, such as the Department of Energy (DOE) or the Department of Defense (DOD),
from having additional requirements for the specific work they do (for example, nuclear facility standards/
regulations such as Federal Register 10 CFR 830 Subpart A). Many national standards have been canceled,
and users have been referred to the U.S.-adopted ISO 9001 standard. A third- party audit normally results in
the issuance of a certificate stating that the auditee organization management system complies with the
requirements of a pertinent (relevant, appropriate) standard or regulation.
Third-party audits for system certification should be performed by organizations that have been evaluated and
accredited by an established accreditation board, such as the ANSI- ASQ National Accreditation Board (ANAB).
As the U.S. accreditation body for management systems, ANAB accredits certification bodies for ISO 9001,
ISO 13485, ISO/TS 16949 QMSs, and ISO 14001 EMSs, as well as for several other conformity requirements
standards.
Charlie Chong/ Fion Zhang