Quality Management Vs Quality Assurance June 2017

Quality Management vs Quality Assurance?
Mostly every organization globally producing products of industrial applications is overseen by

some form a management or quality program. These programs exist to help manage business
effectively and put in place best practice methodologies. Elements within these practices focus
on outcomes which led to time and cost saving measures, increased efficiencies, and
improved customer relationships. These program are successful due to continuous
improvements, gaining greater control over processes, and therefore greater control over the
results. These programs provide an organization a business culture which validates inherent
quality of any product produced using best practice methodologies. Although some programs
are meant to have universal application cross cutting multiple industries, there are specific
industrial applications in which even the most widely used programs fall short.
ISO 9001 has been implemented by more than one million organizations in more than 75
countries. Many organizations interested in pursuing business in the nuclear industry, find that
their ISO 9001 program must be modified to meet the requirements of Nuclear Quality
Assurance. In its basic form, a Quality Management Program such as ISO 9001 is a business-
process program. ISO standards are considered generic management standards that are
universally applicable and do not differentiate between large and small companies.
For the required level of emphasis on safety and regulatory oversight, the aerospace industry
is most aligned to the nuclear industry. The aerospace industry Quality Management System
(QMS), AS9100, was first implemented in 1997, following cancellation of quality system
specifications by the Department of Defense. Due to the lack of a government endorsed quality
system by the Federal Aviation Administration, the aerospace industry independently
developed a sector-specific quality program so that it could pass uniform requirements to its
suppliers. The 2000 edition of AS9100, developed to conform to the 2000 edition of ISO 9001,
added 80 additional requirements and amplified the original 18 requirements. Areas that the
aerospace industry believed were not adequately addressed by ISO 9001 include design,
development, manufacture, assembly, reliability, maintainability, servicing of aerospace
products, and regulatory compliance.
In the nuclear industry similar evaluations have come to same conclusion. Evaluations for
nuclear applicability done by the US NRC (SECY-03-0117), ASME (STP-NU-062), and the
IAEA (Safety Report No. 22) have shown that an ISO 9001 program alone does not guarantee
compliance or quality of end products and services. Most show that requirements in areas
such as the quality assurance program, training and qualification, design and independence of
design verification, and independence of inspection and testing activities did not meet
Hartford Steam Boiler
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applicable requirements for the nuclear industry. Other areas such as, documentation,
nonconformance control, corrective actions, document control and records, inspection and
testing, and audits also had to be heavily modified.
Although some standards such as the RCC-M, JSME, and CSA recognizes ISO in their code
and regulatory frame work, there are usually several supplementary requirements added for
procurement of components. These requirements include additional provisions for design
verification, document and data control, purchasing data, product identification and traceability,
inspection and testing, and control of nonconforming products. In some cases ISO is allowed
only for procurement of components outside the primary system pressure boundary.
Although ISO has improved many organizations best practices, proven successful, and is
widely used, a nuclear organization using ISO alone would not achieve the required level
assurance required by nuclear industry. Most nuclear standards reflect industry experience
and current understanding of the quality assurance requirements necessary to achieve safe,
reliable, and efficient utilization of nuclear energy, and management and processing of
radioactive materials. This standard focuses on the achievement of results, emphasizes the
role of the individual and line management in the achievement of quality, and foster the
application of these requirements in a manner consistent with the relative importance of the
item or activity. The emphasis on the component versus a process orientated approach
assures the safe operation of any nuclear power plant.

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Quality Management vs Quality Assurance?

Mostly every organization globally producing products of industrial applications is overseen by

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