IJCA Vol 4 i1 2025 webmag - Flipbook - Page 52
52 The International Journal of Conformity Assessment
Key Components of a Quality Management
System
A quality management system (QMS) typically
includes several key components, such as quality
policy and objectives, document control, internal
audits, corrective and preventive actions (CAPA),
training and competency measures, customer
feedback, compliance with standards, and a strategy
for performance measurement and continuous
improvement.
Training and Competency
The laboratory staff remains skilled and
knowledgeable, staying updated on developments in
the 昀椀eld. A robust training and competency program
directly supports accurate and reliable test results.
Instrument Calibration and Maintenance
A de昀椀ned calibration and maintenance schedule is
essential for ensuring equipment accuracy, reducing
failures, and maintaining consistency, and is therefore
considered a critical component of a QMS.
Quality Policy and Objectives
Customer Feedback
For laboratory operations to ensure reliable
results, a de昀椀ned and robust Quality Management
System (QMS) is essential. The quality policy, a key
component of any QMS and often regarded as its
foundation, re昀氀ects the laboratory’s commitment
to quality. A well-de昀椀ned quality policy helps
support the organization’s objectives, ultimately
driving continuous improvement. Furthermore, to
complement the quality policy, measurable quality
objectives must be established. These objectives
commonly include goals such as ensuring precision,
reducing turnaround times, minimizing equipment
breakdowns and reducing repeat testing. Together,
these objectives provide a clear roadmap for
continuous improvement and align with customer
expectations.
Customer feedback is a critical component of a
QMS, serving as a valuable tool for understanding
satisfaction, identifying areas for improvement,
and ensuring that services meet expectations. The
effective incorporation of customer feedback into a
QMS involves several key aspects, including feedback
collection and analysis, as well as the implementation
of corrective and preventive actions when necessary.
Document Control
Document control is another major element of a QMS,
ensuring that current and accurate documents are
available for laboratory activities. By maintaining a
robust document control system, laboratories can
minimize errors and enhance compliance.
Internal Audits
The QMS is further strengthened by routine internal
audits, which evaluate compliance with applicable
ISO standards and internal protocols. These audits
help the laboratory meet its organizational objectives,
ultimately contributing to more reliable reporting and
enhanced patient safety, as summarized in Table 1.
Corrective and Preventive Actions
The laboratory must have an e昀케cient corrective and
preventive actions (CAPA) system in place to address
non-conformities and prevent recurrence. A proactive
CAPA procedure improves overall performance by
resolving issues and lowering the possibility of them
happening again.
Compliance with Standards
Another key component of QMS is adherence to
standards (ISO 9001, ISO 17025, ISO 15189, and ISO
17043). Following ISO/IEC 17025 shows pro昀椀ciency
in testing and calibration, fostering client trust with
high standards. Accreditation refers to a formal
recognition from an external body that a laboratory
meets speci昀椀c standards and demonstrates
competence in areas such as testing and calibration.
For example, ISO accreditation veri昀椀es that the
laboratory’s processes meet international standards,
ensuring high-quality results. On the other hand,
regulatory compliance ensures that laboratories meet
legal requirements set by governmental authorities.
Laboratories must comply with national and regional
regulations (such as the U.S. FDA standards and
CLIA) to ensure ethical operations and alignment
with industry expectations. These regulations are
typically enforced by government agencies and are
designed to safeguard public health and ensure safe
practices. The laboratory's commitment to excellence
is demonstrated by obtaining the necessary
accreditations, which also improve its reputation and
validate its quality processes, while also meeting
regulatory compliance criteria to ensure ethical and
legal operations.
To ensure ethical operations and alignment with
industry expectations, laboratories must also comply
with national and regional regulations, such as the
U.S. FDA and CLIA. The laboratory's commitment
