Audit of the healthcare projects.
In the perfect cases, the process of the preparation and introduction of
the quality management system starts at the conceptual planning of the
project and is traced through the entire planning, construction and in to
operations. It usually starts with the preparation of an appropriate
medical task and medical program that fully reflects on the planned
technologies and their quality standards in accordance with the
expected loads and future development.
Exactly at these starting stages many compromises are taken that
ultimately have a negative impact on the final outcome and create many
difficulties for the future of the project that are either too costly or
impossible to fix. Such compromises may also have an impact on to
the economical parameters that is especially significant for startups
and private operations.
Technological project audit for the compliance to the accepted
international standards and norms allows timely introduction of the
necessary corrections and preventative measures and update the
project documentation leading to the conclusive declaration of the
compliance to the current international standards.
Technical audit of the project is performed according to the planned
program and scope of the audit and is a highly structured and
First of all the aims and scopes of the audit are determined with
identification of the standards and objectives, direction and scope of the
audit, approved regulations, norms, procedures and criteria under
which the audit would be conducted.
At the next stage the requested and obtained documentation is
processed, logged, organized and inspected to multiple parameters
according to the scope of the audit procedure. Meetings and interviews
with staff and designers are requested and additional documents,
drawings, medical and technical specifications are defined with
responsible persons and contracting organizations that plan to supply
technology and medical equipment.
The next stage of the audit is a detailed inspection of the information
provided is commenced starting from the architectural planning and
technology solutions to identify and justify the possible violations of the
standards and inconsistencies that have been identified in the audit. At
this stage a preliminary project status report is prepared that indicated
general situation and progress of the audit with the definition of general
comments and suggestions.
Duration of the audit depends on the amount and complexity of the
project and data to be inspected. On average, report preparation takes
about 600 engineering hours, after which the customer receives the
final version of the report and, if necessary, a report presentation is
prepared and defended. In report, identified discrepancies or deviations
from the legislation defined by the scope of the audit are classified on a
scale of their actual or potential impact on the safety and effectiveness
of decisions with mandatory request for correction of the critical
violations. Report is prepared in such a way that any critical
inconsistency or incompliance is supported by the appropriate
reference index of the legislative document with a reference to the
relevant paragraphs of standards.
Depending on the agreements reached, the presentation of the audit
report can be performed before the representatives of the customer
and to independent experts, including specialists from abroad.
The main report is declarative in nature and covers the scope of the
audit area and selected legislative documentation. Since the major
shortfalls directly contradict with the recommendations, standards and
regulatory requirements, such issues require correction and projects
(or project sections) require updating in accordance with the
recommendations provided. After the correction of the plans, a second
round of audit may follow in which the corrected drawings and
technological design decisions are re inspected. The final audit report
declares the project's compliance with relevant industry standards,
defined by the scope of the audit.