Audit and qualification of project documentation

The process of preparation and implementation of a quality management system in medical institutions and laboratories begins at the design stage, when qualified specialists compile the terms of reference in strict accordance with the planned technologies and capacities.

It is at the design stage that many compromises arise, which in the future will affect the process of operation of the laboratory or medical institution, as well as its technical and economic indicators, which is especially important for private entities.

A technical audit of the project for compliance with European standards allows you to make the necessary adjustments to the project documentation in due time and declare compliance with the highest requirements of international standards. Technical audit of projects is subdivided into several stages and strictly follows the planned program of the audit. We set goals, directly that area of ​​the audit, after which the normative acts, regulations, standards and criteria are approved, within the framework of which the audit is carried out.

Next, there is a direct process of collecting and processing information about the project: meetings and interviews with staff and designers, requests for documents, drawings, medical and technical tasks, responsible persons and contractors who plan to supply technological, medical or laboratory equipment.

The next stage of the technological audit is a detailed study of the information provided, and checks the compliance of architectural planning and technological decisions with the identification and justification of violations and non-compliance with the standards set in the audit. At this stage, a preliminary report on the status and progress of the audit is prepared, identifying general comments and suggestions.

The duration of the report depends on the amount of input information and the complexity of the object. In the process of preparation of the report, identified discrepancies or deviations are classified according to the scale of their actual or potential impact on the safety and effectiveness of decisions with mandatory identification of critical violations, compliance with which is prescribed in regulatory documentation for certain audit areas.

Depending on the agreements reached, the audit report can be defended both before the customer’s representatives and before independent experts, including from abroad.

The main report is declarative in nature regarding the compliance of the provided documentation with a certain field of audit. As the main recommendations, standards and regulations are binding, all declared critical remarks require correction, and projects (or sections of projects) require updating in accordance with the provided recommendations, followed by a second round of audit, which checks corrected drawings, technological and design decision. Based on the results of the re-audit, a final report is prepared, which declares the project’s compliance with the high industry standards of a particular audit industry.

LLC TECHNOLOGY PROJECT GROUP provides audit and qualification services for project documentation for medical and laboratory facilities. Our specialists have 10 years of experience in designing medical and laboratory facilities and well known with key international standards governing these areas.