Quality Management System ModuleMinerva Diagnostic Laboratory (MDL) is currently accredited under Dubai Accreditation Center (DAC) as per ISO 15189:2012. It was the first lab in the region to be accredited as per ISO 15189:2012.
MDL offers consultancy services to other labs and hospitals who require guidance for setting up the accreditation process.
Given below is an outline of the Quality management system module followed at MDL.
The quality model used at Minerva Diagnostic Laboratory (MDL) organizes all of the laboratory activities into twelve quality system essentials. These quality system essentials are a set of coordinated activities that serve as building blocks for quality management.
Organization : The structure and management of the laboratory is organized so that quality policies can be established and implemented. MDL has a strong, supporting organizational structure and a mechanism for implementation and monitoring. Personnel : MDL has competent, motivated staff. The quality management system implemented addresses many elements of personnel management, and provides encouragement and motivation. Equipment : MDL uses many kinds of equipment in the laboratory. The quality management system ensures that each piece of equipment is functioning properly. It also addresses details such as choosing the right equipment, installing it correctly, assuring that new equipment works properly, and having a system for maintenance. Purchasing and Inventory : Proper management of purchasing and inventory can produce cost savings in addition to assuring supplies and reagents are available when needed. At MDL, the procedures that are a part of management of purchasing and inventory are designed to assure that all reagents and supplies are of good quality, and that they are used and stored in a manner that preserves integrity and reliability. Process Control : Process Control is comprised of several factors that are important in assuring the quality of the laboratory testing processes. These factors include quality control for testing, appropriate management of the sample, including collection and handling, and method verification and validation. MDL has well documented procedures for pre- examination, examination and post-examination processes. Information Management : MDL has procedures to ensure information (data) is carefully managed to assure accuracy and confidentiality, as well as accessibility to the laboratory staff and to the health care providers. Information may be managed and conveyed with paper systems and with computers. Documents and Records : Documents are needed in the laboratory to inform how to do things, and MDL has many documents. Records are meticulously maintained, so as to be accurate and accessible. MDL has well documented procedures on document and record control. Occurrence Management : An “occurrence” is an error or an event that should not have happened. MDL has a system to detect these problems or occurrences, to handle them properly, and to learn from mistakes and take action so that they do not happen again. Assessment : The process of assessment is a tool for examining laboratory performance and comparing it to standards or benchmarks, or the performance of other laboratories. MDL conducts 2 types of assessment - internal, or performed within the laboratory using its own staff, and external, conducted by a group or agency outside the laboratory. Laboratory quality standards are an important part of the assessment process, serving as benchmarks for the laboratory. Process Improvement : The primary goal of MDL’s quality management system is continuous improvement of the laboratory processes, and this is done in a systematic manner using a number of tools that are useful for process improvement. Customer Service : MDL takes care to understand who the customers are, and assesses their needs and also uses customer feedback for making improvements. Facilities and Safety : The following are a part of the quality management of facilities and safety at MDL • Security - which is the process of preventing unwanted risks and hazards from entering the laboratory space. • Containment - which seeks to minimize risks and prevent hazards from leaving the laboratory space and causing harm to the community. • Safety - which includes policies and procedures to prevent harm to workers, visitors, and the community. • Ergonomics - which addresses facility and equipment adaptation to allow safe and healthy working conditions at the laboratory site.