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Quality Control And Troubleshooting In Art Laboratory
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Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is common place for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customers demand for improved delivery of ART services.
The guidelines set up by the ESHRE constitute the minimal requirements for any laboratory offering assisted reproduction techniques (ART). The implementation of guidelines for good practice in IVF laboratories requires a quality management programme to be in place, integrating quality control, quality assurance and quality improvement. This should be done by the design of a quality policy and a consequent implementation of a quality system that encompasses and integrates the operative units, the processes and procedures that represent the core of ART clinics.
What is the need for Quality management Control in IVF Laboratory?
Quality Control in the IVF Laboratory
International standard and accreditation for IVF centres
ISO 9001 is the basic standard for ISO certification and is a requirement before other standards are implemented such as EN 17025 and 15189. IVF is a clinical enterprise that involves physicians, nurses and others whose tasks go far beyond a clinical laboratory. In fact, it is the integration of the clinical team with the laboratory that requires the most attention to ensure that the highest quality service will prevail.
ISO 9001 forms the basis for a quality management system internationally. Other standards may be sought afterwards by those that may be interested in taking their quality systems further. it is to be noted that ISO implementation can be costly, and careful attention should be made to not set too many standards as a requirement. ISO 9001 serves as an excellent worldwide standard. All IVF centres and IVF Laboratories must be encouraged to consider implementing a quality management system. Experience has shown that, when conscientiously and properly implemented, ISO 9001 can improve employee and patient satisfaction and overall quality. Newly implemented ISO 15189 may offer new and improved standards for clinical laboratories.
The purpose of accreditation, which is voluntary, is to ensure that quality management and quality assurance methods meet highly set standards of quality control. All these involvements require high-laboratory standards with highly qualified personnel, as well as defined quality management systems.
There has been increased demand for transparency pertaining to the safety aspects, effectiveness and health outcomes of ART treatments both from the general public, patients and regulators. The important components that make a laboratory great are the people, procedure, equipment and the laboratory design. Recruiting the right people is the critical step in setting up the best IVF laboratory. An IVF center is only as good as the staff it employs and there is an absolute need to ensure consistent and continuous education and training. QMS, that have been proven effective by other industries, can be used by ART clinics to meet existing requirements by monitoring and controlling the way in which services are delivered. Thus, by determining and meeting the expectations of patients and other stakeholders, implementation of QMS will also be a vital tool for setting, planning and meeting advancements through documented processes enabling continuous improvement.
To design ,built and setting up complete world class IVF center or lab is important turnkey project and you need an expert to take care of it.You need Specialist of IVF lab design like:Shivani Scientific Industries Pvt Ltd. Shivani extends comprehensive service for implementation of ISO 9001 and ISO 17025. Quality Management System provides quality control, quality assurance and quality improvement activities. ISO 9001 system helps ART centers in ensuring quality service for not only the customers but also improving performance in organizations, creating a calibration protocol for equipments, creating proper documentation as per national and international guidelines. The services are also extended to any of those running IVF Labs, who do have the desire and intention of improving upon themselves.
For additional information on this Total Quality Management service, please contact at +912228966770 or at http://www.shivaniscientific.com/index.htm or at http://ivfworld.wordpress.com
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