ISO/IEC 17025:2017 (NABL) Certification for Clinical Biochemistry
The healthcare industry is not the same as it was 10 years ago, it continues to evolve with the coming of breakthrough technologies. As the other fields of medical science are expanding, so is clinical biochemistry. The evolution of automation in clinical biochemistry laboratories is unparalleled. This sector proves extremely important, regarding both financial matters, and quality and safety of the presented diagnosis, as the results indicate a patient’s state, which eventually helps in medical decision-making, and therapeutic conduct.
Clinical biochemistry is one branch of medical professions, sometimes also known as Laboratory Medicine, Clinical Chemistry, and Chemical Pathology. Schwartz and Dubowsk in 1973 termed Clinical biochemistry as a branch of chemistry that deals with the composition and measurement of the secretions, excretions, concretions, and fluids of the human body in health and disease, and the chemical composition of cells and tissues. It is also used to assist the laboratory technologist in test performance, it now includes processing and transport of specimens, loading of specimens into automated analyzers, assessment of the results of the tests performed, and storage of specimens. The practice of clinical biochemistry is founded on the concepts of quantitative and qualitative testing, leading to a diagnosis.
Origins of Clinical Biochemistry
The origins can be traced throughout the entire history of medicine. In the period between Hippocrates and 1500 A.D., physicians made slow progress in discovering the various aspects of urine that could be used as markers for the causes and nature of diseases. The instruments used in these tests were the matula (a spherical vessel with a long neck) for visual assessment and for measuring volume, and the pan balance for measuring weight. Later, in the 16th century A.D, physicians started to perform tests using blood. The blood tests turned out to be more effective as the fluid being studied was closer to the source of the disease, being the fluid that bathes the tissues, rather than the fluid that the body selectively discharges. Slowly more tests were incorporated to assess the patients by physicians. The industry kept on expanding as it started using sophisticated equipment rather than equipment used in the ancient age. However, the fundamental nature of testing continues today to be both quantitative and qualitative assessments of biochemical constituents of body fluids.
This sector is growing at a very good pace in the Indian IVD industry. The biochemistry auto-analyzers are considered as the backbone of major diagnostic chains in the country. As per the report by ADI Media Research, in 2018, the Indian biochemistry instruments and reagents market was estimated at Rs 1742 crore, with reagents continuing to dominate at Rs 1450 crore, at an 83.24 percent market share. The floor-standing analyzers are estimated at Rs 85 crore and 1610 units; benchtop analyzers at Rs 82 crore and 1580 units; and semi-automated analyzers at Rs 125 crore and 15,100 units.
To get the tests done, now the clinical biochemistry laboratories are available which provides an extensive range of testing services to all medical center departments and clinics, other hospitals, HMOs, the army, individuals, and research institutions. The lab also provides testing for research laboratories and skilled researchers at the Medical Center.
These labs must have their quality accreditation from NABL and must have certification for ISO 17025: 2017. In this way, it can be assured that the testing is done accurately and according to the international quality testing standards.
In case, you have Clinical Biochemistry equipment testing lab then you must get it certified for ISO 17025: 2017 – NABL, PrimeCertification can help you with all the formalities involved with the ISO 17025: 2017 NABL certification for Clinical Biochemistry equipment testing lab process. We have a vast team of highly experienced professionals who have been helping our clients in getting an easy ISO 17025: 2017 NABL certification for Clinical Biochemistry equipment testing lab by handling all the audits, inspections, and paper works.