Laboratory & Hospital
(NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry Associations and Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories.
In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO/IEC 17025:2005 and ISO 15189:2012 for medical laboratories. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence.
NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. In addition NABL has to also comply with the requirements of APLAC MR001, which requires the applicant and the accredited laboratories to take part in recognized Proficiency Testing Programmes in accordance with ISO/IEC Guide 43. An applicant laboratory has to satisfactorily participate in atleast one Proficiency Testing programme, while the accredited laboratories are expected to cover the major scopes of accreditation in a cycle time of four years. Towards this objective,
This distinction has brought additional responsibility on NABL and its accredited laboratories. Annual Surveillance is carried out to ensure that the accredited laboratories are continuing to comply the accreditation criteria. NABL and its accredited laboratories are also required to meet the new challenges arising out of requirements such as satisfactory participation in a recognized Proficiency Testing Programme and the requirement of estimating the Uncertainty in Measurements even by the testing laboratories. NABL has already published the revised guideline on Estimation of Uncertainty in Measurement for Calibration Laboratories.
SCOPE
This International Standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
TESTING LABORATORIES- Biological
- Chemical
- Electrical
- Electronics
- Fluid-Flow
- Mechanical
- Non-Destructive
- Photometry
- Radiological
- Thermal
- Electro-Technical
- Mechanical
- Fluid Flow
- Thermal & Optical
- Radiological
- Clinical Biochemistry
- Clinical Pathology
- Haematology and Immunohaematology
- Microbiology and Serology
- Histopathology
- Cytopathology
- Genetics
- Nuclear Medicine (in-vitro tests only)
APPLICATION
NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO/IEC 17025:2005 and ISO 15189:2012 for medical laboratories. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence.
NABL ISO/IEC 17025:2005 IMPLEMENTATION BENEFITS
Formal recognition of competence of a laboratory by an Accreditation body in accordance with international criteria has many advantages:
- Potential increase in business due to enhanced customer confidence and satisfaction.
- Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
- Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
- Increase of confidence in Testing / Calibration data and personnel performing work.
- Customers can search and identify the laboratories accredited by NABL for their specific requirements from the Directory of Accredited Laboratories.
- Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
WHY CHOOSE SGQ Innovations?
- Team SGQ Innovations has IRCA certified ISO 17025:2005 auditors for Consulting Services
- Hands on experience of Team SGQ Innovations in implementing Health & safety tools would help to gain early benefits
Training
We offer a customized training program on ISO 17025:2005 for
- ISO 17025:2005 - Implementation and documentation requirements
- ISO 17025:2005 - Internal Auditor training
Laboratory and Hospital Management System
National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India, set up to establish and operate accreditation Programme for healthcare organizations. The board is structured to cater to much desired needs of the consumers and to set benchmarks for progress of health industry. The board while being supported by all stakeholders including industry, consumers, government, has full functional autonomy in its operation.
NABH Standards for hospitals, 2nd Edition, November 2007 has been released. This standard has been accredited by International Society for Quality in Healthcare (ISQua). The approval of ISQua authenticates that NABH standards are in consonance with the global benchmarks set by ISQua. The hospitals accredited by NABH will have international recognition. This will provide boost to medical tourism.
The standards provide framework for quality assurance and quality improvement for hospitals. The standards focus on patient safety and quality of care. The standards call for continuous monitoring of sentinel events and comprehensive corrective action plan leading to building of quality culture at all levels and across all the function.
In India, Heath System currently operates within an environment of rapid social, economical and technical changes. Such changes raise the concern for the quality of health care. Hospital is an integral part of health care system. Accreditation would be the single most important approach for improving the quality of hospitals. Accreditation is an incentive to improve capacity of national hospitals to provide quality of care. National accreditation system for hospitals ensure that hospitals, whether public or private, national or expatriate, play there Expected roles in national health system. Confidence in accreditation is obtained by a transparent system of control over the accredited hospital and an assurance given by the accreditation body that the accredited hospital constantly fulfills the accreditation criteria.
NABH IMPLEMENTATION BENEFITS
Benefits for Patients Patients are the biggest beneficiary among all the stakeholders. Accreditation results in high quality of care and patient safety. The patients are serviced by credential medical staff. Rights of patients are respected and protected. Patient’s satisfaction is regularly evaluated.
Benefits for Hospitals Accreditation to a hospital stimulates continuous improvement. It enables Hospital in demonstrating commitment to quality care. It raises community Confidence in the services provided by the hospital. It also provides opportunity to healthcare unit to benchmark with the best.
Benefits for Hospital Staff The staff in an accredited hospital is satisfied lot as it provides for continuous learning, good working environment, leadership and above all ownership of clinical processes. It improves overall professional development of Clinicians and Para Medical Staff and provides leadership for quality improvement with medicine and nursing.
Benefits to paying and regulatory bodiesFinally, accreditation provides an objective system of empanelment by insurance and other third parties. Accreditation provides access to reliable and certified information on facilities, infrastructure and level of care.
TRAINING
We offer a customized training programme on NABH for
- NABH - Awareness on implementation and documentation requirements
- NABH - Internal Auditor training
ISO 15189:2012 Medical laboratories - specifies requirements for quality and competence in medical laboratories. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
ISO 15189 Introduction: ISO 15189 is an international standard developed particularly for the medical laboratories. Though it is based upon ISO/IEC 17025:2005 and ISO 9001:2015, it is a standalone standard for medical laboratories with a title particularly referred to "quality and competence”. Under the International Laboratory Accreditation Cooperation (ILAC) Multilateral Mutual Recognition Arrangement(MLA)accreditation of medical laboratories against ISO 15189 and ISO/IEC 17025 are both acceptable.
The basic idea of the European Union is freedom of movement of people, products and services. This is realized through harmonization of practices, for example in the field of laboratory medicine, a patient wants to be sure that the result of a test can be trusted and is interpreted in the right way during his stay abroad. The primary aims of both Evidence-based Health Care(EBHC) and quality management of health care services are to improve clinical effectiveness and patients' outcomes.Evidence-based laboratory medicine (EBLM) is an essential tool in the assessment of effectiveness, as high quality systematic clinical research is necessary for investigating the impact of any intervention on clinical outcome.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.