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1. Formal recognition of competence of a laboratory by an Accreditation
body in accordance with international criteria has many advantages:
2. Potential increase in business due to enhanced customer confidence
3. Savings in terms of time and money due to reduction or elimination of
the need for re-testing of products.
4. Better control of laboratory operations and feedback to laboratories as
to whether they have sound Quality Assurance System and are
5. Increase of confidence in Testing / Calibration data and personnel
6. Customers can search and identify the laboratories accredited by NABL 17025:2015
for their specific requirements from the Directory of Accredited
7. Users of accredited laboratories will enjoy greater access for their
products, in both domestic and international markets, when tested by
TESTING, CALIBRATION, MEDICAL LABORATORIES
- Fluid Flow
- Thermal & Optical
- Clinical Pathology
- Hematology and Immunohaematology
- Microbiology and Serology
- Nuclear Medicine (in-vitro tests only)
(NABL 17025:2015) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL 17025:2015 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.
4. NABL 17025:2015 Secretariat on receipt of application will issue acknowledgement to the laboratory. After scrutiny of application for it being complete in all respects, a unique Customer Registration Number will be allocated to laboratory for further processing of application.
5. NABL 17025:2015 Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking necessary corrective action, if any. The laboratory shall submit Corrective Action Report.
After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organized by NABL 17025:2015. Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.
3. A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit, if any.
After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organized by NABL 17025:2015.
2. The Assessment Team shall consist of a Lead Assessor and other Technical Assessor(s) in the relevant fields depending upon the scope to be assessed.
3. Assessors shall raise the Non-Conformance(s), if any, and provide it to the laboratory in prescribed format so that it gets the opportunity to close as many Non-Conformance(s) as they can before closing meeting of the Assessment.
4. The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the original copy to NABL 17025:2015 Secretariat.
Laboratory shall take necessary corrective action on the remaining Non-Conformance(s) / other concerns and shall submit a report to NABL 17025:2015 within a maximum period of 2 months.
1. After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the Assessment Team and recommend additional corrective action, if any, by the laboratory.
2. Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL 17025:2015 requirements as well as commensurate with the claims made by the laboratory in its application.
3. Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee.
4. Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL 17025:2015 Secretariat.
5. Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the Director, NABL 17025:2015.
6. Whenever possible NABL 17025:2015 will depute its own technical personnel to be present at the time of assessment as Coordinator and NABL 17025:2015 Observer. Sometimes, NABL 17025:2015 may at its own cost depute a newly trained Technical Assessor as "Observer" subject to convenience of the laboratory to be accessed.
1. Accreditation to a laboratory shall be valid for a period of 2 years and NABL 17025:2015 shall conduct periodical Surveillance of the laboratory at intervals of one year.
2. Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation.
Objective of NABL 17025:2015 Certification
NABL 17025:2015 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 17025:2015 as the sole accreditation body for Testing and Calibration laboratories in India.NABL 17025:2015 Accreditation, NABL 17025:2015 Certification is best certification providing company in India, What is NABL 17025:2015 Certification, Details about NABL 17025:2015 Certification.
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About NABL Accreditation
ISO/IEC 20000 is an international IT standard that concede companies to establish excellence and prove best practice in IT management.
ISO 13485:2013 specifies requirements for a qms where an organization needs to demonstrate its ability to provide medical devices and related services..
ISO/TS 16949:2009 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured..
ISO 15000-1:2004 defines the mark-up language vocabulary for creating the electronic CPP and CPA.
This distinction has brought additional responsibility on NABL 17025:2005 and its accredited laboratories. Annual Surveillance is carried out to ensure that the accredited laboratories are continuing to comply the accreditation criteria. NABL is Certification Consultant. 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 Programmer 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.
NABL is the sole accreditation body in India that provides third party assessment and has been authorized by Government of India. 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 15189:2007 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.
Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands.Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. Society also needs to know the technically competent laboratory in fields such as Medical, Forensic, Food Testing etc.
The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product
ISO 9001:2015 applies to any organization, regardless of size or industry.More than one million organizations from more than countries have applied the ISO 9001 standard requirements to their quality management systems.
ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability..
NABL Certification is one of the fastest growing standard certification and business management consulting organization, offering certification consulting services to organizations of all nature and size.