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Certification
Piramal Healthcare Receives Two ISO Certificates
The certificate has been awarded by URS
Piramal Healthcare Ltd has been recently awarded ISO certification
in two categories: manufacturing and sale of In-Vitro Diagnostic Devices (IVD)
and kits for their plant at Pawane, Navi Mumbai.
The certificate has been awarded by URS, a certifying body affiliated to the
United Kingdom Accreditation Services (UKAS). The ISO 9001: 2000 and ISO 13485:
2003 demonstrate Quality Management System requirement specified in international
standard and medical devices — quality management systems requirement for
regulatory purposes, respectively.
Said Dr Swati A Piramal, Director, Piramal Group, "We at the Piramal Group
are proud of the certifications we receive as they restate and acknowledge our
commitment to quality. We are a company that is knowledge, action and care driven.
We firmly believe in innovation and in bringing in newer technologies and ideas
to offer better products to our customers."
Piramal Healthcare's Pawane plant boasts of a state-of-the-art manufacturing
capability for in-vitro diagnostic products. The Rapid Test Manufacturing laboratory
for manufacture of lateral flow rapid membrane tests is of international standards
and currently manufactures rapid tests for malaria and Troponin I.
"The products manufactured at Pawane are well accepted by clinicians and
pathologists across the country and have their presence in almost major disciplines
of medicine including cardiology, diabetes, nephrology, haematology, gastroenterology
and infectious diseases," added Piramal.
The UKRS is recognised internationally through European and world multilateral
recognition agreements. Accreditation by UKAS demonstrates the competence, impartiality
and performance capability of the evaluators. These certifications specify requirements
for a quality management system where an organisation needs to demonstrate its
ability to consistently provide product that meets customer and applicable regulatory
requirements, and aims to enhance customer satisfaction through the effective
application of the system.
EH News Bureau
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