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Bioclone
has a quality management system certified to AS/NZS, ISO 9001 (current
edition), ISO 13485 (current edition), Good Manufacturing Practice (GMP) and
the CE Mark, which is a demonstration of the company’s commitment to clear
and documented quality objectives. Furthermore, Bioclone also has US FDA
clearance with 510(k) approval to market for ten of its ELISA products.
Indeed, these certifications collectively represent a recognition of the
successful implementation and maintenance of a quality management system for
the design, manufacture, sale and distribution of Bioclone’s
immunodiagnostic kits, reagents and antibodies. Bioclone firmly believes in
the principle of exceeding the client’s quality expectations in order to
achieve total satisfaction.
Bioclone
aims to deliver comprehensive solutions for all customer service needs, and
to communicate and document progress through the course of every
association. The extensive experience of Bioclone’s QC department in each
aspect of the quality standards is reflected in all finished products.
The
continuous “in-process testing” and after-sales technical back-up by the QC,
marketing and sales departments, ensure complete customer satisfaction.
The wide
range of regulatory requirements from, for example, Australia’s Therapeutic
Goods Administration (TGA), the US FDA and Europe’s CE Mark, provide
accreditations that Bioclone aims to obtain for products prior to release.
In 2006, Bioclone was granted an overseas manufacturer’s registration under
Japan’s new regulatory framework.
Bioclone
is totally committed to maintaining high quality standards and value in both
our product and service offerings, as well as competitive pricing,
irrespective of the cost imposts stemming from having the above quality
systems in place.
QUALITY POLICY
Bioclone Australia Pty Limited has an unwavering commitment to providing
quality goods and services, based on our desire to exceed customer
expectations. The aims of the Bioclone team include:
· As
a minimum, meeting customer expectations for batch-to-batch
consistency,
accuracy, precision, safety and efficiency at all stages, from research and
development to the manufacture and despatch of final product.
· Sourcing
and delivering superior agency lines to support our research-based
customers.
· Maintaining
a practice of on time delivery, in full, for all manufactured products,
agency lines and contracted activities.
· Focussing
on maintenance, with an aim of continued improvement of all products and
services and effectiveness of the Quality Management System, through the
establishment and review of Quality Objectives.
· Following
Occupational Health and Safety AS/NZS 4801 (Current Edition) regulatory,
legislative and industrial requirements for the manufacture and sale of
in vitro diagnostics.
The Board of Directors is committed to support Bioclone's Quality Management
System, which is certified to the requirements of international quality
system standards, including ISO 9001, ISO 13485 (Current Editions) and the
CE Mark (European IVD Medical Devices Directive 98/79/EC).
The Board calls for co-operation from every employee to follow quality
procedures and to maintain a dedication to quality in all aspects of their
work.
This commitment to quality extends, not only to production of goods and
provision of services, but also to research and development, sales and
marketing and administration and accounting.
The Board expects that Bioclone employees give
their complete support to staff members responsible for the implementation
of the quality policy.
© Bioclone Australia Pty Limited
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