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Quality Assurance

Since 1995 Olympus Australia has been certified to the international Quality Standards ISO 9001. In 2011, we received an Award for Recognition of 15 years of continual certification to ISO 9001, demonstrating our commitment to quality. But what does that mean?

Accreditation means Olympus Australia has a complete Quality Management System that drives how our company defines its customers’ expectations, what processes are required to provide these, and how to keep these processes under control.  Most importantly, it provides a framework within which processes are continually improved. 

Certification to ISO 9001 ensures Olympus Australia’s business processes have been independently audited by an external governing body, and have been recognised as meeting the criteria required by the International Organisation for Standardisation (ISO).  Therefore our customers can be assured of the highest level of quality, service and system standards. 

Our quality system is independently audited every six (6) months, with recertification compliance conducted every three (3) years.

Open the full Certificate of Recognition to read all the details

Open the ISO 9001 Certificate to read all the details

TGA Registration

All Olympus medical devices that fall within the certain guidelines are registered with the Therapeutic Goods Administration (TGA).  This ensures that our equipment is not only technically advanced to our competitors but is of a standard that ensures reliability and safety to our customers and patients alike. 

Olympus ensures that all our medical devices are registered prior to commercial availability within Australia and New Zealand.  This approach guarantees that all products supplied to the market have been manufactured, tested and certified to the highest governing body within the Australian and New Zealand market. 

EMC Compliance

 All electric or electronic devices distributed by Olympus Australia and New Zealand are compliant with the Australian Electromagnetic Compatibility Framework (EMC).  This requires Olympus to have a compliance folder in place for each product commercially viable, including a signed Declaration of Conformity from our overseas Manufacturer’s detailing the European and Australian standards that the equipment has been tested against during the manufacturing process. 

Olympus provides all customers who purchase electric or electronic devices from our product range with a Supplier’s Declaration of Conformity, which details the mandated standards that the equipment has been tested against during and at the completion of the manufacturing process.  All electric equipment that is produced by Olympus Europe is also CE compliant to the relevant European Directive(s). 

To request a current Declaration of Conformity for a product purchased from Olympus Australia or New Zealand please send an email with the relevant order number and product information to emc@olympus.com.au

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