Quality of manufacture is established by meeting benchmarked international standards, via Quality Management Systems (QMS). The basis for all QMS is the International Standards Organisation’s 9001 standard (ISO 9001).
ISO 9001 should be considered the minimum quality standard applicable to e-cigarette devices. Any manufacturer or supplier should be able to provide an up-to-date ISO 9001 certificate for their manufacturing facility.
As the basis for international manufacturing standards, ISO 9001 underlies a series of ‘sector-specific’ manufacturing standards, for example, ISO 13485 is the standard applicable to medical devices. Indeed, the TGA mandates that all medical devices supplied for use in Australia are manufactured to the ISO 13485 standard.
There is currently no jurisdiction globally where e-cigarettes are regulated and commercialised as medical devices. As such, e-cigarettes are not eligible to be formally certified under the ISO 13485 standard. To provide confidence that our devices are manufactured to the highest possible standard, i.e., the standard that medical practitioners would expect of medical devices. Liber’s devices are audited to document conformance with ISO 13485.
If smokers or medical practitioners were seeking a ‘gold standard’ for device quality over and above ISO 9001, a device manufactured to conform with ISO 13485 (in lieu of formal certification) should be considered the benchmark for Nicotine Vaping Products (NVPs).