Medical Device Sponsors Before someone can supply a medical device for sale in Australia they are required to make an application to include the device in the ARTG. The sponsor is the person or company responsible for the importation of…
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What is a medical device? As per the Therapeutic Goods Regulation, Section 41DB, a medical device is: ‘any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application)…
Internal audits MUST be completed for all organizations that are ISO 9001/13485/22716 certified. It is a process that an auditor will review whether at surveillance or re-certification. If you don’t perform internal audits in your organization the probability of striking a…
Deviations may arise as a result of but not limited to: material/product – contaminated, out of specification machine/equipment – failed calibration, validated operating parameters violated method/procedure – approved process not followed personnel error – not appropriately trained or failing to…
What is a medical device? As per the Therapeutic Goods Regulation, Section 41DB, a medical device is: ‘any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application)…
Corrective and Preventive action: A continuous improvement tool that can be extremely effective if used correctly. This tool is used not only for ISO 9001 organizations but also for organizations that comply to Cosmetics GMP ISO 22716, TGA GMP Pharmaceuticals,…
Historically, all equipment/measuring devices that are calibrateable in organizations are calibrated. Rather than calibrating every measuring device, adopt a risk based approach. Use this method also to indicate where equipment qualification is required (ie IQ/OQ/PQ). Eg, equipment that is classified…
Organizations shall determine and provide resources needed: · to implement the quality management system and to maintain its effectiveness · to meet regulatory and customer needs · relevant for its size and the diversity of products A good measure of…
‘The numbers are in. Getting certified to ISO management systems is on the rise. The latest edition reveals a healthy growth across the board for all certifications at the end of 2012, exhibiting a worldwide total of 1 504 213…
Retention of records Although ISO 9001 and ISO 22716 does not stipulate how long records must be retained for, ISO 13485 is more specific – ‘the organization shall retain the records for a period of time at least equivalent to the…