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[…]
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ISO 9001 / ISO 13485 clause 8.3 | ISO 22716 Cosmetics GMP clause 13 – Control of Nonconforming Product / Deviations
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[…]
TGA / Australian Medical Device Sponsors
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[…]
ISO 9001 / ISO 13485 clause 8.5.2 / 8.5.3 | ISO 22716 Cosmetics GMP clauses 13/14/16 | TGA GMP – Corrective and Preventive Action (CAPA)
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 9001 / ISO 13485 clause 7.6 | ISO 22716 Cosmetics GMP clause 5.4 – Control of monitoring and measuring equipment | Calibration
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).[…]
ISO 9001 / ISO 13485 clause 6.1 | ISO 22716 Cosmetics GMP clause 3 – Provision of Resources
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[…]
ISO Survey confirms boost in management systems (ISO 9001 Quality / 13485 Medical Devices / 22716 Cosmetics GMP)
‘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[…]
ISO 9001 / 13485 clause 4.2.4 Control and retention of records | ISO 22716 Cosmetics GMP clause 17
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[…]
TGA Medical Device Sponsors
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[…]
Management Review – ISO 9001 | TGA (Pharmaceuticals / ISO 13485 Medical Devices) | ISO 22716 Cosmetics GMP |
To ensure continuing suitability, effectiveness and adequacy of a Quality Management System (QMS) management reviews should be performed at planned intervals to include assessing opportunities for improvement and the need for changes to the QMS.[…]