‘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.[…]
TGA (Pharmaceuticals / ISO 13485 Medical Devices) | ISO 22716 Cosmetics GMP | ISO 9001
Vendor/Supplier Evaluation The method of evaluating suppliers can be either done via physical/site audit or desktop audit. The type and extent of control applied to the supplier shall be dependant upon the effect of the product on product[…]
Cosmetics GMP – ISO 22716
Cosmetics GMP – ISO 22716 To all Australian cosmetic exporters – the new Cosmetic Regulation “Cosmetics GMP” is now in effect. This means that companies will now be required to demonstrate compliance to this new regulation.[…]
Cosmetics GMP – ISO 22716
A reminder to all Australian cosmetic exporters that the new Cosmetic Regulation kicks in 11 July, 2013. This means that companies will be required to demonstrate compliance to this new regulation. Companies can demonstrate compliance[…]
Cosmetics GMP – ISO 22716
A reminder to all Australian cosmetic exporters that the new Cosmetic Regulation kicks in 11 July, 2013. This means that companies will be required to demonstrate compliance to this new regulation. Companies can demonstrate compliance with[…]
GMP Consultants
The TGA has recently published its new financial year fees. Please refer to the web address below for a summary of 2013-2014 fees. Contact CMS to avoid unnecessary fees. http://www.tga.gov.au/about/fees-130701.htm About CMS: Compliance Management Solutions[…]
Continuous Improvement – ISO 9001 | TGA | ISO 22716 | ISO 13485
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 organisations but also for organizations that comply to Cosmetics GMP[…]