The International Organization for Standardization (ISO) has just published a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision includes a number of important[…]
Cosmetics GMP for Export Purposes (ISO 22716)
If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this new regulation? All cosmetic products[…]
TGA Australian Medical Device Sponsor
As per the Australian TGA Medical Device Regulations, before someone can supply a medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic[…]
ISO 9001 : 2015
The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for[…]
Australian TGA Medical Device Conformity Assessment
As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). Finally, there has been a paradigm shift whereby[…]
Cosmetics GMP ISO 22716
If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this new regulation? All cosmetic products[…]
Cosmetics GMP ISO 22716 – New Cosmetics Global Regulation
If you are a cosmetics exporter, you may have had been notified by mandated bodies that you require to comply with EC Regulation 1223/2009. What are the requirements for this new regulation? All cosmetic[…]
ISO 9001:2015
The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for[…]
TGA – Medical Device Conformity Assessments
As of recent, the TGA was the only Notified Body that can issue Conformity Assessments (CA) for Australian medical device manufacturers (intended to be sold in Australia). Finally, there has been a paradigm shift whereby the[…]
ISO 9001:2015
The International Organization for Standardization (ISO) is at work on a major revision to the ISO 9001 standard, the internationally-recognized standard that outlines the principles for quality management systems. The revision is currently scheduled for[…]