• gloizou
• Feb, 28, 2015
• Uncategorized
• Comments Off on 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 publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 […]

• gloizou
• Nov, 14, 2014
• Uncategorized
• Comments Off on 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 TGA will now accept conformity assessments from 3rd party Notified Bodies.  It will take a few months however for the Government […]

• gloizou
• Sep, 24, 2014
• Uncategorized
• Comments Off on 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 publication in September 2015, and is expected to include a number of important changes for organizations currently holding ISO 9001 […]

• gloizou
• Sep, 20, 2014
• Uncategorized
• Comments Off on Australian Medical Device Conformity Assessments (TGA)

Currently, the TGA is the only Notified Body in Australia that can issue Conformity Assessments (CA). There has been significant movement with respect to CA for Australian medical device manufacturers. It is expected that in 2015 the TGA will accept conformity assessments from 3rd party Notified Bodies.   If you require further information regarding this significant change […]

• gloizou
• Sep, 20, 2014
• Uncategorized
• Comments Off on 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 products exported to Europe will have to be produced according to Good Manufacturing Practices (also includes Asian/US/NZ markets) Cosmetics Good Manufacturing […]

• gloizou
• Sep, 20, 2014
• Uncategorized
• Comments Off on Australian Medical Device Registration / Sponsorship

As you may be aware, 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 Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas […]

• gloizou
• Sep, 20, 2014
• Uncategorized
• Comments Off on Australian Medical Device Distribution

Before someone can supply a medical device for sale in Australia they are required to make an application to include the device/system in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. Please note that all accessories to medical device systems (eg […]

• gloizou
• Aug, 13, 2014
• Uncategorized
• Comments Off on ISO 22716 – Cosmetics GMP

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 exported to Europe will have to be produced according to Good Manufacturing Practices (also includes Asian/US/NZ markets) Cosmetics Good Manufacturing […]

• gloizou
• Aug, 13, 2014
• Uncategorized
• Comments Off on Australian (TGA) Medical Device Sponsor

Australian TGA 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 medical devices into Australia, and/or the supply of medical devices in Australia, and/or the […]

• gloizou
• Jun, 03, 2014
• Uncategorized
• Comments Off on ISO 9001 / ISO 13485 clause 8.2.2 | ISO 22716 Cosmetics GMP clause 16 – Internal Audit

Internal Audits Internal audits MUST be completed for all organizations that are ISO 9001/13485/22716 certified. It is a process that a notified body will review at surveillance or re-certification. If you don’t perform internal audits in your organization the probability of striking a MAJOR NC against you is extremely high. The objective of the audit program is […]