• gloizou
• Oct, 30, 2013
• Uncategorized
• Comments Off on 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 22716, TGA GMP Pharmaceuticals, ISO 13485 medical devices etc. The definitions are as follows: Corrective Action – action taken […]

• gloizou
• Oct, 30, 2013
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• Comments Off on 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). Eg, equipment that is classified as risk levels with severities 3 (serious),4 (critical),5 (catastrophic) will require qualification and calibration. Equipment […]

• gloizou
• Oct, 28, 2013
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• Comments Off on 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 products A good measure of how an organization can meet customer demand is to measure TAKT time. “Takt” is the […]

• gloizou
• Oct, 26, 2013
• Uncategorized
• Comments Off on 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 total of 1 504 213 certificates across 191 countries. Overall, Asia comes up trumps once again in this year’s survey. […]

• gloizou
• Sep, 26, 2013
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• Comments Off on 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 at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two […]

• gloizou
• Sep, 25, 2013
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• Comments Off on 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 responsible for the importation of medical devices into Australia, and/or the supply of medical devices in Australia, and/or the export […]

• gloizou
• Sep, 03, 2013
• Uncategorized
• Comments Off on 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. The intention of Quality System Review is to foster a constantly evolving Quality System to improve and develop processes to […]

• gloizou
• Sep, 03, 2013
• Uncategorized
• Comments Off on 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 realization (final product). Rather than evaluating all suppliers, use a risk based approach. When desktop audits are performed, ensure that they record any […]

• gloizou
• Jul, 16, 2013
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• Comments Off on 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. Companies can demonstrate compliance with this regulation by implementing: ISO 22716 Cosmetics – Good Manufacturing Practices (GMP). For further information […]

• gloizou
• Jul, 01, 2013
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• Comments Off on 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 this regulation by implementing: ISO 22716 Cosmetics – Good Manufacturing Practices (GMP). For further information regarding GMP implementation contact Compliance […]