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 certification, as well as those contemplating the development and implementation of a quality management system. This ISO 9001:2015 version follows the new high-level structure and comprises ten sections: Scope Normative references Terms and definitions Context of the organisation Leadership Planning (including Risk Analysis) Support Operation Performance evaluation Improvement How can you prepare? Organisations that have[…]

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 or a CA quotation, please do not hesitate to contact Compliance Management Solutions.   About CMS:  Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | 13485 (Medical Devices) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:  •        Australian ARTG registration/sponsorship/consultancy (medical devices/medicinal products) •       […]

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 Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This regulation sets the requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetic products circulating onto the European Market will have to be produced according to Good Manufacturing Practices. This can be demonstrated by implementing ISO 22716.  Why implement[…]

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 manufacturer of medical devices and you require Australian registration, let Compliance Management Solutions act as your sponsor. About CMS:  Compliance Management Solutions is an Australian based consultancy assisting organizations in TGA | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 certification, registration and consultation. Our services include:  •        Australian ARTG registration/sponsorship/consultancy (medical devices/medicinal products) •        Implementation[…]

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 defibrillator pads, tubing, filters, masks etc) must also be registered in the ARTG if sold individually.   The application process can be exhaustive as this is dependant upon the classification of the device. Once a product has been approved for supply, the obligations of sponsors continue.  The device must continue to meet regulatory, safety and[…]

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 Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics. This regulation sets the requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetic products circulating onto the European Market will have to be produced according to Good Manufacturing Practices. This can be demonstrated by implementing ISO 22716. Why[…]

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 export of medical devices from Australia, as well as making application to the TGA to have their device included in the ARTG. The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia. If you are[…]

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 to ensure continuing compliance to the requirements of ISO 13485, ISO 9001 and ISO 22716. A first party audit (aka internal audit) schedule should always be used. Audits will only be conducted by appropriately trained and competent personnel: trained by a recognized body or successful completion of at least three audits as a trainee auditor[…]

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 to eliminate the cause of an EXISTING nonconformance in order to prevent recurrence. This is pretty straight forward- an organization has a non-conformance and they implement training or a change to prevent recurrence. Preventive Action – action taken to eliminate the cause of a potential nonconformance in order to prevent recurrence. If you are having[…]

Australian Medical Device Sponsorship 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 of medical devices from Australia, as well as making application to the TGA to have their device included in the ARTG. The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia. If you are[…]