What is a medical device? As per the Therapeutic Goods Regulation, Section 41DB, a medical device is: ‘any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and that does not achieve[…]

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[…]

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 that are low risk – severities 1(negligible) and 2(minor) will not require any qualification/calibration.   About CMS: Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001[…]

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 German word for the baton that an orchestra conductor uses to regulate the speed, beat or timing at which musicians play. So TAKT Time is “Beat Time”, “Rate Time” or “Heart Beat”. Lean Six Sigma uses TAKT Time as the rate that a completed product needs to be finished in order to meet customer demand.[…]

‘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. Spurred by continued economic growth and important industrial and manufacturing production, China remains in the top 10 countries for six out of the seven standards covered in this survey. ISO 9001 gives the requirements for quality management systems. Certification to the standard is used in global supply chains to provide assurance about suppliers’ ability to[…]

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 years from the date of product release by the organization or as specified by relevant regulatory requirements’ As per the Therapeutic Goods (Medical Devices) Regulations 2002, the manufacturer must keep all manufacturing records for at least 5 years from the last date of manufacture or the lifetime of the device, whichever is longer. Distribution records[…]

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. Responsibilities of a medical[…]

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 meet the company’s changing direction and needs. It promotes management ownership and responsibility for quality. Quality Systems Review (QSR) should ensure the QMS is achieving its objectives. During QSR meetings; complaints, corrective actions, customer feedback and relevant trends are a couple of applicable key focal points. A copy of the QSR meeting minutes and actions[…]

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 certification the organisation has and that you maintain a current certificate. There have been many instances where organizations have been caught out by regulators for not having the updated supplier certificate. Supplier re-evaluation should also be performed; this can be as simple as asking for an updated registration certificate. When a supplier has no certification, use history[…]

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 regarding GMP implementation contact Compliance Management Solutions or your nearest SGS agency. About CMS: Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification.