ISO 13485

Demonstrate absolute commitment to the quality of your medical devices Regulatory requirements and customer needs are becoming tighter where the quality of medical products, devices and their components are concerned. Therefore, legal manufacturers and their suppliers throughout the world are expected to pro-actively comply with the highest standards and regulations. Certification is needed prior to entry into new markets or before customers place orders. ISO 13485:2003 is now the basis of all regulatory requirements, so it is essential not only for companies who export but also for the local market and for suppliers and sub contractors to prove products are of the highest quality. Proof that you are committed to your customers Whether you are a small company or a multi national corporation certification from SGS will show your commitment to the highest possible standards and form the basis for meeting your regulatory requirements now and in the future. It will also serve as a management tool to improve your quality management systems and key processes. Regulatory Certification Whereas ISO 13485:2003 certification alone may meet the requirements of medical device sub-contracting organizations and manufacturers of low risk medical devices, most manufacturers will have to obtain regulatory certification to be able to access to the main world markets. This is where the value of the SGS service becomes most apparent. It is the policy of SGS to obtain all the medical device regulatory approvals possible to offer clients now and in the future access to all the world markets. Currently these include*: Directive 93/42/EEC Annex II, V, VI for CE marking (Europe) JPAL (Japan) CMDCAS (Canada) TCP Program for ROC (Taiwan) FDA Accredited Persons Programme (US) Other EC Directives that overlap with Medical Devices e.g. Personal Protective Equipment and Pressure Vessels * This list continues to increase In addition, SGS ISO 13485:2003 and Directive 93/42/EEC certification is accepted by many other countries and organizations such as the World Health Organisation (WHO). SGS Assessments ISO 13485 and regulatory certification requires regular site audits, which SGS undertake on a global basis. With some regulatory certification this is combined with reviews of technical documentation against standards and regulatory requirements. In all cases, it is possible to combine these audits saving clients money and time. The SGS client base, counted in thousands, now ranges from small manufacturer to multinationals and low risk devices through in-vitro diagnostic devices to the highest risk equipment and implants containing animal tissue or pharmaceuticals. Over time SGS certification translates into increased performance and helps build your commercial success in regulated markets. Benefits of SGS Certification Using SGS as your certification partner will give several extra benefits: Not all certification is perceived as having the same standing. SGS medical device certification, whether to ISO 13485 alone or in combination with regulatory certification will be seen by your customers, distributors and authorities as your absolute commitment to the quality of your medical devices during the approval or bidding process. Most medical device manufacturers will want to eventually sell their products worldwide and so the SGS policy of offering all approvals possible will help you achieve this objective Regular assessments performed by SGS help you monitor and improve your management system and processes. This improves the reliability of your operations and products ,ensures compliance with regulatory and customer requirements and increases financial performance Why SGS? Our global brand is built upon our presence in 80 countries with over 100,000 certificates globally. SGS is the world’s leading certification body in diverse standards, including ISO 9001:2000, ISO 14001:2004 and food safety in addition to regulatory certification. Audits are a tool to improve the efficiency of your processes, i.e. increase your profitability. Audit services are not only a measurement tool, but also a building block of your continuous improvement systems. They recognize the past efforts, show how far the organization has already traveled and materialize the impetus of your business. The SGS approach is transparent and logical, which is why we become your partner towards improvement and in meeting your business and regulatory objectives. We do not turn audits into the simple filling-in of a checklist and checking of your document systems. Our auditors are trained the “SGS way“, they listen to the client and are objective, knowledgeable and ethical at all times. Our network of experienced auditors identifies non conformities in a consistent manner, globally. Our auditors are trained on multiple standards and can perform integrated audits when needed.

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