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ROI CalculatorISO 13485 sets global standards for the quality of medical devices produced by manufacturers. If your company has ISO 13485 certification you will be able to demonstrate to regulators, partners and customers that you have quality systems in place that support your commitment to patient safety and meet all applicable regulatory requirements.
For the organizations who are pursuing or maintaining ISO 13485 certification:
The standard requires a quality system built around risk management at every stage
Complaint handling, CAPA, and design controls are core areas of assessment
Certification is not a one-time achievement, it requires sustained operational discipline
Auditors look for evidence of real implementation, not policy documentation alone
ISO 13485 is a solid base on which serious manufacturers of medical devices build everything else. Different markets have different requirements but in many cases there is no alternate path to demonstrating compliance with regulatory requirements. Although ISO 13485 is not a legal requirement everywhere it will often be considered as a condition to showing that you meet local regulatory standards.
A well-organized QMS does more than just provide a certification mark. Certification strengthens your market position, helps you with risk management, and provides greater visibility and safety to your company. Certified companies have better controls over their processes and are more certain of their actions when being subject to inspections and/or approvals, providing real competitive advantage.
Achieving ISO 13485 Certification is not merely getting some documents together, it will require an ongoing commitment to develop a functional QMS throughout the course of everyday operations. This will be important for identifying risk, determining responsibilities, ensuring processes are in place and you uphold regulatory requirements.
Fill in and submit forms at the beginning, questions about the company and the scope of the certification are answered. This information forms the basis for everything else.
Determine the procedure and start preparations. An accredited inspection body coordinates with your company, plans the procedure and clarifies which documents must be available before the audit.
Check eligibility for certification before the actual audit, the certification body checks whether all requirements have been met.
On-site audit and processing of open points implementation is checked. If there are any deviations, they are documented and must be rectified before approval is granted.
Receive certificate and have it confirmed annually once everything has been completed, the certificate is issued for a period of three years. During this time, annual inspections are planned to maintain the validity of the certificate.
Certification for ISO 13485 is much more than just the actual ISO audit. The whole process begins six months prior to the ISO audit itself, from the first step in preparing to get ISO 13485 certified until the day the actual ISO Certification is issued, depending upon how developed your QMS. It is important that you take the appropriate time for your internal preparations, because if you are structured in your approach, you will save time on the day of the ISO audit.
