ISO 13485 Certification in Thailand
ISO 13485 certification is a globally-recognized quality management system standard that provides guidance for medical device manufacturers. To achieve ISO 13485 certification, a manufacturer must demonstrate that they have implemented an effective quality management system that meets the requirements of the standard.
Many medical device manufacturers choose to pursue ISO 13485 certification in order to demonstrate their commitments to high-quality medical device production, patient safety, and product reliability.
ISO 13485 certification can also help manufacturers streamline operations and gain access to new markets.
The ISO 13485 standard is used in the European Union (EU) and other international regions under The Medical Devices Directive (93/42/EEC), which provides a common framework for the regulation of medical devices within countries that are members of the EU. Although the Medical Devices Directive stipulates that manufacturers of medical devices must be ISO 13485 certified, not all countries require ISO 13485 certification for companies that wish to market their products within their borders.
The process to get ISO 13485 Certification
- Contact IAS, Complete the application form, and submit it. IAS will review your application form and help you to review your manufacturing process flow.
- IAS will provide a formal quotation for the scope of conformity assessment activities, including the number of days needed.
- Payment terms are required to start the conformity assessment process.
- On receipt of payment, IAS will commence the conformity assessment process
- Stage 1 and Stage 2 Audit will be planned and conducted as per ISO 17021-1
- The ISO certificate is issued once corrective actions are completed.
Benefits of ISO 13485 Certification
- Compliance with International and National Standards
ISO 13485 certification demonstrates that a manufacturer's quality management system has been assessed by an independent third party as conforming to the requirements of ISO Certification. This is especially important for medical device manufacturers exporting to markets like the EU, which requires all devices to be produced in accordance with certification, as well as the ISO 13485:2003 standard.
- Streamlining Operations
An effective quality management system is a critical foundation for streamlined operations that yield minimum waste and downtime, all of which contribute to increased productivity and profitability. A properly implemented quality management system can also help a company respond more quickly to customer needs and market changes, provide more accurate forecasts, and expand into new markets.
- Increased Competitiveness
An ISO 13485 certification can make a medical device manufacturer more competitive in their local market by making them more attractive to prospective customers in regulated jurisdictions. An Certification can also help companies enter new international markets that require manufacturing in accordance with the Medical Devices Directive (93/42/EEC).
- Improved Patient Safety
The ISO 13485 standard is designed to help manufacturers produce medical devices that are safe and reliable for patients. Implementing an effective quality management system helps to ensure that all aspects of the manufacturing process meet the highest standards for safety and quality.
- Reduced Regulatory Costs
Medical device manufacturers that choose to pursue ISO 13485 certification may benefit from reduced regulatory costs when exporting their products. It's important for medical device manufacturers to understand, however, that not all countries require this type of certification in order to import devices into the country.
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