ISO 13485 CERTIFICATION

 

What is the ISO 13485 standard?

ISO 13485 is a quality management system standard created specifically for medical devices and equipment. This International Standard establishes the criteria for an organization's QMS to consistently deliver high-quality medical products. It allows organizations to monitor, maintain, control and minimize errors and waste. It helps companies deliver high-quality medical equipment that meets customer needs on a regular basis. In addition, the ISO 13485 standard ensures that companies comply with applicable legal requirements.

About ISO 13485 certification

iso 13485 argentina is a guarantee that medical devices and equipment are manufactured and verified using a high quality controlled process. This accreditation contributes to the success of a business by increasing brand recognition. ISO 13485 certifications for medical devices are intended to be used by all organizations involved in the design, manufacture, marketing and maintenance of medical devices and technologies. In addition, ISO 13485 standards aim to be implemented equally in all countries for medical services and products.

Any organization dealing with medical devices ensures by complying with ISO 13485 certification standards that its products are of the highest quality, more efficient, safe, reliable, sustainable and less wasteful than medical devices of other types. This allows organizations to reduce their overall operating costs. It also increases the efficiency of the supply chain around the world by simplifying cross-border trade.

ISO 13485 certification in Argentina

ISO 13485 certification in Argentina is proof that an organization has successfully implemented an effective quality management system for medical devices. The ISO 13485 certification in Argentina is crucial for the organization that handles medical devices, since it is mandatory for all organizations that are engaged in the manufacture, assembly, import, packaging, labeling or distribution of medical devices throughout the world. It is intended to meet the requirements of this standard.

ISO 13485 certification is an international quality management system that allows us to better manage our processes and products for high-quality medical items.

Certification helps organizations drive business growth by demonstrating compliance with the standard. ISO 13485 aims to help organizations achieve premium status, increase customer trust, increase sales, optimize financial performance and improve operational efficiency.

Why does an organization need ISO 13485 certification?

By acquiring ISO 13485 certification, a company can gain the following benefits.

This is a crucial step in the FDA's GMP program. Helps you build customer trust and improve QMS performance. Ensure high-quality medical devices by making sure manufacturers/suppliers meet your expectations. It also helps with compliance with legislative and regulatory standards. Potential risks can be avoided.

Steps to achieve ISO 13485 Argentina Certification

  • Complete the IAS application form and send us
  • Contact us for a free discussion on ISO 13485 accreditation in Argentina procedure or process.
  • Basically, our ISO 13485 certification audit includes 2 stages
  • Stage 1 Audit: Readiness Audit
  • Stage 2 audit: effectiveness audit
  • Based on the application form submitted by your organization, IAS will develop the plan to conduct an audit
  • IAS will prepare a detailed audit report with a statement of deviation (if applicable) and send it to you after completing the assessment and analyzing the technical documents.
  • Deviations must be closed within the timeframe specified by our auditors.
  • The IAS audit team will verify and approve the corrections and corrective actions.
  • Once the non-conformities have been addressed, the ISO 13485 Certificate will be issued, restricting the audited scope.
  • IAS will conduct annual surveillance audits to ensure your company's management system is up to date and adheres to current best practice.

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