By obtaining ISO 13485 certification, South African medical device companies can demonstrate a commitment to quality that sets them apart in the marketplace. This certification serves as a powerful tool to enhance brand credibility, open doors to new business opportunities, and ultimately, ensure that medical devices used in South Africa are safe, effective, and reliable.
Process reliability through documented procedures
Proof of compliance with legal requirements
Increased product safety for patients & users
Increased customer & employee satisfaction
Highlighting the competence of the company
ISO 13485 certification demonstrates a company’s commitment to producing safe, reliable, and effective medical devices. It provides customers, regulatory bodies, and other stakeholders with documented proof of a company’s adherence to best practices and legal requirements. Certification enhances confidence, enabling manufacturers and suppliers to enter new markets, maintain industry compliance, and foster a reputation for quality and safety, especially when dealing with complex regulatory environments like those in South Africa and Africa.
This standard allows manufacturers to streamline their processes, enhance product development cycles, and ensure that their products consistently meet quality requirements. By adhering to ISO 13485, companies in South Africa and across Africa can demonstrate to regulatory authorities, customers, and investors that they are committed to maintaining a rigorous and effective quality management system. Achieving ISO 13485 certification not only improves operational efficiency but also serves as a key differentiator in a competitive global market.
The standard covers all aspects of medical device production, including ensuring compliance with applicable South African legal frameworks and international regulations. Companies certified to ISO 13485 benefit from a structured process that not only improves product safety but also ensures alignment with market demands and regulatory bodies. This comprehensive approach assures the consistent delivery of quality products that meet the highest standards of patient safety and user satisfaction, essential in the South African medical device industry.
By meeting ISO 13485, manufacturers can prove their compliance with SAHPRA, the South African Medicines Control Council (MCC), and international regulations such as the European Union Medical Device Regulation (MDR) and FDA standards. This not only helps in legal approval but also aids in importing and exporting medical devices globally. The certification offers local manufacturers a clear path to achieving global market acceptance, ensuring they meet all required legal and regulatory frameworks.
For South African manufacturers looking to expand their market reach, EN ISO 13485 offers an essential certification for entry into the European market. Adopting both ISO 13485 and EN ISO 13485 can significantly broaden a manufacturer’s global reach, ensuring compliance not only with South African regulations but also with those of key international markets. This combination of certifications helps companies effectively navigate the regulatory landscape in both the EU and other regions, such as Africa, where global recognition is crucial for business growth.
Begin by understanding the local medical device regulations that apply to your operations in South Africa. The South African Health Products Regulatory Authority (SAHPRA) oversees the regulations for medical devices and in-vitro diagnostic products. It's essential to ensure that your company complies with SAHPRA's guidelines for medical device registration, quality control, and post-market surveillance. Align your internal documentation, manufacturing processes, and reporting practices with these local legal requirements.
For companies operating globally, it’s crucial to understand the international regulations that apply alongside ISO 13485 compliance. In South Africa, as part of the global medical device industry, understanding global standards such as the EU’s Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) is essential. These regulations ensure the safety, quality, and performance of medical devices. If your company plans to export, your products must adhere to international standards, which can streamline market entry and enhance global trust in your products.
ISO 13485 harmonises with other international standards and regulatory requirements from bodies like the International Medical Device Regulators Forum (IMDRF). Familiarity with this harmonisation will ensure that your quality management system (QMS) is not only ISO 13485-compliant but also meets global regulatory expectations. For South African businesses aiming for international market access, complying with ISO 13485 and global standards fosters trust and positions your products for successful entry into key markets worldwide.
In the lead-up to the audit, coordination with DQS is essential to schedule the audit and ensure all necessary documentation and resources are in place. It’s important to brief your team on the audit process and clearly define their roles and responsibilities. Ensure everyone understands the expectations and how they can contribute effectively to the audit's success.
The assessment of your Quality Management System (QMS) follows a structured process, conducted in two stages.
Stage 1 - Documentation Review: The first stage involves a comprehensive analysis of your QMS documentation. Our auditors will review your quality manuals, procedures, and records to ensure they align with the requirements of ISO 13485. This stage helps identify any significant gaps or areas for improvement, offering valuable insights into the scope of your QMS and preparing for the on-site assessment in Stage 2. Following this review, you will receive feedback on any deficiencies, allowing you to address these concerns before progressing.
Stage 2 - On-site Assessment: The second stage of the audit involves an on-site evaluation where our auditors assess how effectively your processes are implemented and their compliance with ISO 13485 standards. After the on-site audit, auditors will highlight any non-conformities or observations that require corrective actions. You will need to develop and implement corrective measures, which you should communicate to DQS to demonstrate your commitment to quality and continuous improvement.
Once the audits are complete, a final meeting will be held to present the results and discuss the next steps. If your QMS is found to be compliant, DQS will make a decision on your certification. A detailed report will be provided to summarise the results and outline any actions required for certification approval. This step marks the final stage before you can begin reaping the benefits of ISO 13485 certification.
DQS will conduct a comprehensive review of your QMS and evaluate the effectiveness of any corrective actions taken. This final assessment determines if your QMS meets ISO 13485 requirements. Based on the audit results and resolution of any issues, DQS will either issue or deny the ISO 13485 certification. Successful certification confirms your compliance and commitment to quality management standards in South Africa.
Get your medical device company certified to ISO 13485 by a trusted partner with local accreditation in South Africa, ensuring compliance with industry standards and regulations. Benefit from DQS's expertise and local presence to streamline your certification process and enhance your credibility in the medical device industry.
