What is the ISO 13485 standard and why is it important for medical device manufacturers?

• ISO 13485 is an international standard that specifies requirements for a quality management system in the medical device industry.
• It is important because it ensures that organizations can consistently produce safe and effective medical devices that meet user requirements and legal regulations.
• It helps organizations manage risks and improve the quality of their products and services.

Which organizations can apply the ISO 13485 standard?

• Organizations involved in any phase of the life cycle of medical devices, including design, development, manufacturing, storage, distribution, installation and servicing.

• Suppliers and external parties that provide products and services related to the quality management system to organizations that manufacture medical devices.

What are the key benefits of ISO 13485 implementation and certification?

• Proof of commitment to the quality of medical products.

• Improving overall process performance.

• Improving communication with the market and access to new customers and markets.

• Increasing efficiency and reducing costs.

• Proof that safer and more effective medical devices are being produced.

• Evidence of knowledge of legal requirements and customer expectations.

• Increasing profits and competitiveness.

• Increasing customer satisfaction.

• Improvement of internal relations.

• Acquiring international verification of good business practice.

• Creating a framework for continuous process improvement.

What are the key components of the ISO 13485 standard?

• Risk management: Identification, assessment and control of risks associated with medical devices.

• Document control: Document and record management to ensure traceability and compliance.

• Process control: Management of production, inspection, testing and servicing processes.

• Control of non-conforming products: Management of products that do not meet requirements.

• Corrective and preventive measures: Identification and elimination of the causes of non-compliance.

• Monitoring and measurement: Monitoring process and product performance.

How is certification according to the ISO 13485 standard carried out?

• Choosing a certification body: Find an accredited certification body.

• Preparation of documentation: Prepare all necessary documentation.

• Preliminary audit (optional): Identification of potential problems before the main audit.

• Main audit: The certification body performs a compliance check.

• Issuance of certificates: If the organization is compliant, it receives a certificate.

• Regular checks: The certification body carries out regular checks to ensure continued compliance.

What are the key differences between ISO 13485 and ISO 9001 standards?

• ISO 13485 is specific to the medical device industry, while ISO 9001 is a general standard for quality management systems.

• ISO 13485 has stricter requirements for risk management and control documentation.

• ISO 13485 requires compliance with legal regulations relating to medical devices.

How does ISO 13485 contribute to patient safety?

• Ensures that medical devices are manufactured in accordance with high quality standards.

• Reduces the risk of non-compliance and product recalls.

• Improves product traceability and control.

• Increases patients’ confidence in medical devices.

ISO 13485 is a key standard for organizations that want to ensure the quality and safety of medical devices. Its application contributes to the protection of patients, improving the image and increasing the competitiveness of the organization.

TMS has an internationally recognized ISO 13485 accreditation.