ISO 13485 is an international standard designed to define the quality management system requirements for manufacturers of medical devices and suppliers in the healthcare industry. This standard ensures that the quality and safety requirements of medical products are met.

• About the Standard: ISO 13485 focuses on applying quality requirements to the manufacturing of medical devices and supplies used in healthcare to ensure compliance with legal regulations and to guarantee that devices are free from contaminants. By complying with ISO 13485, organizations establish strict quality management systems that cover product design, manufacturing, distribution, and after-sales services. The standard aims to improve production processes and ensure that companies adhere to the highest standards of quality and performance.

  By adopting ISO 13485, organizations can enhance their efficiency and effectiveness in medical device manufacturing, contributing to the delivery of safe and effective products for patients and consumers. Compliance with this standard is a crucial step in building a strong reputation in the medical device industry and ensuring that market and regulatory requirements are met.

• Benefits of ISO 13485 Certification:

  1. Compliance with International Standards: Certification ensures that the company adheres to the highest internationally recognized quality standards in the medical device industry.

  2. Improvement of Processes and Efficiency: By implementing ISO 13485's quality management system, companies can enhance their efficiency and overall performance.

  3. Increased Trust and Credibility: Earning this certification increases customer and partner confidence in the quality of the company's products and compliance with health and legal standards.

  4. New Business Opportunities: ISO 13485 certification can open doors to collaborations with other companies and expansion into international markets.

  5. Risk Reduction and Effective Response to Changes: Certification helps identify potential risks and develop effective strategies to address them.

  6. Ensures Compliance with National and European Regulatory Requirements: This helps medical devices comply with current European and national regulatory and legislative requirements.

  7. Strengthens Consumer Confidence: Certification guarantees that the medical device meets international, European, and national standards as well as current legal and regulatory requirements.

  8. Enhances Product Competitiveness: Certification boosts the product’s competitive advantage in the market.

• Why ISO 13485 is Beneficial:

  1. The standard specifies comprehensive quality management requirements for medical device manufacturers.

  2. It includes requirements to ensure quality at every stage of medical device design, development, and production.

  3. ISO 13485 establishes stringent product quality requirements, including process control and compliance verification.

  4. The standard requires effective risk assessment and management in the context of medical device manufacturing.

  5. It includes requirements for monitoring and evaluating various processes involved in medical device manufacturing.

  6. ISO 13485 requires regular internal audits and system reviews to ensure compliance and continuous improvement.

• Requirements for ISO 13485 Certification:

  • The company must be legally established, with a trade registry, operating license, or legal entity.

  • Compliance with the latest version of ISO 13485 standard requirements.

  • A documented and reliable management system.

  • Training and qualifying the workforce to professionally apply ISO 13485 requirements and fully understand international standards.

  • The company’s ability to correct errors, implement procedures to prevent recurrence, and identify root causes through an internal review team.

  • Successful completion of an external audit or “field inspection” without major non-conformities, leading to a recommendation for ISO 13485 certification.

  • Submission of an application for ISO 13485 certification to an accredited and internationally recognized certification body.

• Entities Eligible for ISO 13485 Certification: The ISO 13485 standard and certification are designed for all companies involved in the manufacturing of medical devices and equipment.

• Procedures for Obtaining ISO 13485 Certification:

  1. Employee Awareness and Training: Employees are trained on ISO 13485 requirements through workshops, seminars, and training sessions to ensure a full understanding of the standard’s objectives and their roles.

  2. Internal Audit Team Qualification: The internal audit team is trained to audit and review the organization’s quality system, contributing to improved implementation and compliance with the standard.

  3. Creation of Quality System Documentation: This step involves establishing quality policies, vision, mission, and objectives, as well as creating detailed procedures and instructions for the organization’s quality management system.

  4. Final Implementation: This phase involves executing tasks according to the prepared documents and instructions and conducting internal reviews to ensure compliance with the standard’s requirements.

  5. External Review and Certification: An external audit is requested to review the organization’s quality system, and certification is granted if all requirements are met.

• Strong Steps for Achieving ISO 13485 Compliance:

  1. Submit an application for ISO 13485 certification.

  2. Conduct a two-stage audit of the organization’s management system, reviewed by certified auditors.

  3. Hold opening and closing meetings to ensure the audit plan’s accuracy and address any organizational challenges.

  4. Write a comprehensive audit report and present it to the certification committee for review.

  5. Notify the organization of the certification process results and final observations.

  6. Implement and review the necessary corrective measures.

  7. Issue the certification after confirming that corrective measures have been successfully implemented.

  8. Implement periodic monitoring of the organization’s management system by expert teams to evaluate implementation and control effectiveness.

• Validity Period of ISO 13485 Certification: ISO 13485 certification is valid for three years, with periodic audits conducted during this period to ensure the continued application and effectiveness of the quality management system. The audits over the three years are divided as follows:

  1. First-Year Audit: This includes an initial stage to review documents, records, and the organization’s scope of work to verify compliance with ISO 13485 requirements.

  2. Second-Year Audit: A regular audit is conducted to ensure the system’s continued application and effectiveness, reviewing the organization’s processes and evaluating performance improvements and updates.

  3. Third-Year Audit: Another regular audit is conducted to ensure the effective continuation of the quality system and assess the effectiveness of corrective and preventive measures taken.

After the three-year period, the organization must renew the ISO certification by undergoing a new round of audits and reviews in accordance with updated requirements. This includes updating documents and ensuring continued system implementation, which incurs additional financial costs.

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Smart Innovations for Professional Consulting (SIFC): The Trusted Partner for ISO Certification Services

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SIFC is a trusted partner for organizations in their journey to obtain various ISO accreditation and quality certificates. We offer specialized consulting services to help these organizations understand the requirements of the needed certificate and implement the correct practices to achieve it. The company relies on a team of quality management experts accredited by IRCA, who have the experience and knowledge to help government agencies, institutions, factories, banks, and others maximize the benefits of obtaining the certificate. With a constant focus on providing innovative and results-oriented solutions, SIFC ensures the successful completion of all qualification stages, from gap analysis, system development, documentation, error correction, awareness, and training, to internal review, external audit, and obtaining the recognized international certificate and enhancing the organization’s profile in the international accreditation forum.