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Achieving ISO 13485: HTD’s proven audit checklist

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Apr 04, 2024

9 min read

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

We at HTD Health are thrilled to announce a great achievement in our continuous pursuit of excellence within the medical device industry which is securing the ISO 13485 certification. This accomplishment isn’t just about reaching an international standard; it’s a testament to our continued commitment to the highest quality management practices across our operations. Recognizing the difficulties faced by many in achieving this certification, we want to share our ISO 13485 audit checklist with insights on how to prepare for ISO 13485 certification.

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Understanding the Challenges in Getting ISO 13485 Certification

Embarking on the journey to ISO 13485 certification is no trivial task. It requires a deep understanding of the standard’s requirements and the implementation of robust quality management practices. Our experience has taught us the importance of preparation and the dedication required to align with these high standards. The process has been an enlightening one, filled with learning and rigorous effort, underscoring our commitment to quality in the creation of medical devices.

Achieving ISO 13485 certification demands more than just a surface-level commitment; it requires a deep dive into the organization’s processes, a willingness to undergo rigorous scrutiny, and the capacity to adapt and improve continually. This section will shed light on the challenges we faced and how overcoming them has fortified our dedication to excellence.

Preparing for the ISO 13485 Audit: A High-Level Overview

Embarking on the ISO 13485 certification journey involves navigating through a series of critical steps, each requiring detailed attention and rigorous preparation. In this article, we offer a high-level overview of the key areas that are checked during the ISO 13485 certification audit. This overview serves as an introductory guide to the comprehensive checklist that can help in the audit preparation process. The areas covered include management responsibility, resource management, product realization, and the mechanisms for measurement, analysis, and improvement.

Here’s a high-level ISO 13485 audit checklist to guide you through the preparation process:

Documentation and Records Management

  • Ensure the Quality Manual is updated and aligns with ISO 13485 requirements.
  • Verify that all procedures, work instructions, and policies are documented, controlled, and easily accessible.
  • Review and update document control and records management procedures.

Management Responsibility

  • Confirm that top management demonstrates commitment to the development and implementation of the quality management system and continually improves its effectiveness.
  • Check that quality objectives are established, communicated, and reviewed for continued suitability.
  • Review management review meeting minutes for compliance with ISO 13485 requirements.

Resource Management

  • Assess the adequacy of resources (human resources, infrastructure, and work environment) to ensure product quality and conformity.
  • Verify that personnel are competent, based on education, training, skills, and experience.
  • Ensure the work environment and contamination control practices are suitable for the products being manufactured.

Product Realization

  • Review the processes for product development, risk management, and design control to ensure they meet regulatory requirements.
  • Verify that customer requirements are identified, documented, and met with the aim of enhancing customer satisfaction.
  • Check that purchasing processes are controlled to ensure that external providers meet the organization’s requirements.

Measurement, Analysis, and Improvement

  • Implement a monitoring and measurement system for processes and product parameters to demonstrate product conformity and ensure the quality management system’s effectiveness.
  • Conduct internal audits at planned intervals to determine conformity to the quality management system, product requirements, and ISO 13485 requirements.
  • Establish a process for receiving, recording, and addressing customer complaints.
  • Review the process for managing nonconforming product, including identification, documentation, evaluation, segregation, and disposition of nonconforming product.

Risk Management

  • Ensure that risk management is applied throughout product realization, in accordance with ISO 14971, the application of risk management to medical devices.
  • Document risk management procedures for each stage of product life cycle.

Regulatory Compliance

  • Verify that all regulatory requirements related to the product and its intended market are identified and met.
  • Ensure that the labeling and marketing materials comply with the regulatory requirements.

Supplier and Outsourced Process Management

  • Evaluate and select suppliers based on their ability to meet specified requirements, including quality requirements.
  • Establish criteria for the evaluation, selection, monitoring, and re-evaluation of suppliers.
  • Control and monitor outsourced processes to ensure compliance.

Final Steps

  • Conduct a Pre-Audit: Consider conducting a pre-audit or gap analysis to identify areas of non-compliance or improvement opportunities.
  • Employee Training and Awareness: Ensure that all employees are aware of and understand their role in the quality management system, including relevant procedures and controls.
  • Corrective and Preventive Actions (CAPA): Review and strengthen the CAPA process to effectively address root causes of nonconformities and prevent their recurrence.

Preparing audit checklist for an ISO 13485 requires detailed planning, review, and implementation of a quality management system tailored to the medical device industry’s stringent requirements. This checklist provides a high-level overview, but each organization must tailor its preparation to its specific operations, products, and regulatory requirements.

This high-level checklist is just the beginning. To truly excel in your ISO 13485 audit checklist preparation, a deeper dive into each of these areas is required. We are excited to share that in our next newsletter, we will provide a comprehensive checklist that delves into the specifics of preparing for the ISO 13485 audit. This detailed guide will equip you with the necessary insights and tools to navigate the audit process with confidence.

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Conclusion: Reflecting on HTD’s Success

Achieving ISO 13485 certification has been a great journey for HTD Health, marking a significant milestone in our commitment to quality and excellence in the medical device industry. This certification not only enhances our company’s reputation but also reinforces our operational excellence, providing a solid foundation for continuous improvement and customer satisfaction.

The journey to ISO 13485 certification is challenging but deeply rewarding. For organizations embarking on this path, our experience underscores the importance of thorough preparation, a strong commitment to quality, and the willingness to engage in continuous improvement. By sharing our journey, we hope to inspire and guide others towards achieving their own certification goals, enhancing the quality and safety of medical devices worldwide.

If you are preparing for ISO 13485 certification or you are looking for a design and development partner that has ISO 13485 certification, send us a message and we will be more than happy to discuss your needs and see how we can help!

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