ISO 13485 is an internationally recognized standard that provides an outline for organizations involved in the production, design, or installation of medical devices. Organizations in the medical device industry require auditing of ISO 13485 to get the certification. That’s where a lead auditor helps them with the audit and identifies whether an organization complies with ISO 13485 standards.

Becoming a lead auditor can be an exciting journey for anyone. However, if you are unaware of this field, this guide will help with the necessary skills and ISO 13485 Lead auditor training required to become a lead auditor.

Responsibility of an ISO 13485 Lead Auditor

Before we explore the process of becoming a Lead Auditor, let's clarify the responsibilities associated with the role. ISO 13485 Lead Auditors are tasked with assessing an organization's quality management system to ensure compliance with the ISO 13485 standard. They conduct audits, pinpoint areas for improvement, and offer suggestions for enhancing the quality system.

Steps to Become ISO 13485 Lead Auditor

To become an ISO 13485 Lead Auditor, follow these steps:

Educational Background

While there is no strict educational requirement for this role, having a bachelor's degree in a relevant field like quality management, engineering, or a scientific discipline can be beneficial. Additionally, pursuing courses or certifications in quality auditing is highly recommended.

ISO 13485 Lead Auditor Training

Specialized ISO 13485 Lead Auditor training is essential for success in this role. These courses, often provided by accredited training providers, cover auditing intricacies, compliance, and the ISO 13485 standard itself. Completion of such training is usually a prerequisite for certification.

Gaining Relevant Experience

Experience plays a crucial role in becoming a proficient ISO 13485 Lead Auditor. Start by working in quality assurance or regulatory affairs positions within the medical device industry. This hands-on experience will provide valuable insights into industry nuances and challenges.

Obtaining Certification

One of the most critical steps in your journey to becoming an ISO 13485 Lead Auditor is obtaining the necessary certification. The most recognized certification for Lead Auditors is the Certified ISO 13485 Lead Auditor credential, which is globally accepted and respected.

Continuous Learning and Development

The field of quality management is dynamic and ever-evolving. To remain at the forefront as a Lead Auditor, commit to continuous learning and professional development. Attend ISO training to stay abreast of the latest industry trends and regulatory changes.

Concluding Remarks!

Becoming a certified ISO 13485 Lead Auditor is a challenging but rewarding journey. By following these steps, aspiring Lead Auditors can play a vital role in ensuring quality management in the medical device industry. INTERCERT is a leading certification body that is internationally recognized. We provide ISO training to aspiring lead auditors in their respective domains. For instance, our ISO 13485 Lead auditor training helps a professional conduct auditing for ISO 13485 standards.

Get in touch with INTERCERT to become a lead auditor.