Frequently Asked Questions About ISO 13485 and ISO 13485 Training

What kinds of companies or organizations benefit from Medical Device Management Systems?

Organizations of all sizes that design, manufacture, or supply medical devices benefit from a structured Medical Device Management System.

This is especially important for small businesses looking to establish consistent quality practices and for companies wanting to ensure global compliance and readiness for diverse regulatory markets in preparation for entering international trade.

Below are some examples of the kinds of companies that benefit from medical device management systems and how they benefit from them.

• Manufacturers – Gain a structured approach to medical product development, streamlined production processes, risk-based thinking, and lifecycle management to support regulatory compliance and reduce delays.

• Component Suppliers – Improve supplier management, ensure product traceability, maintain control of nonconformities, and demonstrate reliability to manufacturers, strengthening supply chain confidence.

• Distributors – Ensure proper handling, storage, and documentation of medical devices, support post-market surveillance activities, and maintain compliance with international trade requirements.

• Critical Subcontractors – Align subcontracted processes with regulatory standards, reduce production risks, and ensure their work meets the same quality and traceability expectations as primary manufacturers.

• Crucial Suppliers – Maintain high-quality inputs, track materials throughout the supply chain, and support manufacturers in achieving ISO 13485 certification through strong risk management and consistent product quality.

• Small Businesses / Startups – Establish structured quality assurance processes early, implement effective corrective actions, and build a pathway toward ISO 13485 certification to support growth and market entry.

• Contract Manufacturers – Align outsourced production with regulatory requirements, reduce the risk of nonconformities, and facilitate collaboration with original manufacturers through lifecycle management and compliance documentation.

Are deGRANDSON’s ISO Lead Auditor Courses Certified?

 Yes. All deGRANDSON courses are certified to the following international standards:

• ISO 21001:2018 – Educational Organizations Management Systems – This Ensures the course is designed and managed according to globally recognized education management practices.
• ISO 29993:2017 – Learning Services Outside Formal Education- This covers non-traditional learning environments such as professional development programs, corporate training, and online courses.
• ISO 29994:2021 – Additional Requirements for Distance Learning – This sets extra criteria for online and remote learning, including learner engagement, accessibility, and effective assessment methods.

The ISO 21001 certification is issued by Business Quality Assurance International (BQAI), an accredited body under the Irish National Accreditation Board (INAB). 

INAB is a signatory to both the European cooperation for Accreditation (EA) Multilateral Agreement and the International Accreditation Forum (IAF) Multilateral Arrangement, ensuring global recognition of the qualification.

What benefits do courses being certified to these standards provide?

• Recognition by Employers and Certification Bodies: Being accredited to international standards gives your certificate credibility, making it a globally recognized auditor qualification that enhances professional standing.
• Consistency and Trust: Every module is developed and delivered under an externally audited educational management system, ensuring reliable, high-quality learning outcomes.
• Confidence in Online Learning: ISO 29993 and ISO 29994 alignment guarantees that distance learning is effective, transparent, and engaging, validating your competency in a professional context.

Are your courses IRCA certified?

deGRANDSON’s ISO Lead Auditor courses are ISO 21001 certified, which provides a university-grade, independently audited standard for educational organizations. While IRCA (now CQI/IRCA) approval is well-known, it is largely UK-focused, limited in ongoing monitoring, and does not audit the full educational organization. 

ISO 21001, in contrast, ensures that both the learning services and the management of the provider meet international standards, giving learners and sponsoring organizations confidence in the effectiveness, reliability, and credibility of the training experience.

How are deGRANDSON’s ISO auditor, implementer, and consultant courses different from other courses?

When comparing different ISO auditor, implementer, or consultant courses, it can help to look beyond the course title alone and consider how the training is actually delivered, supported, assessed, and verified.

Small differences in structure, flexibility, resources, and certification processes can have a real impact on your learning experience and how useful the qualification is in practice.

The table below can help you compare these aspects side by side and decide whose courses best fits your needs and expectations.

Does taking your ISO 13485 training courses count toward Continued Professional Development?

Yes. ISO 13485 auditor, implementer, and consultant courses count toward Continuing Professional Development. CPD tracks formal and informal learning, including training, workshops, self-directed study, and practical application. 

deGRANDSON developed its own CPD model, following best international practices and deriving rules for assigning CPD Units (sometimes called SCU Units in North America), enabling auditors to document ongoing skill development and demonstrate professional credibility.

Please see the table showing different ISO 13485 auditor, implementer, and consultant courses and their corresponding CPD units.

Do You Have a Sample Lesson?

Yes. If you are interested in online ISO auditor training but not ready to start yet, we got you covered. We have a 5 min Trial Lesson that you can take to give you a quick overview of how our online training for ISO courses works. This includes our e-training methods, our certification process, and the differences among our ISO courses.

It also contains tips on how to find out which course will be appropriate for your needs. If you have more time and you want to take a closer look at our online courses, you can also check out our more detailed 30 min Trial Lesson. It contains an actual lesson sample as well as a short sample test that you can try for yourself.

Where to Find More Information if You Want to Become an ISO 13485 Auditor, Implementer, or Consultant?

For more in-depth information about ISO 13485 auditors, implementers, or consultants, we recommend you read ISO 19011:2018, especially: Part 7: Competence and evaluation of auditors, and Annex A: Additional guidance for auditors planning and conducting audits.

You will also find useful information on our Other ISO Courses page.