ISO Standard for Training Internal Auditors to ISO 13485

ISO stands for the International Standards Organization. The ISO has developed a set of standards governing the practices of internal auditors in the medical device industry. This set of standards is called ISO 13485.

ISO 13485

ISO 13485 is a set of standards designed to govern quality management systems in the medical device industry. With regards to internal auditors, the standards ensure that they are prepared to conduct audits manage their resources effectively.

Training Targets

ISO 13485 training should be undertaken by all professionals who work in the medical device industry and conduct internal audits or participate in internal audits in some capacity. ISO training is helpful to companies in that it increases trust among companies, employees and customers, thereby facilitating healthy economic relationships.

Standards and Courses

Courses on ISO 13485 for internal auditors provide information on the elements of an effective quality system, audit preparation and resource management, collecting audit evidence, proper documentation, audit follow-up surveillance and effective questioning and listening. Training includes formal instruction and hands-on workshops.

References

• ASQ Learning Institute: ISO 13485:2003 Internal Auditor Training (RABQSA Certified)
• Praxiom Research Group Limited: ISO 13485 2003 Translated into Plain English