ISO 13485 Auditor Training

ISO 13485 ensures the quality of medical devices and equipment.

ISO 13485 is a standard established by the International Organization of Standardization (ISO) which governs quality management systems (QMS) related to the production of medical devices and related services. ISO 13485 training teach candidates how to audit a QMS for ISO 13485 compliance.

Identification

ISO 13485 auditor training helps candidates learn and develop the skills necessary to perform ISO13485 audits. Candidates can train as an ISO 13485 lead auditor, who generally works for an auditing organization, or they can train as an ISO 13485 internal auditor, who generally works for a company looking to pass an audit. Each training results in a certification issued by the training institution.

Background

Many companies set up a QMS to help them produce quality products and services and the QMS has to meet industry standards. ISO 13485 helps medical device companies ensure their QMS meets international standards.

Features

Training specifics vary between training institutions and whether or not candidates train as a lead or internal auditor. But, in general, all options will include fundamentals such as teaching candidates how to apply ISO 13485 standards, identify a sound QMS, perform pre-audits, conduct an audit and perform post-audit and follow-up activities.

Significance

Because medical devices have to meet high quality standards, compliance to ISO 13458 can help medical device companies win contracts. Trained internal ISO 13458 auditors play a critical role in helping corporations both design and audit a QMS for ISO 13458 compliance.

References

• International Organization for Standardization: ISO 13485:2003
• ASQ Management Systems Inc:ISO Lead Auditor Training Plus
• ASQ Learning Institute: Internal Auditor Training for ISO 13485:2003 (RABQSA Certified)