(NSAI: Dublin, Ireland) -- The National Standards Authority of Ireland (NSAI) is teaming up with the Kelmac Group to hold a quality management system (QMS) auditor/lead auditor training course certified by the International Register for Certified Auditors (IRCA) and based on the International Organization for Standardization (ISO) international standards, ISO 9001 and ISO 13485. The five-day course will take place June 20–24, 2011 in Chicago and costs $1,995 per person.

“This is an excellent opportunity for quality managers, quality assurance managers, consultants, supply chain managers, regulatory and enforcement officers, and others to gain a better understanding of the philosophy, concepts, and benefits of a medical device QMS,” says Chris Morrell, vice president of NSAI. “Those who attend will learn about the purpose and intent of ISO 13485 and ISO 9001 and leave knowing how to conduct process-based audits in accordance with ISO 19011 and ISO/IEC 17021. They’ll learn how to handle the difficult situations that can arise during an audit and how to objectively observe and assess the situation, and write their findings in a way that will allow them to effectively improve their systems.”

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