Author Description

Now! A Checklist for ANSI/AAMI/ISO Standard 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes ISO 13485. This standard goes much further than ISO 9001 in requirements for documentation; and represents a major change in concept, being a stand-alone quality system standard for medical devices. The Checklist is an invaluable tool to ensure all the required documentation is identified for your organization. It clearly defines the procedures, plans, records, documents, audits and reviews that are required or suggested. This is a must have for all quality managers involved in ANSI/AAMI/ISO Standard 13485:2003 certification, presenting all the required items that are necessary to demonstrate evidence of conformity. It includes many suggestions for items that are not specifically required by the standard but hinted at in the text. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This standard calls out or suggests over 300+ items of physical evidence. The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any organization to meet the requirements of this important standard. Every Checklist comes with four hours of free consultation. SEPT will answer any question concerning the standard or checklist for 60 days after purchase. Use the Checklist to save time and money, it will aid in meeting certain regulatory requirements! The Checklist is a quality product at a reasonable price!