|
For compliance with ANSI/AAMI/ISO 13485:2003 Medical Dvices - Requirements for regulatory purposes
Download (PDF) 160 KB, 71 pages
Item No.: RCG022ASEP, published June 2004
Description
Checklist for ANSI/AAMI/ISO Standard 13485:2003 Medical devices - Quality management systems- Requirements for regulatory purposes ISO 13485. Being a “stand-alone” quality system standard for medical devices, this standard represents a major change in concept and goes much further than ISO 9001 in requirements for documentation. The checklist is an invaluable tool to ensure that all the required documentation is identified for an organization. It clearly defines the procedures, plans, records, documents, audits and reviews that are required or suggested. This checklist 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. The purchase of this checklist includes four hours of free consultation during 60 days after date of purchase, providing answers to questions about the standard and checklist. Using the checklist saves time and money, and will aid in meeting certain regulatory requirements! The Checklist is a quality product at a reasonable price!
|
