ISO 13485 In Our Company, - Self-Study Course for Personnel

The ISOXpress ISO 13485 In Our Company training booklet is an ISO 13485 and FDA QSR (21 CFR 820) orientation course for personnel. The course explains what the standards and regulations are, how the quality system works, and how everyone should prepare themselves and their work areas for the compliance or certification audit. The workbook is intended for distribution to all personnel for self-study or group training. It includes a short multiple-choice test and a certificate of completion. This course satisfies ISO 13485: 2003 and FDA QSR (21 CFR 820) requirements for training personnel in understanding and using the quality management system.

The ISOXpress ISO 13485:2003 In Our Company comes on a CD-Rom with three PDF files (booklet, test and certificate) and license to train 10 persons. It can be integrated into the ISOXpress Document Control and ISO Management software, and be used together with ISO 13485 template manual and procedures, internal audit and gap analysis checklist, and Medical Device Risk Analysis Manual (ISO 14971 Hazard Analysis Process). These products can be purchased together in our ISOXpress Complete Package.