DIGIRENT - ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Jack Kanholm
[PDF.ay06] DIGIRENT - ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms Rating: 4.79 (431 Votes)
ISO 13485:2003 & FDA Jack Kanholm epub ISO 13485:2003 & FDA Jack Kanholm pdf download ISO 13485:2003 & FDA Jack Kanholm pdf file ISO 13485:2003 & FDA Jack Kanholm audiobook ISO 13485:2003 & FDA Jack Kanholm book review ISO 13485:2003 & FDA Jack Kanholm summary | #13796170 in Books | 2003-11 | Original language:English | 6.50 x4.75 x.25l, | Binding: CD-ROM | 218 pages||1 of 1 people found the following review helpful.| Excellent time saver for implementing a new ISO system|By E. de Feo|At first I was put off by the price tag, but then I bit the bullet and purchased it anyway. The templates are very complete and help ensure that your system will be compliant. It includes all the required documentation from a system point of view. You will still need to build your system below these top level d|About the Author|Jack Kanholm holds an Engineering Master of Science degree from the Technical University of Denmark. He is a Registered Lead Assessor licensed by the International Register of Certified Auditors (IRCA), a Lead Auditor under the Registrar Accr
Template documentation on CD-ROM includes a quality manual, 34 operational procedures, and forms. While organized into an ISO 13485:2003 system, the documentation also specifically covers FDA QSR (21 CFR 820) requirements, and thus complies with both the international and US FDA regulations (if you don't need to comply with US regulations, there are instructions how to take out QSR-related sections). This fully developed two-level documentation defines a generic quality ...
You easily download any file type for your device.ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms | Jack Kanholm. I have read it a couple of times and even shared with my family members. Really good. Couldnt put it down.
