IA - Objectives, Scope, Criteria Team 3 [18/11/21] by Comply Guru Instructor https://padlet.com/complyguru/q1y4qfv9xohpl6nb Your contribution is important! Use your own words to answer each question en-us 2021-10-29 09:04:22 UTC 2021-11-18 09:14:11 UTC hello@padlet.com https://padlet-uploads.storage.googleapis.com/511422770/e3d19b02a56b048228c906795382ed0d/Guru_Front.png Compliance against regualtory standards https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899040139 2021-11-18 09:03:39 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899040139 outline the purpose of the audit https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899041477 2021-11-18 09:04:30 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899041477 Level of compliance against ISO 13485 https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899041931 2021-11-18 09:04:48 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899041931 the extent and boundaries of the audit https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899042468 2021-11-18 09:05:08 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899042468 Physical / locations / time period https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899043074 2021-11-18 09:05:31 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899043074 outliine a set of requirments agasints the audit objectives set https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899045836 2021-11-18 09:07:21 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899045836 process agaisnt the relevant proedures ( manuafacturing/sampling)/work instructions https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899047714 2021-11-18 09:08:32 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899047714 observations - how the operators are working against procudure, are complying - inspection - access performance against procedures https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899050123 2021-11-18 09:09:54 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899050123 To check the organisations document control - check training records for competency to perform the task https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899052758 2021-11-18 09:11:28 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899052758 interview - what/where/who open style questions - show me then? https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899054442 2021-11-18 09:12:28 UTC https://padlet.com/complyguru/q1y4qfv9xohpl6nb/wish/1899054442