LA - Objectives, Scope, Criteria Team 2 [11/10/21] by Comply Guru Instructor https://padlet.com/complyguru/vlvj2cuz4ejtspaj Your contribution is important! Use your own words to answer each question en-us 2021-09-30 17:23:21 UTC 2021-10-11 10:59:42 UTC hello@padlet.com https://padlet-uploads.storage.googleapis.com/511422770/e3d19b02a56b048228c906795382ed0d/Guru_Front.png certification audit https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807270462 to determine compliance to ISO 13485]]> 2021-10-11 10:46:48 UTC https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807270462 Surveillance Audit https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807273298 To ensure continuous compliance to ISO 13485]]> 2021-10-11 10:48:34 UTC https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807273298 The definition of the audit objective is to determine that the company is able to achieve their intended outcomes, and the the QMS meets all regulatory requirements. https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807283097 2021-10-11 10:54:24 UTC https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807283097 The definition of the audit scope, is what topics will be reviewed and focused on and how broad the audit will be depending on audit type. https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807286744 2021-10-11 10:56:15 UTC https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807286744 Example https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807289203 An example would be an audit primarily focusing on purchasing. ]]> 2021-10-11 10:57:42 UTC https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807289203 the definition of the audit criteria, is the standard you are auditing against or procedures you are auditing against https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807291299 2021-10-11 10:58:59 UTC https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807291299 Example https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807292383 auditing to iso13485 clauses]]> 2021-10-11 10:59:42 UTC https://padlet.com/complyguru/vlvj2cuz4ejtspaj/wish/1807292383