LA - Objectives, Scope, Criteria Team 2 [06/12/21] by Comply Guru Instructor https://padlet.com/complyguru/alwey81uzrh5gsif Your contribution is important! Use your own words to answer each question en-us 2021-11-22 13:52:08 UTC 2021-12-06 11:13:18 UTC hello@padlet.com https://padlet-uploads.storage.googleapis.com/511422770/e3d19b02a56b048228c906795382ed0d/Guru_Front.png Determine if the QMS conforms with the requirements of the standard and determine if the QMS is implemented and maintained https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930833451 -their procedures, Policies and other applicable regulatory requirements
- Plan the ressources
- measure effectiveness of the program]]> 2021-12-06 10:55:11 UTC https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930833451 extend and boundaries of an audit https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930844733 - locations
- processes
- time period
- auditees representatives and functions of organization units
- activitiies

sales, design and development of sterile something

]]> 2021-12-06 11:03:57 UTC https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930844733 Clauses of the standard and regulator requirement https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930851050 - Clauses of ISO 13485 
- MDR / IVDR
- contracts with suppliers
(Question: their own additional processes)]]> 2021-12-06 11:08:55 UTC https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930851050 https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930853215 - Sampling and Testing
- Interview
- Observations
- Review of QMS Documents
- Data analysis]]> 2021-12-06 11:10:31 UTC https://padlet.com/complyguru/alwey81uzrh5gsif/wish/1930853215