Surdomics LA - Objectives, Scope, Criteria Team 2 [18/10/21] by Comply Guru Instructor https://padlet.com/complyguru/mtniqru3n7t2xht0 Your contribution is important! Use your own words to answer each question en-us 2021-09-30 17:10:27 UTC 2025-11-13 23:22:48 UTC hello@padlet.com https://padlet-uploads.storage.googleapis.com/511422770/e3d19b02a56b048228c906795382ed0d/Guru_Front.png https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823725180 What needs to be achieved.


]]> 2021-10-18 10:15:48 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823725180 https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823727370 The specific area / range of capabilities identified that satisfy the requirements of the objective.]]> 2021-10-18 10:17:28 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823727370 https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823728786 Level of compliance to process or procedures identified in scope]]> 2021-10-18 10:18:23 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823728786 Supplier Audit https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823729305 Identifies the limits of the Audit
Audit of available QMS, production capabilities, storage/shipping capability, or QA (NCR/CAPA control)]]> 2021-10-18 10:18:31 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823729305 https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823731016 Which ISO standards are in scope (ISO 9001:2015, ISO 13485:2016, ISO 17025:2017)]]> 2021-10-18 10:19:43 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823731016 Supplier Objective https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823737049 Supplier meets the companies requirements in relation to either Product or Service they are providing]]> 2021-10-18 10:23:30 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823737049 Internal Audit https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823741039 Determine if process/procedures implemented are effective and meet defined ISO standards (ISO 13485:2016)]]> 2021-10-18 10:26:04 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823741039 Internal Audit https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823744461 Specific area of the QMS (Monitoring and Measurement), location (Device Production), technical file, or process.]]> 2021-10-18 10:28:19 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823744461 https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823749717 Statutory Regulatory requirements (MDR)]]> 2021-10-18 10:32:00 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823749717 Supplier https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823751923 Conformity to Supplier / Quality Agreement.
Conformity to purchase Order / Specification (e.g. PN0001-01)]]> 2021-10-18 10:33:38 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823751923 https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823753820 Set of requirements used as a reference against which objective evidence is compared.]]> 2021-10-18 10:34:49 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823753820 https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823767657 Evaluate the auditees understanding of the applicable standard/procedures]]> 2021-10-18 10:43:54 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823767657 https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823770791 Location: Where and when the Audit it to take place.]]> 2021-10-18 10:46:21 UTC https://padlet.com/complyguru/mtniqru3n7t2xht0/wish/1823770791