LA - Objectives, Scope, Criteria Team 2 [02/11/21] by Comply Guru Instructor https://padlet.com/complyguru/ll6q9qmoyp0ebzvy Your contribution is important! Use your own words to answer each question en-us 2021-10-18 06:45:35 UTC 2021-11-02 11:42:53 UTC hello@padlet.com https://padlet-uploads.storage.googleapis.com/511422770/e3d19b02a56b048228c906795382ed0d/Guru_Front.png Objective: Something we try to achieve by conducting the audit, check if organization complies with ISO standards and Regulatory requirements, Find the gaps and areas for improvement. https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861326102 2021-11-02 11:24:36 UTC https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861326102 to assess the conformity of manufacturing process of needles in 🤬 organization against ISO 13485:2016. https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861329366 2021-11-02 11:26:35 UTC https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861329366 scope describes the extend and boundaries of the audit and includes such factors as locations, activities, and processes to be audited. https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861331518 2021-11-02 11:27:49 UTC https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861331518 1. Location of manufacturing facility 2. Different processes/ procedures/ WIs/ records including design and development and different stages of manufacturing processes and procedures from the start, DHRs, labelling activities, training records for operators, release DoCs of the product, checking suppliers records (evaluation records) https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861342776 2021-11-02 11:34:26 UTC https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861342776 Set of requirements used as reference against which objective evidence is compared https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861344770 2021-11-02 11:35:35 UTC https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861344770 Reference of Requirements ISO-13485, specific clauses ? example different SOPs https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861351761 2021-11-02 11:39:39 UTC https://padlet.com/complyguru/ll6q9qmoyp0ebzvy/wish/1861351761