ABC Medical are revising the Instructions for Use (IFU) for their product portfolio of Paediatric Tracheostomy Tubes to increase the duration of use from 7 days to 10 days.
Outline and explain, the steps you would take in order to assess, plan, implement and document this change which complies with the FDA QSR (21 CFR Part 820) regulations and ISO 13485:2016. As part of your answer you should also consider impacts to other QMS elements that would need to be addressed.
(Percentage Allocation: 40%)
You are in charge of the Internal Audit programme at ABC Medical. You have created the annual internal audit schedule and your first audit of the year will be in one month’s time. You are in charge of the first audit which should comply with all elements of ISO 13485:2016.
Outline your audit plan which should include from audit initiation, audit execution, audit closure and effectiveness checks. You address and include all roles and responsibilities that apply. You should also provide any templates, forms or records that wll be used to carry out the audit.