I am newly join to a medical device supply company which under the restructuring the management and nature of its businesses. The company has certified to the ISO13485:2016. However, under the new structure of business strategy, few activities of the company (as such production of medical device) is taken off from main process line as few others as well.
My question is, do the company need to revise the entire documentation of Quality manual/procedure before the upcoming survelience audit?
Will it impact the certification to the ISO 13485:2016
Please help to highlight your opinion on my curretn situation to corelated it with the certification of ISO 13485:2016