ISO 19011 defines the term "audit" as a systematic, independent and documented process for obtaining objective evidence and evaluating it objectively.
For an audit conducted by the US health authority – the Food and Drug Administration (FDA) – checks are carried out on companies wanting to manufacture products relating to public health and sell them in the USA. This includes foodstuffs, pharmaceutical products, medical equipment and combination products, as well as cosmetics and tobacco products.
Depending on the audit, adherence to various standards, such as the ISO 9001 Quality Management Standard, will be checked as a benchmark in order to ensure fulfilment of the audit criteria on this basis.
rantronik is very happy to support you in preparing for the audit, during the audit and the in follow-up.