Article 17: Audit

1.   Risk-based audits of the quality system shall be performed at regular intervals according to a common methodology to ensure that the quality system complies with the requirements set out in Articles 8, 14, 15 and 16 and to ensure its effectiveness.

2.   Corrective action, including a follow-up audit of deficiencies, shall be taken where necessary. The audit report shall be sent to the management responsible for the matters audited. The dates and results of audits and follow-up audits shall be documented.