Common use of Surveillance Audits Clause in Contracts

Surveillance Audits. 3.9.1. The purpose of this audit is to perform a detailed review in order to determine whether the management systems and infrastructure conditions provided by the company for the product or service continue to conform to the requirements of (EU) 2017/745 Regulation as well as the effectiveness of post market surveillance, clinical follow-up and vigilance systems created by the company for the continuation of the product and service safety and performance and availability of parallel implementations as declared by the company. 3.9.2. Some of the sections may be left outside the scope during surveillance audits but SZUTEST Konformitätsbewertungsstelle GmbH must have assessed all the relevant points that are required to be assessed in a certification cycle which is 5 years. 3.9.3. The first surveillance audit shall be performed in maximum 12 months after the certification date. Other following routine surveillance audits shall be performed in maximum 12 months after the previous surveillance audit however SZUTEST Konformitätsbewertungsstelle GmbH may choose to perform early surveillance audits. 3.9.4. Surveillance audits may cover testing where necessary. Samples may be taken from the company or market and tests may be performed either by using company’s existing capabilities or by using 3rd Party test laboratories.

Surveillance Audits. 3.9.1. The purpose of this audit is to perform a detailed review in order to determine whether the management systems and infrastructure conditions provided by the company for the product or service continue to conform to the requirements of (EU) 2017/745 Regulation as well as the effectiveness of post market surveillance, clinical follow-up and vigilance systems created by the company for the continuation of the product and service safety and performance and availability of parallel implementations as declared by the company. 3.9.2. Some of the sections may be left outside the scope during surveillance audits but SZUTEST Konformitätsbewertungsstelle GmbH must have assessed all the relevant points that are required to be assessed in a certification cycle which is 5 years. 3.9.3. The Surveillance audits must be performed minimum once a year however first surveillance audit shall must be performed in maximum completed within 12 months after as from the certification starting date. Other following routine Routine surveillance audits shall be performed in maximum carried out every 12 months after the previous surveillance audit in accordance with MDR Annex IX 3.3 however SZUTEST Konformitätsbewertungsstelle GmbH may choose to perform early surveillance audits. 3.9.4. Surveillance audits may cover testing where necessary. Samples may be taken from the company or market and tests may be performed either by using company’s existing capabilities or by using 3rd Party test laboratories.