ISO 13485 LA Practice Questions - PECB ISO 13485 Lead Auditor Exam

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Which ISO standard provides the requirements for a Medical Devices Quality Management System (MDQMS) that ISO 13485 Lead Auditors must audit against?

ISO 9001:2015 Quality Management Systems ISO 13485:2016 Medical Devices — Quality Management Systems ISO 14971:2019 Medical Devices — Risk Management ISO/IEC 17021-1:2015 Conformity Assessment

Correct Answer:

ISO 13485:2016 Medical Devices — Quality Management Systems

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