ID号码 0000027229: 1st and 2nd Party Auditor Medical Devices International (TÜV)

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认证项目名称:1st and 2nd Party Auditor Medical Devices International (TÜV)
入学要求:

Qualification „Expert Quality Management Medical Devices International (TÜV)“. A minimum of 2 years of professional experience in the medical devices industry or in the performance of audits in other industries. Successful participation in the TÜV Rheinland Academy’s qualification 1st and 2nd Party Auditor Medical Devices International (TÜV)“ with the individual seminars:

  • Outsourcing of processes in the medical devices industry (8 teaching units) (Course no. 09331)
  • Validation of processes in the medical devices industry (8 teaching units) (course no. 09476)
  • Auditor in the medical devices industry (16 teaching units (course no. 09451)

all of which have to be completed within a maximum period of three years. Admission to the examination is granted upon a minimum attendance of 80% of the total of 32 teaching units

考试内容:
  • Written exam (Multiple Choice)
必需具备的能力:

In the examinaition, candidates prove their knowledge in the following areas:

  • Outsourcing of processes in the medical devices industry
  • Validation of processes in the medical devices industry
  • Policies, requirements for auditors and procedure of audits

1st and 2nd Party Auditors Medical Devices International can plan prepare, implement, evaluate and check for legal compliance in the required depth. They know the requirements and current models for process validation and how to prepare documentation and agreements with suppliers with regard to their contents thus ensuring relevant regulations are met.

目前适用地区:德国