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System Certification

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1) Pharmaceutical Industry
  > GMP Certification, CFDA
  > cGMP Certification, FDA
  > cGMP Certification, EMEA
  > PQ Certification, WHO



2) Medical Devices
  > GMP Certification, CFDA
  > QSR820 Certification, FDA
  > CE Marking, EU
  > ISO13485 Certification, ISO



3) Dietary Supplements
  > GMP Certification, CFDA
  > HACCP Certification, CAC
  > QS Certification, CFDA


4) Cosmetics Industry
  > ISO22716 Certification, ISO 
  Step 1:
To study the hardware & software details of target factory by site visit for example facilities & equipment’s status, documentations, personnel competence etc.
Step 2:
Establish system certification master plan to involve but not limited to schedule, action list, facilities & equipment’s rectification solutions, operational system new establishment or improvement plan, training matrix etc.
Step 3:
Help clients to implement the certification plan for example hardware rectification, operational system establishment or correction by the way of site coaching, training or contracting.
Step 4:
To execute simulation audit when all establishment and rectification work completed and to optimize the operational system again based on trial observations.
Step 5:
To be audited by authority. If necessary, follow up the whole auditing progress together with clients to improve the communication with auditors and ability of quick response.
Step 6:
Initial the end of audit, wrap up !