Step 1: Obtain Management Support.

Step 2: Establish the Project (Project Plan – Budget – HR Plan).

Step 3: Identify customer & other requirements.

Step 4: Define Scope, Management Commitments & other requirements.

Step 5: Define Quality Policy, Quality Objectives and start preparing Quality Manual.

Step 6: Implement Support Procedures.

  • Procedures for Document & Record controls.
  • Internal Audit.
  • Corrective & Preventive actions (CAPA).

Step 7: Develop Risk Management processes for production (Record Risk Management activities).

Step 8: Implement Process Procedures for

  • Design & Development.
  • Purchasing etc.

Step 9: Perform Training awareness program (Develop & maintain Training Records).

Step 10: Operate the MDMS (Medical Device Management Systems). (Maintain Records identified by MDMS).

Step 11: Conduct Internal Audit (Reports —> Corrective actions).

Step 12: Conduct Management Review Meeting (MRM).

Step 13: Choose Certification Body for final Audit.

Step 14: Stage 1 Certification Audit (Report —> Corrective actions).

Step 15: Stage 2 Certification Audit (Report —> Corrective actions).

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