Title

Write an SOP for Internal Audit

Why

Every year, for every audit, the same procedure needs to be followed to ensure that audits are performed correctly and in compliance with ISO 15189.

What

Write an SOP for Internal Audit. The complete audit system has been set up in phase 3 in the previous activities. Document all these procedures in an SOP, from making the audit plan, preparing the audit, conducting the audit, drafting the audit report to development of the action plan to solve nonconformities identified and monitoring the implementation of the action plan.

How & who

Quality Officer:

  1. Write the SOP for Internal Audit according to the protocol for writing a Procedure SOP in the Master SOP and use the template Procedure SOP attached to the Master SOP.
  2. Review and authorize the SOP in accordance with the procedures of the SOP for Document Control. When the SOP needs to be reviewed, ensure that the reviewers are colleagues that are fellow certified Internal Auditors.
  3. Add the SOP to the Read and Understand List and indicate that the staff members trained as Internal Auditor have to read the SOP.
  4. Present the final SOP to all Internal Auditors and explain that they must read the SOP. From now on they have to adhere to this SOP for conducting internal audits.
  5. Monitor if all Internal Auditors have read the SOP.

Back to Roadmap Activity Overview
This activity belongs to the QSE Assessment

 

ISO15189:2007: 4.2.1
ISO15189:2012: 4.2.2.1
ISO15190:2003: