Title

Write an SOP for Document Control including the Document Retention List

Why

In phase 2 the document control system was established ensuring regular review of quality management documents (SOPs, Laboratory Service Manual, Quality Manual chapters and Biosafety Manual chapters with all the appendixes and forms). This way correctness of the documentation underlying laboratory practice is assured which in turns increases quality assurance. To ensure that the document control system is kept in a functional state and that all the procedures related to document control are always carried out correctly, completely and in the same way, the document control system also need to be standardized.

What

Develop an SOP for Document Control. In this SOP all the procedures related to document control established in phase 2 must be documented:

How & who

Quality Officer:

  1. Write the SOP for Document Control according to the protocol for writing a Procedure SOP in the Master SOP. Use the template of a Procedure SOP attached to the Master SOP. Add the Document Retention List developed earlier in phase 2 as appendix to this SOP.
  2. Let the SOP be reviewed and authorized according to the procedure described in the Master SOP.
  3. Determine at which locations copies of this SOP need to be stored and indicate these locations on the front page of the SOP (as this SOP is only relevant for you and, if applicable, document managers, a copy of this SOP may only have to be stored in the office area and in the quality documentation archive).
  4. Print the SOP and distribute it to the locations indicated on the front page.
  5. Determine who should read this SOP: not all the sections of this SOP are important for all the staff members. However, the procedure for unplanned revision of documents upon detection of an error is relevant for most staff members and they should thus be aware of this procedure and be able to act according to this procedure. Add this SOP to the Read and Understand List and indicate who should read the SOP.
  6. Give a presentation on the document control system in a weekly staff meeting and explain why it has been established and how it works. Present the SOP for Document Control in the same meeting and indicate who should have to read it and what section(s) they must read.
  7. Monitor correct implementation of the procedures according to the SOP.

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This activity belongs to the QSE Documents & Records

 

ISO15189:2007: 4.2.1 4.3.1 4.3.2 4.13.1
ISO15189:2012: 4.3 4.13
ISO15190:2003: