Title

Create an archive dedicated to quality management documentation

Why

All copies of replaced versions of SOPs need to be archived for 5 years (or longer if national law requires this). This enables the laboratory to look back in time and see how procedures were performed in the past. It also enables the laboratory to see what has changed over time in the different procedures.

What

Create a new archive for quality documentation or, if the laboratory already has an existing archive, create a separate section reserved for quality documents.

How & who

Quality Officer:

  1. Create the quality documents archive as described above. In phase 3 the archive for laboratory records will be upgraded to get it to comply with the ISO requirements. For now it is enough to have a separate section reserved for quality documentation.

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This activity belongs to the QSE Documents & Records

 

ISO15189:2007: 4.13.1 4.13.2
ISO15189:2012: 4.3 4.13
ISO15190:2003: