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Writing quality SOP for work infrastructure

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Guest user Created:   Dec 07, 2020 Last commented:   Dec 08, 2020

Writing quality SOP for work infrastructure

How to write quality SOP for work infrastructure?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Dec 08, 2020

In SOP for infrastructure you need to consider the following:

  • Description of the buildings, workspace, and associated utilities
  • What kind of the process equipment you have (both hardware and software)
  • What kind of supporting service you have
You need to document requirements for the maintenance activities and with what kind of records you will prove that those maintenance requirements are fulfilled.

More information on this topic you can find in the following article:

You can also see how the procedures for infrastructure and records of the infrastructure maintenance in our ISO 13485:2016 documentation toolkit look like:

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Dec 08, 2020

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