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Scoping Validation for Incoming Inspection Tools/Equipment

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Mohsin Farooqui, Nov 16, 2017.

  1. Mohsin Farooqui

    Mohsin Farooqui New Member

    Nov 16, 2017
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    Hello everyone! First time posting here, so go easy on me :).

    I am looking to scope the validation for different types of tools and equipment used in the incoming inspection department at our company. I need guidance as to what level of validation to perform on each piece of equipment or whether it is required at all.

    Is there some reference out there that tabulates how to come up with the level of validation required for a specific type of tool/instrument used in inspection processes? A table like the following would help:


  2. Vintage Goose

    Vintage Goose Active Member

    Oct 6, 2015
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    Hi Moshin

    Unfortunately, I dont think there is a standard table that will answer you questions. For all of these I suggest some form of IQ. For a complex system such as a video system or CMM this could be a full installation qualification followed by an OQ. However for simpler items, you probably just need to document the rationale for calibration frequency based on risk. You could include training and maintenance requirements on the IQ document.

    Any test method that provides an acceptance criteria needs to be validated. So it is likely that most will require either a Gauge R&R or Attribute TMV.

    Paul Bennett and Atul Khandekar like this.