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Using Summary Sheet for Documenting Training Activities

Using Summary Sheet for Documenting Training Activities

Using Summary Sheet for Documenting Training Activities

Hi all,

Our company develops software for the medical device manufacturers. We are certified against ISO 9001 and ISO 13485. This year we were audited by our certification body and received several recommendations. One of these recommendations makes me confused. It is related to training process: "Yearly training (other than SOP related training) is documented in the different employee's evaluation sheets, however there is no summary sheet showing schedule and authorization of the yearly planned / performed training activities".
I can see no value in combining all types of training documents (I mean training plans, training needs and training records regarding all kinds of training activities performed in our company) into the one summary document.
In our company training-related activities may be performed by different departments. For example HR department maintains records on work-related training activities, Development maintain records on project-related sets of training (on each project we have different training needs) an so on. Thus it seems complicated to maintain all types of records in the same document. But maybe I'm wrong.
Could you please help me to understand are there any benefits in using such a document taking into account that it is time consuming task to keep it up to date?

Thank you!

RE: Using Summary Sheet for Documenting Training Activities

No, I do not see any benefit other than to satisfy your notified body. But that can be called a benefit for your company, too. I think what they just want to see is a sheet which proves that training is not performed accidentally but is planned and approved. Our management sends an Excel sheet every year to every department. All departments must fill the sheet with the kind of training they plan for the next year, for whom they plan it, when (months, quarter) they plan it and how much the training will cost. These sheets are then put together in one common sheet which is finally approved by management. That's how we do it and we are certified acc. to ISO 9001:2000, too.

RE: Using Summary Sheet for Documenting Training Activities

Thanks for your reply!

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