Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Device

[Ajit Basrur]

In Reply to Parent Post by Ronen E

Only if they make finished medical devices, or accessories to such, or their customer so requires (and they dear it enough). Pretty much like ISO 13485.

Yes, true

[Jshene]

Thanks everyone! I am still very new to ISO and this website/forum has been very helpful to me. I appreciate the responses

[DietCokeofEvil]

On this note- we had an audit by one of our customers who had some findings against the ISO13485 standard. We are a calibration house- but we do calibration for some medical device manufacturers- very tight tolerance gages come our way from them.

Since we calibrate for them, but do not make anything, are we held to the 13485 standard as well? We are 17025 accredited, but we have never been audited against the 13485 standard before- even by other medical device mfrs that I am aware of.

[Ronen E]

In Reply to Parent Post by DietCokeofEvil

we had an audit by one of our customers who had some findings against the ISO13485 standard. We are a calibration house...

Makes no sense to me!...

ISO 13485:2003:

0 Introduction
0.1 General
This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

[Ajit Basrur]

In Reply to Parent Post by DietCokeofEvil

On this note- we had an audit by one of our customers who had some findings against the ISO13485 standard. We are a calibration house- but we do calibration for some medical device manufacturers- very tight tolerance gages come our way from them.

Since we calibrate for them, but do not make anything, are we held to the 13485 standard as well? We are 17025 accredited, but we have never been audited against the 13485 standard before- even by other medical device mfrs that I am aware of.

Yes, ISO 17025 makes sense for a calibartion house but why did you go in for an ISO 13485 ?

[DietCokeofEvil]

Sorry,

We are not 13485- we had an audit where the customer had findings against this ISO standard, even though we are not accredited to it.

[somashekar]

In Reply to Parent Post by DietCokeofEvil

Sorry,

We are not 13485- we had an audit where the customer had findings against this ISO standard, even though we are not accredited to it.

Oooh dear ?
There is a chance that a specific ISO13485 requirement was stated by your customer to you, and that he audits on this as a customer requirement. He is only stating the ISO13485 thereby opening up a totally new area that you are not aligned with ?
Please tell us those some findings your customer found and reported to you against the ISO13485 standard.