Audited to ISO 13485 standard although customer was aware we're not and have no plans to be

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#1
Hi All,

We had a new customer onsite to perform an audit of our business management system. The customer is in the medical industry and is ISO 13485 certified as a result. We've been very clear with them we are not ISO 13485 certified and have no plans to be, we are ISO 9001:2015 certified. Anyway, we just got the audit report back and it was written to the ISO 13485 spec. What is the recommended response for SCARs they've opened against the ISO 13485 spec that we don't adhere to and are not listed in ISO 9001:2015?

Thanks,
Eddie
 
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GStough

Staff member
Super Moderator
#2
Hi Eddie,

I'm very interested in any discussion your question raises. IMO, you should NOT have been audited against ISO 13485, since you are not registered to it. However, I know there are some who disagree with that point of view. When I audit a supplier, I use the standard to which they are registered, as long as it's within my knowledge base (obviously, being in the medical device field, I wouldn't attempt to do an audit to an aerospace or automotive standard). If they are not registered to any ISO standard, then I use their own internal procedures and our supplier quality agreement, our specifications/drawings, etc. It seems unfair to audit a supplier to a standard of which they have little or no knowledge.

I hope that helps a little. Like I said, I'm very interested to hear others' thoughts.
 

John Broomfield

Staff member
Super Moderator
#3
You customer’s auditor should know better than to impose audit criteria on your organization. Did they discuss the objectives of the audit with you beforehand? If so how did you respond? If not why did you not ask for a copy of the audit plan ahead of the audit (as is your right)?

Your sales team may have a clearer understanding of this client’s expections. Somehow you need to address this snafu with them so you can demonstrate your commitment to understand their true requirements.
 

yodon

Staff member
Super Moderator
#5
Since they are ultimately responsible for ensuring all regulatory requirements are met, I'm guessing they are citing these findings as regulatory gaps.

One option for you would be to raise your rates and offer to do those things! :)

It would be very interesting to learn how they qualified and approved you as a supplier if their criteria included you being 13485. Hmm...
 

Golfman25

Trusted Information Resource
#7
I don't see an issue with them auditing you to 13485. My issue is issuing non-conformances against a standard you don't comply with. As a medical company they probably have certain medical requirements they want to see. Kind of like auto wanting suppliers to us AiAG ppaps. I guess it's a conversation to have with your customer-- what do they need and whether you want to make the changes.
 

somashekar

Staff member
Super Moderator
#8
Hi All,

We had a new customer onsite to perform an audit of our business management system. The customer is in the medical industry and is ISO 13485 certified as a result. We've been very clear with them we are not ISO 13485 certified and have no plans to be, we are ISO 9001:2015 certified. Anyway, we just got the audit report back and it was written to the ISO 13485 spec. What is the recommended response for SCARs they've opened against the ISO 13485 spec that we don't adhere to and are not listed in ISO 9001:2015?

Thanks,
Eddie
For a moment, forget all the standards. Look at the SCARs.
Do you think you can work around and respond to them. (I don't know how many though)
Do you feel any of them are beyond your QMS and are purely ISO 13485 requirements ? (Now study the standard as you have already mentioned. I believe you have one)
Does your management want to address them ?
YES >> Address the SCAR accordingly
NO >> Write back to customer as to why you are not going to address the particular SCAR.

Remember that its a customer audit and your response will have direct bearing on your business sustainability.
Does this process lead to customer asking you to be ISO 13485 certified ?
Upgarde your QMS. After all any QMS certifications is primarily a business need.
 

JoshuaFroud

Involved In Discussions
#9
This has happened to me on many occasions in a previous role, we produced a large number of bacterial culture media and related paraphernalia. As such we had many customers who produced pharmaceuticals buying our products when they would audit us they would often give us findings against pharmaceutical standards or GMP (we were not a GMP facility).

How we usually addressed these issues was to state that we had no regulatory obligation to meet the items raised and would not consider them a non-conformance, however, we would take it under advisement and add it to our continual improvement plan. This was usually enough to appease most customers.
 

dwperron

Trusted Information Resource
#10
Good answers here!

Chipping in here, did the customer give any indication as to whether or not they were seeking for you to be 13485 "compliant"?

They may be attempting to use you as an "accredited" supplier and are hoping that their 13485 supplier audit will be sufficient to withstand investigation when they are audited. It won't, but that's not your problem.
 
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