Is ISO 13485 required at each different location?

R

regmeddevices

#1
Hi Experts,

I have a question regarding requirement of ISO 13485 certification. Ours is a manufacturing facility (X) and we have two other manucaturing facility (A) and (B) at two different locations. All manufacturing facilities manufacture finished medical devices.

Our facility X has ISO 13485 certification do we need to get separate ISO certifications for both facilities A and B separately? or the ISO certification of X will work for both A and B?

Also I would really appreciate if you could point me to a reference document to find this type of information.


Thank you!!
I look forward to your earliest response :)
 
Last edited by a moderator:
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somashekar

Staff member
Super Moderator
#2
Re: ISO 13485 required?

Hi Experts,

I have a question regarding requirement of ISO 13485 certification. Ours is a manufacturing facility (X) and we have two other manucaturing facility (A) and (B) at two different locations. All manufacturing facilities manufacture finished medical devices.

Our facility X has ISO 13485 certification do we need to get separate ISO certifications for both facilities A and B separately? or the ISO certification of X will work for both A and B?

Also I would really appreciate if you could point me to a reference document to find this type of information.


Thank you!!
I look forward to your earliest response :)
You would need ISO13485 for A and B
OR
Your ISO13485 of X can be scope expanded to include site A and B.
Refer the attached IAF Mandatory document for how a CB approach this multisite auditing and you can plan your QMS accordingly...
 

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Last edited:

DannyK

Trusted Information Resource
#3
Hi Experts,

I have a question regarding requirement of ISO 13485 certification. Ours is a manufacturing facility (X) and we have two other manucaturing facility (A) and (B) at two different locations. All manufacturing facilities manufacture finished medical devices.

Our facility X has ISO 13485 certification do we need to get separate ISO certifications for both facilities A and B separately? or the ISO certification of X will work for both A and B?

Also I would really appreciate if you could point me to a reference document to find this type of information.


Thank you!!
I look forward to your earliest response :)
I would recommend that you speak with your CB about the options.
If X oversees the system at A & B by controlling CARS/PARS, internal audits & management review, then a multi-site certification is a good option.
If the sites are independent then they will have to get their own certifications.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Re: ISO 13485 required?

You would need ISO13485 for A and B
OR
Your ISO13485 of X can be scope expanded to include site A and B.
Refer the attached IAF Mandatory document for how a CB approach this multisite auditing and you can plan your QMS accordingly...
Please remember that IAF MD9 has restrictions concerning sampling of sites for ISO 13485:
MD 9.1.5 Multi-site sampling
Design and development and manufacturing sites cannot be sampled.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#5
Hi Experts,

I have a question regarding requirement of ISO 13485 certification. Ours is a manufacturing facility (X) and we have two other manucaturing facility (A) and (B) at two different locations. All manufacturing facilities manufacture finished medical devices.

Our facility X has ISO 13485 certification do we need to get separate ISO certifications for both facilities A and B separately? or the ISO certification of X will work for both A and B?

Also I would really appreciate if you could point me to a reference document to find this type of information.


Thank you!!
I look forward to your earliest response :)
You would probably want each site to have their own certificate. It protects you against potentially losing certification at a site but being able to continue to manufacturer in a certified site.
 
W

William_55401

#6
Steven, I understand the logic that individual site certificates mitigates the risk of the losing a single multi-site certificate. However, my question is have you ever heard of / experienced a Notified Body not granting QS certification? In my experience, the probability is extremely low and would recommend going the multi-site with a single QS certificate route. Also, by going multi-site, it would drive QS collboration and alignment between sites.
 
#7
You would probably want each site to have their own certificate. It protects you against potentially losing certification at a site but being able to continue to manufacturer in a certified site.
In all reality this is unlikely to happen. With common system, with HQ oversight, the auditor should be "looking" at how the other sites are performing, how changes are handled, improvements made etc. The whole story about losing a certificate and protecting the other sites isn't as big an issue as it used to be in the 'old days'. A good CB will work with the client to ensure there are no weaknesses and it can take quite a while before a certificate is actually "pulled".
 

Statistical Steven

Statistician
Staff member
Super Moderator
#8
In all reality this is unlikely to happen. With common system, with HQ oversight, the auditor should be "looking" at how the other sites are performing, how changes are handled, improvements made etc. The whole story about losing a certificate and protecting the other sites isn't as big an issue as it used to be in the 'old days'. A good CB will work with the client to ensure there are no weaknesses and it can take quite a while before a certificate is actually "pulled".
William and Andy....your points are right on. I guess my thinking is that if more pressure is put on the CBs will this "free pass" mentality go away?
 
#9
William and Andy....your points are right on. I guess my thinking is that if more pressure is put on the CBs will this "free pass" mentality go away?
Steven - as part of some due diligence on the part of the client, when selecting a registrar, these types of situations can be easily resolved. I find it interesting that, instead of contacting their CB representative, such a question is posted here.

I understand that seeking independent validation of options is often important, but it casts doubt, at least in my mind, about the partnership which should be developed between a CB and their clients, such that the CB becomes the 'trusted adviser' in such matters.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#10
Steven - as part of some due diligence on the part of the client, when selecting a registrar, these types of situations can be easily resolved. I find it interesting that, instead of contacting their CB representative, such a question is posted here.

I understand that seeking independent validation of options is often important, but it casts doubt, at least in my mind, about the partnership which should be developed between a CB and their clients, such that the CB becomes the 'trusted adviser' in such matters.
Andy

Curious what your thoughts are on maintaining independence. If the CB becomes a trusted advisor can they still maintain independence of the audit. I was at a conference where they discussed this in parallel to financial auditing and how the Big 5 had to divest their consulting practices to maintain independent (SEC requirement). The speaker stated that CBs should never offer "consultation" but rather guidance (not sure I know the difference).

I agree that asking the CB for an opinion is always wise.
 
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