ISO 13485 - Moving towards common (single) certification for multiple locations

S

SGquality

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#1
#1
Dear friends,

My organization is having 3 locations with individual ISO 13485 certifications. Now we are thinking of having a common ISO 13485 certificate with multiple locations.

All the 3 loactions share almost common procedures however there is a minor difference. The common certification would be lot more advantageous as it would help harmonize all procedures and practices across.

Does anyone have similar experience ? Could some one help me with list of activities that could help me plan for the common certification.

Thanks in advance :thanks:
 
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S

SGquality

Quite Involved in Discussions
#3
#3
Re: ISO 13485 - moving towards common certification

Sidney Vianna said:
It could be beneficial for you to acquaint yourself with the IAF Mandatory Document 1 for the Certification of Multiple Sites Based on Sampling.
Click to expand...
Thanks Sidney. I have reviewed the IAF and also the GHTF document, http ://www .ghtf. org/documents/sg4/sg4final_n83.pdf - DEAD (404) LINK UNLINKED ... these documents relate to audit methodology.

I wanted to know the readiness which my organization has to plan to get ready towards developing the common QMS.
 
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sagai

sagai

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#4
#4
Re: ISO 13485 - moving towards common certification

Is multisite certificate necessarily means a common QMS?
Cheers!
 
sagai

sagai

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#6
#6
Re: ISO 13485 - moving towards common certification

What if the QMS enables QMS tailoring by project or by legal entity and the tailoring at the end results in tailored QMSs for projects and for legal entities?
(not end up with fully same quality frameworks)
I hope I have expressed what I mean clearly ...
 
Ronen E

Ronen E

Problem Solver
Moderator
#7
#7
Re: ISO 13485 - moving towards common certification

Have you already done a gap analysis? I.e. identified and listed the differences between the different sites' QMSs?

If the differences are not big and you seek a more centralized / unified operation then maybe this is a good opportunity to unify the QMSs. However if the business entities culture holds dear every site's independence then unifying the QMSs may encounter resistance (albeit a quiet one). It's not only quality, it may affect management style in general.

Good luck,
Ronen.
 
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somashekar

somashekar

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#8
#8
Re: ISO 13485 - moving towards common certification

sagai said:
What if the QMS enables QMS tailoring by project or by legal entity and the tailoring at the end results in tailored QMSs for projects and for legal entities?
(not end up with fully same quality frameworks)
I hope I have expressed what I mean clearly ...
Click to expand...
It never means common QMS. It gives you the liverage to have central management (lead site) focus on all the sites and lets the sites manage the QMS with proper responsibilities and authorities and the lead site exercising top management control. Which of the processes are governed by the lead site and which of the processes governed at sites (site 1 / site 2 / site x) must be having the clarity within the top level QMS document.
I am with sagai and perhaps understand what he meant. It is not common QMS, but QMS deployment and exercising of necessary controls with clarity of process responsibilities and authorities of sites and linkage with lead site stated clearly.
The scope of the QMS needs deeper reviewing to understand this.
Perhaps you can also have different quality policy for some of the sites. The QMS can be as flexible as this.
The GHTF/SG4/N83:2010 can be an eye opener to the way QMS can be established and internal audited, and hence lead to effective certification auditing...
Good luck and keep moving ahead SGquality ...
 
Last edited:
S

SGquality

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#9
#9
Thanks somashekar.

Could you please help me with some checklist or action items which would help me make my organization ready for multiple site certification ?

Much appreciated.
 
Ajit Basrur

Ajit Basrur

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Admin
#10
#10
Re: ISO 13485 - moving towards common certification

sagai said:
What if the QMS enables QMS tailoring by project or by legal entity and the tailoring at the end results in tailored QMSs for projects and for legal entities?
(not end up with fully same quality frameworks)
I hope I have expressed what I mean clearly ...
Click to expand...
Refer attached ppt for more details. There are different situations being discussed - Single. Multiple, Campus, Several Sites and Complex.

.
 

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