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

SGquality

Quite Involved in Discussions
#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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SGquality

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

It could be beneficial for you to acquaint yourself with the IAF Mandatory Document 1 for the Certification of Multiple Sites Based on Sampling.
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.
 
Last edited by a moderator:

sagai

Quite Involved in Discussions
#4
Re: ISO 13485 - moving towards common certification

Is multisite certificate necessarily means a common QMS?
Cheers!
 

Ajit Basrur

Staff member
Admin
#5
Re: ISO 13485 - moving towards common certification

Is multisite certificate necessarily means a common QMS?
Cheers!
Yes ... multi-site certification can be done when different sites are managed by a central site with common QMS processes.
 

sagai

Quite Involved in Discussions
#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

Problem Solver
Staff member
Moderator
#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

Staff member
Super Moderator
#8
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 ...
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:

SGquality

Quite Involved in Discussions
#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

Staff member
Admin
#10
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 ...
Refer attached ppt for more details. There are different situations being discussed - Single. Multiple, Campus, Several Sites and Complex.

.
 

Attachments

Thread starter Similar threads Forum Replies Date
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Lead time to schedule an ISO 13485 audit General Auditing Discussions 2
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 9
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
K Medical Device Repairs and ISO 13485 Scope ISO 13485:2016 - Medical Device Quality Management Systems 7
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9

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