ISO 13485 & ISO 9001 certified with addition of site.

somashekar

Staff member
Super Moderator
#1
Glad to inform that we got through successfully the ISO 13485; ISO 9001:2008; and the MDD assessment with the scope expansion of adding a site and a new product assembly process. Wish to share some of the learning had in this project .
1. The GHTF proposed document , Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 4: Multiple Site Auditing was very useful in the modifications to the Quality manual
2. Establishing a quality agreement between the two sites with regard to process ownership and interaction, communication between the lead site and site 1 was a strong point.
3. Key areas that were recognized as strong points were process re-validation plan and activity, Internal audit program and management, Relook at customer property management after direct link to customer documents server access and download was established, Progressive management reviews at shorter intervals during the establishment of the new site, Proper and timely notified body communication about significant changes in the QMS, Mapping of ISO 13485 clauses to the two site activities within the Quality management document, Linkage of the two organization charts within the quality manual, Bringing shop floor lighting activity within the work environment monitoring.
A tough but good audit and a sense of satisfaction having made this scope expansion audit along with the annual recertification assessment.
 
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jkuil

Quite Involved in Discussions
#5
Congratulations, multi site companies can be tough to certify.

In your QMS you have taken the approach to consider the activities performed by the satilite site as outsourced processes, with a quality agreement in place to identify the responsibilities. I support that recommendation. With a mutual QMS and a mutual senior management you are not required to draft a Quality Agreement. You could refrain to document the responsibilities in your policies and procedures, which you did as well. But a Quality Agreement does focus everybodies mind on the shared responsibilities and will therefore be very benificial.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Thanks for letting us know and for the brief commentary!
 
S

seema kabra

#7
Is it possible for you to share the quality agreement copy? We are also building a new manufacturing site for our medical devices, similar to the existing one and would like to leverage a lot of SOPs. I understand that the Equipment, facilities, utilities, processes will need to be re-validated. But just wanted to see how the Quality plan was written and any document to show the linking between the 2 sites for different processes.

Thanks - Seema
 

somashekar

Staff member
Super Moderator
#8
Is it possible for you to share the quality agreement copy? We are also building a new manufacturing site for our medical devices, similar to the existing one and would like to leverage a lot of SOPs. I understand that the Equipment, facilities, utilities, processes will need to be re-validated. But just wanted to see how the Quality plan was written and any document to show the linking between the 2 sites for different processes.

Thanks - Seema
Yap. Will do from my desk tomorrow.
 
S

seema kabra

#9
Hi Somashekar:

I would really appreciate if you could send the requested document(s) to me at your earliest. My hotmail id is seema Underscore kabra at hotmail.

Thanka and regards..
Seema
 
S

samsung

#10
Is it possible for you to share the quality agreement copy? We are also building a new manufacturing site for our medical devices, similar to the existing one and would like to leverage a lot of SOPs. I understand that the Equipment, facilities, utilities, processes will need to be re-validated. But just wanted to see how the Quality plan was written and any document to show the linking between the 2 sites for different processes.

Thanks - Seema
We also did the same a few years ago but now I realize that it wasn't a good decision to share the documents of the existing site with the new facility located off site. When you hand over something 'ready made' to people (they will also be new, I suppose), they probably won't do anything other than copying & pasting the stuff without delving into the processes. On the other hand when you let them write their own procedures/ SOPs with whatever level of understanding, you will realize that they really 'own' their documents and in due course of time they would start finding ways to improve the documents and thus the processes.

This is my experience which I shared with you. You may have different opinions on this issue.
 
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