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How do I start the process of ISO 13485 Certification

S

snaphardcore

#1
Greetings, I am new to this forum, but must say it is an excellent information tool. I work in a Medical Device facility and we are trying to get the ISO 13485 CERTIFICATION. I am new to this certification. How do I start the process, any forms I need to request, fill out, which documentation or proofs do I need or write. I really need help in explaining this in a very basic way step by step if you could, thanks.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: ISO 13485 certification

Greetings, I am new to this forum, but must say it is an excellent information tool. I work in a Medical Device facility and we are trying to get the ISO 13485 CERTIFICATION. I am new to this certification. How do I start the process, any forms I need to request, fill out, which documentation or proofs do I need or write. I really need help in explaining this in a very basic way step by step if you could, thanks.
Welcome to the Cove.

Are you starting from ground zero on Policy and procedures (none in existence)?
 
S

snaphardcore

#3
Re: ISO 13485 certification

We have our regular SOP's and Batch Records, but yes I am starting from scratch.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#4
Re: ISO 13485 certification

We have our regular SOP's and Batch Records, but yes I am starting from scratch.
My suggestion (s) are (after the Management Policy has been established by Top Management):

Flow chart your processes from womb to tomb (beginning to end).

Determine the critical processes that could affect the outcome of the product.

Document the critical processes.

Determine Regulatory requirements and customer requirement.

Note: This could be a long process to do this. I should have asked do you have help or are you going at this as the Lone Ranger without Tonto :) before I go more in depth.
 
#5
Getting the help of someone who is competent in the standard etc. to do a needs or gap analysis is vital. You need to know what you have currently and if it's sufficient and what else needs doing to bring you to a state of readiness for certification. Two key issues to also consider are if you need CE marking and also CMDCS approvals to sell in Canada.
 
S

snaphardcore

#7
Yes, we are also working on getting the CE Mark and the CMDCS approvals. Are there any manuals, forms and/or checklists that I should follow that anybody could supply.
 
#8
Yes, we are also working on getting the CE Mark and the CMDCS approvals. Are there any manuals, forms and/or checklists that I should follow that anybody could supply.
The use of other peoples' documents if you are new to this, is going to be confusing, IMHO. Without the understanding of how to go about implementation - which the consultant will bring - is going to be very difficult. You won't know why someone wrote a document or if it's much use. Find a guide to help you create your particular system - your people will 'own' what they create!
 
S

snaphardcore

#9
I understand, what about like a basic checklist of the items that we need to have available for submission.
 
#10
I understand, what about like a basic checklist of the items that we need to have available for submission.
If you navigate to the small green bar by the lighthouse, 'Post attachments List', click that and you can search by keyword for such a checklist if there's one been posted. If not, come and tell us, someone may have one to share.
 
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