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ISO9001 & ISO13485 QMS for 2 types of products

R

Remik

#1
Hello everybody, first post on the forum :)

I am currently working in a small company; our customers are mainly industrials and laboratories. We don’t have a complete QMS and we are not ISO 9001 compliant. The management want to get the ISO 9001 certificate; and I have started to work on the implementation.
But at the same time, we have started to develop with a partner company, a product which will be a medical device for the EU market; therefore we plan to be ISO 13485 certified in approximatively 2-3 years. That why I need to think carefully when preparing for ISO9001, because I don’t want to have to “break” everything in 2 years. The scope will be the same for 9001 & 13485; we will develop & sell both non-medical & medical products.

My professional background is mainly QA in Medical Device industry, so I know the requirements of ISO13485.
In the long term we will have 80% of our products which will be sold to industrial; and 20% which will be Medical Devices. The goal is not really to apply a double certification 9001/13485 to everything in the company; but more to have 2 level of requirements. So when we produce/develop industrial products we don’t have to follow (all) the medical device requirements. But I don’t see yet where to draw the line; and how to separate practically the activities between medical/non-medical since it's the same type of product, manufactured on same site.

For some processes it would be tedious and unnecessary to apply 13485 everywhere; for example:
- Section 4.2.4: retention time for obsolete controlled document during lifetime of product
- Section 6.4: Cleanliness
- Section 7.1&7.2: documented product requirements, risk management in product realization
- Section 7.3: Design and development procedures need to be documented
- Section 7.5: Identification& traceability
- Section 7.6 documented monitoring and measurement procedure
- Section 8.2.2: Complaints must be investigated, and if no action taken, a justification of why must be documented
- Section 8.5.3&8.5.3: record investigation for CAPA

As I see it some of the processes shall be ISO 13485/9001 compliant and applied to the entire company: HR; Complaint; Analysis of Data; CAPA, Document management…
And some others would have “two level of requirements” according to the type of products concerned (non-medical/medical)

Any thought or feedback about this kind of double certification; with different products?
 
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QAengineer13

Quite Involved in Discussions
#2
Hello everybody, first post on the forum :)

I am currently working in a small company; our customers are mainly industrials and laboratories. We don’t have a complete QMS and we are not ISO 9001 compliant. The management want to get the ISO 9001 certificate; and I have started to work on the implementation.
But at the same time, we have started to develop with a partner company, a product which will be a medical device for the EU market; therefore we plan to be ISO 13485 certified in approximatively 2-3 years. That why I need to think carefully when preparing for ISO9001, because I don’t want to have to “break” everything in 2 years. The scope will be the same for 9001 & 13485; we will develop & sell both non-medical & medical products.

My professional background is mainly QA in Medical Device industry, so I know the requirements of ISO13485.
In the long term we will have 80% of our products which will be sold to industrial; and 20% which will be Medical Devices. The goal is not really to apply a double certification 9001/13485 to everything in the company; but more to have 2 level of requirements. So when we produce/develop industrial products we don’t have to follow (all) the medical device requirements. But I don’t see yet where to draw the line; and how to separate practically the activities between medical/non-medical since it's the same type of product, manufactured on same site.

For some processes it would be tedious and unnecessary to apply 13485 everywhere; for example:
- Section 4.2.4: retention time for obsolete controlled document during lifetime of product
- Section 6.4: Cleanliness
- Section 7.1&7.2: documented product requirements, risk management in product realization
- Section 7.3: Design and development procedures need to be documented
- Section 7.5: Identification& traceability
- Section 7.6 documented monitoring and measurement procedure
- Section 8.2.2: Complaints must be investigated, and if no action taken, a justification of why must be documented
- Section 8.5.3&8.5.3: record investigation for CAPA

As I see it some of the processes shall be ISO 13485/9001 compliant and applied to the entire company: HR; Complaint; Analysis of Data; CAPA, Document management…
And some others would have “two level of requirements” according to the type of products concerned (non-medical/medical)

Any thought or feedback about this kind of double certification; with different products?
------------------------------------------------------------------------------------------------------------------------
Few learning from my end , I would like to share with you:

"The scope will be the same for 9001 & 13485; " --- This is not a good strategy to begin with from a business perspective only because the ISO scope are very specific in terms of the design Development and manufacturing requirements for a " Specific Product type" and you having the same scope for Industrial and Medical doesn't make sense.

Secondly, redundancy because you spent all that money to get ISO 9001 and ISO 13485 for what " Same Scope" think again ! does that make sense.

Thirdly, like you mentioned its the QMS rigour so "YES" have common QP/QI but in Quality Manual explain this clearly about the common and specific QP/QI for ISO 13485 ( A table form would be ideal as an appendix in QM).

Please discuss with your Notified body about the SCOPE and you will learn more about what I mean. Happy to discuss, if you want specifics about this topic.
 
R

Remik

#3
Thank you for reply.

About the scope of the future certifications; it's yet to be defined. What I wanted to show it's that basically both medical/non-medical product would go through the same rough process: customer order->(conception)->manufacturing->post-deliveries activities.
I agree with you the scope will in reality be different; ISO 9001 scope will be: conception & manufacturing of industrial electrical equipment... ; the scope for ISO13485 will be : conception & manufacturing of medical electrical device...

Thirdly, like you mentioned its the QMS rigour so "YES" have common QP/QI but in Quality Manual explain this clearly about the common and specific QP/QI for ISO 13485 ( A table form would be ideal as an appendix in QM).
Thanks for this input, this confirms to me that this is a possible solution; as you stated it must be clearly identifiable which requirements apply specifically to MD products.

I will try to keep this thread updated throughout the QMS implementation project
 

QAengineer13

Quite Involved in Discussions
#4
Thank you for reply.

About the scope of the future certifications; it's yet to be defined. What I wanted to show it's that basically both medical/non-medical product would go through the same rough process: customer order->(conception)->manufacturing->post-deliveries activities.
I agree with you the scope will in reality be different; ISO 9001 scope will be: conception & manufacturing of industrial electrical equipment... ; the scope for ISO13485 will be : conception & manufacturing of medical electrical device...



Thanks for this input, this confirms to me that this is a possible solution; as you stated it must be clearly identifiable which requirements apply specifically to MD products.

I will try to keep this thread updated throughout the QMS implementation project
If you have any further questions, thing you would like to discuss, always happy to discuss and help! :) Good Luck with your implementation
 
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