R
Remik
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?
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?