ISO 13485:2016 Quality Policy Requirements

[Manto]

As stated above I have several brands under one roof and we order all our parts through BRAND X and I just assemble them into my medical device.
Is there a rationale for this ???

 

[Jim Wynne]

With it understood that I have no expertise in medical devices, what you're describing doesn't sound unusual. Who owns the design of the finished product? Your BOM should be structured such that all of the components are traceable to their individual sources.

 

[indubioush]

As stated above I have several brands under one roof and we order all our parts through BRAND X and I just assemble them into my medical device.
Is there a rationale for this ???

Your parts can be ordered under the different brand; however, you must meet the following requirements:

• Parts must have an approved, documented specification. You must show that the specification was approved by the medical device branch of the company.
• Parts may only be received from an approved supplier. Supplier approval requirements must be based on the risk that part poses to the final device.
• You must have a change agreement with suppliers to ensure they do not change a medical device component without notifyying you.
• Parts must be reviewed/inspected to ensure they meet specification.
• Parts must be labeled and stored in a way that will prevent mixups between medical device and non-medical device parts.
• All employees who submit purchase orders, receive parts, inspect parts, inventory parts, must be trained to the medical device procedures relevant to their activities.

Sounds like you just need to create some dividing lines to distinguish medical and non-medical items.

 

[Manto]

Your parts can be ordered under the different brand; however, you must meet the following requirements:

• Parts must have an approved, documented specification. You must show that the specification was approved by the medical device branch of the company.
• Parts may only be received from an approved supplier. Supplier approval requirements must be based on the risk that part poses to the final device.
• You must have a change agreement with suppliers to ensure they do not change a medical device component without notifyying you.
• Parts must be reviewed/inspected to ensure they meet specification.
• Parts must be labeled and stored in a way that will prevent mixups between medical device and non-medical device parts.
• All employees who submit purchase orders, receive parts, inspect parts, inventory parts, must be trained to the medical device procedures relevant to their activities.

Sounds like you just need to create some dividing lines to distinguish medical and non-medical items.

Thanks
That sounds easier than I thought
appreciate the help

 

[Manto]

Looking for a consultant to help me figure out what I need to accomplish to get certified in a years time. I have some documents in place but need to find someone that can help me with getting management on board. any recommendations?

 

[indubioush]

Looking for a consultant to help me figure out what I need to accomplish to get certified in a years time. I have some documents in place but need to find someone that can help me with getting management on board. any recommendations?

I maybe can help you out by creating the remaining quality system documents. However, getting management on board is another issue. If your management seems apathetic about having a quality system, I can provide a training/educational session; however, that is no guarantee they will provide you support after that.

 

[Manto]

I maybe can help you out by creating the remaining quality system documents. However, getting management on board is another issue. If your management seems apathetic about having a quality system, I can provide a training/educational session; however, that is no guarantee they will provide you support after that.

Could you send me a quote? I need it for corporate.

 

[indubioush]

I need some further information. I'll send you a direct message.

 

[indubioush]

Looks like I am unable to send direct messages at this time. This is odd because I have been a member of this forum for a long time. I'm hoping this gets resolved soon. I send an error request.

If you can send me a private message, please do so. Can you tell me where you are located, how large the company is, whether you have a design history file, the product development stage you are in, and the type of device(s) you manufacture. Thanks!