Should Quality System scope cover non-medical devices?

[s.parakos]

Hi,

We currently manufacture one Medical Device which we are constantly improving, and plan to introduce more, hence we have implemented a quality system based on ISO13485.
We also manufacture a number of other similar devices for (much lower risk) non-medical industries.

My question is for people involved in similar companies - how do you implement your quality system? Do you segregate it and only apply it to Medical Devices or does it cover all of the devices you manufacture? Maybe you have restructured your company?

We are finding it quite onerous to apply the full quality system to all our products and would preferably like to apply it just to our medical devices. However this becomes quite complicated (having different procedures and processes for different products) and I have heard the Auditors don't particularly like it.

If anybody has any comments on how they have structured things they would be much appreciated.

thanks
Simon

 

[harry]

Hi Simon,

Simply put, ISO 9001 + Medical Sector Specific Requirements - Continuous improvement Element = ISO 13485. Certainly ISO 9001 is simpler than ISO 13485 and thats why I cannot understand why you would want the system (ISO 13485) to cover all your products.

I think dual certification is the way to go. ISO 9001 for non medical parts or products and ISO 13485 for the medical ones.

See this recent discussion: Questions about upgrading from ISO 9001 to ISO 13485 or do I have both?

 

[DannyK]

I agree with Harry. ISO 13485 was established to deal with medical devices. I am sure your registrar can perform an ISO 9001 audit at the same time.

The auditor's job is to audit against the scope. If your non medical devices are not part of the scope, he cannot audit that section.

 

[Ajit Basrur]

...... My question is for people involved in similar companies - how do you implement your quality system? Do you segregate it and only apply it to Medical Devices or does it cover all of the devices you manufacture? Maybe you have restructured your company? .......

Agree with the previous responses. The ISO 13485 should be applied only for medical devices and can use the ISO 9001 systems for non medical.

As a system, try to look for common issues and address them jointly - the classic being those minimum 6 procedures required per ISO 9001. Similarly there are other requirements like Technical File or Device History Record (DHR) that are unique for medical devices. These need not be applied for non medical parts.

For some instances like Process Validation, Equipment Qualification, the degree or the depth of the study could be varied between medical and non medical.

Some organizations have personnel dedicated for medical and non medical so that the training could be effectively imparted.

This becomes an interesting and challenging mix within the organization's QMS. Not difficult though