Training and Reference Materials for ISO 14971

[SteveCt]

Hi,

I was made Quality Manager for a very small manufacturer of IVD instruments several years ago, though I have little quality experience and no formal training in quality. We manufacture instruments for several IVD OEM's, who market the instruments with their IVD kits, and have been audited by one of the OEM's several times since I became Quality Manager (with a staff of zero). I have managed to improve our Quality System to the point where the number of observations has dropped dramatically (to one in the last audit) since the first audit I was involved in.

However, we need to be compliant with ISO 14971, and after reading a lot about it, I feel that I need some formal training to be able to establish the SOP's required and to put an effective system in place, while avoiding a system that our small company does not have the resources to use or comply with. Can anyone recommend a company that provides training (preferably on site here, so that a couple of engineers and managers can participate) that could help me get better up to speed, and that is familiar with the restraints a small company has? Also, any recommendations on books that can help (preferably with sample SOP's and information on different hazard analysis techniques, such as FMEA, etc.)?

Thanks,

Steve

 

[qusys]

Re: Training for ISO 14971

Hi,

I was made Quality Manager for a very small manufacturer of IVD instruments several years ago, though I have little quality experience and no formal training in quality. We manufacture instruments for several IVD OEM's, who market the instruments with their IVD kits, and have been audited by one of the OEM's several times since I became Quality Manager (with a staff of zero). I have managed to improve our Quality System to the point where the number of observations has dropped dramatically (to one in the last audit) since the first audit I was involved in.

However, we need to be compliant with ISO 14971, and after reading a lot about it, I feel that I need some formal training to be able to establish the SOP's required and to put an effective system in place, while avoiding a system that our small company does not have the resources to use or comply with. Can anyone recommend a company that provides training (preferably on site here, so that a couple of engineers and managers can participate) that could help me get better up to speed, and that is familiar with the restraints a small company has? Also, any recommendations on books that can help (preferably with sample SOP's and information on different hazard analysis techniques, such as FMEA, etc.)?

Thanks,

Steve

For FMEA I would suggest the AIAG Manual . If you are interested , there are other guidelines manual on SPC, Control Plan, APQP, PPAP.
In those manual there are reported the recognized guidelines to apply the methodology.

 

[Jen Kirley]

Re: Training for ISO 14971

In addition to good input from qusys I wonder: are you doing internal audits? Lead Auditor is something that gets specialized training for.

ISO 14971 is a risk management standard. Do you really mean your organization is to certify to ISO 13485? Training for implementing a QMS to 13485 requirements is available from places like Kelmac Group (I have no affiliation) who also offers Lead Auditor training.

To find this group I did a Google search that produced this list to look at.

I hope this helps!

 

[SteveCt]

Re: Training for ISO 14971

Yes, we are doing internal audits. An ISO 14971 compliant risk management system is what I want to put in place. Our instruments must be certified for compliance with IEC 61010-2-101 (among other safety and EMC requirements), which I understand requires that risk analysis compliant with ISO 14971 has been done for the product being examined. Right now, we are not looking for ISO 13485 certification.

Thanks for your reply,

Steve

 

[harry]

Re: Training for ISO 14971

A paper that I think you should refer to is: Implementation of Risk Management Principles and Activities Within a Quality Management System by the GHTF.