Developing the Risk Management Plan - Risk Management Policy and Objectives

Dear MatesS,

I am now developing the Risk Managment Plan.

Is there any examples of Risk Management Policy?

Is it mandatory to develop the Risk Management Objectives and how does it look like?

Tiff

Re: Risk Management Policy and Objectives

Tiffany,

ISO 13485 (7.1) has:

The organization shall establish documented requirements for risk management throughout product realization.
Records arising from risk management shall be maintained (see 4.2.4).

Recently audited and this was something that got picked up on i.e. the part about "throughout product realization" - not just a risk assessment on the product but at each stage of development. To back this up I do have a policy which you might find useful (see attached).

Steve

Re: Risk Management Policy and Objectives

Hi Steve,

Thanks for the sharing here.

According to the ISO 13485, the Quality Objectives shall be measurable. Is that having the same application for Risk Management Objectives as it must be measurable as well?

Tiff

Re: Risk Management Policy and Objectives

Hi Tiff,

I am still pondering this very matter post-audit. I think it is the recording part (which will be a measure) which is important. If you have not done so already, check out SG3/N15R8 " Implementation of risk manement principles and activities within a QMS" at the GHTF website.

Steve

Re: Risk Management Policy and Objectives

SteveK said:

Tiffany,

ISO 13485 (7.1) has:

The organization shall establish documented requirements for risk management throughout product realization.
Records arising from risk management shall be maintained (see 4.2.4).

Recently audited and this was something that got picked up on i.e. the part about "throughout product realization" - not just a risk assessment on the product but at each stage of development. To back this up I do have a policy which you might find useful (see attached).

Steve

Click to expand...

your attached file is not opening.
V.J.Brahmaiah

Re: Risk Management Policy and Objectives

brahmaiah said:

your attached file is not opening.

Click to expand...

Just a quick note: I was able to open it. Any particular error messages?

/Claes

Re: Risk Management Policy and Objectives

When I try to open the file I receive a message:"There is an error. this file is not found". It has happened twice.
V.J.BRAHMAIAH

Re: Risk Management Policy and Objectives

brahmaiah said:

When I try to open the file I recieve a message:"There is an error. this file is not found"iIt has happened twice.
V.J.BRAHMAIAH

Click to expand...

Hi VJ,

I think it must be a problem at your end - maybe you should try downloading a recent version of the Adobe software.

Steve

Re: Risk Management Policy and Objectives

brahmaiah said:

"There is an error. this file is not found"

Click to expand...

Ok... I see nothing wrong in your profile, and nobody else has reported the same problem. Steve may well be right. Could you try his advice and see if it helps?

/Claes

Re: Risk Management Policy and Objectives

Thank you ,The problem was at my end.I have now sorted it.
V.J.Brahmaiah