Developing the Risk Management Plan - Risk Management Policy and Objectives

T

Tiffany

#1
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 :thanx:
 
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S

SteveK

#2
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
 

Attachments

T

Tiffany

#3
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 :thanx:
 
S

SteveK

#4
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
 
B

brahmaiah

#5
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
your attached file is not opening.
V.J.Brahmaiah
 
B

brahmaiah

#7
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
 
B

brahmaiah

#10
Re: Risk Management Policy and Objectives

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