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Where to document Quality Objectives

A

AliceW

#1
Where is the best place to document the Quality Objectives required by ISO13485? As an appendix to the Quality Manual or in a separate independent document - is there a typical way to document them accross the medical device industry?

Thanks for any help

Alice
 
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qusys

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#2
Re: Quality Objectives - where to document them

Where is the best place to document the Quality Objectives required by ISO13485? As an appendix to the Quality Manual or in a separate independent document - is there a typical way to document them accross the medical device industry?

Thanks for any help

Alice
The choice should be beneficial and usefull for the entire organization.
For example, consider also the local intranet network . Besides , to make deployment and foster the awareness of the organization, organize training and /or team meeting with top mgmt representative, use bulletin board and email to have them known and well explained, so that personnel can be involved and understand how they contribute in the accomplishment.:bigwave:
 

somashekar

Staff member
Super Moderator
#3
Re: Quality Objectives - where to document them

Where is the best place to document the Quality Objectives required by ISO13485? As an appendix to the Quality Manual or in a separate independent document - is there a typical way to document them accross the medical device industry?

Thanks for any help

Alice
Hi Alice...
It is best to your convenience. Keep it prominent and visible.
Remember that it is the top management that has to establish quality objectives at relevant areas. If you are establishing it, ensure that the same has been recorded in the management review and has management decision.
As you have got to make a measure of the set objective, and see if you are meeting it., it is best to have it put up on your area notice board.
There is no typical way and what suits you best is best for you. Let it not get hidden in paper files or computer files...
 
K

kgott

#4
Re: Quality Objectives - where to document them

Hi Alice...

Remember that it is the top management that has to establish quality objectives at relevant areas. If you are establishing it, ensure that the same has been recorded in the management review and has management decision.
Somashekar; I like your idea of getting objectives I myself write; endorsed by management in some way. My position is not considered of sufficient status to attend the management group meetings so the best I'm lilkey to get is a return email from the MD saying they are ok, if I even get that.

How might I get some kind of management ensdorsement of objectives I write so that I can publicise them on the intranet, particualry those I have developed for the quality system.

We are a company of about 100 people.

thanks -k
 
H

HotRodHon

#5
Re: Quality Objectives - where to document them

Another good place is the Management Review. The Objectives should be fluid and updated regularly.
 

somashekar

Staff member
Super Moderator
#6
Re: Quality Objectives - where to document them

Another good place is the Management Review. The Objectives should be fluid and updated regularly.
An objective is a set target to be met within set time. Within this time the trending towards objective is regularly (defined review periods spanning the time to meet objective) reviewed. Within this time the objective should not be fluid.
Whatever the defined review period (day /week / fortnight / month), I would say the updation to be periodically rather than regularly.
 

somashekar

Staff member
Super Moderator
#7
Re: Quality Objectives - where to document them

Somashekar; I like your idea of getting objectives I myself write; endorsed by management in some way. My position is not considered of sufficient status to attend the management group meetings so the best I'm lilkey to get is a return email from the MD saying they are ok, if I even get that.

How might I get some kind of management ensdorsement of objectives I write so that I can publicise them on the intranet, particualry those I have developed for the quality system.

We are a company of about 100 people.

thanks -k
I would use the organization hierarchy to reach the objective to the top management. This way the objective that is picked may also get some refinement.
Be very clear in explaining how your selected objective, when met, also falls in line with meeting the quality policy that is established.
Give some work to top management ... :cool:
 
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