ISO 13485 7.4.2 - Purchasing Information - Qualification of Personnel

R

rick poole

#1
Hi All,

just after a little help on ISO 13485 (7.4.2) Purchasing Information.

the clause says:-

Purchasing Information shall describe the product to be purchased, including where appropriate

b) Requirements for qualification of personnel.......

what does this mean?

any help would be appreciated.

TIA
 
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Doug Tropf

Quite Involved in Discussions
#2
Re: ISO 13485 7.4.2 - Purchasing Information - Qualification of Personel

ISO 14969 offers this relative example:

"When cleaning operations in environmentally controlled areas are carried out by a supplier, a written contract specifying the limits of responsibility of the organization and the supplier should be considered in order that product is not contaminated by cleaning agents or personnel, or that areas are left uncleaned due to oversight. This contract should include details of the documented cleaning procedure and specify the training to be given to cleaning staff."
 
R

rick poole

#3
Re: ISO 13485 7.4.2 - Purchasing Information - Qualification of Personel

Many thanks for that Doug, i managed to find a good article on this clause on the cove website.


*Thread deleted* (hope this link works) (thread topic 15823 - hope people can find the discussion from this number?)

i think this discussion solves my little problem.

many thanks.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#4
Hi All,

just after a little help on ISO 13485 (7.4.2) Purchasing Information.

the clause says:-

Purchasing Information shall describe the product to be purchased, including where appropriate

b) Requirements for qualification of personnel.......

what does this mean?

any help would be appreciated.

TIA
Just in case, the clause relates to purchasing of services. The classic example is hiring consultants. You must qualify the that the consultants are qualified.
 
R

rick poole

#5
Hi Steve,
thanks for that. how come it means only services? i dont see anywhere that states services only?
it does sound logical for consultants etc, but how about welding services? welding specs? or calibration services? UKAS acredited?, assembly? time served? etc?
 

Statistical Steven

Statistician
Staff member
Super Moderator
#6
Hi Steve,
thanks for that. how come it means only services? i dont see anywhere that states services only?
it does sound logical for consultants etc, but how about welding services? welding specs? or calibration services? UKAS acredited?, assembly? time served? etc?
It appplies to all those situations. Basically, it is a statement about your suppliers must be competent in the goods and services they supply.
 
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