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​ Site Web ​ ISO/IEC 17025 Clause 6.6.3.c

The solution ?

According to me, this clause is not always relevant BUT it is mandatory. So, how to get rid of it ?

Let's take the purchase of a chemical reagent. How can I communicate the compertence required ?

If, in your process of selecting a provider, you look for certified provider, it could do the job as competnece and training of peaople are part of the ISO 9001.

If the provider is not certified, than check a little bit more the quality of the reagent before and during use. Always specify in details what you buy from a provider (eg the purity).

If you buy a service like a calibration and are lucky enough, the provider is accredited, the job is done as competences are covered by norms like ISO/IEC 17025, 17043, 17034. Beware that I hears auditors saying "this is not enough", even if the supplier is accredited, you have to specify the competence and qualification criteria... They probably forgot what the ISO 17xxx series are about no ?

If the provider is not accredited, it is more complicated (according to me). If you buy a service, one reason is that you cannot perform the service yourself (within your lab). In that case, how do you know the required competences and required qualification in order to properly do the job ?

If you buy a more general service, like maintenance of an equipment, then, it could be good to have a contract with some competence specifications. I really had trouble in my own lab with the maintenance of equipments like LC-MS-MS not performed by the right person.

So, some tips (not sure that all auditors will accept) :

- add that point in the risk identification system in order to explain that you do not always specify competence and qualification (reagents with enough details on the purchase order, calibration servives by an accredited organism, again specify this on the purchase order).

- in your documentation, specify that you fulfill this requirement "whenever necessary"

- why not, create some general conditions of purchase, specifiyng that, for all purchase of products and services, the provider must ensure that the personnel is competent and have the required qualification. It is a little bit poaching but why not ?

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