Approved Suppliers - ISO 13485 Normal Supplier Qualification Process Requirements

P

pangchiaboon

#1
Dear Sirs,

We always talk about "approved supplier".
As what i understand from ISO 13485, we just need to focus on suppliers that supply products that can affect our product quality.

Do you think we need to use the formal supplier qualification process to approve suppliers that supply pump / motor / accesories / spare part that has no direct impact to the product quality? What is the right practice?

Please share. Thanks.
 
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K

keres

#2
Re: Approve supplier

If you need pump / motor / accessories / spare part to repair your machines to complete an order in contracted terms the quality of product would be affected.
 
P

pangchiaboon

#3
Re: Approve supplier

Thanks Keres.
Let's use a clearer example. Let say we use CNC machine to produce product that customer want from us. One day the machine brokedown, and we need to call some body from outside to repair the machine. Do you think this supplier is compulsory to be approved under formal supplier approval process before we can ask for their service?
 
K

keres

#4
Re: Approve supplier

One supplier may be approved AFTER reparation of the machine. You can't evaluate one supplier without you know about its job.
 
P

pangchiaboon

#5
Re: Approve supplier

That means your view is compulsory to formally approve this supplier, in this case should be after the service. Thanks.

How about other opinion / experience from other experts?
 

qusys

Trusted Information Resource
#6
Re: Approve supplier

That means your view is compulsory to formally approve this supplier, in this case should be after the service. Thanks.

How about other opinion / experience from other experts?
Hi,
welcome on the forum.
I would say that you shall have a process in place with clear criteria to follow.
You shall establish who are the suppliers critical to you and with what rules.
For istance if you have an approved list of suppliers ( that is not mandatory document as per ISO standards, but you have established to have for your internal documented procedures, so in this sense it is mandatory), you shall acquire services, parts and materials only from them. This implies that you shall have a process of suppliers qualification to enter into that list, and not after being providing with a service. This could be a non conformity from quality system standpoint.
Consider that the type and the extent of the control on the the supplier depend on the effect on the quality of the realized product as per ISO 9001.
There is no unique or right response. To meet the intent of the clause you shall set the process and your criteria based upon the product you supply and meet the customer requirements:bigwave:
 
Last edited:

somashekar

Staff member
Super Moderator
#7
Re: Approve supplier

That means your view is compulsory to formally approve this supplier, in this case should be after the service. Thanks.

How about other opinion / experience from other experts?
Formal supplier qualification process is more of a need to be assured of good products and services irrespective of an ISO13485 or ISO9001. It is a common sense good purchasing practice.
Now coming into ISO13485, major part of what is said is also said in ISO 9001.
Look at this section in 7.4.1:
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.
You have the freedom to establish the criteria based on the merit of your requirements.
Hence it is not about all or none. It is about need vs availability.
Approvals can be as simple as necessary to as in depth as the product and organizations requires.
One needs to make a good technical, logical, commercial, approval decision.
 

yodon

Staff member
Super Moderator
#8
Re: Approve supplier

A couple of quick points using your CNC example.

1) How do you know the person (or company) is capable of repairing the machine without doing some sort of supplier assessment?

2) I presume you'll re-validate the equipment after the repair (won't you?)? That, to some degree, will mitigate the effects of the repair process but you still want to have someone that knows what they're doing lest they do more harm than good!
 
S

SilkTie

#9
Re: Approve supplier

You can divide your suppliers in groups based on the product/service they supply and what effect it has on the quality of your products/processes, e.g. level I/II/III/etc. (I've worked in an environment where we had 5 or 6 levels of suppliers, depending on bulk or custom made, sterile or non-sterile, pre-packed/pre-labelled or not, etc.).
Based on that you define requirements for supplier approval/evaluation, which points need to be addressed for which level and which not.

You are free to define your supplier levels and approve/evaluate accordingly. Of course your rationale should be properly documented.
 
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