Question on Purchasing clause 7.4.1 of ISO 9001

A

AmyFTP

#1
Hello All,

I'm hoping I can get some clarification on the Purchasing section of ISO 9001:2008. Clause 7.4.1 Purchasing Process
The organization shall ensure that the purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

So this is where I get confused. :confused: We purchase raw material (aluminum ingots) and component parts and all of this goes into our finished product so I understand that these items fall under that clause since they affect final product but I was told that the company that calibrates our gauges, or the company that services our tow motors for us would also fall under this clause. Is that true? Im really trying to understand this ISO stuff but Im still getting stuck on some clauses. If anybody could offer some help-I truly would appreciate it. :thanx:
 
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A

AmyFTP

#2
I posted the original question. I guess what I'm really asking is we have strict controls placed on raw materials and outsourced processes such as the company that does heat treating to our parts. Heres where the problem comes--I had an auditor tell me that the company that services our tow motors and cranes fall under the same category as the company that heat treats our parts. I am having a very hard time processing that. I understand that we have to have control over those services but I don't consider them to be in the same catergory so therefore they don't need as strict controls over them. Any help is appreciated
 

yodon

Staff member
Super Moderator
#3
Maybe by "category" your auditor just meant purchased services? How do you know that your calibration service provider is properly calibrating the equipment? Are they using equipment traceable to NIST standards? Are they accredited to 17025? Do you get "as received" results? Do you require them to be?

It's up to you to determine the qualifications for service providers (and up to you to confirm that they meet the qualifications). The bigger the potential impact to quality or safety or business (risks), the more controls should be applied.
 

somashekar

Staff member
Admin
#4
I posted the original question. I guess what I'm really asking is we have strict controls placed on raw materials and outsourced processes such as the company that does heat treating to our parts. Heres where the problem comes--I had an auditor tell me that the company that services our tow motors and cranes fall under the same category as the company that heat treats our parts. I am having a very hard time processing that. I understand that we have to have control over those services but I don't consider them to be in the same catergory so therefore they don't need as strict controls over them. Any help is appreciated
What goes into the finished product or what treatment is done on the finished product, are effects on the final product directly.
Services like the servicing of your tow motors and cranes may have some effect on your QMS support services which can have a bearing on the final product in terms of deliver of final product or handling and movement of the final product (in other words product realization)
Now read the below and see the highlighted .... Can you see what the auditor was coming to ~~~
The organization shall ensure that the purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
Do not think on lines of strict controls or casual approach. Look for type and extent of controls depending upon the effects.
 
Last edited:

Helmut Jilling

Auditor / Consultant
#5
I posted the original question. I guess what I'm really asking is we have strict controls placed on raw materials and outsourced processes such as the company that does heat treating to our parts. Heres where the problem comes--I had an auditor tell me that the company that services our tow motors and cranes fall under the same category as the company that heat treats our parts. I am having a very hard time processing that. I understand that we have to have control over those services but I don't consider them to be in the same catergory so therefore they don't need as strict controls over them. Any help is appreciated
No, your concern is correct, and your auditor is over-reaching. Yes, your forklift is important, and where you buy your coffee supplies is important, and your lunch deli order....but the standard is focused on product, materials and services that directly affect the product.
 

Mark Meer

Trusted Information Resource
#6
I think the confusion is the specific use of the term "product", which should be read as "product and services".

Basically any supplier of a product or service that can affect your product/service should be considered.

Is transportation critical (e.g. special conditions required)?
Contract sterilization?
Calibration or test-labs affect verification and quality?
These are all examples of suppliers of services that would be considered...

It is up to you to define the supplier requirements (whether a product or service), and assess the potential impact on quality/safety and set appropriate controls, evaluation requirements... accordingly.

Yodon gives good considerations for calibration lab requirements in post #3.
 

Mikishots

Trusted Information Resource
#7
Hello All,

I'm hoping I can get some clarification on the Purchasing section of ISO 9001:2008. Clause 7.4.1 Purchasing Process
The organization shall ensure that the purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

So this is where I get confused. :confused: We purchase raw material (aluminum ingots) and component parts and all of this goes into our finished product so I understand that these items fall under that clause since they affect final product but I was told that the company that calibrates our gauges, or the company that services our tow motors for us would also fall under this clause. Is that true? Im really trying to understand this ISO stuff but Im still getting stuck on some clauses. If anybody could offer some help-I truly would appreciate it. :thanx:
My take on 7.4.1:

Make sure that the purchased product OR PURCHASED SERVICE meets your expectations. Adjust the amount of control you apply, based on how critical both the Supplier, and the product OR SERVICE they supply, are to your final process output.

Define how you go about selecting who you buy from, how you measure or evaluate their performance initially and how you'll be keeping tabs on them on an on-going basis. Keep records of those evaluations.

Since purchased services are included in the subclause, they must be controlled in the same way that products are. Which are critical? Which are non-critical? Start by listing the services you buy and group them based on their impact on your business or customers. ISP's, Shipping and contract maintenance might be considered critical, whereas office cleaning isn't.

So yes...it's true.


Sound OK?
 

somashekar

Staff member
Admin
#8
No, your concern is correct, and your auditor is over-reaching. Yes, your forklift is important, and where you buy your coffee supplies is important, and your lunch deli order....but the standard is focused on product, materials and services that directly affect the product.
Form where in the standard was this inferred sir, that you underlined ...
 
#9
"The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product."

The main thing I get from this is that there is no "one size fits all" for purchasing controls, to either supplier controls or product/service controls.

The level of control needed is whatever you as an organization determines to provide effective control.

Flaky suppliers need closer scrutiny, and critical or somewhat unstable products need closer scrutiny.

You determine and apply the level of scrutiny needed to mitigate risk to a manageable level.
 
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