Does the ISO/TS 16949 scope have to include all processes, even if outsourced?

E

ed82610

#1
We are going to start to make our products in the manufacturing company. That company has ISO/TS certification.
Does our scope have to include that company? or just enough to control with 7.4 (excluded our scope)?
 
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T

tbsiva

#2
Re: Does the TS Scope have to include all manufacturing processes, even if outsourced

Can you elaborate the situation a bit please??
 
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qusys

Trusted Information Resource
#3
Re: Does the TS Scope have to include all manufacturing processes, even if outsourced

We are going to start to make our products in the manufacturing company. That company has ISO/TS certification.
Does our scope have to include that company? or just enough to control with 7.4 (excluded our scope)?

Please, give us more detail.
At first glance, I have understood that you are not ISO TS certified but you give productionto another mfg site that has ISO TS certification. Right?
 
E

ed82610

#4
Re: Does the TS Scope have to include all manufacturing processes, even if outsourced

thank you for your replys ,qusys and tbsyba.
I'll explain more detail.

we have iso/ts16949 certification. our scope include all of requirement of ts. so, our company has manufacturing prosess.
recently,we need more capacity of manufacturing. so we are going to start to deal with manufacturing company which has ts certification.
i remember that QS9000 required all manufacuturing process in the scope. not outsource.(this is true or not?) this is why i posted the question.

do you understand our situation?
pls give me some advice.
 

Stijloor

Staff member
Super Moderator
#5
Re: Does the TS Scope have to include all manufacturing processes, even if outsourced

thank you for your replys ,qusys and tbsyba.
I'll explain more detail.

we have iso/ts16949 certification. our scope include all of requirement of ts. so, our company has manufacturing prosess.
recently, we need more capacity of manufacturing. so we are going to start to deal with manufacturing company which has ts certification.
i remember that QS9000 required all manufacuturing process in the scope. not outsource.(this is true or not?) this is why i posted the question.

do you understand our situation?
pls give me some advice.
Here is your answer:

From ISO/TS 16949:

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.

NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.

NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as

a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,

b) the degree to which the control for the process is shared,

c) the capability of achieving the necessary control through the application of 7.4.
 

qusys

Trusted Information Resource
#6
Re: Does the TS Scope have to include all manufacturing processes, even if outsourced

thank you for your replys ,qusys and tbsyba.
I'll explain more detail.

we have iso/ts16949 certification. our scope include all of requirement of ts. so, our company has manufacturing prosess.
recently,we need more capacity of manufacturing. so we are going to start to deal with manufacturing company which has ts certification.
i remember that QS9000 required all manufacuturing process in the scope. not outsource.(this is true or not?) this is why i posted the question.

do you understand our situation?
pls give me some advice.
Hi,
I have read the response now.
I agree with Stijloor.

This is the case of the outsourcing.
I have understood that you rely on another fab that is ISO TS certified too.
In my opinion it is important to have in place the contract with them given that you will provide them the product design, I believe.
In this case it is important APQP and PPAP.
Hope this helps:bigwave:
 
E

ed82610

#7
stijloor,qusys Thank you for your advice.

I understand that this case should be the outsourcing. Our contract have a clous of ISO/TS certification. We request fab to have the TS certification. But not mentioned about APQP or PPAP.
We are going to discus about a clous of APQP and PPAP.

best regards:)
 

howste

Thaumaturge
Super Moderator
#8
stijloor,qusys Thank you for your advice.

I understand that this case should be the outsourcing. Our contract have a clous of ISO/TS certification. We request fab to have the TS certification. But not mentioned about APQP or PPAP.
We are going to discus about a clous of APQP and PPAP.

best regards:)
Here's the answer for PPAP:
TS 16949:2009 said:
7.3.6.3 Product approval process

The organization shall conform to a product and manufacturing process approval procedure recognized by the customer.

NOTE Product approval should be subsequent to the verification of the manufacturing process.

This product and manufacturing process approval procedure shall also be applied to suppliers.
 
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