Do non-IATF customers need to be included in audit scope?

Dan M

Involved In Discussions
#1
Hi,
We have an automotive customer. The fluid we produce ends up on the vehicle. However, the customer does not require suppliers to be certified to IATF 16949. In fact, the Customer's supplier quality manual only states ISO 9001 as a supplier requirement. In audit planning, our CB asks us to list the customer and products. Do we need to include this customer in the scope of our IATF audit? Some background: not all of the customers and products we manufacture are automotive, so we have many customers and products that are not relevant to the IATF audit. Thanks.
 
Elsmar Forum Sponsor

Golfman25

Trusted Information Resource
#2
You have the nightmare scenario. Technically, all automotive customers whether they subscribe to IATF or not are supposed to be included. So yes, you need to include that customer. But you also have the situation where some products are non-automotive. You'll need to identify what is and what isn't automotive. Otherwise, you'll be stuck dealing with auto requirements on products that don't need them. Good luck.
 

Pau Calvo

Starting to get Involved
#3
If you are IATF certified it means that your quality system must be compliance, therefore all your products must be indeed IATF compliance. If that is not the case you might have issues with the ISO9001 since you are not compliance with your own system for the non-auto products.
It is important to not mix product requeriment with system requeriments, IATF is system requirement.
An other thing is that your IATF audit scope only should target auto products.
 

Golfman25

Trusted Information Resource
#4
If you are IATF certified it means that your quality system must be compliance, therefore all your products must be indeed IATF compliance. If that is not the case you might have issues with the ISO9001 since you are not compliance with your own system for the non-auto products.
It is important to not mix product requeriment with system requeriments, IATF is system requirement.
An other thing is that your IATF audit scope only should target auto products.
I am not sure what you are trying to say here. IATF doesn't apply to non-auto products. So for example, you can have different ISO auditors vs. IATF auditors which require more qualifications as laid out in the standard.
 

Pau Calvo

Starting to get Involved
#5
My comment was a bit off-topic.

What I want to say is that if your quality system is IATF and you do not apply it for non-automotive parts that can lead to a non-conformity in a ISO 9001 audit for the non-automotive parts since you are not respecting your own quality system.
Therefore your non-automotive parts will have same system requeriments than your automotive parts.

Regarding the question of the OP if your product is applied to automotive industry and you have to go through an IATF audit you must include the customer. The auditor must target only the references related to automotive industry.
 

Golfman25

Trusted Information Resource
#6
My comment was a bit off-topic.

What I want to say is that if your quality system is IATF and you do not apply it for non-automotive parts that can lead to a non-conformity in a ISO 9001 audit for the non-automotive parts since you are not respecting your own quality system.
Therefore your non-automotive parts will have same system requeriments than your automotive parts.

Regarding the question of the OP if your product is applied to automotive industry and you have to go through an IATF audit you must include the customer. The auditor must target only the references related to automotive industry.
There are some things that over lap and make sense to apply to both automotive and non-automotive. However there are a lot of areas where automotive requirements are overkill. So we make exceptions for those. Auto is handled one way and non-auto can be handled with less stringent requirements. PPAP process and the AIAG books (which are usually required by CSRs) is one area for example.
 

Ron Rompen

Trusted Information Resource
#7
My own personal experience with this has taught me that (in the end) it is easier to have ONE quality management system which is applied to ALL products, no matter who/what the customer is. If you try and differentiate between two product types (one IATF, one not) then you will invariably end up with some employees working under the wrong system for the wrong parts. Much simpler to have it all the same.
 

Golfman25

Trusted Information Resource
#8
My own personal experience with this has taught me that (in the end) it is easier to have ONE quality management system which is applied to ALL products, no matter who/what the customer is. If you try and differentiate between two product types (one IATF, one not) then you will invariably end up with some employees working under the wrong system for the wrong parts. Much simpler to have it all the same.
So IATF essentially requires ISO certified suppliers with plans to get to IATF. ISO requires no such thing. Would you use ISO suppliers on products where you're better off with those that choose not to go ISO (ie: one/two man shops -- who offer better cost, delivery and quality)? I would say, no. You're procedures should contain exceptions for non-auto products.
 

Pau Calvo

Starting to get Involved
#9
So IATF essentially requires ISO certified suppliers with plans to get to IATF. ISO requires no such thing. Would you use ISO suppliers on products where you're better off with those that choose not to go ISO (ie: one/two man shops -- who offer better cost, delivery and quality)? I would say, no. You're procedures should contain exceptions for non-auto products.
I totally agree with you in that point, but you can use a QAA to address that point is no need to have the IATF certification requeriment for suppliers in your procedure. In my opinion procedures should be much more generalistics.
 

Golfman25

Trusted Information Resource
#10
I totally agree with you in that point, but you can use a QAA to address that point is no need to have the IATF certification requeriment for suppliers in your procedure. In my opinion procedures should be much more generalistics.
Then you're essentially running under two systems.
 
Thread starter Similar threads Forum Replies Date
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Crimpshrine13 IATF 16949 Audits to include Processes and Products from Non Subscribing Customers IATF 16949 - Automotive Quality Systems Standard 20
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
C Fact or fiction - Repeat minor becomes a major IATF non-conformance IATF 16949 - Automotive Quality Systems Standard 7
P IATF 16949 Clause 8.4.2.3 - Justification for non-certified suppliers IATF 16949 - Automotive Quality Systems Standard 12
P Are red non-conformance bins required anywhere in the ISO or IATF standards? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A IATF 16949 - Non-conformity on 5.1.1.2 Process effectiveness and efficiency IATF 16949 - Automotive Quality Systems Standard 5
M IATF 16949 - Capability study on non critical dimensions? Statistical Analysis Tools, Techniques and SPC 4
B IATF 16949: Definition Major/Minor Non-conformity IATF 16949 - Automotive Quality Systems Standard 6
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 4
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
N Competent Authority notification for non-EU manufacturer EU Medical Device Regulations 4
M CE marking for NON-EU EU Medical Device Regulations 0
E Non-GMP examples in Pharmaceutical industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
blile Increasing PFMEA occurrence ranking after non-conformance FMEA and Control Plans 4
S Non-Conformance and Deviations ISO 13485:2016 - Medical Device Quality Management Systems 4
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
C If it doesn't prevent a non-conformance, is it a preventive action? IATF 16949 - Automotive Quality Systems Standard 13
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Non-Conformance vs OFI -- your best descriptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 61
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
J Medical System with non-medical device and FCC US Food and Drug Administration (FDA) 5
L PMA and Non-PMA parts in same finished goods area? Federal Aviation Administration (FAA) Standards and Requirements 1
W Non-Conformance from recent Audit carried out on Purchasing AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
D Do purchasing controls apply to non-medical parts? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Service record requirements for Non-Serviceable Medical Devices CE Marking (Conformité Européene) / CB Scheme 1
S Industry Labelling Standards - non medical Manufacturing and Related Processes 0
B Using non CE parts in a machine CE Marking (Conformité Européene) / CB Scheme 1
B To detect the non standard variable IATF 16949 - Automotive Quality Systems Standard 5
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
K Relying on mitigations implemented in non-medical device IEC 62304 - Medical Device Software Life Cycle Processes 5
M What to do about Non Conformance forms that are deleted or missing? Nonconformance and Corrective Action 4
Marc A 20 Hour Non-Stop Flight - (October 2019) Travel - Hotels, Motels, Planes and Trains 19
C On spontaneous but non-standard rankings FMEA and Control Plans 3
N Non traumatic edge - Remark in some of my company drawings EU Medical Device Regulations 1
Q Internal Audits - Categories of non conformances Internal Auditing 12
C Neglect or legitimate deferral? Is excessive workload or lack of resources in a department or a team a valid root cause for a non-conformance? Problem Solving, Root Cause Fault and Failure Analysis 12
D Standard guide for shelf life determination of non sterile component with degradation materials Reliability Analysis - Predictions, Testing and Standards 1
S What's meant by ISO9001 clause 8.7 non conforming output? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1
Ed Panek Are audit non conformances also risk based? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Similar threads


















































Top Bottom