Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers

#1
We are an automotive manufacturer certified to IATF 16949 and also ISO 9001 with the same automotive products scope. Recently, we have got potential customers wants to manufacture non-automotive according to ISO 9001. We don't want to apply automotive IATF 16949 requirements for non-automotive products, please I am having the following questions:
1- Can we have 2 different scopes, IATF 16949 for automotive products and ISO 9001 for automotive and non-automotive products?
2- Shall this require 2 separate external audits, one for automotive IATF 16949 products and the other for ISO 9001 non-automotive products?
3- Our QMS documentation is built according to IATF 16949, do we need to update every procedure to differentiate between ISO 9001 and IATF 16949 requirements? Can we prepare an ISO 9001 Matrix for all current IATF 16949 QMS procedures and highlight what is not applicable for ISO 9001?

Please advise with other ideas or best practice

Thanks
 
Elsmar Forum Sponsor

John C. Abnet

Teacher, sensei, kennari
#2
1- Yes.
2- Check with your registrar for details regarding how they will handle it
3- Your organization's procedures (I hope) are written for your organization and the policies/activities defined within. (e. the corporate intent for how your organization is to act and perform.) They should not be written for an auditor or even necessarily for a specific "standard" . I can't imagine a procedure or policy that you would have (should have) that would need to be changed, however, only you and your organization know what those procedures and policies state, so only you and your organization can make that determination.

Hope this helps.
Be well (and stay safe)
 

Golfman25

Trusted Information Resource
#4
Keep as much the same as possible. Most things won't make a difference, such as preventive maintenance. Where you can use less stringent ISO requirements, do so. For example, the standards have different requirements for suppliers and their development. Break them into two groups where necessary -- automotive and non-automotive.

In our experience, you won't have two separate audits. You'll generally have extra time added to audit on non-IATF products and processes.
 
#5
Thanks Golfman25, I have already started analyzing ISO 9001 requirements versus IATF 16949 and prepared a list not required processes and company system process like preventative maintenance, ERP (common software), Supplier evaluation (common software), etc. Now, I think the best way is to go through every SOP and decide either to update for non-automotive or deploy the system for both.
Your comment about adding extra audit time is clear, please if you can advise regarding
Thank you very much
 

Golfman25

Trusted Information Resource
#6
Thanks Golfman25, I have already started analyzing ISO 9001 requirements versus IATF 16949 and prepared a list not required processes and company system process like preventative maintenance, ERP (common software), Supplier evaluation (common software), etc. Now, I think the best way is to go through every SOP and decide either to update for non-automotive or deploy the system for both.
Your comment about adding extra audit time is clear, please if you can advise regarding
Thank you very much
In the past, my registrar would add a 1/2 day to our audit to handle none IATF (TS at the time) products. That's where you'll see the biggest difference. ISO is much more flexible in the production related docs you need -- ie; ppap, control plans, etc.
 
Thread starter Similar threads Forum Replies Date
J Scope of 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
G APQP Scope and scale tool APQP and PPAP 2
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
C IATF 16949 - Scope or not? IATF 16949 - Automotive Quality Systems Standard 2
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
Q To raise a NC beyond the audit scope? Two signatures were missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 2
D Scope of Facility - Our auditor asked us last week for our "Scope of the Facility" AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 12
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
F API Spec Q1 Scope - Limiting the scope of certification Oil and Gas Industry Standards and Regulations 3
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 9
Q ISO 9001:2015 8.5.1 f - Scope with customer special process requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
F Information Technology in IATF 16949 audit scope IATF 16949 - Automotive Quality Systems Standard 12
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
S Regulatory Certification Exam (RAC) - Global Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
P Injection Molding Machine Validation Scope Capability, Accuracy and Stability - Processes, Machines, etc. 6
S ISO 9001:2015 - Scope of Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
T Restricting scope of AS9100 certification to a couple of customers AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A AS9120 External Provider Registry Scope of Approvals AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
K CQI-23 Molding System Assessment Scope IATF 16949 - Automotive Quality Systems Standard 3
F Definition Commercial Distribution - Definition - Scope of Commercial Distribution Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J AS9100 - Working Outside of Scope of Certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
M Service Industry - Scope of the QMS & Scope of Certification Service Industry Specific Topics 13
Similar threads


















































Top Bottom