Permitted exclusion on ISO 9001 but not on ISO/TS 16949

tony s

Information Seeker
Trusted Information Resource
#1
Currently, we have an ISO 9001 certificate from a well-known certifying body with a scope statement saying: “Manufacture of Flexible Printed Circuits…” The same scope is also indicated in our ISO 14001 and OHSAS 18001 certificates – still from the same CB. Our company here in the Philippines receives product drawings from our sister company which is based in Japan. Thus, our Philippine company is not responsible for the product design. We just manufacture them as specified in the product drawings.

However, when we opted to seek certification to ISO/TS 16949, our CB asserted that they need to audit the design function of our sister company. Is this necessary? Or a requirement by IATF?

Hope you can help out my fellow Covers.:bigwave:
 
Elsmar Forum Sponsor

Howard Atkins

Forum Administrator
Staff member
Admin
#3
Are you selling parts that are designed by the customer or by your sister company?
If they are designed by your sister company then you are selling your product and not a customer designed product.
The design of a product which is not built to your customers design must be audited as a support function.
 
M

mohamedhrr

#4
Dear Sir,

We are into manufacturing and sales of engine parts to automotive industry, hence we are going for TS16949 certification.

Since the Design & Development is done in other unit (Other Country) which is already TS Certified, what are all the clauses which can be excluded from the manual and what evidence should be shown.

Thanks
Mohamed
 
M

mohamedhrr

#5
The Product is designed by our sister company with an input data from the customer,
Our sister company is already TS certified, we are following the same design and manufacturing the product.

Thanks
 

tony s

Information Seeker
Trusted Information Resource
#6
Since the Design & Development is done in other unit (Other Country) which is already TS Certified, what are all the clauses which can be excluded from the manual and what evidence should be shown
Your company can claim exclusions on ISO/TS 16949 clauses 7.3.2.1 - Product design input; and 7.3.3.1 - Product design output. Clause 6.2.2.1 - Product design skills is also not applicable to your scope. However, clause 1.2 - Application mentions that "The only permitted exclusions ...relate to 7.3 where the organization is not responsible for product design and development."
 
Thread starter Similar threads Forum Replies Date
L Audit boundaries - Is a Registrar permitted to audit a company's QMS by visiting their suppliers? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 26
P CBs are not permitted to certify to AS9100 Rev C until 2011? True or False? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
T Small Engineering Company Certification - Are Diverse Roles permitted? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J AAR M-1003 - No design exclusions permitted Design and Development of Products and Processes 4
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
K Design and Development Exclusion Quality Management System (QMS) Manuals 1
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
P Design exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C 6.3Infrastructure & 6.4Work environnement & contamination control exclusion ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
D IATF 16949 Design Exclusion Clauses which can be N/A IATF 16949 - Automotive Quality Systems Standard 7
M Exclusion of IATF 16949 Clause 4.4.1.2 - Product Safety IATF 16949 - Automotive Quality Systems Standard 2
SATHYABALARAMAN Exclusion of IATF 16949 Clauses - 8.5.5.1 & 8.5.5.2 & Justification IATF 16949 - Automotive Quality Systems Standard 9
I ISO 9001 Scope - Exclusion of Design in an engineered solutions company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
B AS9100 - Exclusion for 7.3 Design and Developement as we do not design AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T Exclusion of 7.3 for infrastructure consulting company Service Industry Specific Topics 4
S Design and Development Procedure with Design Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Office that only manages Contracts - Exclusion of Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Can Design & Dev (7.3) Be An Exclusion For A Facilities-based Service Company? Service Industry Specific Topics 7
M TS16949 Design Exclusion when Design is done in a different Facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Crusader Service-Type Supplier Evaluation Exclusion? Supplier Quality Assurance and other Supplier Issues 12
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Justification for Exclusion of Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 8
H New Multiple Sites - Scope Change or Exclusion(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T ISO 9001 Clause 7 Exclusion in a Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A We do not design anything brand new from scratch - Design Exclusion? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Non-Conformance for Not Taking Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M 7.5.2 Exclusion in a Contract Procurement Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Consultancy company - ISO 9001 Implementation and Design Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Exclusion to Purchasing - AS9100 Clauses 7.4.1 & 7.4.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Exclusion of Medical Device Reporting of Components for Medical Systems ISO 13485:2016 - Medical Device Quality Management Systems 4
somashekar Exclusion of Design and Development Controls for Class 2B Medical Devices EU Medical Device Regulations 8
S ISO9001 Exclusion 7.6 Control of Monitoring and Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Y Clarification on ISO 9001 - Exclusion of Design and Development, Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Permissible Exclusion for Clause 7.5.2 in a Real Estate Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A ISO 9001 Clauses 7.5.1 and 7.5.2 - Exclusion for Design Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Service Provider in NC Programing and Design - Exclusion clause in AS 9100 Rev C Quality Manager and Management Related Issues 5
V Exclusion of 7.4.1 in a company that is part of a group ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Justifying Exclusion of Clause 7.3 in a Service Organization. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B ISO 13485 Class I Medical Device Design Exclusion ISO 13485:2016 - Medical Device Quality Management Systems 10
B Customer Property Exclusion as it applies to Personal Data ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Exclusion of AS9100C Clause 7.1.1 and Clause 7.1.3 for a Small Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
J Labeling Contraindication vs. Clinical Trial Exclusion Criterion Other US Medical Device Regulations 7
B Design and Development Exclusion - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 13485 Requirements - Design Exclusion - Predicate Products Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 8
somashekar Definition Exclusion vs. Non-Application - Definitions in ISO 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
C Taking an Exclusion to 7.2? Manufacturing arm is in China ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23

Similar threads

Top Bottom