Exclusion of IATF 16949 Clause 4.4.1.2 - Product Safety

morteza

Trusted Information Resource
#1
Hello all

I think that ISO 9001 requirement for exclusion of standard requirements is more logical than IATF 16949, because it has a general statement in clause 4.3 that you shall justify any exclusion of standard requirement anywhere in standard: in clause 8.3 or other clauses.
But IATF has limited the ISO 9001 general requirement to clause 8.3 and only product design.

My questions are:

1-Why shall I think about and provide some processes for product-safety related products, when our product is not a safety product?

2- Does this requirement (considering clause 4.4.1.2 in your QMS) has any logical justification where you not any product-safety related products?


Thanks all.
 
Elsmar Forum Sponsor

QualitySpirit

Involved In Discussions
#2
there are many more clauses in this new version especially those about embedded software that can never be applied to most of the factories.

if you are certain that your factory will never someday in the future get a new product that turns to be a safety related product. I think it makes sense that you ignore it.
 
Thread starter Similar threads Forum Replies Date
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
D IATF 16949 Design Exclusion Clauses which can be N/A IATF 16949 - Automotive Quality Systems Standard 7
SATHYABALARAMAN Exclusion of IATF 16949 Clauses - 8.5.5.1 & 8.5.5.2 & Justification IATF 16949 - Automotive Quality Systems Standard 9
K Exclusion of 8.3 Design and Development for Design Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
S Exclusion of chapter 7.5 production for clinical investigation ISO 13485:2016 - Medical Device Quality Management Systems 1
P Exclusion of clause 8.2.3 Reporting to regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 7
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
Z Why Control Limits are not the same depending on type of exclusion of data points Using Minitab Software 7
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 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
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
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
tony s Permitted exclusion on ISO 9001 but not on ISO/TS 16949 Misc. Quality Assurance and Business Systems Related Topics 5
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
armani 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

Similar threads

Top Bottom