Exclusion from Validation of Processes for Production and Service Provision?

S

SteelWoman

#1
Hey ya'll (gee, can you tell I'm from Bama? :D) I just got a copy of an ISO cert newly issued to one my suppliers of raw material (steel) and noted that they claimed (and apparently got) an exclusion from "Validation of Processes for Production and Service Provision". Hmmm.... I gotta' say this is a first for me - I've never seen/heard of anyone even attempting to justify an exclusion from that clause. Have you? And if so, what was the basis for the argument?
 
Elsmar Forum Sponsor
S

SteelWoman

#3
Hmmm... thanks for the direction - I read the example and I guess I understand what they're saying, but.... I don't know, maybe this is okay but I've not read any interpretation or guidance or HEARD anything that indicates this clause could really be excluded by anyone. interesting...
 
F

fuzzy

#4
The old "Special Processes" clause?

SteelWoman,

My first post so please excuse...I'm pretty sure this is the 2000 version (7.5.2) of the 1994 clause regarding special processes - my old definition being processes that by their nature can be validated only by destroying the product during the inspection, i.e. welding was the classic example. Hence the list of "arrangements" such as qualified personnel (certified TIG welder), approved equipment (weld unit #7), specific methods (SOP-75-TIG), etc.,etc.

Along the lines of this concept, you would need knowledge of your supplier's processes to know if this exclusion is actually valid in your opinion. Apparently the supplier convinced their registrar...
 
Last edited by a moderator:

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
SteelWoman said:
Hmmm... thanks for the direction - I read the example and I guess I understand what they're saying, but.... I don't know, maybe this is okay but I've not read any interpretation or guidance or HEARD anything that indicates this clause could really be excluded by anyone. interesting...
In principle, any clause (sub-clause or requirement) within section 7 of ISO 9001 can be considered for exclusion if it does not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

So, if my product realization processes are always able to be monitored by testing or inspecting the (Intermediate and finished) products, then it is perfectly OK to claim an exclusion to 7.5.2.
 
J

John E Hopkinson - 2010

#6
I actually don't audit anyone who does not exclude that clause - most companies can verify the resulting output of the process. The clause says where you cannot validate the item you must validate the process, so if you can validate the item you must do that and not the process.
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#7
Sidney Vianna said:
So, if my product realization processes are always able to be monitored by testing or inspecting the (Intermediate and finished) products, then it is perfectly OK to claim an exclusion to 7.5.2.
We claim exclusion to this. We just machine and assemble - no special processes.
 
S

serggie

#8
If we employ a series of verification inspections and validation tests before we install/deliver the final product(s) to customer, can we exclude the requirement validation of processes for production and service provision knowing that we have already identified and corrected mostly the major deficiencies early on? while we are still developing the product? I would appreciate if you can offer some advice. Thanks a lot!

Regards,

Serggie Tabanao
 
Last edited by a moderator:
J

JaneB

#9
If we employ a series of verification inspections and validation tests before we install/deliver the final product(s) to customer, can we exclude the requirement validation of processes for production and service provision knowing that we have already identified and corrected mostly the major deficiencies early on? while we are still developing the product? I would appreciate if you can offer some advice. Thanks a lot!

Regards,

Serggie Tabanao
Serggie, I couldn't even begin to offer any useful advice here because there's just not enough info to make a reasonable decision on & thus respond. I also wonder if this is in the wrong forum - this one's for SERVICE industry topics, yet you keep referring to 'product'. I'd try the 9001 forum instead. And provide more information.
 
S

serggie

#10
Hi Jane! I believe that the term "product" is applicable to both tangible commodities and services knowing that its definition is a result or output of a process after converting all inputs. Refer to ISO 9000:2005.

I am just hoping to get some sensible advices if we can exclude the requirement "validation of processes for production and service provision - clause 7.5.2 of ISO 9001 & AS9100" since we use multiple verification and validation tests to make sure that our end product conforms to all identified requirements. Meaning, we will only install our system/product into the aircraft until we are sure that it serves its purpose and satisfies all the functional requirements from customers. Perhaps, we can say that we don't need to validate the processes for production or service provision since our resulting output can be verified subsequently by constant monitoring and in-service support.
 
Thread starter Similar threads Forum Replies Date
L Validation of Processes - Resulting Output can not be Verified - Exclusion to 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
T Design Validation - Justifiable Exclusion for an Electrical Engineering Consultancy Design and Development of Products and Processes 11
K Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validation Design and Development of Products and Processes 6
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
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6
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
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
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

Similar threads

Top Bottom