Non applicable clauses in a reseller?

qualprod

Trusted Information Resource
#1
Hello all

What clauses could be declared with no applicability in the next case.
It is a small company, 50 employees, Iso 9001 2008, certified.
Buying and reselling, paper for packing , plastic accessories, steel wire rolls, etc.
Just 5 realization processes, sales, purchasing, delivery and quality, and as support processes: Hr, IT, and top management.
We only buy and immediately send to our customers the products, we dont manufacture anything.
We are declaring as no applicable, 8.3, 8.5.1f .
In this case what else do we have to consider?

Because we don't have production, I was thinking in considering 8.0, but I'm in doubts.
Opinions are welcomed.

Thanks
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
I wouldn't declare anything. Just write your "Procedures" according to what you do, and disclaim what you don't do right in those procedures.
Frankly, its just easier that way...

To "make" a product, you buy it and inspect it (Purchasing, QC). That's your manufacturing process. Easy, fast, done.

Why invent fights you don't need to fight?
 

qualprod

Trusted Information Resource
#3
Thanks Ninja
But in order to defend clauses in the scope, I have to declare which is not applicable, it isn't so?
 

dsanabria

Quite Involved in Discussions
#4
Hello all

What clauses could be declared with no applicability in the next case.
It is a small company, 50 employees, Iso 9001 2008, certified.
Buying and reselling, paper for packing , plastic accessories, steel wire rolls, etc.
Just 5 realization processes, sales, purchasing, delivery and quality, and as support processes: Hr, IT, and top management.
We only buy and immediately send to our customers the products, we dont manufacture anything.
We are declaring as no applicable, 8.3, 8.5.1f .
In this case what else do we have to consider?

Because we don't have production, I was thinking in considering 8.0, but I'm in doubts.
Opinions are welcomed.

Thanks
Yes - you are correct 8.3 Design & Development can become non-applicable - once you can justify why is it that you don't do it...
 

qualprod

Trusted Information Resource
#5
Sanabria
I have been thinking into this issue.
Ok I may declare non applicable 8.3 for the side of products, but what about services.
Could fit services in these activities?
In your opinion, what are services? In the ISO point of view?

Thanks
 
Thread starter Similar threads Forum Replies Date
qualprod Only manufacturing, non applicable - ISO 9001 Clause 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
qualprod Is it a NC, if a clause is not declared as non applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T IATF16949:2016 8.7.1.4 Control of non-applicable reworked product IATF 16949 - Automotive Quality Systems Standard 3
C ISO 9001:2015 - Non Applicable Design and Development (Power Plant Operator) Design and Development of Products and Processes 2
K Customer NCR - How to respond to a non-applicable NCR? Nonconformance and Corrective Action 7
S Are ISO/TS 16949:2009 requirements applicable to our non-automotive products? IATF 16949 - Automotive Quality Systems Standard 26
A What is the difference between exclusion and non applicable? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Can "7.5.1.2 cleanliness of product and contamination control" be non-applicable? ISO 13485:2016 - Medical Device Quality Management Systems 4
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 0
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Non-Conformances Found After 3rd Party Sorting Supplier Quality Assurance and other Supplier Issues 12
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
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
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
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
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
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
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, NADCAP and Aerospace related 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

Similar threads

Top Bottom