Design and Development Exclusion

kensonic_qmr

Starting to get Involved
#1
Good day everyone. It's been awhile since I posted here. I'm just basically a lurker here. I want to hear your opinion regarding my dilemma. I'm a newly hired Deputy QMR of a new company. The scope of their QMS is Installation and Distribution of a certain equipment.

My question is related to the Design and Development clause. I'm thinking of excluding it in the QMS for a reason: Although we create a drawing on how we will install the equipment on a company/residential house, I don't consider it as a Designing activity. Is my thinking correct? :)

Thank you in advance for answering.

Our company is targeting ISO 9001:2015 certification
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
ken,

It seems that your company provides an installation and distribution service.

As such your company designed and redesigns its service as an ongoing business and then further develops its service for each customer, contract or project.

That maybe the extent of your design and development but it’s important to your customers and to the continuity of your business.

Kindly let us know if I’ve got this wrong and why.

Thanks,

John
 
Thread starter Similar threads Forum Replies Date
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
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
S Design and Development Procedure with Design Exclusion AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
J Justification for Exclusion of Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 8
somashekar Exclusion of Design and Development Controls for Class 2B Medical Devices EU Medical Device Regulations 8
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 Design and Development Exclusion - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Design and Development, Support parts - Clause 7.3 Exclusion AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
A Can this be a case for Design and Development Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 64
D Do we need to include ISO 9001 Clause 7.3? Design and Development Exclusion Design and Development of Products and Processes 8
quality1 Sister Company makes Cables & Wires - Design & Development Exclusion Design and Development of Products and Processes 1
R Design and Development exclusion? We repair and refurbish electric motors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Design & Development in Food and Beverage Services - Permissible exclusion or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
H Exclusion of Design and Development Requirements (7.3 & sub-clauses) in TS16949? Design and Development of Products and Processes 9
M Exclusion of Design and Development - Construction and Renovation of Premises Design and Development of Products and Processes 11
Q Exclusion of Design and Development Controls - ISO 13485 Section 1.2 Design and Development of Products and Processes 6
S EN AS 9100 Permissible Exclusion and Provision - Aerospace design and development Design and Development of Products and Processes 4
C ISO 9001:2000 clause 7.3 Design & Development Exclusion - Collagen casing for sausage Design and Development of Products and Processes 19
I Design & Development - Exclusion of 7.3 - We Manufacture to Customer Prints Design and Development of Products and Processes 14
K Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validation Design and Development of Products and Processes 6
J Acceptable Wording in the Quality Manual - Design and Development Exclusion Quality Management System (QMS) Manuals 12
L Design & Development of a SERVICE Service Industry Specific Topics 8
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
M Design Development MDR Design and Development of Products and Processes 0
O How can I justify excluding the R&D group and the design and development clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S ISO 9001 Clause 8.3 - Design & Development for training course center ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
AlienraverX Design and Development Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
S Waterfall model or v-model design and development ISO 13485:2016 - Medical Device Quality Management Systems 2
JoshuaFroud Design and Development of Software under 13485:2016 or 62304? ISO 13485:2016 - Medical Device Quality Management Systems 3
M IATF Clause 8.3 - Design and Development IATF 16949 - Automotive Quality Systems Standard 5
K Design and Development Exemption/NA confusion Design and Development of Products and Processes 6
C AS9100 8.3.5.e Design and Development Outputs - Key Characteristics / Critical Items AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
S Purchasing for Design and Development Organization ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Development separated from design? ISO 9001 cl. 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Design and development of user centric audit report visualisation tool Design and Development of Products and Processes 5
D IATF 16949 Design and Development Planning IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 Cl. 8.3 - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 1
A ISO 13485:2016 Certification for Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 0
R Development of Design FMEA - Functional Requirements FMEA and Control Plans 1
G ISO 9001:2015 8.3 Design and Development (in Civil Engineering) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M AS9100D excluding Design and Development - Small Job Shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 18
Similar threads


















































Top Bottom