Design and development of products and services

#1
Hai team,
The mentioned clause having so much confusion.
We are having trading company does not involve any design and development. Can I exclude the mentioned clause from our QMS
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
adilabdu,

No.

A trading company that adds value for its suppliers, customers or both?

Figure out how what you do adds value for others outside your company.

And then make sure that service(s) is designed and any changes are subject to design change control.

Please share your service design information here (with any trade secrets removed of course!).

Best wishes,

John
 

tony s

Information Seeker
Trusted Information Resource
#3
We are having trading company does not involve any design and development. Can I exclude the mentioned clause from our QMS
What do your customers require/buy from you? Trading services or the products you sell? Note 1 of the Scope of ISO 9001:2015 provides clarification that "In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer". Give weight on this statement to establish whether 8.3 Design and Development of Products and Services applies to your organization.
 
Thread starter Similar threads Forum Replies Date
R Role of QA during Design and Development of Products and Processes Design and Development of Products and Processes 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Y ISO 9001 Cl. 8.3 - Design and Development of Products and Services not applicable ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Company) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G ISO 9001:2015 8.3 Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J TL9000 Common Measurements - Design and Development for Telecommunication Products TL 9000 Telecommunications Standard and QuEST 5
C D&D (Design and Development) Requirement for Semi-Finished Products Design and Development of Products and Processes 4
S Product Development Program - Design, develop, approve and manufacture new products Design and Development of Products and Processes 6
R Design & Development - We sell products that we design and products we don't design Design and Development of Products and Processes 1
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
S Design & Development records for Medical Devices Packaging and Labelling ISO 13485:2016 - Medical Device Quality Management Systems 8
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
L Design & Development of a SERVICE Service Industry Specific Topics 13
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
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6
S ISO 9001 Clause 8.3 - Design & Development for training course center ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
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
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
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 6
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, NADCAP and Aerospace related 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
qualprod 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
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
A ISO 13485:2016 Certification for Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 0
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
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, NADCAP and Aerospace related Standards and Requirements 18

Similar threads

Top Bottom