Inclusion of 7.3 design and development (previously excluded)

I

isaiah.w

#1
Is it necessary to include the clause (have been excluded for the past 5-6 years) if our internal IT dept somehow decide to do software development? But usage/deployment is limited to internal customer. The applications developed are requested by other departments to simplify/automate processes. Will not sell the software. I foresee complications if we decided to include the 7.3 clause without actually selling the "product", i.e. determining and reviewing customer requirements, customer satisfaction, etc. Please advise on how to document 7.3 product design and development without actually selling the product.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Is it necessary to include the clause (have been excluded for the past 5-6 years) if our internal IT dept somehow decide to do software development? But usage/deployment is limited to internal customer. The applications developed are requested by other departments to simplify/automate processes. Will not sell the software. I foresee complications if we decided to include the 7.3 clause without actually selling the "product", i.e. determining and reviewing customer requirements, customer satisfaction, etc. Please advise on how to document 7.3 product design and development without actually selling the product.
Internal customer is a fad. There is nothing like internal customer. These are processes which interact and as a part of the interaction towards planning for product realization, which is a part of the clause 7.1., your IT dept is providing necessary support.
Hence you are not involved in the 7.3 activity and therefore no scope for inclusion.
 

John Broomfield

Staff member
Super Moderator
#3
Is it necessary to include the clause (have been excluded for the past 5-6 years) if our internal IT dept somehow decide to do software development? But usage/deployment is limited to internal customer. The applications developed are requested by other departments to simplify/automate processes. Will not sell the software. I foresee complications if we decided to include the 7.3 clause without actually selling the "product", i.e. determining and reviewing customer requirements, customer satisfaction, etc. Please advise on how to document 7.3 product design and development without actually selling the product.
isaiah,

If you want to improve IT's performance when it comes to software design then include clause 7.3 as criteria for their management system. After all, someone said software is 98% design and 2% production!

But do not expect your registrar to audit this because the software is not sold and it will not appear in the scope of your certificate.

It is common for the scope of the management system to be wider than the scope stated on the certificate.

John
 

somashekar

Staff member
Super Moderator
#4
If you want to improve IT's performance when it comes to software design then include clause 7.3 as criteria for their management system.
John.
There is nothing in the OP's post which suggests that the IT dept is not doing the software planning and design to meet the other departments automation and simplification. The steps what the IT dept can take in providing solutions is more apt in the 7.1 c) of the ISO9001.
Inclusion of the 7.3, how is it justified for a product / service realization process.
 

John Broomfield

Staff member
Super Moderator
#5
John.
There is nothing in the OP's post which suggests that the IT dept is not doing the software planning and design to meet the other departments automation and simplification. The steps what the IT dept can take in providing solutions is more apt in the 7.1 c) of the ISO9001.
Inclusion of the 7.3, how is it justified for a product / service realization process.
somashekar,

Yes, they will be planning the realization of their software as well.

But planning is no substitute for design of the software.

John
 

qusys

Trusted Information Resource
#6
Is it necessary to include the clause (have been excluded for the past 5-6 years) if our internal IT dept somehow decide to do software development? But usage/deployment is limited to internal customer. The applications developed are requested by other departments to simplify/automate processes. Will not sell the software. I foresee complications if we decided to include the 7.3 clause without actually selling the "product", i.e. determining and reviewing customer requirements, customer satisfaction, etc. Please advise on how to document 7.3 product design and development without actually selling the product.
What do you sell? What is your "product" or "service" you provide to the customer to make business?
 
Thread starter Similar threads Forum Replies Date
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S ISO/IEC Guide 51: 1999, Safety Aspects - Guidelines for their inclusion in standards Food Safety - ISO 22000, HACCP (21 CFR 120) 4
V Coverage of Process Failures in dFMEA (Scope/Boundaries for Inclusion) & vice versa Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
F Quality Manual Inclusion and Exclusion Justifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Supplier Scorecard Inclusion of Corrective Actions Supplier Quality Assurance and other Supplier Issues 3
D Sales targets (KPI's) and their inclusion in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Q Inclusion of company safety manual and procedures in QMS Document Control Systems, Procedures, Forms and Templates 8
Q MDD inclusion in Quality Policy - MDD Annex 5, 3.2 was referenced ISO 13485:2016 - Medical Device Quality Management Systems 3
S The essential criteria for inclusion in a test method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
D PPAP for Electronics - Inclusion of Dimensional Data and Material Specifications APQP and PPAP 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
R Design and Manufacture Guidelines for Surface Mount Technology Misc. Quality Assurance and Business Systems Related Topics 8
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A Design process goal for ISO 9001 Manufacturing and Related Processes 23
Z Definitive definition of design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Design FMEA for Industrial Machinery FMEA and Control Plans 3
M Design Development MDR Design and Development of Products and Processes 0
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
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
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
D Design Verification - Is testing required? Design and Development of Products and Processes 5
D DHF Responsibility after design handover Document Control Systems, Procedures, Forms and Templates 4
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
Similar threads


















































Top Bottom