What results need to be defined in IATF 16949 Clause 8.3.4

J

jelly1921

Quite Involved in Discussions
The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined

Do the results defined in 8.3.4 and 8.3.4.1 & 8.3.4.2 ?
Anything else?

Thanks

Jelly
 
M

maggylu168

Involved In Discussions
Re: What results need to be defined in ISO 9001 Clause 8.3.4

jelly1921 said:
The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined

Do the results defined in 8.3.4 and 8.3.4.1 & 8.3.4.2 ?
Anything else?

Thanks

Jelly
Click to expand...

I am also curious for what reason the monitoring measurements including quality risks, costs, lead times, critical paths as the results (outputs) from design and development controls are an input in management review. Shouldn't we do this in design review meeting? For which item from section 9.3.2.1 can be connected to this 8.3.4.1?
 
A

AMIT BALLAL

Super Moderator
Re: What results need to be defined in ISO 9001 Clause 8.3.4

Results can be targets for Quality, Reliability, Maintainability, Cost, process capability, etc. which are to be achieved.

You may decide which results are required out of the design and development as applicable to your organization.

Thanks,
Amit
 
E

eturns

Re: What results need to be defined in ISO 9001 Clause 8.3.4

We measure and report on on time delivery of projects, cost vs budget, iterations of jigs and check fixtures etc. You are assessing the process of design and development so it will be the departments KPIs.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C I need some clearing on requirements of Asuring the validity of results ISO 17025 related Discussions 2
V Note Change to Print - Do I need dimensions results? APQP and PPAP 1
S Need help with Corrective Actions that work - Registration Audit Results Nonconformance and Corrective Action 16
D I need a copy of a Material Test Results Form Document Control Systems, Procedures, Forms and Templates 2
D Comparing inline Conductivity instrument with offline test results General Measurement Device and Calibration Topics 0
S Minimum Retention Time for Records of internal audit results as per AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Calculate FPY for Audit Results AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
qualprod Do sum of results of quality objectives should met a high level goal? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Nadcap - Heat Treatment Proof of Verification question for Digital results AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G AMS 2750 F Instrument Calibration Results and Recording AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Spinal implant predicate device test results 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A ISO 13485 Calibration Requirements- Assess and Record validity Previous measuring results ISO 13485:2016 - Medical Device Quality Management Systems 5
S Comparing measurement results for a part from two ring gage General Measurement Device and Calibration Topics 3
T ANOVA Results ISO 17025 related Discussions 1
T IATF 16949 Recording inspection results IATF 16949 - Automotive Quality Systems Standard 2
E Raw data retention for Diagnosis Results EU Medical Device Regulations 4
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
Nihls When the MSA results show no operator influence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Q IATF audit - Root Cause Analysis results IATF 16949 - Automotive Quality Systems Standard 5
P Ppk results shown as asterisk after the transformation of Non-normal data Using Minitab Software 4
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
A MSA results differences - Supplier results vs. My results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
J Audit Finding For Not Retaining Test Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F ISO 17025:2017 Clause 7.7 Ensuring the validity of results - Threshold ISO 17025 related Discussions 9
P AS9102 Form 3 Dimension Results Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
H Graphical analysis of results - Confidence level bands nomenclature Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
G What information to put on measurement Dimensional Results APQP and PPAP 7
A Calibration Certificate Results General Measurement Device and Calibration Topics 3
F Measurement Audit and ILC for ISO 17025 Clause 7.7.2 - Comparison with results of other laboratories ISO 17025 related Discussions 0
KCalaba21 ISO 9001:2015 6.2.2 E - "e) how the results will be evaluated." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
J ISO 17025 - Please share a sample procedure for monitoring the validity of results ISO 17025 related Discussions 1
A Acceptance p-value for linearity and bias analysis in minitab results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
Marc European universities dismal at reporting results of clinical trials - 2019 Other Medical Device Regulations World-Wide 0
T Final process capability results - What I am supposed to present? Cp and CpK? APQP and PPAP 11
V Recording CMM dimensional results on CFG-1003 APQP and PPAP 3
Prashant G AS9100 Requirement - Verification of characteristics results with drawing requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
A Supplier Audit Results - when do you prepare? General Auditing Discussions 10
U ISO 17025:2017 Clause 7.7 Ensuring the Validity of Calibration Results ISO 17025 related Discussions 7
M FDA News FDA Safety communication – Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings Medical Device and FDA Regulations and Standards News 0
armani Definition Intended Results - What does "Intended Results" mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
G ANOVA GR&R: Minitab vs AIAG MSA results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
G ISO 9001:2015 - Management Review 9.3.2 c) 5) - Monitoring and Measurement Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Tensile Test Strain Rate - Impact on the Test Results Manufacturing and Related Processes 3
K Taguchi Experiments for Factorial Design Analysis - Reliability of Minitab Results Using Minitab Software 1
B How to interpret Grindometer Gage R&R Results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
C Leveraging previous results in IQOQs - Environmentally Controlled Room 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W MR Inputs (9.3.2) - "Monitoring and Measurement Results" vs. "Process Performance" Management Review Meetings and related Processes 15
S Is it mandatory to provide the results of the validation report in handwriting? ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom