SBS - The best value in QMS software

8.4 - Analysis of Data - What is Data?

C

cristina

#1
#1
What is "Data"?

Hello

I have a doubt: Which is the difference between "data" mentioned in ISO 9001:94(4.5) and "data" refered in ISO 9001:2000 (8.4)

Thanks in advance
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
C

Cristina

#3
#3
I think that they are different because in the ISO 9000 is not mentioned "data control", and the ISO refers only data after the process.

Thanks for the reference.
 
C

Cristina

#4
#4
I think that they are different because in the ISO 9000 is not mentioned "data control", and the ISO refers only data after the process.

Thanks for the reference.
 
R

Ross Simpson

#5
#5
Cristina: You are refering to two different subjects;
4.5 of 1994 is Doc. and Data CONTROL (see note 15 in the Standard).
8.4 of 2000 is "Analysis of Data".
The term "data"(per Webster's)is "factual information used as a basis for reasoning, discussion or calculation".
As stated in 2000 standard,"may be in any form or medium"
Soooo...Just about anything can be considered data,ie: SPC charts, management review minutes, company e-mails, etc.
Just my 2c. worth.
Ross
 
R

rsalinger - 2007

#6
#6
The "data" referred to in Document and Data Control, element 4.5, ISO 9000:1994, is intended to be similar to the "documents" mentioned in that element. These data are information that is used to control a process or action. For example, the software that runs an analyzer. Or, the punched tape that runs a robot machine. It is clearly NOT output data from a process, from a test, or spc, etc. But the word is ambiguous, and it is also used to describe information about almost anything, as Ross has mentioned.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
lanley liao How to correctly understand the bullet list d) of 6.3 Analysis of Data for API Spec Q1 Oil and Gas Industry Standards and Regulations 7
M Data analysis Design of Experiments Using Minitab Software 3
S Minitab - Factor Analysis: Label on second series of data for Biplot Using Minitab Software 4
J ISO 13485 8.4 Analysis of Data - Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
T Likert Analysis of Data from a Survey Statistical Analysis Tools, Techniques and SPC 6
E Risk Analysis - Events which may cause to Data Loss ISO 14971 - Medical Device Risk Management 12
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
M Treatment system data analysis - Subject to CFR part 11? Entire system? Qualification and Validation (including 21 CFR Part 11) 7
N Tool frequency change - Data Analysis needed Statistical Analysis Tools, Techniques and SPC 9
R Need Help on Analysis: How to know potential causality model from historical data Problem Solving, Root Cause Fault and Failure Analysis 5
R Variables Data Type Analysis help Quality Tools, Improvement and Analysis 4
M PCDMIS-Excel Data to Minitab for Analysis Using Minitab Software 2
F MSA - Measurement System Analysis Attribute Data Crosstab sheet APQP and PPAP 1
A Recording Data and Data Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Y Statistical Analysis of Road Traffic Data Statistical Analysis Tools, Techniques and SPC 11
M PhD Thesis Data Statistical Analysis Methods Statistical Analysis Tools, Techniques and SPC 2
R MCF analysis with Left & Right Censored (Truncated) Data Reliability Analysis - Predictions, Testing and Standards 1
R Sample vs. Population (Data Analysis) Statistical Analysis Tools, Techniques and SPC 11
A Repairable System Reliability Analysis: Uptime/Downtime Hours, Failure Modes Data Reliability Analysis - Predictions, Testing and Standards 2
N Critical Analysis of Medical Device Bench Testing data ISO 13485:2016 - Medical Device Quality Management Systems 6
V MSA Attribute Data Analysis Study IATF 16949 - Automotive Quality Systems Standard 1
S Data for Analysis - Construction Industry Table of Data for Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
W What kind of data is expected for a PPAP Material Analysis Report IATF 16949 - Automotive Quality Systems Standard 7
optomist1 Data Analysis - Transform Data or Not Capability, Accuracy and Stability - Processes, Machines, etc. 9
R Capability Analysis (using Histogram) for Subgrouped Data Statistical Analysis Tools, Techniques and SPC 16
F Dealing with, and Analysis of, Data Statistical Analysis Tools, Techniques and SPC 6
T SPSS for Analysis of Medical Data - Need help Statistical Analysis Tools, Techniques and SPC 12
H Minitab DOE Analysis of Data and Transforming Using Minitab Software 4
Q What data analysis software do you use? Quality Assurance and Compliance Software Tools and Solutions 4
M Analysis and Use of Data clarification - TS 16949 Clause 8.4.1 IATF 16949 - Automotive Quality Systems Standard 4
K Non-Normal Data Analysis Literature, Websites, Books for Learning Quality Tools, Improvement and Analysis 2
G The Documentation of Data Analysis for an ISO 13485 Medical Device Submission ISO 13485:2016 - Medical Device Quality Management Systems 9
C Process Capability - Attribute Data Analysis (Template) Document Control Systems, Procedures, Forms and Templates 0
C Process Capability - Variables Data Analysis (Template) Document Control Systems, Procedures, Forms and Templates 0
Q Regression Analysis for the Attached Data - help needed - TIA Reliability Analysis - Predictions, Testing and Standards 13
F SPC Data Analysis - Excel Spreadsheet I can use for Diameters and Perpendicularity Capability, Accuracy and Stability - Processes, Machines, etc. 6
J Applicable Statistical Analysis Method for this Data Six Sigma 17
C Who does the Analysis of Nonconformances and other Data Analysis? Nonconformance and Corrective Action 23
Y Analysis of Data Procedure: Requirements for OBL (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 2
P Data Analysis - Johnson Transformation/Weibull Distribution/Capability Analysis Capability, Accuracy and Stability - Processes, Machines, etc. 15
A Best Way for SPC via Optical Comparator with output to Computer for Data Analysis Statistical Analysis Tools, Techniques and SPC 4
V Help on C Sat Data Analysis - Should I use discriminant analysis? Six Sigma 8
K Data Analysis of Milk Composition (Seven Parameters like Protein, Fat, Lactose, etc.) Using Minitab Software 18
7 Data Analysis of Tensile Strength Test - Graphical Presentation of Results Statistical Analysis Tools, Techniques and SPC 2
T Analysis of Sample Data Sets - Incidence of Canine Rabies Statistical Analysis Tools, Techniques and SPC 2
K GR&R (Gage R&R) Analysis for Negative Measurement Data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
B FDA QSR Data Analysis & Trending Requirements US Food and Drug Administration (FDA) 5
Hami812 Normality of Data Question - Minitab Analysis Statistical Analysis Tools, Techniques and SPC 12
Statistical Steven Continuous Data Analysis Sample Size Determination Six Sigma 3

Similar threads

Top Bottom