Whats the difference, ISO vs EN ISO Std's

R

RG Ohidy

#1
I need to purchase a couple of standards as EN 46002 is going away and I have to be recertified as my certs are expiring. I have the choice of purchasing an ISO 13488 or EN ISO 13488 standard. Whats the difference? Will I have a problem with my auditor if I reference EN ISO and have the ISO standard? Also, with regards to ISO 13488, this standard was issued in 1996, but from what I am told and have read there is a 2000 version and that it is identical to the 1996 version. So, in looking at standards to purchase, it appears I can only purchase a 1996 version and not the 2000 version. Again, would I run into troulbe with an auditor if I referenced 13488:2000 in my documents and my standard is 13488:1996?
Rich
 
Last edited by a moderator:
Elsmar Forum Sponsor
#2
Hullo Rich,

Nothing to worry about. EN stands for European Norm, and the contents are exactly the same. The standard in question is simply approved as both international and European norm.

You can also find standards beginning with a third letter combination, like SS-EN ISO.... The example stands for: Swedish Standard, European norm (standard) and International Standard.

/Claes
 
J

Jimmy Olson

#4
I would agree that you will probably want to look at ISO 13485:2003. There will no longer be an ISO 13488. This version is also designed to be a standalone standard, insteas of requireing 9001 (like the old version did). There have been several discussions here regarding 13485:2003 with some good information and there are some people her that have a pretty good knowledge of it. As always, feel free to ask any questions.
 
R

RG Ohidy

#5
Thank you all for the comments.
I do have ISO 13485-2003, which I have implemented into my quality system. I was planning on upgrading to this standard during recertification this month, however I can't. According to my registar, as this standard has just been released they have no one that can audit it yet, nor does anybody else. The problem I have now is that I have to back track, as my cert's expire at the end of this month, so I am forced to pursue ISO 13488-1996. Hence the need for these standards. I would blame this problem on myself for not watching this closer, however (isn't there always?), I was focused on the implementation of ISO TS 16949, which I am half way through with our auditors. Fun is. So far so good.
 
Last edited by a moderator:
J

Jimmy Olson

#7
Claes Gefvenberg said:
You can also find standards beginning with a third letter combination, like SS-EN ISO.... The example stands for: Swedish Standard, European norm (standard) and International Standard.
Why does a 'Standard' have multiple designations. Isn't that self-contradicting? :p


RG Ohidy
Gee no further replies, is pricing a taboo subject?
It's not necessarily a taboo subject, but something that I think some people don't like to talk about. 15k sounds a bit high, but I don't know all the details (is this annual, one time, how many day, what all is included, etc..). Plus all my info is based on 9001, which I know is less expensive than medical. Give it a couple days and I'm sure you will get some responses. It just takes a while sometimes. :)
 
Thread starter Similar threads Forum Replies Date
P Whats the difference between SOP and QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
G Whats the difference in applying error factor and correction factor? General Measurement Device and Calibration Topics 1
J Quality Manuals and Quality Plans - Whats the difference? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
L Process Measurement - ISO 9001:2008 Clause 8.2.3 - Whats your Interpretation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Whats the rationale for a Sample size of 30 for Capability Analysis? Statistical Analysis Tools, Techniques and SPC 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
gramps What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 5
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Nicole Desouza The Difference of being AS 9100D Compliant vs.Certified AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
R The difference b/w FMEA & Risk analysis as per iso 14971 ISO 14971 - Medical Device Risk Management 8
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
J What is the difference between Process Variation and Tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
qualprod What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Difference between uncertainty and expanded uncertainty of measurement General Measurement Device and Calibration Topics 1
S Is there a difference in the process? Analyze residuals, construct interval estimate Using Minitab Software 2
S EASA Part 145 - The difference between non-certifying staff and Certifying staff Federal Aviation Administration (FAA) Standards and Requirements 2
S Certification Body, Registrar, Notified Body - What is the difference? Registrars and Notified Bodies 3
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
S What is the difference between a service request and a complaint? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q AS 9100 C and D Purchasing requirements difference AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Difference Process Objective/Opportunity for improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I What is the difference between OOS/OOT Imported Legacy Blogs 3
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
O Difference in 60601-1-2 3rd and 4th ed separation RF portable equipment CE Marking (Conformité Européene) / CB Scheme 1
Q Difference between Monitor & Measurement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T QA vs. RA - The difference between QA and RA Coffee Break and Water Cooler Discussions 6
A Difference between Discrimination and Least Count IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom