SBS - The best value in QMS software

Knowing when an EN version modifies the base standard

rothlis

Involved In Discussions
#11
Well, not all NBs are the same...

If you never had any issues surrounding that, and don't plan on changing your NB, I would let it go. If you do a risk-benefit analysis, I think that the risk of getting cited for a non-equivalent standard seems low enough to leave it alone.
Yes, that's the route I'm planning. I was just thought maybe there was a middle ground, something other than:
a) waiting for an auditor to tell us that we're missing requirements that are only in an EN version, or
b) buying dozens of $300 coversheets that tell me what I bought is identical to a document I had already purchased before
 
Elsmar Forum Sponsor

CharlieUK

Quite Involved in Discussions
#12
Not all Standards Bodies are expensive.

Most standards can be purchased through Estonian Standards, http://www.evs.ee/shop, where:
- you can buy a standard such as EN ISO 14971:2012 for 22 Euro
- or Read any standard (for 24 hours) for just 2 Euros
- generally obtain copies of AC corrigenda without charge.
 

CharlieUK

Quite Involved in Discussions
#15
Hmmm...
- BSI shop: 295 Euro
- ISO shop (original): 164 Euro
- Estonian Standards: 22 Euro???

Too good to be true? Seems fishy...
No, completely legitimate and real.

Estonia is a member of the EU and Estonian Standards is a member of the relevant European standards committees.

As I understand it, the Estonian Government wants to help its companies have access to these standards, and the website makes them available to all.

There was a recent discussion on the IEEE EMC-PSTC forum relating to costs of standards for telecom/IT equipment and the following ranking comparison was obtained, where the % is the relative cost compared to most expensive.

1 Estonia http://www.evs.ee/shop 9%
2 Denmark http://www.ds.dk/en 38%
3 Luxembourg ILNAS https://ilnas.services-publics.lu/ecnor/home.action 43%
4 Global IHS https://global.ihs.com 56%
5 Techstreet http://www.techstreet.com 89%
6 BSI http://shop.bsigroup.com/Navigate-by/Standards/ 93%
7 ANSI Store http://webstore.ansi.org 100%
8 DocumentCenter https://www.document-center.com ---
 
Thread starter Similar threads Forum Replies Date
A Receiving paper from the customer and never knowing when it will arrive Quality Manager and Management Related Issues 1
J Standards & Standard Maintenance - Knowing what the latest revisions are Document Control Systems, Procedures, Forms and Templates 15
V Process Status - Any TS 16949 requirements related to knowing the process status? IATF 16949 - Automotive Quality Systems Standard 7
T Containment Without Knowing Cause Nonconformance and Corrective Action 28
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
S API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
M When is EN 62133-1 (new version i.e. IEC 62133:2017) mandatory in EU Other ISO and International Standards and European Regulations 3
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 8
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
dgrainger Informational Updated Borderlines manual - Version 1.22 (05-2019) EU Medical Device Regulations 0
A Usable version of MDR in Word format CE Marking (Conformité Européene) / CB Scheme 0
dgrainger MHRA guidance on Virtual manufacturing - version 2 EU Medical Device Regulations 1
M Scrubbed version of a labeling procedure that is MDR compliant wanted EU Medical Device Regulations 3
B QRQC vs JIDOKA - I read somewhere that QRQC is like a French version of JIDOKA Problem Solving, Root Cause Fault and Failure Analysis 2
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
Sidney Vianna Accessing the Xenforo version of Elsmar via a smartphone Elsmar Xenforo Forum Software Instructions and Help 8
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
D I heard that there is no new version of ISO 18001 OHSAS after 2017 version Occupational Health & Safety Management Standards 3
M Which Version of 60601-1 to Purchase (IEC, EN, ANSI...)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M How to get an electronic version of IATF 16949:2016 which is Searchable IATF 16949 - Automotive Quality Systems Standard 8
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
I ISO 22001 and ISO 22003 French version Food Safety - ISO 22000, HACCP (21 CFR 120) 2
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
K UDI "Version or Model" for Stand-Alone Medical Device Software US Food and Drug Administration (FDA) 6
R IEC 60601-1 4th Edition - Is a "Red-line" version available? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Current version of EN62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
Y Which version of ISO 13485 would be considered for MDSAP certificate? Canada Medical Device Regulations 8
G Insights into the 2016 Version of TS16949 (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 74
T Firmware version in EMC report / DoC CE Marking (Conformité Européene) / CB Scheme 1
M Current standard references IEC 60601:1988 instead of current version EU Medical Device Regulations 5
L Medical Device Software Document released version (article 5.8.4) IEC 62304 - Medical Device Software Life Cycle Processes 7
P Is an English version of CFDA YY0664-2008 available? China Medical Device Regulations 3
C Registration to the 2015 Version of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J How to document discontinuation or end of life for a software version ? IEC 62304 - Medical Device Software Life Cycle Processes 3
R EU updated borderline manual - version 1.16 EU Medical Device Regulations 2
S How to upload GM's MMOG survey version 4 to GM Powersupply Customer and Company Specific Requirements 3
V Locking in a Standards Version (ANSI Z1.4) Statistical Analysis Tools, Techniques and SPC 1
S Is Revision and Version the same in the Quality Manual? Quality Management System (QMS) Manuals 13
S Queries of new version ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11

Similar threads

Top Bottom