Difference Between Iso, En - Iso And Bs - En - Iso

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Document Center's Standards Forum What is the difference between an ISO, EN-ISO and BS-EN-ISO Standard? We often get asked this simple question: “What is the difference     between an ISO, EN-ISO and BS-EN-ISO Standard?” The simple answer is “Not much.” But there’s more to it than than that. I’ve talked about this in a previous blog, but since the question still crops up with much frequency, I’m going to address the question again. There are three issues at play in answering the question: 1. Location, 2. Adoption, and 3. Certificatio Certification. n. Search … 1. Location: An ISO document is developed developed as an international international standard. It is DOCUMENT CENTER INC. – YOUR STANDARDS EXPERTS About Claudia Bach intended to have world-wide usage. It is written under strict protocols with participation from delegates from all over the world. Once released, it is publicly available available for distribution. About Document Center Inc. An EN document is developed developed as a regional regional standard. It is Why do I blog? intended to be used in the European Union. It is written under protocols with participation from delegates of the member states.  Once released, it is not available for public distribution. distribution. BLOGROLL Document Center Inc. Document Center's Standards Blog A BS-EN document (or DIN-EN or AFNOR-EN, etc.) is a national standard. It is published as each country in Europe adopts the EN document. There are strict requirements for the withdrawal of  any conflicting or duplicating standards. 2. Adoption: RECENT ITEMS OF INTEREST Metals and Alloys in the Unified Numbering System 2017 When an ISO document is released, countries have the right to republish the standard standard as a national adoption. adoption. So, when the ISO14971, for example, is issued, the European Union has the right to How are standards written? adopt and republish the standard.  JESD 659 for Reliability Monitoring Updated When the EU chooses to adopt an ISO standard, they add a level Major Changes for the 2017 Boiler and Pressure Vessel Code What ever happened to ISO 594? of administrative administrative overhead. Thus, the EN adoption has a later issue date than the original ISO document, plus additional cover sheet information. Usually, the true title of the EN standard will show you exactly what revision level of the ISO standard is being adopted. So in CATEGORIES our example of EN-ISO-14971, 2009 Edition, the title is “Medical devices – Application of risk management to medical devices (ISO Select Category 14971:2007, Corrected version 2007-10-01).” As you can see, the complete title shows you what edition of the ISO document has been adopted. ADMINISTRATION However, as we noted above, the EN edition when issued is not Log in actually available for public distribution. Copies in English, Entries RSS French and German are supplied to each member of the EU. Comments RSS WordPress.org The British Standards Institute publishes the official English language edition (in this case, BS-EN-ISO-14971), the German Standards Institute (DIN) publishes the official German language edition, and the French (AFNOR) publish the official French SIGN UP BELOW!  Join Our Monthly Newsletter and Get Your Free PDF Copy of  ASME's BPVC Changes for The 2017 Editions! Email First Name language edition. The issue dates on each of these national adoptions will differ as the administrative time to review national standards for possible withdrawal varies. 3. Certification: As we have seen, we have a core ISO document that becomes increasing “wrapped” in layers of administrative adoption Last Name processes. While our first impulse would be to go to the source document, I encourage you to take a moment to consider the I WANT MY FREE PDF! political undercurrents involved. Because the EN editions of all standards are called out in the European Union’s regulatory schema (the European Directives AUTHOR – CLAUDIA BACH, PRESIDENT, DOCUMENT CENTER INC. harmonization process), many certification professionals will only accept EN standards when reviewing customer facilities and practices. Additionally, the EN editions have the Z Annexes, Google which do have an impact on your understanding of how the clauses in an individual harmonized standard relate to the relevant Directive. So if you know that your trading partner in the European Union is in Germany and they want your auditor to come from a German firm, you may be well advised to get the English language editions of the DIN-EN standards where ever possible. And if you are going to be audited by a firm based in England, like BSI for example, you should definitely consider purchasing the BS-EN editions of any ISO standard you use. This can save you much time during your audit, even th ough it costs significantly more when you purchase the standard itself. So, in conclusion, ISO, EN-ISO, and BS-EN-ISO documents all contain the same core information. Only the administrative “wrapping” changes with each subsequent adoption level. I hope this helps you understand this complex issue! Let me know if you have any questions. I can be reached by phone (650-591-7600), fax (650-591-7617) or email ([email protected]). Or my expert staff can easily help you out. PUBLISHED BY Claudia Bach Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+ View all posts by Claudia Bach September 9, 2011 Claudia Bach General Standards Questions 28 thoughts on “What is the difference between an ISO, EN-ISO and BS-EN-ISO Standard?” Utsav September 26, 2013 at 10:39 pm Dear mam, I would thank you very much for above information which is satisfactory upto much extent. As per above answer it seems that content will be unaltered but whether it is always so or there can be addition or modification sometimes, would you please let us know? Claudia Bach September 27, 2013 at 8:41 am Thanks so much for asking. The situation is this — When an ISO standard is adopted, it is adopted as written. When an IEC standard is adopted it usually is adopted as written. However, because of the national variations in the use of electricity, there may be some variation. In addition, the rules of the EU require each nation to review their standards prior to the adoption and publication of each EN 10 standard. These rules require that any duplicate or conflicting standards be withdrawn in favor of the EN edition.  You may find administrative information from the specific country that is publishing the standard in the cover sheet. This information (depending on the country) may offer insight into the documents that have been affected by the adoption and publication of the EN edition you’re using. I hope this is helpful to you. 49 Best regards, Claudia Dirk van Putten December 5, 2013 at 11:17 am Hello Document Center: Can you improve each document’s description on your website with full explanations of their titles? For EN-ISO-14971, why not list it as European Union regional standard (EN), English Language, of ISO 14971:2009? Why not make it as easy as possible for customers to to find and buy standards? Claudia Bach December 6, 2013 at 8:54 am Hi Dirk: Thank you so much for asking about this.  Your idea is a great one! I always think of the problem of the various adoptions and republications as strictly an educational issue — Customers are not aware of the policies of the various standards organizations so this proliferation of document numbers is confusing. But I have not thought about actually providing an explanation of the situation in the results page on our site. It may take us a while to implement your idea, but we certainly will as it will make it much easier for folks to identify what copy they actually need to order. Thanks for bringing this to our attention! Best regards, Claudia Document Center Inc. khalid February 6, 2014 at 5:55 am dear Claudia thank you for this information I’d like to ask this question in different way, Is there any relationship between BS and EN? In addition, ISO? I’ll be very thankful if you could give me answer for this. many thanks Khalid, Claudia Bach February 6, 2014 at 9:35 am Thanks for asking. There is a relationship between BS and EN. The EN organizations are a regional grouping for the countries that belong to the European Union. So the 2 EN standards bodies (CEN and CENELEC) are composed of representatives from each of the member nations. For the UK, that would be BSI (the organization that publishes the BS standards). Since the EN standards are not released to the general public as  just EN standards, it is up to each nation in the EN system to publish each standard as it is adopted in that country. The official English language editions of the EN standards are always published by BSI as BS EN documents. OK. So far so good! Now what about ISO? ISO is the International umbrella organization for standardization. It is made up of representatives from various countries around the world. Since one major goal of standardization these days is to bring as much harmonization into the system as possible (the use of a single standard worldwide for a specific topic is the ideal), it makes a lot of sense for as many countries as possible to u se ISO standards. In order to accomplish this in Europe, the process is for the EN to adopt an ISO standard. This becomes an EN ISO standard. But again, it cannot be publicly distributed as such. In comes each country in Europe with the publication of our EN ISO document as it is adopted for use. Now we have BS EN ISO standards. They are the official English Edition of the European Adoption of a specific ISO standard!  Yipes! And yet, that’s the way the system works… Hope this is helpful. Regards, Claudia  John November 4, 2014 at 7:44 am Thank you for the explanation. I am teaching design to HNC Engineering students from both electrical and mechanical backgrounds. The explanation is simple and makes easy reading. I will use this in my teaching notes (if you have no objections?). Claudia Bach November 4, 2014 at 8:27 am Hi John: I would be delighted to have you include this in your teaching notes. One of my primary goals in writing this blog is to help folks understand standards and how they’re properly used. And one important group for such education is in academia — specifically engineering students. Thanks so muc h for thinkin g of us! And do let me know if there’s other topics you’d like to have me post a blog on as well. Regards, Claudia Sukri Ismail  January 5, 2015 at 1:44 am Wow, this is as easy as ABC to understand for such a confusing question. Tq Claud! marco  June 1, 2015 at 2:14 am Very nice explanation. I would like make sure that I got your example right: “So if you know that your trading partner in the European Union is in Germany and they want your auditor to come from a German firm, you may be well advised to get the English language editions of the DIN-EN standards where ever possible.” The English language editions is the one published by The British Standards Institute and referring to the same EN or is actually the translation of the official German language edition published by the DIN. If I have understood correctly the the English language edition (by the British Standards institute) and the DIN version, translated in English may have some differences due to national standards. Hope I have this right. Kind Regards, Marco Claudia Bach  June 1, 2015 at 9:14 am Hi Marco: And thanks for asking. So to make it easy on ourselves, here is the situation: EN provides official copies of all EN Standards to the European National Standards Bodies in three languages – English, French and German. The “official” English language copy is published as a BS EN document, the “official” French as the AFNOR EN and the “official” German as the DIN EN. All national EN publications can have national cover sheets. Some National Standards Bodies use those cover sheets to tell you administrative information like when they process the standard internally, what other of their standards might have been withdrawn in favor of the EN and so on. Each National Standards Body has the right to publish any EN standard in any of the three language editions that come from EN. So they can publish that same source EN document in English as BSI does, for example. They also have the right to publish a national translation. Most countries publish one of the three official language copies rather than going to the trouble of translating. So no matter where in Europe you get your copy, as long as it’s one of those three official language editions, it’s always the same (with the exception of the administrative cover sheet material). I hope this is helpful to you! Regards, Claudia marco  June 2, 2015 at 12:22 am Claudia, Very clear. Thank you for the quick reply. Best, Marco Graham  June 18, 2015 at 3:35 am Claudia,  Your initial blog explanation and res ponses to the follow-up questions are crystal clear. Brilliant. Thank you … I am re-educating myself on security, crisis management and business continuity standards as I am preparing for job interviews. Researching the various standards in these areas; ‘what is the difference’ was an obvious question, which you answered comprehensively yet very clearly. Many thanks! Graham Claudia Bach  June 18, 2015 at 9:06 am Thanks so much, Graham! I’m glad you found this to be of assistance. Other questions? Let me know. I always welcome the chance to help people be more effective standards “consumers”! Cheers, Claudia Sabrina August 18, 2015 at 2:44 am Very nice article Claudia! I am hoping you can clarify one more thing for me. Since there is no difference in the core text between the ISO and EN ISO Standards, do you know if it is a requirement to purchase both standards if the company is being certified for example to both EN ISO 13485 and ISO 13485? We already have all applicable BS EN ISO standards and I think buying the ISO standards would just be a duplicate since the core text remains unchanged. Thank you, Sabrina Sabrina August 18, 2015 at 6:10 am Great article Claudia! I posted a comment this morning but I don’t see it in the thread so hopefully this won’t be a duplicate. Do you know if a company is required to purchase both the BS EN ISO standards and the ISO s tandards if the quality management system is certified to both EN ISO 13485 and ISO 13485? We currently have all applicable BS EN ISO standards, but I am not sure if it is also a requirement to buy the ISO standards since the certification will be for both EN ISO 13485 and ISO 13485. Since the content of the core text remains unchanged between the EN ISO and ISO standards, I don’t think it would be necessary to buy both EN ISO and ISO standards but I am not sure if the notified body would expect us to have duplicates of all standards. Hopefully you can shed some light. Thank you, Sabrina Claudia Bach August 18, 2015 at 8:33 am Hi Sabrina: Thanks so much for asking. My understanding is that Notified Bodies will not accept the ISO Edition in lieu of the EN ISO Edition. However, for certifying just to the ISO Edition, there can be many versions to choose from and any (including the EN ISO’s) are acceptable as long as there are no national exceptions. I hope this answers your question! REgards, Claudia Seman September 22, 2015 at 6:43 pm Dear Claudia, My questions to you would be : 1/ BS 8903 talks about sustainable procurement 2/ ISO 20400 also considered the same except one additional elements included. Is it possible to state that both Standards are same in terms of  comparing them ? And secondly, why in the UK, they have ISO and BS separately ? Are they not same ? Adithyan  January 11, 2017 at 5:11 am Dear Claudia, First of all, Thank you so much for the valuable piece of  information. While reviewing the technical documents in my organization, I’ve came across similar codes with varying standardization. BS ISO 7121- Steel ball valves for general-purpose industrial applications. BS 7121- Code of practice for safe use of cranes. In this case please clarify how should i distinguish these codes with respect to our discussion or subject. Claudia Bach  January 12, 2017 at 10:18 am Thanks so much for asking, Adithyan: These are two separate documents. One is a British Standards series — The BS 7121 series on cranes.  You’ll find them as BS-7 121-1, BS 7121-2, etc. They are British standards for use in Britain only. The second is the British adoption of an ISO standard. This item was originally published as International Standard ISO 7121 on steel ball valves. When the British reviewed this publication, they determined that they would like to adopt it as an official British standard. So because they belong to ISO and helped to write the standard, they can indeed adopt it. The method by which they adopt standards is to republish them in full with an administrative cover sheet. So now you have the BS ISO 7121 which has the British cover sheet and the inclusion of the original ISO 7121 as the text of the standard. Having lots of different standards organizations using alpha numeric designations like this can be confusing. Remember, first look at the initial alpha component of the number — It usually is an acronym that tells you what organization(s) issued the document. Then the numeric part tells you what unique document it is from that organization. Let me know if you still have questions. And thanks again for asking! Regards, Claudia Satha A. M.  January 12, 2017 at 8:34 pm Hi Claudia Thank you very much for all the clarification above. Its helped throw some light into some of the confusion I have been facing. Could you please help me with the following. 1) You have indicated that the EN standard is released in three languages to the EN countries, and that once the respective countries adopt them, they are then commercially available as say, BS EN 123456, DIN EN 123456. Does that mean that the standard “EN 123456” per se, is not available at all for purchase by the public? 2) You have indicated that once a country adopts a EN standard, it may include some minor changes such as (voltage, etc.). Besides these nuances, are the adopting countries required to adopt the full context of the EN Standard. I am particularly interested in the potential variation of EMC test procedures, and EMC immunity and emission limits – are they required to follow the same. 3) Having considered the differences between EN, BS EN, could you please throw some light on differences with IEC. Thanks Claudia. Satha Claudia Bach  January 13, 2017 at 8:42 am Hi again, Satha: I can easily answer question 1. Any EN is only available in a national adoption. So all EN’s are not available as the source document given to each of the national bodies. You must purchase them in a national edition only. Question 2. Certainly, the technical issues involved in the adoption of the IEC standards are beyond my technical expertise. However, it is my understanding that any deviations from the text of the source document must be notated in the cover sheet administrative information. I will check in with my sources to see if I can get you a more definitive answer. Finally, with regards to testing requirements. I would strongly suggest that you use a reputable testing lab and follow their expertise for these issues. Hope this is helpful! Best regards, Claudia  Jonathan Sandler  January 27, 2017 at 12:23 pm Hello Claudia, Thank you for the informative write-up and comments. This has usually been a source of confusion for me, and apparently others as well, so I just want to confirm my understanding. Apologies if  this is completely repetitive: 1) ISO standards are international/global and the foundation for which all subsequent standards of the same number (i.e. 13485, 14971, 62366, etc.) are based. 2) EN ISO standards are the ISO standards specifically adopted for the European community (whatever those changes might be). When dealing within Europe, the EN ISO standards supersede the ISO standards. 3) BS EN ISO is the English language version of the European standard, DIN EN ISO is the German language version of the European standard, and so on.  Your confirmation of my understanding or any further clarification is greatly appreciated. Best regards,  Jonathan Claudia Bach February 7, 2017 at 9:20 am Hi Jonathan: By Jove, you’ve got it! I will note that the reason that the EN ISO are used exclusively in Europe is that the EN documents are specifically referred to in the Directives. So when dealing with Europe, as you noted, only the EN ISO’s need apply. And one further note, even though a DIN EN ISO is the “German language edition,” often times it will be published in both German and English language editions. The English language edition is identical to any other English language edition published in Europe, including the BS EN ISO one. This blog is my most popular posting! I am amazed at how many people need assistance with this particular topic. I’m glad to be of  assistance to you all with this one! Regards, Claudia Deane February 8, 2017 at 8:46 pm Hi Claudia, Thank you for your great explanation! I do have a question though. For instance, ETSI EN 301 489-1 has recently been updated and is citing EN 61000-4-4:2012 as one of its normative references. Will a lab be required to purchase the EN 61000-4-4:2012 standard if it already has IEC 61000-4-4: 2012? Claudia Bach February 9, 2017 at 9:39 am Hi Deane: Thank you so much for asking. I know that CEN and CENELEC (the other 2 European Standards Bodies) have instituted a mandate to use the EN editions of all referenced standards (if available)in their publications. So in my opinion, you’ll need the EN edition of the 61000-4-4 for ETSI as well. Please confirm this with your testing lab and certification body. One of my staff members and I were just thinking about the World Standards Day theme from a decade or so back – “One Standard, One Test, Accepted Everywhere.” The protocols of  adoption and distribution for the EN standards in particular seem to make this goal feel more distant than ever! Regards, Claudia Deane February 22, 2017 at 6:26 pm Hi Claudia, Thank you for your response. That clears up my confusion about the need for EN version. That being said, I do have a question relating to standards that have their status withdrawn. Can we still make use of a withdrawn standard for reference if that particular standard has an updated version, say for example, ENxxx: 2004 has been replaced by ENxxx: 2012? Best Regards, Deane Claudia Bach February 23, 2017 at 9:54 am Hi Deane: Another good question. First, some contracts do call out obsolete versions of standards. This can be for a number of reasons, usually involving replacement parts. So we do find any number of folks us ing obsolete standards at any given time. However, I think your question is more about transition dates. A common question is how much time do I have before I have to move to the new Edition of a standard? For EN standards that are on a harmonized list (like the harmonized list of standards for the Medical Device Directive), a new Edition of a reference standard has to be formally accepted. This is done by publication in the Official Journal. Once that happens, the new Edition is put on the harmonized list. And a “Cessation Date” is provided. This date is when the old Edition is no longer valid. You must be compliance with the new edition after that date. Many standards are not on the harmonized list. So, sometimes you need to see what the regulations are in the jurisdictions you’re going to be selling your product. You need to meet the legal requirements and sometimes that includes specific editions of a standard. If there are no specific legal requirements regarding which edition to use, then it is up to you. I would caution that using out- dated standards comes with a legal liability. Standards represent “best practice,” using the most up-to-date protocols. This provides you with a level of protection against lawsuits based on negligence. Hope this is helpful! Regards, Claudia Leave a Reply Your email address will not be published. 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