EN ISO vs. ISO standards - Why to use ISO 11737-1 instead of EN ISO 11737-1

M

MIREGMGR

#21
Perhaps it would help with general understanding if, instead of using "European version" as the practical meaning of EN (as opposed to (en), the language indication), we consistently said "EC Harmonized version".

Lots of standards are in use in Europe, and available in an English language version, but are not EC Harmonized. It's very important to distinguish between EN standards and (en) standards.

The rule as I understand it for demonstration of conformance to the Essential Requirements is:

1. Declare conformance to an EN standard, with appropriate documentation. The reviewing body must presume validity of the declaration, assuming proper documentation.

2. Or, as a second option, declare conformance to a non-EN standard. This might be an international standard that for some reason has not been formally adopted by the EC central authority and the member nations, or a standard that is recognized nationally but not internationally. In this case, there is a limited presumption of conformance, but the reviewing body may conduct a more thorough review of the conformance evidence.

3. Or, as a third option, demonstrate conformance to the Essential Requirements via other evidence. In this case, the reviewing body may require a comprehensive explanation of the adequacy of the conformance, and the burden of proof is on the claimant.
 
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Marc

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#24
Stanley Taylor posted this in the LinkedIn discussion:
Stanley Taylor said:
This is the best answer i have come across and makes it easier to under stand.

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.”
There are three issues at play in answering the question: 1. Location, 2. Adoption, and 3. Certification.

1. Location:

An ISO document is developed as an international standard. It is 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 for distribution.

An EN document is developed as a regional standard. It is 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.

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:

When an ISO document is released, countries have the right to republish the standard as a national adoption. So, when the ISO-14971, for example, is issued, the European Union has the right to adopt and republish the standard.

When the EU chooses to adopt an ISO standard, they add a level of 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 our example of EN-ISO-14971, 2009 Edition, the title is “Medical devices – Application of risk management to medical devices (ISO 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.

However, as we noted above, the EN edition when issued is not actually available for public distribution. Copies in English, French and German are supplied to each member of the EU.

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 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 processes. While our first impulse would be to go to the source document, I encourage you to take a moment to consider the political undercurrents involved.

Because the EN editions of all standards are called out in the European Union’s regulatory schema (the European Directives harmonization process), many certification professionals will only accept EN standards when reviewing customer facilities and practices.

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 though 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.
Comments?
 
M

MIREGMGR

#25
In my view, while the quoted discussion is all true, it focuses too much on the administrative processes and not enough on the regulatory significance.

As I commented in a post above, when your need is to demonstrate conformance to the Essential Requirements of a European Directive, there are three ways to proceed:

1. Declare conformance to an EN standard, with appropriate documentation. The reviewing body must presume validity of the declaration, assuming proper documentation.

2. Or, as a second option, declare conformance to a non-EN standard. This might be an international standard that for some reason has not been formally adopted by the EC central authority and the member nations, or a standard that is recognized nationally but not internationally. In this case, there is a limited presumption of conformance, but the reviewing body may conduct a more thorough review of the conformance evidence.

(One important instance where this path might be chosen would be if the base standard has been revised in its latest version in an important way, and that revised version has not yet achieved EN status.)

3. Or, as a third option, demonstrate conformance to the Essential Requirements via other evidence. In this case, the reviewing body may require a comprehensive explanation of the adequacy of the conformance, and the burden of proof is on the claimant.
 
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