Which edition of a standard should I use? This question comes up regularly as our customers work on setting up compliance libraies for their companies. There are two aspects of this question that I’d like to review for you today.
Sometimes the question has to do with which national adoption of an EN standard to use. Since all national publications contain the required EN text, this is easy to answer. Go ahead and use any national adoption of the EN standard you need. Your only concern may be the use of a particular national source (BS, DIN, and so on) if your auditing body is from a particular location. So if you’re being audited by a German organization, you may want to use the DIN adoptions and so on.
But more often the question more specifically means “Which edition will satisfy my regulatory requirements?” The answer to this question requires a little more work on your part. This is because each regulatory jurisdiction has the ability to dictate the version of a particular standard that you’ll need to meet.
For example, in order to meet European requirements, you’ll need to use an EN version of any given standard. Many times you’ll find the standards you need the the EU Harmonized Standards Lists. But let’s say you’re also required to meet FDA certification. The FDA has adopted specific versions of standards too. And sometimes those are not the same as the EN edition. So you may need to review the list of FDA approved consensus standards too. Here is the link to the search page for these FDA adopted standards.
Other jurisdictions may have adopted other versions of your standards. You’ll need to know which locations your products will be marketed in and take a look at each set of requirements! Guess what? You may be buying and reviewing multiple versions of the same document. This is a tedious process, but well worth it. There may be slight differences in the various publications. Knowing and accounting for them as early in your development process as possible will avoid costly problems later.
I want to mention that the standards community has had a goal of “one standard, one test” for many years now. This is the foundation of the movement towards harmonized standards. Naturally there are times when that goal cannot be met (think of the many electrical outlets and plugs you can find when you travel). And certainly, politics and economic protectionism plays a role. However, it is clear that standards organizations have made positive strides in minimizing differences from jurisdiction to jurisdiction.
Questions like “Which edition of a standard should I use?” are brought to us all the time. This is because many people using standards have no formal education in the standards process, protocols, and conventions. For folks like you, Document Center Inc. is a valued resource. We have the knowledge that you need when making many of your compliance documentation decisions. We hope that you will contact us with any questions you have and to purchase the standards you need. You can reach us by phone (650-591-7600) and email (info@document-center.com). Our website, www.document-center.com, is also a wealth of information. Make us your Standards Experts!
