EN Adoptions of IEC Standards

I recently had a question about the EN adoptions of IEC standards.  The question was basically, “How can I know when an EN adoption of an IEC standard is identical to the original IEC document?”  This is a valid question since the EN adoptions may or may not include changes from the source material.

Of course, since all EN ISO adoptions are labeled that way (i.e., “EN ISO 9001”), questions come up frequently about why the IEC adoptions are not the same.  I have always answered that since the IEC adoptions are not necessarily identical to the source, the same numbering protocol has not been used.  While true, most customers are not very pleased with this answer!

Well, good news for all you standards users out there!  CENELEC and IEC have signed a new agreement that will change the way that the adoption process is handled.  Here are some highlights from the new Frankfurt agreement last October.

Currently 80% of the EN adoptions of IEC standards are identical to the source material.  From now on, IEC documents that are adopted without changes will be labeled “EN IEC.” This will be just like the ISO adoptions.  So when you see a new release numbered “EN IEC,” you’ll know the IEC content has not been changed.

Further, CENELEC and IEC are striving to harmonize an even greater number of standards.  So there should be more European adoptions that are identical to the source IEC standards. Organizations that rely on these documents for their electronic products (now almost 20% of all global trade) are sure to be pleased.

National differences in standards make for confusion and expense.  And they detract from a region or country’s competitiveness.  This is good news indeed that Europe is working towards a reduction in these types of variations.

The lack of clarity in the current situation has been a hindrance to global usage of the EN adoptions.  It has caused confusion in the marketplace when a product meets the requirements of the EN adoption.  Folks just don’t know if meeting the EN edition is the same as meeting the IEC edition.  Over time, the new protocol will make it easier to understand equivalencies.

The last time the EN adoptions of IEC standards were administratively addressed was back in 1996 in Dresden.  Times have changed and industry is pushing for more harmonization as markets continue to globalize.  Expect to see the new system implemented soon.  And don’t be surprised when some of the numbers of the standards you frequently use are updated.  Now that you know what the revision means, you’ll be glad to see it happening!

Meantime, if you have any further questions, don’t hesitate to get in touch.  Our staff will be happy to work with you so you can understand the migration path of your compliance information.  Reach out to us by phone (650-591-7600) or email (info@document-center.com).  And go ahead and search for and order the standards you need at the Document Center Inc. webstore, www.document-center.com.  We’ve been working with standards for over 35 years.  Make us your Standards Experts!

Further thoughts on Brexit and BS EN Standards

Recently I blogged about the Brexit and BS EN Standards.  As time goes on, the likelihood of a “soft Brexit” seem to be diminishing.  So my initial analysis certainly looks less likely.

After the Brexit vote, there was talk of Britain taking the same path as Norway and Switzerland.  That is, Britain would choose to remain part of the European Economic Area (EEA) while exiting the EU itself.  This would certainly be the least disruptive option.  However, with many of the statements that Prime Minister May has made, this path seems to be out of the question now.

The most recent positive news suggests that May is interested in retaining some economic ties to the EU.  There is talk of adopting the entire body of EU laws and regulations.  This would mean that the EN standards would remain in force in the UK after an EU exit.

However, the possibility of the British Standards Institute (BSI) remaining on as the publisher of the official English language editions of the EN standards is questionable at this point.  Since Britain would not be officially part of the EU or EEA, the right to publish official documents does not seem possible in my eyes.  There is no doubt that the institution would continue to audit for compliance.  They would simply be assigned those rights by a Notified Body still within the remaining EU.

Many of our Document Center Inc. customers have invested in extensive collections of BS EN standards.  Further, those editions are often referenced in company documentation.  Moving forward, you may want to rethink this policy if you are in this situation.  There are English language editions of the EN standards published by other national standards bodies.  These editions have the same weight as those from BSI and are identical except for the cover sheets.

If you are uncertain of what to do, check in with your certification body first.  Then, get in touch with us for suggestions of other options for your EN standards purchases.  You can reach our staff by phone (650-591-7600) and email (info@document-center.com).  While immediate action is not required, development of a long term strategy is certainly be advisable.

 

World Standards Day 2016

Today we’re celebrating World Standards Day here in the U.S.  In most countries, the date is usually the 3rd Thursday in October.  However ANSI takes advantage of the event to schedule a week-long series of meetings for the various standards constituencies it represents.  So this year the date of  the U.S. World Standards Day is today, the 27th.

The theme for this year’s  World Standards Day is “Standards Build Trust.” Some regular activities include an international competition (usually a paper, but this year a video).  And here in the U.S., there is also a paper competition sponsored by SES, the Society for Standards Professionals.

For those of us in the standards business, standardization does represent a methodology for achieving consistency and safety in the products and services we use every day.  Standardization underpins commerce, creating an inherent confidence in the functionality of the products we buy.   And having “Standards Build Trust” as the World Standards Day theme reenforces this basic concept.

However, certainly within SES, there has come to be a movement towards acknowledging the supporting role certification plays in making the greater goals of standardization a reality.  Peter Unger of the American Association for Laboratory Accreditation has been a champion for this viewpoint.  The introduction of the testing and certification into the SES agenda has provided a fresh look at the interaction between standards and the realities of the marketplace.  “Trust but verify” seems to be the mantra here.

I know that many organizations find additional 3rd party testing to be combersome at times.  However, I noticed in a Wall Street Journal article the other day that the Samsung phones currently undergoing a recall were only tested in-house.  This suggests that such testing is not only appropriate to meet compliance requirements, but also to provide outside validation of design and manufacturing decisions prior to the release of a product.

Be that as it may, there is no doubt that the standardization community is growing.  With the addition of players from around the world, it’s clear that the global community deeply understands the value of standards.  Face it, we live on just one planet and the needs of one are really the needs of many.  Here at Document Center Inc., we are proud to be a part of that “hidden infrastructure” that makes that world a safer, more integrated, and sustainable place.

ANSI/ASSE Z9.1 2016 Released

ANSI/ASSE Z9.1 has been updated.  The new 2016 Edition is titled “Ventilation and Control of Airborne Contaminants During Open-Surface Tank Operations.”  It is available now from Document Center Inc.  You can get a copy in either paper format or for pdf download.    The 2016 Revision replaces the previous 2006 Edition, which is now obsolete.

ANSI/ASSE Z9.1 provides you with guidelines for the control of health hazards resulting from open-surface tank operations.  There are many industries that employ open-tanks.  Such operations include washing, dyeing, coating (including electroplating), and so on.  What are some of the hazards involved in these operations?  Appendix A gives you information on potentially toxic contaminants.  The use of protective devices required by the standard, including ventilation systems, will protect the health and well-being of tank workers.

ASSE, the American Society of Safety Engineers, focuses on worker safety issues and requirements for the protection of workers.  The ANSI/ASSE Z9.1, like many safety standards, provides minimum criteria and can be adapted to the needs of the user.  The introduction notes that when codes are more stringent than the standard, the regulatory requirements should be applied.

Also note that the ANSI/ASSE Z9.1 is “auditable.”  The Appendix B is an audit form that can be used to confirm compliance with the standard.  It is a series of statements, numbered to refer to the specific sections in the standard.  A space for checking off compliance for each item is included.

The committee has give no exact information on the changes in this 2016 update.  However, I will note that the standard is in a two-column format.  The requirements of the standard are presented in the left-hand column.  Additional clarifying information is provided on the right.

If you have open-tank operations at any of your facilities, you’ll want a copy of this new revision.  You can search for and order standards at the Document Center Inc. webstore, www.document-center.com.  Here are links to the order page for ANSI/ASSE Z9.1 in paper format and the order page for the ANSI/ASSE Z9.1 for pdf download.  Document Center Inc. is an authorized distributor of the ASSE publications.

Perhaps you have additional questions or want to order directly with our staff.  Reach us by phone (650-591-7600) or using email (info@document-center.com).  We have been working with standards since 1982. You’ll find our staff to be knowledgeable about the standards you use.  And we have a broad spectrum of products and services to support your compliance requirements.  Make us your Standards Experts!

What’s happened to IPC Kits?

IPC, the Association connecting Electronic Industries, has discontinued the sale of “kits.”  These IPC Kits were a combination of a paper copy and CD Rom copy of any given standard.  As part of IPC’s move to stop distributing the IPC standards on CD Rom, the kits have been the first to go.

Moving forward, you’ll be able to get your IPC Standards from Document Center Inc. in both paper format and for pdf download.  Site licensing is also available.

One thing to remember with the electronic copies of IPC standard is the suppression of the print functionality.  IPC pdf copies are “read-only” and cannot be printed.   Should you need a printed copy of any IPC standard, you’ll need to purchase it.

This supports a tenet of copyright law that standards users sometimes don’t understand.  The format of the publication you purchase is the only format that is available to you.  It is illegal to  take a copyright document in one format and transform it into another.  So if you purchase a paper copy and plan to scan it into your network system, you’re actually breaking the law.  However, for most of the single user pdf standards sold by Document Center Inc., your license will authorize both the use of the file by 1 user on 1 computer and the right to print 1 paper copy.  IPC is one of the few associations that we represent which does not permit the printing of a paper copy from the pdf file.

Here at Document Center Inc., we have noticed that many organizations are moving away from CD Rom distribution.  The format is problematic for copyright owners — illegal distribution can become an issue.  So it is not surprising that IPC is moving away from the practice.  Indeed it was one of the last associations to rely heavily on this media.

If you need any IPC standards, please search for and order them at our webstore, www.document-center.com.  We are an authorized distributor and can assist you with any questions you may have.  Document Center Inc. has been selling standards since 1982 and has been on the web since 1993.  Make us your Standards Experts.

Are IETF Standards Free?

Are IETF Standards Free?  This is the third standards development model I am reviewing as part of my presentation at the SES (Society for Standards Professionals) Conference in Denver next week.  As SDOs (Standards Developing Organizations) consider distribution options, understanding models that do not charge users for standards is important.  And in my opinion, the IETF (Internet Engineering Task Force) model is the only one where standards are really free!

In this discussion, I will really simplify the IETF standards process in order to make my points.  But if you are interested in the organization, their mission, and their real standards development protocol, you need to take a look at two of their web pages.  The first is the “Getting Started in the IETF” page for newcomers to the IETF.  The second is the “The Tao of the IETF:  A Novice’s Guide to the Internet Engineering Task Force.”

The IETF is not a traditional standards developing organization.  It does not have dues and participation is free (except for attendance at any of the 3 annual meetings which do have a fee).  Documents generated by the IETF are called RFCs (Requests for Comments).  Some become standards, many don’t.

RFCs can be authored by a single individual or by a group.  Usually they are proposed within the structure of one of the many IETF working group.   Discussion may ensue, with commenting and revision being an essential part of the process.  A draft that has been through a number of updates may then be considered for adoption as an RFC.   Eventually, some RFCs are elevated to the status of BCPs (Best Current Practices) and some become Standards (STDs).  To learn more about this, take a look at RFC 2026,  “The Internet Standards Process – Revision 3.”

All RFCs are freely available on the Internet.  Of course, there are certain quirks that you need to be aware of.  An RFC that has been replaced with a newer revision will not have any indication that it is out-of-date.  You need to learn how the documents are kept and where to search in order to make sure you get the latest edition of a standard.

Also, you can imagine that over the years there have been plenty of attempts to create RFCs for topics that are of low interest to the community or attempts to derail Working Group projects.  So there are protocols in place to make sure that the IETF stays focused on areas where consensus is important to the development of the Internet.

There are some things to note when you look at the IETF, their publications, and their processes.  Because the group deals with the Internet, technology tools that make collaboration and consensus possible at a distance have been adopted by the IETF from the very beginning.  By relying heavily of open source tools and protocols, the group keeps costs to a minimum.

Also, since the work is highly technical in nature, participants really are “birds of a feather.”  And since all work is done on a volunteer basis, this usually means that only those directly involved with a particular aspect of Internet technology will be part of the appropriate working group.

How does this model differ from the traditional SDO protocol?  The constraints of “good standards development practices” as typlified by ANSI protocols make administration of the standards authoring process essential.  The IETF model does not meet ANSI requirements.  Right out of the gate, the need for due process, wide participation in authoring, and maintenance over the lifetime of the standard creates challenges the IETF does not have.  Traditional standards are expected to be reviewed once every 5 years.  Revision is often necessary.  All these things take money.

Are IETF Standards Free?  As you can see, the IETF RFC process and distribution practices are indeed without formal costs.  The IETF is an unusual and unique organization in the world of standards developers.  Yet this extraordinary model for consensus and documentation does offer other SDOs an opportunity to look at an entirely different way of operating.  Over time, there is no doubt that some of the IETF practices will be adopted by the traditional SDO community.

Are Consortium Standards Free?

Are Consortium Standards Free?  I’m looking at the broader issue of standards and public access for my presentation at the SES (the Society for Standards Professionals) Convention in Denver this month.  There are some standards that are made available for no charge.  I reviewed the Mil Specs and Standards set last week.  Today I’m going to take a look at Consortium Standards.

What is a Consortium?  Luckily, one of my co-panelists has a webpage with a detailed answer to this question: Consortium Info Essential Guide.  For our purposes today, let’s just say that a consortium is a group that has joined together to promote a specific technology or technological solution.  They often fast-track the development of standards in a particular area to provide the technical support to get a product or service to market quickly.

Why is a Consortium different that other Standards Developing Organizations (SDOs)?  The consortium process is often called “pay to play.”  That is, the standards system used is not particularly open in the classical standards sense.  It is a system based on the participation of a few key players.  These folks support the activities of the consortium with dues, often rather expensive in comparison with other SDOs.  They are interested in rapid consensus and deployment.  Their mission is to get their standard(s) in use as quickly as possible.

Are consortium standards provided at no charge?  Usually during the development process, consortium standards are not available.  This is primarily in the interests of time (and sometimes business interests as well).  Introducing additional players into the mix can end up in too much input, slowing down the process.  It may also give competing technology advocates a chance to see what is going on in a certain group.  Or give them a chance to derail the consortium’s goals.

However, once consortium standards are adopted and published by the group, they often are available at no charge.  This is to support the mission of the consortia — Wide adoption of the technology as a tool for promotion of the group’s products or solutions.  Let’s think of the original business strategy for the PC industry — Make PC standards open in comparison with Apple closed standards as a tool for increasing marketshare.

So consortium standards are not free — they do take money to develop, as do most of the standards we use.  However, by choosing to make the final publications available at no charge, a consortium is furthering its core mission — adoption of a specific technology.

What happens if a consortium standard is widely adopted?  How is the standard maintained?  This is an issue of standards development that presents a problem for many consortia.  The authoring group is brought together to get a technology adopted.  When it is, the group’s mission has been met.  Usually, at this point the consortium is dissolved.  But about the standard?

Much to the initial suprise of the traditional SDO community, it is at this point that many consortia hand over their publications to another standards organization.  IEEE has been the happy receipient of a number of standards developed by various consortia.  Why?  A traditional SDO is not only geared up to develop standards but also support them throughout their lifecycle.  For example, standards should be able to be revised if technical errors are discovered.  Standards should be reviewed once every 5 years.  Standards need to be distributed to a potentially large audience over a long span of time.  And even when cancelled, they still may be required for legal or regulatory purposes.

And when this transition takes place, does a consortium’s standard still get distributed at no charge?  Usually not.  While the costs for development are borne by the consortium’s organizers, the costs for maintenance are not.  So a traditional SDO who inherits this type of standard usually begins charging for it immediately.

The use of no-charge distribution of standards is a tactical choice for any consortia.  It is a tool to be used to achieve an end.  It can be very effective but does come with a price.  Many of the benefits of traditional standards development (open process, public review, and so on) are not available during the consortia process.  However, in exchange, a consortium will be able to gain consensus quickly, bring a standard to market in a timely fashion, and attempt to gain penetration of the market by open access to the document(s).

For a tranditional SDO, use of no charge distribution should also be considered a tactial choice.  It should be considered when issues of public interest and achievement of organizational goals make a strong business case and the costs of standardization can be covered by means other than standards sales.

Are MIL Specs and Standards Free?

Are MIL Specs and Standards free?  Should all standards be free?  How should we pay for the development and maintenance of standards?  These are some of the questions that I’ll be talking about at the SES (Society for Standards Professionals) convention in August.  As the standards community reflects on the impact of technology, questions about copyright are front and center.  It’s a basic Internet question:  Should information be free?

Let’s take a look at the DoD system of standards.   They are correctly referred to as public domain documents.  This means that they are not covered by the laws of copyright.  You can use them at no  charge but they are paid for by U.S. taxpayer dollars.  So to answer our question “Are MIL Specs and Standards Free?” we must say no, they are not free.  However, the costs are not borne by the user but by the public at large.

How has this  worked out?  Is this a model that industry should use?  Why was this system developed and what has it accomplished?

DoD specs and standards were developed to support the purchasing needs of the U.S. military.  Since government purchasing can have an impact on jurisdiction communities, it has to meet both practical and political needs.  It has spawned great successes and some well-documented failures.

Back in the day, I saw some shortcuts to good practices in the areas of authoring.  For example, one of our customers was requested to write a mil spec for an electrical component.  He added requirements that made his company the sole supplier for the item.  How could this happen?  The military standardization program just didn’t have enough resources to write all that documentation necessary in-house.  So on occasion it enlisted the help of the vendors themselves, with mixed results.

Other authoring and distribution challenges exist.  Finding appropriate tools for authoring and for conversion of legacy documents has been expensive.  The problems of providing paper copies have thankfully been resolved with the use of pdf delivery.  However, helping mil spec customers keep up with changes continues to be problematic.

Another issue created by this use of an exclusive set of documentation is certification.  In the past, visits to thousands of suppliers were needed to make sure products met the requirements.  Now with the adoption of the ISO 9001 requirements, third party certification has a place in the procurement system.

The development of a standards program specifically for government procurement did lead to purchasing scandals in the past.  Dr. Perry’s Mil spec reform in the 1990’s was an effort to reduce the DoD standards collection to a set comprised of military-only requirements.  For all widely available products, the military and other federal level purchasers moved to the use of industry standards.  So, much of the burden of cost of standardization is no longer paid for by taxpayers.  And now military purchasers have the ability to purchase goods in the open marketplace which saves even more millions of dollars.

The old DoD standardization program did have one shining benefit:  The standards set was widely used thoughout industry.  This penetration of the marketplace was an unintended side effect of the no charge availability of the documents to users.  When the DoD decided to cancel many of their publications during MIL Spec reform, it was a real blow to many standards users.  While most companies moved to industry specs, there is a significant number that stopped using standards altogether.

Of course, when it comes to standards, some developers are interested in fast adoption of a new technology.  In these cases, no charge distribution is a real plus.  But for many traditional standards developers, their documentation supports less “sexy” applications.  In these cases the funding for the transparent development and maintenance of their standards may be best achieved by selling the documents themselves.

The standardization community like other content creators will have to deal with many questions regarding copyright and the distribution of information moving forward.  Many of our common public issues like the promotion of trade, the health and safety of our population, environmental stewardship, and interconnectivity of products can be solved with the use of standards.  Finding a way to promote the use of proven solutions provided by standardization is one factor.  Finding a way to support the uncompromised development of this data is another.

New In Vitro Diagnostic Devices Regulation (IVDR)

There’s a new In Vitro Diagnostic Devices Regulation (IVDR) on the way, likely to be complete at the end of the year or the beginning of next.  Then of course, there will be a time lag as the text of the revised European Union (EU) regulation is prepared for distribution.  For those of you in the MedDev business, this and the new Medical Devices Regulation (MDR) will definitely have an impact.  Let’s take a look at some of the probable areas where you can expect change.

For the medical device industry, standards and regulations go hand in hand.  This is especially true in the EU since a number of regulatory requirements can be met with the use of compliance to specific standards.  So this major revision of these EU regs will require some changes to the way you do business.

First, you’ll want to know that it’s expected that the definition of IVD MD will be expanded to include any device that is a reagent, a reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended to be used in vitro.  This is for diagnosis (predisposition to a disease, possible reactions to a treatment, any collection of blood and/or other tissue samples).  You’ll only be exempt if your products are for laboratory or research use, plus 3 other special cases.

The proposed new IVD Reg includes a new supply chain regime and expands the Eudamed database (to be renamed the MDR Eudamed).  FYI:  The MDR Eudamed identifier number is intended to aligned with the FDA UDI numbering scheme.  It’s expected that there will be perhaps 25,000 European manufacturers in the database, as well as a similar number located outside the EU.  Not only will new records be added, but old records will be retained.

Other regulatory changes for IVD include a ‘lifestyle tests’ extension when working with the concepts of purposes and prediction.  Also, IVDs will be evaluated by the risk classes developed by GHTF (Global Harmonization Task Force) instead of the current list-based system.  Only Class A (low risk) will be exempt from conformity assessment by a notified body (NB).  This change in the risk assessment means changes in conformity assessment as well.  Many IVDs that can be self certified will now need to be certified by an NB.  Estimations put the change from 20% of IVDs now to 80% needing 3rd party certification when the regs come into effect.

Lastly, clinical performance studies will be required to support the CE mark under the updated IVDR as it is currently being proposed.  What does this mean for you?  Likely you’ll need to product significantly more clinical evidence.  You’ll need to be able to prove scientific validity, as regulations move to making you fully responsible for the clinical utility of your IVDs.

When will compliance with the revised In Vitro Diagnotistic Devices Regulation be mandatory?  Unlike the new MDR with it’s probable 3 year transition period, there may be a 5 year “grace” period for you to make the migration from the old regulations to the new.  And of course, should the new MDR Eudamed prove a failure, the regulations to implement it will not be enforceable.

If you’d like additional help in monitoring the new directives and obtaining the supporting standards as they are released, please get in touch with us.  Here at Document Center Inc. we support many medical device manufacturers.  We have a range of services as well as standard sales all geared to improve your compliance for the various certification schemes your product must comply with.  Use our webstore, www.document-center.com, for your purchases.  Or contact our staff by phone (650-591-7600) or email (info@document-center.com) for additional assistance.  Make us your Standards Experts!

Brexit and BS EN Standards

Now that we’re all getting used to the idea that the U.K. has voted to leave the European Union, what about the Brexit and BS EN Standards?  Does the Brexit affect Britian’s participation in CEN and CENELEC and the publishing of the BS EN documents?  Will BSI continue to act as a notified body?  Will it continue to be able to certify your organization’s products for sale within the EU?  Does this rejection of the regulatory burdens placed upon the U.K. by the EU affect British standards making?

For those of you who have referenced BS EN standards in your product documentation, you can breathe a sigh of relief.  While there will be some changes, the U.K. will remain within the CEN and CENELEC standards making process.  BSI should continue to adopt and distribute the BS EN standards.  And should their status as a notified body be withdrawn, they will surely find a notified body that they can represent in order to continue their certification activities.

How can this be?  Doesn’t the Brexit mean that the U.K. will not be a part of the European Union any longer?  Actually, there are several non-EU countries already participating in both CEN and CENELEC.  These include Iceland, Norway and Switzerland as well as candidate countries Macedonia and Turkey.  This is done by way of particiation in the European Free Trade Association (EFTA).  There is no suggestion as yet that the U.K. would pull out of this group.

There will be one notable result of leaving the EU for Britian:  It won’t be involved in the formal discussions in CEN and/or CENELEC on the needs of the EU with regards to any specific standard.  It will also be out of any discussions about mandates or decisions about harmonized standards.

So while Britians may be thinking that the Brexit vote will reduce the regulatory burden, this will be true only to a limited extent where goods and trade is concerned.  Part of the requirements that accompany national participation in CEN and CENELEC mandates adoption by a specific date.  They also dictate that duplicating or conflicting national standards be withdrawn by a specific date.  So while certain domestic regulation will again revert to the nation, much of the overhead of compliance with EU Directives and the Harmonized Standards system will remain.

Should you be concerned or want to use EN standards from an alternative European source, please get in touch with us.  Here at Document Center Inc. we have a number of options for you with regards to your EN standards.  Take a look by searching for standards at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!