Hot Topics in Standardization Archives - Page 10 of 10

Is BS-EN-ISO-14971 identical to ISO-14971?

Here at Document Center Inc. we have bought in to the concept of “One Standard, One Test, Accepted everywhere”, the theme of World Standards Day 2002.

So when BSI, the British Standards Institute, states that BS-EN-ISO-14971 (Medical devices. Application of risk management to medical devices) is identical to both EN ISO 14971:2009 and ISO 14971:2007, we believe it.

However, we’ve heard of a couple of cases where auditors at customer sites have not accepted the ISO-14971 2007 Edition as being equal to the BS-EN-ISO-14971 2009 Edition for use in certifying to the EU Medical Device Directive.

We are putting out a call to the auditors themselves to see if we can get clarification on why the documents are not interchangeable for purposes of meeting the EU Directive requirements.

Having to purchase multiple copies of a single ISO standard to meet certification requirements for different jurisdictions is problematic. The costs can rise rapidly and references to multiple versions of a document can be cumbersome and difficult to manage when updates are made.

Do you have an opinion on this? Are you an auditor who can speak with authority on this issue? We ‘d love to hear from you.

Claudia Bach, President, Document Center Inc (www.document-center.com)

The AS-5553 helps manufacturers avoid using counterfeit electronic parts

The SAE standard AS-5553, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition, was released in 2009 to help manufacturers avoid the use of counterfeit components. With electronic component fakes posing an increasing threat to U.S. manufacturing, from military to medical devices, the standard supports processes geared to counterfeit avoidance and discovery.

The problem of counterfeit parts is plaguing both the military and private sector. U.S. customs has seized 5.6 million counterfeit chips between November 2007 and May 2010, with untold millions getting though anyway. As reported by the San Jose Mercury this month, 3,868 counterfeit incidents were reported in 2005 where the military and its suppliers found bogus electronics. By 2008, that number had risen to 9,356.

AS5553 is designed for use by aerospace and military manufacturers and contractors. It provides uniform requirements, practices and methods to mitigate the risk of receiving and installing counterfeit electronic parts. Of course, no standard can guarantee that counterfeit components will be avoided, but the document does provide a framework for minimizing risk.

As such, the SAE G-19 committee developed a set of requirements, practices and methods geared to provide benchmarks for parts management, vendor management, procurement, inspection and test evaluation and of course, what to do when counterfeit parts are discovered.

Both NASA and NAVAIR have adopted the use of this standard already. And studies this year by the Department of Commerce and by the GAO (Government Accounting Office) have again pointed out the vulnerability of the military to “knock-off” electronic chips.

Military contractors and others should be proactive in developing defensible and effective practices for avoiding the use of fakes in commercial products. Bogus electronics pose a real threat to the population at large and to the military in particular.

You can buy a copy of the AS-5553 from Document Center Inc. on our website at www.document-center.com, or by email at info@document-center.com, phone at +650-591-7600 or by fax at +650-591-7617. The document is in stock for immediate shipment.

Out of Sync — Why EN-ISO’s are changing and the core ISO’s are not…

There’s been a lot of confusion in the standards-using community over recent EN-ISO revisions just issued on some very popular ISO titles. Some examples? The EN- ISO-10993 series is out in 2009 Editions, while the ISO-10993 series itself hasn’t changed. Another? EN-ISO-11607-1 was upgraded to a 2009 Edition replacing the 2006 Edition, yet still remains identical to the ISO-11607-1 1st Edition from 2006.

How can the EN adoption of the ISO come out in a new edition and still be identical to the original ISO document?

Here’s the reason — The EN (European Union) administrative information has been modified, which has prompted the revision of the document even though the ISO document which it adopts remains the same.

So for the EN-ISO-11607-1, the change is the addition of Annex ZA, which is an informative annex only. This 1 page addition to the document has a table which identifies the relationship between the EN-ISO-11607-1 and the essential requirements of EU Directive 93/42/EEC.

How about the EN-ISO-10993-1? It has the insertion of 2 Annexes, both informative: ZA, again on the relationship between this standard and the EU Directive 93/42/EEC, and ZB, on the relationship of EN-ISO-10993-1 to Directive 90/385/EEC.

The rest of the EN-ISO-10993 series has been revised for the very same insertions.

If you reference the EN-ISO documents in your documentation, you are required to purchase the new revisions or risk being out of compliance.

If you reference the source ISO standards instead, no revisions are necessary, as the underlying ISO documentation remains stable.

More questions? Contact us at info@document-center.com or check out the website at www.document-center.com.

Attack of the Clones: Why are there so many versions of some ISO standards?

Here is a question I get asked all the time: “Which standard should I use: ASQ-Q9000, ISO-9000 or BS-EN-ISO-9000?”

And every day I look at the 2002 poster for World Standards Day with the tag line “One standard, One test, Accepted everywhere.”

So the question is, why are there so many editions of some ISO documents when our stated goal is to just have one?

To get to the bottom of this question, we’ll be talking about 3 concepts: Jurisdiction, Adoption, and Translation. When we get done, you’ll at least know the reason for the many “clones” of some of the most widely used ISO standards.

First of all, the concept of jurisdiction. The ISO standards are meant to be International Standards, hence ISO, International Organization for Standardization. However, there are other jurisdictions as well — Regional (like the European Union) and National (like the United States).

You might think that once an International Standard is published, everyone should be free to use it and that would be the end of the story.

But no — In the European Union, for example, regional standards are a response to legal regulation (the directives). In order to assure legal compliance to regional regulation and laws, EN standards are created as designated by applicable directives.

If an ISO document meets the requirements of a particular directive, it can be adopted by the European Standards Body (CEN). Then, it is published for public distribution by each country in Europe as the document is implemented. That way, it is clear which countries are in compliance at any given time.

So, with the ISO-9000, EN adoption creates 27 differently numbered documents (like, BS-EN-ISO-9000, the official English language edition, DIN-EN-ISO-9000, the official German language edition, and so on), one for each country in the European Union.

ISO standards are also adopted by countries as well as regions. An example of this is the Canadian Standards Association document CSA-ISO-9000. In this case, the ISO-9000 is republished when Canada adopts the standard, at the national rather than regional layer of jurisdiction.

One feature to pay attention to is the fact that the ISO standard will be reprinted in it’s entirety when adopted, but will have cover sheet administrative information as well in most cases. This information may be about what national documents were withdrawn in favor of the ISO or EN adoption, or when the standard must be implemented by users.

And lastly, a country that is involved in the development of an ISO standard has the right to republish the document as a country-specific translation. So, because ASQ (the American Society for Quality) participates for the U.S. in the Quality committee at ISO, the ASQ-Q9000 is the U.S. translation of the ISO-9000. The U.S. translations are almost word-for-word identical to the English language ISO originals — the only difference is that the ISO standard uses British English spelling, and the U.S. uses American. So if an ISO standard includes the word “colour” the U.S. translation would have the word spelled “color.”

So in 1992, there were 42 adoptions or translations of ISO-9000 in existence. In 2002, 134 countries were issuing certificates of compliance and in 2007 there were 175 countries counted.

Our advice to customers is to use the highest level of jurisdiction whenever possible, because it will be revised first at the highest level. So for the ISO-9000 standard series, ISO (the international jurisdiction) will be the first to issue technical content changes. All adoptions and translations will happen after the initial ISO release.

However, sometimes there are reasons to choose other editions. If cost is a factor, a national translation may often be the least expensive way to go, as all revenues go to the publishing organization only, as a way to cover the costs of committee participation.

Another reason to choose a different edition is to cater to either an important customer or a particular auditing body. If your auditor is from BSI, you might choose the BS-EN-ISO-9000 series so that your auditor is impressed by your concern to follow the administrative information that is published in the adoption section of the publication. If you do business in Australia, you might use the AS/NZS ISO 9000, the Australian/New Zealand joint adoption of the ISO standard.

This is always a hard concept for many people to understand. If you’ve still got questions, please ask us by emailing us at info@document-center.com.

For our next blog, we’ll be looking at this same issue but from a different viewpoint. I’m getting a lot of questions about why EN adoptions of ISO standards are coming out with new revisions when the ISO documents remain unchanged. So, until next time…

Health Informatics — A Classic Standards Tale

What makes a classic standards story? Money, politics, dueling committees — listen, health informatics has it all!

Standards for Electronic Medical Records (EMR, also known as Electronic Health Records, EHR) are just a new development in a process that has been going on in the medical industry for some time. Frankly, many of the document formats and records management protocols in recent years have been in response to the medical sector’s heavy investment in technology to improve patient care.

But with the entry of the U.S. Federal government into the fray with the e-Health initiative that is part of the stimulus package, we’ve definitely entered a new era for standards development and EMR products. The recent release of the Department of Health and Human Services’ RIN 0991 – AB58 (Interim Final Rule on Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology) makes it clear that the Federal Government is going to be a big player in this process.

Let’s see, money… Health Informatics has already been identified as a hot growth sector, with estimates of market being in the range of $1 billion in 2005, with a growth potential of $4 billion in 2013. But, with regulators looking to mandate the use of EMR to submit Medicaid and Medicare transactions, the estimates could be significantly understated.

Politics? The government’s stated intention to become a major user of EMR has generated responses from Doctors, Health Care Privacy organizations, and from the Standards Organizations that are already involved in this work. Believe me, the idea of electronic health records in the hands of government bureaucrats gets some people going. Add to this the draft stimulus package’s requirement to use EMR-generated databases to provide “biosurveillance,” and life gets exciting!

And of course, no standards classic would be complete without competing standards. Like VHS and BetaMax, there are 2 sides to this story. ASTM is on one side, with the CCR Standard (Continuity of Care Record) and Health Level 7 (HL7) is on the other with CDA (Clinical Document Architecture) and CCD (Continuity of Care Document).

It appears the the ASTM-led effort has produced a Standard that is less complicated and is used successfully in software products geared for private physician practices. The HL7 set has been implemented for larger scale products aimed for hospital applications. And wouldn’t you know it? Google and Microsoft are getting into this business, with the Google application being based on CCR and Microsoft’s using both the CCR and CDA/CCD approaches!

But wait! RIN 0991-AB58 suggests that the Dept. of Health and Human Services (DHHS) is going to sponsor a whole new round of standards development in order to satisfy newly issued government requirements. Thank goodness the American National Standards Institute (ANSI) has created a Standards Panel (HITSP) in the hopes of providing assistance to keep everything straight. Looks like it’s just another day in the wonderful world of Standards….