How are standards written?

Here at Document Center Inc., our goal is to help our customers and others become better standards users.  But many people don’t even know what standards are.  So I use this space to answer some of the basic questions about standards and standardization.  “How are standards written?” is one of those questions.

Why is it important to know how standards are written?  As a standards user, you’ll become very familiar with one or more standards.  You may have questions about the technical content.  Or you may find something that you think should be corrected.  (I’ve found mistakes in standards before!)

Knowing the standards process can be helpful when you’re implementing standards.  It will provide you with guidance on how and where the requirements matter.

First, what are standards?  The easy answer is that they are technical documents used to describe a material, a test, a product, a process or a service.   By adhering to these “norms,” the things around us are safe and are interoperable.

Who usually writes standards?  Standards are usually written by National Standards Bodies (NSBs) or by Standards Developing Organizations (SDOs.)  These groups can be developing standards to promote safety for those folks within their jurisdiction.  Or their goal may be to promote safety and interoperability for products and services within their industry.

How can standards like this be developed?  Standards are usually written as “consensus” documents.  They are written by a variety of experts.  When a standard is developed, the goal is for the standard to meet the needs of all interested parties, both technical and lay.

This means NSBs and SDOs first serve an administrative function.  When the need for a standard is put forward, they need to find experts from many areas of society to work on it.  Good standards practice requires the input of all those who might be affected by a given document.

Different groups have different development processes.  But standards usually pass through a number of common benchmarks.  First is the committee draft.  This is the initial pass at standardization, used within the committee to iron out differences and goals of the participants.  It may go through a number of changes until the committee is satisfied.  At this point, the draft will normally be issued for “public review.”

All standards users with critical interest in specific areas of standardization should pay attention to these public review drafts for standards in their industry.  This is the time when anyone not on the committee can bring forward comments and concerns.  Committees usually take a look at all comments.  They will determine if a given comment necessitates a change to the standard.

When a draft standard has made it through the public review stage, it is normally brought forward to the SDO or NSB’s membership or other authorizing body.  At this point, the source organization votes or has some other mechanism for adoption.  If accepted, the document is now a final draft.

Final drafts head off to the organization’s publications department for layout and other editorial corrections.  Soon afterwards, the publication of the accepted standard is made.  Now the document has official status and can be used legally.  Drafts do not have the same legal authority as the published standard.

Review of standards on a five-year basis is starting to become the industry norm.  If there are no technical changes, a committee will usually have a reaffirmation or reapproval status to use.  Technical updates can be released in a number of ways, depending on the organization’s processes.

Some things I’d like you to note.  Most standards are developed by committees.  There is usually a committee chair and many times an administrative liaison.  Most SDOs make some information on these committees public.  Certainly, if you have a question, correction, or other concern, most organizations can help you contact a technical expert or authority connected to the committee.

When our customers have these types of questions, we often do the legwork to help them find the correct contact.  We do have many friends in high places within the standards world.  So we are able to help you either pass your information along or get in touch with the appropriate person.  (Connect with us by phone (650-591-7600) or email (info@document-center.com).

Standards developers want your input.  If your company is going to be impacted by a developing standard, the committee would like your participation.  Standards are only as good as the people who are writing them.  In fact, many times committees not only need technical experts, but also public emissaries.  The point of view of the user is valid and desired in many standards organizations.

I hope I have shed some light on the question, “How are standards written?”  And I hope I have encouraged you to be a more participatory standards user.  Standards are living documents.  They change over time.  And they are sensitive to changes within society and the environment.  When you use a standard, please take a moment to share any concerns or questions with the standards developer.  Only in this way can standards continue to positively impact our world.

 

JESD 659 for Reliability Monitoring Updated

JESD 659, Failure-Mechanism-Driven Reliability Monitoring, has just been revised. The new Revision C is available from Document Center Inc. in both paper format and for pdf download.  You can even get a copy as part of our Standards Online cloud access subscription service.  This standard is used to monitor component and subassembly reliability in the electronics industry.

A part of a statistical process control (SPC) system, many reliability metrics are focused on a stress-driven approach.  The JESD 659 differs from this, with metrics for monitoring failure mechanisms.  What might these be?  They can be intrinsic (wearout and systematic) and extrinsic (defect-base) sources of failure.

How does it work?  The supplier must assess all failure mechanisms that significantly contribute to the failure rate in the field.  Then a monitoring test for each needs to be set up.  So the JESD 659 reviews process controls, identification of failure mechanisms, when to establish a monitor, what is included, your control action system, and how to optimize your monitor(s).

Of course, those of you using the JESD 659 Revision B will want to know what changes have been made in the new Revision C. Luckily for you, the authoring committee has provided you with an informative Annex A with your answers!  This Annex reviews the differences in the two editions.  But do note, the new Revision C is a significant revision and simplification of  the previous document.

Now you need your copy.  Consider purchasing it from Document Center Inc., an authorized distributor of the JEDEC standards.  Why?  You’ll get a variety of delivery choices, plus our best-in-class notification service for future changes is included at no additional charge.

For those of you in the electronics industry, you’ll also be pleased to learn that Document Center Inc. has a wide variety of standards geared towards your industry.  We are also authorized distributors for IPC and have a complete collection of MIL and SMD drawings in our catalog as well.  Search for and order the publications you need at our webstore, www.document-center.com.  Here is a direct link to the order page for JESD 659 for your convenience.

Document Center Inc. has been selling standards from our Silicon Valley location since 1982.  With over a million documents from world-wide sources, we’re both convenient and a knowledgeable resource.  Reach out to us by phone (650-591-7600) or email (info@document-center.com) for additional information on our many support services.  And make us your Standards Experts!

Major Changes for the 2017 Boiler and Pressure Vessel Code

The 2017 Boiler and Pressure Vessel Code (BPVC) is coming soon and you can pre-order your copies of the sections you use now from Document Center Inc.  And ASME has provided us with a copy of the 40-page synopsis of the major changes to the code.  We’re happy to pass it on to you.  If you need more detailed information, we have that too.

How do you get your copy of the Major Changes for the 2017 Boiler and Pressure Vessel Code?  Sign up for our newsletter at the lower left hand corner of this page.  You’ll automatically get a copy of the detailed review.

Want even more information?  Check in with our staff by phone (650-591-7600) or email (info@document-center.com).  We’ll get your the information you need from ASME and forward it on to you.

What is the Boiler and Pressure Vessel Code?  It is one of the most widely used engineering standards in the world.  First issued in 1914, it originally focused on stationary steel boilers.  As with many standards, several serious events triggered it’s inception.  In this case, there were a number of boiler explosions in Massachusetts that drove the need for safety requirements.  The Code has since expanded into 12 Sections, including extensive safety standards for the nuclear industry.

How often is the Code revised?  The BPVC is updated on a 2-year cycle now in contrast to the previous 3-year cycle.  As part of ASME’s focus on safety, the information on the major changes of new revisions is routinely made available.  To get an idea of the information provided, take a look at the posts that we issued when the 2015 Edition was released three years ago.  Here’s the link to the post on Sections 1 to 5, Sections 8 and 9, and Sections 10 to 12.

As with most industry codes and standards, all development of the content is done by subject matter experts.  Updates reflect the constantly changing environment and technologies impacting boilers and other pressure vessels.  It is essential to keep up with the updates to ensure safety when working with this type of equipment.

To get your copies, head to Document Center Inc.’s webstore at www.document-center.com.  Here is a link to the page devoted to the 2017 Boiler and Pressure Vessel Code.  You can also order directly from this page.

You’ll be pleased to know that Document Center Inc. has a wide range of support services for your compliance requirements.  Our notification service is best-in-class and is free with the purchase of any standard in our catalog.  We have been selling standards since 1982 and know what you need to meet best practices benchmarks.  Make us your Standards Experts!

 

What ever happened to ISO 594?

In any industry, standards that have been in place for many years sometimes get replaced by entirely new documents as technology or requirements change.  That’s the case with the ISO 594 series on Luer Connectors for Medical Devices.  Over the years, industry realized that existing standards were not meeting current risk management benchmarks.  So the ISO 80369 standards (ISO 80369-7 specifically) for small-bore connectors for liquids and gases in healthcare applications are being developed.  Let’s take a look at the new documents and discuss the rationale for the new publications.

Medical Device manufacturers and health care professionals have committed to the principles of identifying hazards and risks posed by both intended use and foreseeable misuse, and to eliminate or reduce such risks by safe design and construction.  So for small bore connectors used in healthcare, the ISO 80369 provides guidance using this new concept.

The overview standard, ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements, replaces the EN 15546-1.  It contains general requirements to be used with the other parts.  It explains that the series is being produced to avoid mis-connection between small bore connectors used in different applications.  In the introduction, the committee points out that in some coronary care units, there can be as many as 40 luer connections used on medical devices for just 1 patient!  No wonder the industry decided to find a systemic solution for the problem.

It is the intention of the joint working group that has oversight of these publications to deliver a total of 8 standards for the series.  So far an additional 4 have been released. Let’s take a look.

ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications.  This publication was developed to help avoid catastrophic mistakes involving either medication errors into the alimentary canal, or administration of enteral solutions via incorrect routes.  There was no previous standard on this.

ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications.  Issued for similar reasons to the Part 3 — With the errors involving vincristine in this case.

ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications.  This is the part of the series that specifically replaces both the ISO 574-1 and the ISO 574-2.  The material in the older standards is consolidated and technically revised.  There are 4 major technical updates identified by the authoring committee:

  • New terms and definitions better define various luer connections,
  • Requirements are included for new dimensions, developed specifically to reduce the mis-connection risks the series aims to mitigate,
  • Older gauging requirements have been replaced by dimensional ones.  Again, this results in more precision (necessary for risk reduction), and
  • Division of requirements for semi-rigid material connectors and those made from rigid materials is now part of the standard.

The more rigorous design requirements are specifically included to make sure that the increased number of connectors, each for a specific use, cannot mate incorrectly.   And these new specifications will also insure that correct connections will be safe and secure.

ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods.  This was the second standard in the series to be issued.  It specifies the test methods you should use in order to evaluate the performance of any ISO 80369 connectors.  Validating performance through the use of appropriate test methods is essential to confirming your design choices.  Failure to do so may result in non-conformance, which in the case of these connectors can lead to catastrophic results.

What other standards are expected in this series?  Here are the Parts which are not completed at this time:

Part 2:  Connectors for breathing systems and driving gases applications

Part 4:  Connectors for urethral and urinary applications

Part 5:  Connectors for limb cuff inflation applications

If you need one or more of these standards, please head to the Document Center Inc. webstore at www.document-center.com.  You’ll be able to search and order from our catalog of over 1 million publications.  Many obsolete editions are available should you need to reference a historical document.

We also have a number of products and services to help you keep your compliance documentation in good order.  Ask us about our notification services, delivery options, company-wide cloud subscription solutions, and our various reports.  We have been working with standards since 1982.  Make us your Standards Experts!

ISO 10993-4 Revised – Testing for medical device interaction with blood

ISO 10993-4, Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood, has been revised.  The new 3rd Edition is available now from Document Center Inc.  The standard is one of the critical ISO 10993 series on biological evaluation of medical devices, used around the world.  The new update replaces the previous 2nd Edition with Amendment 1.  It is a technical revision.

Medical devices have generated a revolution in healthcare, but they do come with hazards.  One of the most critical is any interaction a medical device can have with the patient’s blood.  Thrombosis is a critical risk, so all efforts must be made to reduce any material or mechanical dangers.  This risk reduction is confirmed by the use of specialized tests.

ISO 10993-4 contains these tests and the criteria for choosing the ones best suited to any identified risks.  It does this by defining a classification system for medical devices intended for use in contact with blood.  It provides the principles to use in evaluating this type of interaction.  And it provides you with the rationale for choosing specific tests for your product.  The details of each test are found in other test method documents.

Changes in this new revision are extensive.  A synopsis is found in the forward to the publication.  Some highlights include:

  • Modification to the definitions clause (including new definitions).
  • Tables 1 and 2 have been consolidated, as have Tables 3 and 4.
  • The Annexes have been renumbered and rewritten.  Additional information on mechanically-induced haemolysis is also added to Annex D (formerly Annex C.)
  • New Annexes cover complement testing and best test method practices, less common tests, and in vivo thrombosis.
  • Language has been refined throughout the standard.
  • the Bibliography has been reorganized and expanded.

If you use this standard, you’ll want to get your copy soon.  It’s available in paper format or for pdf download at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 10993-4 for your convenience.

ISO 10993-4 has been adopted by any number of jurisdictions, most notably in Europe.  If you’re using an EN edition, you can expect adoption of the new edition.  Since the process may take a while, you may want to get a copy of the ISO edition now, since it will be adopted without changes.

Document Center Inc. has been an authorized distributor of standards from around the world for many years.  You can order from us with confidence.  And you’ll be surprised at the many services we offer standards users like you.  To learn more about our best in class notification service, our cloud-based enterprise subscription solution, and our array of reporting services, get in touch!  We can be reached by phone (650-591-7600) or email (info@document-center.com).  You’ll soon learn why so many companies make us their Standards Experts!

IEC 62115 for Electric Toys updated

IEC 62115, Electric toys – Safety, has been updated.  The new Edition 2.0 is available from Document Center Inc. now.  It is a technical revision and replaces the previous 1st Edition (including Amendments 1 and 2).  The 202-page standard is used for the safety of toys that make use of electricity in some way, including batteries.

IEC 62115 was developed in order to reduce risks when children are playing with electric toys.  You’ll note that these types of toys are labelled for specific age groups.  So there are issues created by toys being given to children who are too young.  But like all products that use electricity, even when used appropriately, there can be dangers that are not obvious.   So while the standard can’t reduce risks to zero, it provides testing criteria that will spot issues that could present avoidable risks for children using a given toy.

What are the changes in the new Edition 2.0 for IEC 62115?  The committee points to the following areas of the standard in the forward:

  • In Clause 5, the general conditions for tests have been reworked.
  • In Clause 6, criteria for reduced testing has been changed.
  • Clause 7 warnings have been added for toys using button batteries and coin batteries, and for ride-on toys.
  • Clause 13 has requirement changes for the accessibility of batteries.  Requirements to cover toys placed above a child or connected to other equipment have been added.
  • Annex E safety requirements for toys with optical radiation sources have been changed.  Measurement details have been updated.
  • Annex I on integrated field source generating EMF measurements added.
  • Annex J added for safety or remote-controls for ride-on toys.

The IEC 62115 is an essential toy safety standard for many manufacturers.  If you design or manufacture these products, you’ll need a copy of the new standard soon.  The committee suggests that your toys need to meet this new Edition within a 12 to 36 month time frame.  Various jurisdictions may have other transition requirements.

To get your copy of this standard (or any of the other 1 million documents we have in our catalog), please go to our webstore at www.document-center.com.  Search for and order the items you need with confidence.  Here is a direct link to the order page for IEC 62115 for your convenience.   And take a look at our Document Center List of Standards on Toys while you’re there!

You can order your copy in either paper format or for pdf download.  If you’d like extended access rights for your organization, check in with us.  Our Standards Online cloud-base subscription service may be just what you’re looking for.  Reach us by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards since 1982 and are a trusted authorized distributor of these compliance publications.  Make us your Standards Experts!

ISO 16192 Updated for Space Systems Lessons Learned

ISO 16192, Space systems – Experience gained in space projects (lessons learned) – Principles and guidelines, has just been updated.  As space systems and programs move into the commercial sector, the need for international standards in this area increase.  Making use of lessons learned is an important contributor to decreasing risks and losses within the industry.

The United States is an active participant in standards development in the aerospace sector.  For example, the ISO 16192 is “owned” by Technical Committee 20 under the ANSI (the American National Standards Institution) secretariat.  Chris Carnahan from AIA is the secretary.  Subcommittee 14 on Space Systems and Operations is chaired by Paul Gill from NASA.  In speaking with Paul recently, I learned that many of the work items in this sector are being brought forward for standardization by the Chinese.

The 2017 Edition of ISO 16192 is a technical revision of the previous 2010 publication (now obsolete).  The document reviews the basics of the lessons learned activities — management, process, data collection, implementation, and effectiveness.  Annex A provides you with generic “lessons learned” forms.  Annex B is a shorter form as an alternative.  A 2-item bibliography completes this 20 page standard.

The committee points out two primary areas of changes:

  • Clauses 2 and 4 have been reorganized for clarity and reduction of duplication.
  • Annex A now covers only the form.  Other informative text has been moved to Clause 4 (regarding the lessons learned process itself).

Development and deployment of space systems is certainly a growth area out here in Silicon Valley and other areas of the U.S.  If your organization is involved in this activity, you’ll want a copy of this new publication.

Head to the Document Center Inc. webstore to get your authorized edition of the new update.  You can search for and order any of 1 million standards there at www.document-center.com. Here is a direct link to the order page for the ISO 16192 for your convenience.  And you may want to take a look at the Document Center Inc. List of Standards on Space Systems and Operations as well.

Should you have additional questions or need help managing your compliance documentation, get in touch with us.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We’ve worked with customers in the aerospace industry since 1982. Make us your Standards Experts!

ISO/IEC 17021-3 Auditor Competence Standard updated

ISO/IEC 17021-3 for the competency of quality auditors and auditing teams has been revised.  And now it’s a standard rather than a technical specification like the previous 2013 Edition.  There are a number of technical changes that you’ll want to review and implement.

The title of the new ISO/IEC 17021-3 is Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 3: Competence requirements for auditing and certification of quality management systems.  As with many of the quality management systems (QMS) standards, it has been impacted by the release of the ISO 9001 2015 Edition.

Here are some major changes you’ll find in the new 17021-3:

  • Additional competency requirements have been added to support the modified requirements of the new ISO 9001.
  • The view of fundamental concepts, principles, and their application has been expanded.
  • Increased knowledge of the leadership role in QMS focused organizations is included.
  • Improved criteria have been added for understanding the context of an organization.
  • The need for competency in the area of risk management and risk-based thinking is included.

Remember, ISO/IEC 17021-3 complements and supports the use of the ISO/IEC 17021-1 on the competence of folks involved in the certification process defined by Clause 7 and Annex A.  When you choose your certification body, you have every right to expect the level of competency found in ISO/IEC 17021-3.

A review of the standard will give you an idea of what to expect in the knowledge level for the following areas:

  • QMS concepts and principles
  • Organizational context
  • The level of understanding of your products, services, processes and organization

If you’d like a copy of this new standard, head to the Document Center Inc. webstore at www.document-center.com.  Here you can search for the publications you need from our catalog of over 1 million records.  For your convenience, here is a direct link to the order page for ISO/IEC 17021-3.  Rest assured, Document Center is a long-time authorized distributor of the ISO and IEC standards.  Your purchases can be made with confidence and security.

Many of you have questions about standards or about our many additional products and services.  If this is you, please get in touch with us by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards since 1982.  We know the challenges you face when working with this type of compliance documentation.  So you have maximum flexibility in how you purchase and receive your  documents when using Document Center Inc.  Make us your Standards Experts!

ASTM E122 updated for calculating sample size

ASTM E122, Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process, has just been revised.  The new 2017 Edition updates the previous 2009 Edition (with an editorial correction), which is now obsolete.  The standard covers a number of simple methods for calculating unit values for valid sampling.  ASTM E122 is one of our all-time best-selling sampling and process control standards!

Sampling is a proven methodology used extensively in quality and process control.  In order to have valid results, you need to understand how many units need to be used in order to achieve a specified precision.  And accuracy depends both on the units chosen and the time interval.  This practice was developed so you have the tools to measure variability.

It’s been a while since the ASTM E122 was revised.  You’ll find corrections in a number of areas.  First, the scope paragraph is expanded to include information on the system of units for the standard.  Also, a disclaimer assures the user that the standard was developed in accordance with standardization principles accepted by the WTO Technical Barriers to Trade Committee.

A new definition of pooled standard deviation has been included.  A number of equations have been changed.  At the end of the publication, a new clause 12 for keywords has been added.

If you want to have more information on these changes, you should purchase the redline edition of the document from us.  With this option, we provide you with both a clean copy of the 2017 Edition plus a marked-up copy of the 2009 so you can clearly see each modification.  Just go to the Document Center Inc. webstore at www.document-center.com.  Here is a link directly to the order page for ASTM E122.

When you place your order, request the redline in the order comments area.  It will cost you 20% more and save you a lot of time and headaches!

Many of our customers need additional assistance.  So our staff is very knowledgeable about the standards themselves.  You’ll also find that we have a number of services and products geared to help you maintain your compliance documentation collection.  You can even get cloud access to your standards library using our Standards Online subscription service.  Contact us for more information by phone (650-591-7600) or email (info@document-center.com).  Make us your Standards Experts!

ISO 10007 Updated for Configuration Management Quality

ISO 10007, Quality management – Guidelines for configuration management, has just been updated.  The new 3rd Edition cancels and replaces the previous 2nd Edition from 2003.  It has been released in order to bring the requirements in line with the ISO 9000 and ISO 9001 2015 Editions.

Configuration management is used to meet product and service identification and traceability requirements, like those in ISO 9001 subclause 8.5.2.  It is the management and control of information for product or service  design, manufacture, verification, operation and/or support.  It makes use of such tools as change control, status accounting, and configuration audits.  It is a management activity with both technical and administration requirements, used over the lifecycle of a product or process.

Like other quality management standards, the document begins with the usual scope, referenced documents, and definition sections.  Then responsibilities and authorities for configuration management are reviewed in Section 4.  Clause 5 covers the configuration management process itself.  Annex A provides information on the structure and content of a configuration management plan.  A 3-item bibliography completes this 18 page standard.

Configuration management is a critical activity in many organizations, both large and small.  The standard can be used by them all to improve performance.  And certainly if you’re ISO 9001 certified and are using this standard, you’ll need a copy of the new ISO 10007 2015.

Use an authorized distributor for your purchase.  Order with confidence at Document Center Inc.’s easy-to-use website, www.document-center.com.  We have over a million documents from around the world.  Here is a direct link to the order page for ISO 10007 for your convenience.

The original 1st Edition of ISO 10007 was adopted as an EN standard.  However, when the ISO 10007 was revised in 2003, the adoption was dropped.  It is not clear if the new edition will be part of the European standards set with this new release.

If you have any additional questions or need to know if there is a configuration management standard specifically for your industry sector, please get in touch.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We have many additional services to help you with your document control function.  And our knowledgeable staff can answer many of your standards questions.  Make us your Standards Experts!