New ISO 50003 – Auditor requirements for Energy Management Systems

October 23rd, 2014

You’ve decided that you’re going to maximize your usage of energy by setting up an Energy Management System (EnMS).  Now, how do you go about following up to confirm that you’re hitting your goals?  Remember, for quality the mantra is PDCA – Plan, Do, Check, Act.  The ISO 50001, “Energy management systems – Requirements with guidance for use,” has provided you with the basis for both planning and doing.  And the ISO 50002, “Energy audits – Requirements with guidance for use,” has shown you how to check.  But how do you evaluate the folks who’ll be doing the checking?  The new ISO 50003, “Energy management systems – Requirements for bodies providing audit and certification of energy management systems,” provides the answers.

Of course, if your organization does energy audits for others, you’ll need to review this standard to confirm that your staff and processes are in compliance.  But if your organization is going to enter into an agreement with a certification body for auditing, you’ll also want to take a look at this new document.

How would ISO 50003 be helpful to you?  You’ll get an overview of the requirements for the audit planning process, the initial certification audit, the on-site audit, the duration of the audits and multi-site sampling.  You’ll also get a definition of the auditor competence, which will be helpful in setting your own expectations.

Some other helpful features of ISO 50003 are a discussion of the various stages of an EnMS audit in Clause 5.  There’s a table with information on the required EnMS knowledge expectations for the auditor in Clause 6.  Also, Table 2 reviews “technical areas,” a way to classify organizations undergoing auditing to provide a sample of the types of energy uses that are typical for each.  An example would be Heavy Industry, which can include chemical plants, oil refining, semiconductors, ship-building, and so on.

The three Annexes supply additional information (and requirements) for the duration of the EnMS audit, multi-site sampling, and the topic of continual improvement for energy performance.  An eight item bibliography rounds out the publication.

Now you’re interested in EnMS and the auditing process, and you know you need to get the standards in the series.  What’s the next step?  You’ll need to choose an authorized dealer in order to make your purchase.  And for this, you’ll find Document Center Inc. to be your best choice.  We’ve been providing standards from our Silicon Valley location since 1982 and have been on the web since 1993.

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New ASME B31.8 Code for Gas Transmission

October 22nd, 2014

ASME B31.8 covers gas transmission and distribution piping systems, including gas pipelines, gas compressor stations, gas metering and regulation stations, gas mains, and service lines.  Now there’s a new 2014 Edition available from Document Center for this Code, as well as a 2014 update for the companion supplement, ASME 31.8S.

ASME B31.8 is updated on a regular basis.  The last edition was in 2012 (FYI: that revision is now  obsolete and withdrawn).  The Code covers the design, fabrication, installation, inspection, and testing of pipeline facilities used for the transportation of gas. It also covers safety aspects of the operation and maintenance of those facilities.

Titled “Code on Gas Transmission and Distribution Piping Systems,” ASME B31.8 is  applicable up to the outlet of the customer’s meter set assembly. You’ll use it for gas transmission and gathering pipelines, including those that are installed offshore for the purpose of transporting gas from production facilities to onshore locations.  It also covers gas storage equipment of the closed pipe type that is fabricated or forged from pipe or fabricated from pipe and fittings as well as gas storage lines.

The supplement, ASME B31.8S, was written to provide you with the information necessary to develop and implement an effective integrity management program.  Such a program can decrease repair and replacement costs, prevent malfunctions, and minimize system downtime.  Considering the downside to failures of such a system, it makes good sense from personnel and community viewpoints as well as from a business perspective.

Now you need copies of the new updates.  Turn to Document Center for your purchase.  You can order them at our web store at www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing standards to industry from our Silicon Valley location since 1982.  Make us your Standards Experts!

ISO/IEC 17788 and ISO/IEC 17789 – Standards for Cloud Computing

October 21st, 2014

You know it had to happen!  Cloud computing is the “hot” technology area and here come the standards!  However, if you’re responsible for developing contracts or fulfilling them, you’re glad of it.  And the new standards I’ll review today cover the basics you need.  ISO/IEC 17788, “Information technology – Cloud computing – Overview and vocabulary,” puts everyone on the same page with regards to concepts and terminology.  ISO/IEC 17789, “Information technology – Cloud computing – Reference architecture,” shows you how the functional layers are structured.  We’ll cover ISO/IEC 17788 and ISO/IEC 17789 separately.

ISO/IEC 17788 (also published as ITU-T-Y.3500) was developed by JTC1′s subcommittee on distributed application platforms and services.  The first half of the document provides you with a list of definitions for 44 terms, as well as other acronyms (FYI: some definitions are taken from other standards).  Then the balance of the standard gives you a review of what cloud computing is, the key characteristics, various roles and activities, and cloud service types.  OK, I thought we’re primarily talking about SaaS (Software as a Service).  But, hey, there’s all sorts of things that can be put on the cloud!  I may be in trouble since Management as a Service is also included (I think that’s my job…)

ISO/IEC 17789 also has been published as an ITU document (ITU-T-Y.3502). There is a brief definitions section followed by Clause 5 on conventions.   Next, cloud computing reference architecture goals and objectives are covered.  Then the standard dives into the heart of the matter, providing you with detailed descriptions and charts to model the user view and the corresponding functional view.  Discussion in Clauses 7 through 10 covers various activities, relationships, and so on.

Annex A delves further into these two views with sections on the relationships between:

  • Customer and service provider
  • Provider and provider (aka “inter-cloud”)
  • Cloud service developer and cloud service provider and
  • Cloud service provider and auditor

A short bibliography of 6 additional standards for further review rounds out this publication.

Now you’ll want to get copies of these two standards.  Head to Document Center’s webstore at www.document-center.com.  Here you can order the standards you need in both paper format and for pdf download.  Want multi-user access?  Ask our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks like you since 1982.  Make Document Center your Standards Experts!

New ASTM A480/A480M and ASTM A484/A484M – Subscription Service Available!

October 20th, 2014

ASTM A480/A480M and ASTM A484/A484M are two examples of ASTM standards that are frequently revised.  So Document Center Inc. would like to suggest that if you use either or both of these publications, you may want to consider purchasing them from us as multi-user licensed subscription standards.  And now is the perfect opportunity, since both documents have again been updated.

FYI: The ASTM A480/A480M, “Standard Specification for General Requirements for Flat-Rolled Stainless and Heat-Resisting Steel Plate, Sheet, and Strip,” is now updated to the 2014b Edition for $62.00.  The ASTM A484/A484M, “Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings,” is now the 2014a Edition for $49.00.

Why would a subscription service be a good option for ASTM A480/A480M and ASTM A484/A484M?  There’s a couple of reasons.  First, a multi-user license means that more than one person can access the standard via the Document Center online portal.  If your organization feels hampered by the usual single-user license that accompanies the usual pdf purchase of ASTM standards, this is a way to open up access throughout the company.  And the additional functionality doesn’t come with a high price!

The other important benefit of the Standards Online subscription service for ASTM standards is the automatic updating feature.  This means that when your standard changes during the period the subscription is in force, your copy is automatically changed to the newest edition at no additional cost to you.  You no longer have to be concerned with frequent updates to these ASTM standards.  They will be processed for you automatically.

The Standards Online service is an annual subscription service which needs to be renewed once a year.  However, the overall costs to you for these ASTM standards that are updating more frequently will be a reduction in cost, an increase in user access, and the reduction of risk posed by out-of-date documentation.

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New EN 1672-1 – Safety Requirements for Food Processing Machinery

October 17th, 2014

Standards pervade the world around us, in ways that we might not be aware of.  Food and food processing is such an area.  Now there’s a new standard for the safety requirements for food processing machinery.  It’s the EN 1672-1 and it’s just been released.  Titled “Food processing machinery. Basic concepts. Safety requirements,” the document provides guidance for the eurozone.  However, many manufacturers of such equipment will want to take note if they sell product into this market.

EN 1672-1 deals with the significant hazards, hazardous situations and events relevant to commercial and industrial food processing machines.  You’ll need to be concerned with situations where your equipment is used as intended and also  under conditions of misuse which should have reasonably been foreseen.  These events can occur during transport, assembly and installation, commissioning, setting, teaching, programming, process changeover, operation, cleaning, fault finding and maintenance.

The standard deals with those risks which occur commonly in food processing machines.  It is expected that common technical requirements can be set which can be applied to all (or most) machines which have that defined  hazard.

Remember, this is not geared for the domestic use product, but for commercial equipment.  And it will also not address packaging machines.

If you need a copy, you can purchase it online at the Document Center webstore (www.document-center.com).  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We have been providing standards to industry since 1982 from our Silicon Valley location.  Make us your Standards Experts!

2015 IATA Dangerous Goods Regulations is here!

October 16th, 2014

The IATA, International Air Transport Association, publishes the Dangerous Goods Regulations (DGR).  It’s updated each year at this time, so for folks who ship products that are classified as hazardous, it’s essential to keep up with the changes.  If you use this manual, you’ll want to purchase the new 56th Edition and you can get your copy from Document Center!  It will be in effect as of January 1, 2015 and includes all changes of the ICAO, International Civil Aviation Organization, for the upcoming year.  And it also contains the IATA’s operational requirements for airlines as well.

What kinds of changes will you find in the Dangerous Goods Regulations 56th Edition?  Here’s a partial list:

  • The GHS (Globally Harmonized System for classification and labeling of chemicals) has been added.
  • Lithium metal batteries are now prohibited from passenger aircraft.
  • There’s new provisions for adsorbed gases.
  • Various terms for restraint systems like air bag modules or inflators have been renamed “safety devices,” electrically initiated or pyrotechnic.
  • If your shipment of environmentally hazardous substances is less the 5 kg per receptacle, it’s no longer subject to regulations.
  • Some restrictions for overpacks have been removed (for cargo aircraft only).
  • Provisions for radioactive materials have been updated in response to the 2012 edition of the IAEA (International Atomic Energy Agency) Regulations for the Safe Transport of Radioactive Material.

You’ll use the DGR to determine if your shipment is considered dangerous.  And if so, you’ll find complete information on the regulations that apply to your products.  With the issue of the safe transport of hazardous material by air in the news, you’ll want to make sure that you’re using the latest information to protect your shipment and those responsible for it during transit.

Order your copy online at the Document Center Inc. webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll find we have a wide range of additional services that will help you procure and maintain your compliance information collection.  Make us your Standards Experts!

IEC/TR 62354, Guidance for Medical Electrical Equipment Testing, Updated

October 15th, 2014

For those of you who use IEC 60601-1 in your business, you know that the IEC/TR 62354, provides you with information on testing for meeting those requirements.  Now the technical report, titled “General testing procedures for medical electrical equipment,” has been updated.  The new 3rd Edition of the publication is available from Document Center now, in paper format or for pdf download.  And it can be included in your multi-user access online subscription service as well.

The IEC/TR 62354 is intended to provide guidance on general testing procedures according to the IEC 60601-1.  So it’s no surprise that it has been updated to align the guidance with the modifications made to the IEC 60601-1 by the Amendment 1 released in 2012.  For this reason, the 3rd Edition of the IEC/TR 62354 is a technical update, withdrawing and replacing the previous 2nd Edition.

What’s new in this revision?  The changes are centered in Section 13, procedures for testing, including particular conditions.

For Clause 13.2, Tests to be performed by inspection, you should particularly review Sections 13.2.1 (risk management), 13.2.4 (durability and legibility of marking), 13.2.5 (battery markings), 13.2.8 (potential equalization terminal) and 13.2.14 (usability of medical electrical equipment).

For Clause 13.3, Measurements and tests performed on non-energized equipment, you’ll need to look at Sections 13.3.1 (humidity preconditioning), 13.3.2 (impedance of PE [protective-earth] connection), 13.3.7 (creepage distances and air clearances), 13.3.12 (instability), 13.3.13 (castors and wheels), 13.3.14 (safety catch evaluation), 13.3.17 (overflow), 13.3.18 (spillage), 13.3.23 (impact), 13.3.24 (drop impact), 13.3.25 (rough handling), 13.3.27 (actuating parts of controls) and 13.3.28 (construction of transformers).

For Clause 13.4, Measurements and tests for equipment that is operating, please review sections 13.4.1 (essential performance – functional), 13.4.3 (voltage mismatch), 13.4.4 (limitation of voltage, current or energy), 13.4.5 (defibrillation-proof applied part protection), 13.4.6 (energy reduction), 13.4.7 (earth leakage current), 13.4.9 (patient leakage current), 13.4.14 (sound pressure level measurements), and 13.4.16 (X-radiation measurement).

You’ll note that some of these sections are new, while others have been revised.

Now to get your copy of this new revision.  Head to Document Center’s webstore at www.document-center.com.  It’s easy to order the publications you need from our collection of over 500, 000 unique titles of specifications and standards from around the world.  Need to talk to an expert before you make your purchase?  Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping folks like you from our Silicon Valley location since 1982.  Make us your Standards Experts!

New FDA Guidance for Medical Device Cybersecurity

October 14th, 2014

Medical Device Cybersecurity has been a hot topic as medical information is increasingly being exchanged electronically, including medical device monitoring.  The FDA has been issuing guidance ever since 1998, when the organization first addressed the issue of software in medical devices.  Now, a new guideline has been released.  Titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” it’s the final publication for a draft that was issued in 2013.  You’ll use it to review how you reduce the risk that your device functionality will be compromised by inadequate software security issues.

The new guidance is intended to supplement the information that’s found in 2 previous FDA guidance documents:  ”Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” and “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”  It’s divided into various clauses, beginning with an introduction and then a scope paragraph.

Next is a definitions section, Clause 3, which relies heavily on terms and definitions found in ANSI/AAMI/ISO 14971.  Following this, Clause 4 provides you with the general principles that the FDA uses in assessing the cybersecurity controls a given developer or manufacturer uses in their products.

Section 5 covers cybersecurity functions, the mantra of identify, protect, detect, respond and recover.  Here you’ll find the detailed suggestions for how to provide limited access to software by trusted users only, ensuring trusted content, and so on.

Section 6 is particularly useful, as it provides the recommendations of the agency for the type of documentation they expect to see in your premarket submission.  Of course, the recommendations expect that you’ll have support for the implementation and management of this issue as part of your quality system as defined in the Quality System Regulation (including Design Controls).

The new publication concludes with a list of FDA recognized consensus standards that deal with IT (information technology) and software security for medical devices.  Of the 6 referenced standards, five have IEC as the source organization and one has been developed by CLSI.

If software, including any networked components, is part of your medical device, you’ll want to get a copy of this new guidance on medical device cybersecurity.  Head to Document Center’s webstore at www.document-center.com.  There you can pick up a copy in either paper format or for pdf download.  You can even add it to your Standards Online multi-user subscription service.

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New ISO 8124-4 Update – Toy Safety for Swings and Slides

October 13th, 2014

I spent Saturday afternoon at a birthday party for our two-year-old nephew (cute kid, I must say!)  And how did the birthday boy spend his party time?  On the slide that’s part of the new landscaping his parents put at the end of the summer!  Like many other types of toys, there’s an ISO safety standard for family use slides and swings, and it’s just been updated.  The new ISO 8124-4 2nd edition, “Safety of toys – Part 4: Swings, slides and similar activity toys for indoor and outdoor family domestic use,” is available now from Document Center Inc.

This new update extends the types of toys covered by the standard.  The requirements section now includes inflatable activity toys and paddling pools.  The warnings and labeling clause 5 has also been expanded to include a new clause 5.4 specifically on warnings.  This is in part a response to the added dangers of the new types of toys introduced in this edition.

The expansion of the requirements clause 4 means that the clause 6 for test methods has also been lengthened.  As you might expect, the new sections are 6.9 on the deflation of inflatable activity toys and 6.10 for the static load test for paddling pools with non-inflatable walls.

Users of ISO 8124-4 will also be interested to find that the Annexes have been extended.  In additional to Annex A on Rationale and Annex B on playground surfacing material consumer information sheets, there’s a new Annex C.  This new Annex addresses safety labeling guidelines for certain types of activity toys.  What kinds of guidelines does it include?  Information on label definition and location for hazards introduced by inflatable toys and those that may accumulate water are in this section.  And so is information on providing the customer with warnings of the dangers posed by connection tubes for inflating activity toys as well as the possibility of friction burns.

If you need copies of this or any ISO standard, you can order it online at the Document Center website, www.document-center.com.  You’ll have over 500,000 unique titles to choose from!  You can specify delivery in paper format or for pdf download, and you can even include them in your Standards Online multi-user subscription service.  Want help from our staff?  Contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing standards to customers like you since 1982.  Make us your Standards Experts!

New AAMI TIR34 – Water for reprocessing Medical Devices

October 10th, 2014

AAMI, the Association for the Advancement of Medical Devices, has two main roles in standardization here in the U.S.  First, it acts as the Technical Advisory Group (TAG) for medical device standardization at the international level.  And secondly, it provides guidance for U.S. companies when international standardization has not yet taken place.  One of these AAMI Technical Reports, AAMI TIR34, has just been updated.  Document Center has the new 2014 Edition now so you can purchase it in paper format or for pdf download.

Titled “Water for the reprocessing of medical devices,” AAMI TIR34 covers the complete range of issues involved in what is basically sterilization of medical devices using water.  You’ll learn why water quality is important, the categories of both medical devices and of water for the reprocessing function, what types of water treatment you’ll need to consider, and the stages of medical device reprocessing where water quality is a factor.

Of course, in order to set up an effective water treatment process you’ll need to know about the various water treatment systems available and what will work best in your situation.  The standard covers this, down to the issues of the physical layout of the water purification system to distribution and storage.  You’ll also get complete guidance on how to monitor the water quality in your system, both in clause 7 and in Annex B.  Concluding sections cover strategies for bacterial control, personnel considerations, and quality concerns.

You’ll also be pleased to know that there are 7 Annexes that review the various issues in detail — from the monitoring issues noted above to thermal disinfection, water treatment using filtration and the typical presentation of quality issues during reprocessing.

What’s new in this edition?  Of course, there are many updates and organization enhancements throughout the document.  But the committee also brings the fact that the water categories have been reduced to two from the previous four that were specified in the 2007 Edition.

How do you get a copy?  Due to copyright considerations, you’ll want to make sure you purchase your copy from an authorized dealer.  Document Center Inc. is such a source.  You can order any standards you need at our web store, www.document-center.com.  Or feel free to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Interested in multi-user online subscription access?  We have that too!  Remember, Document Center has been providing standards to folks like you since 1982.  Make us your Standards Experts!