ANSI/ASSE Z359 Series extended

February 27th, 2015

The ANSI/ASSE Z359 Series has been extended with the release of three new/updated parts for the Fall Protection Code.  All three are 2014 Editions, but have only been released this month.  They have an unusual layout that will help you use and understand these standards easily.  And you can get your copies now in paper format or for pdf download from Document Center Inc.

We’ll take a look at each of the three new ANSI Z359 standards separately, but I would like to review some features that they have in common.  Most notably, they are formatted in two columns.  On the left is the text of the standard itself.  On the right are explanatory notes, providing insight and resources for users.  Also, the three documents have been developed with OSHA requirements in mind.  So you’ll get information on how these publications relate to your regulatory mandates.

Now let’s take a closer look at each of the three new releases:

ANSI/ASSE Z359.11, 2014 Edition, Safety Requirements for Full Body Harnesses

Full body harnesses are used for commercial purposes, but also for travel restraint, suspension, and/or rescue applications.  This standard provides you with the requirements needed for performance, design, marking, qualification, instruction, training, test methods, inspection and use, maintenance and removal from service.  It can be used anywhere in the harness lifecycle, from design, manufacture, testing and certification, regulation, and use.

Not only does the standard review all this material, it also has a number of figures that illustrate the requirements as well.  Annex A provides you with information that must be included in the user’s instruction manual.  The requirements of ANSI/ASSE Z359.11 will be effective 9/1/2015.

ANSI/ASSE Z359.14, 2014 Edition, Safety Requirements for Self-Retracting Devices for Personal Fall Arrest and Rescue Systems

The ANSI/ASSE Z359.14 does the same thing as the Z359.11, only for self-retracting devices, including self-retracting lanyards, including those with integral rescue capability and leading edge capability.  So if you’ve been using the ANSI/ASSE Z359.1 or ANSI/ASSE Z359.4 for these types of devices, you’ll want to move over to this new Part 14.

Again, the 56-page document is comprised of the text. Appendix A then gives you a table with the mandatory inspection requirements.  Appendix B provides you with the various figures you’ll be using.  The document is a revision of the 2012 Edition, which is now obsolete.

ANSI/ASSE Z359.15, 2014 Edition, Safety Requirements for Single Anchor Lifelines and Fall Arresters for Personal Fall Arrest Systems

The Z359.15 covers lifelines and fall arresters.  There are two notible exceptions:  window cleaning belts and sports-related equipment.  And requirements for horizontal lifelines are also not included.  The standard provides you with the requirements for design, testing and performance, marking and instructions, your user inspections, maintenance and storage, and removal from service.  It is organized into two sections:  Text and Figures.

So now you realize that you need one or more of these new publications.  You can orader the copies you need online at the Document Center webstore, www.document-center.com.  Or you can contact our customer service staff for more information.  They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  With over 30 years of experience in working with standards, you can rely on Document Center to help you not only purchase your documents but also use and maintain them.  Make us your Standards Experts!

Data Privacy and Strategic Standardization

February 26th, 2015

Data Privacy and Strategic Standardization – It’s a familiar plot line for those of us in the standards business.  It has to do with the use of standards and regulations as a tool for market manipulation.  It’s sometimes done in committee work far from the public eye, but with data privacy it’s right up front.  The case in point:  Data protection rules being put forward by the European Union.  It was reported in the Wall Street Journal yesterday and certainly got my attention!

What’s most interesting to me is that the chief negotiator for the European Parliament made the situation clear:  Jan Philipp Albrecht expects the data protection law to have a beneficial effect on European web companies equal to the impact of the adoption of GSM had on telecommunications companies back in the 1990’s.

For those of you who remember, at that time Qualcomm owned the CDMA chip market. Everything was great until the Europeans decided to standardize on GSM, hoping to push the U.S. company out of the market.  While Qualcomm is still doing just fine, the European move to GSM proved a tremendous boon to such companies as Nokia and Ericsson.  Albrecht specifically referred to this incident recently.

No wonder U.S. Internet companies are starting to spend so much time and effort in Europe!  There’s no doubt that the EU regulators are looking a Google and other U.S. Internet giants with an eye to the competitive environment.  And how could such regulations skew the marketplace in favor of the European market?

As regulators there say, a move to promote products and services already being developed in Europe specifically to address these new restrictions will likely put European companies ahead of others.  Should these type of regulations become global, it could be a competitive disadvantage for the large U.S. Internet giants.

In a perfect world, standards would be ruled by technology.  But in our real one, politics and financial advantage play a huge role and standards developers and users shouldn’t forget it.  If you are not paying attention to the political forces that shape your industry, you stand a good chance of being blindsided.

As part of your standards program, don’t forget to pay attention not only to what’s impacting your company now, but what’s brewing for the future.  You’ll want to capture information from those in your company who participate in standards work.  And you’ll want to get feedback from staff familiar with the various markets you’re selling in.  There’s always someone looking to find a way to get some of what you have!  And it may be happening where you least expect it.

For standards and services to support your use of standards, make Document Center your first choice.  You can order standards online at our webstore, www.document-center.com.  And you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) with any questions or orders you may have.  Make us your Standards Experts!

New IEC 62741 – Dependability

February 25th, 2015

There’s a new IEC 62741 available, “Demonstration of dependability requirements – The dependability case.”  It’s been released to support the IEC 60300-1 dependability standard and is available now from Document Center Inc.   It is part of IEC’s Technical Committee 56’s program of dependability and risk assessment standards.  It provides you with guidance to show how your system meets predetermined dependability requirements.  It’s an evidence based process used to confirm that your dependability plans are meeting the goals.

Dependability cases are best used at the inception of a project, but can be implemented anywhere in the lifecycle.  It is highly dependent on having a clear definition of the level of dependability that the customer of the product or system expects.  This activity is part of the IEC 60300 series on dependability managed by TC56.  And it is closely related to various risk assessment requirements as well.

What is the dependability case?  It is a process of reviewing the dependability requirements of a system and obtaining evidence of how the system meets those requirements.  It is often considered to be most successful if initiated at the concept stage, with revision occurring as the project moves forward.  Many times various reports are generated at predetermined milestones.  And it may continue to be used all the way through product or system retirement.

What is the difference between a dependability plan and a dependability case?  A dependability plan provides you with a roadmap for the activities, techniques and resources you’ll need to achieve your goal.  The dependability case provides continuing assurance that the requirements of the plan are being met, using concrete evidence that demonstrates that the plan is meeting those targets.  In other words, the plan shows how risks are going to be managed, the case proves that the plan has done it’s job.

What exactly does the IEC 62741 cover?  After the usual scope, referenced documents and definitions sections, the standard first provides you with background information.  Then Clause 5 addresses the principles involved while Clause 6 covers the development of the dependability case itself.  Finally, Clause 7 provides you with guidance on determining the adequacy of the evidence you’re using.

Three Annexes will be useful to you.  Annex A gives you an overview of the evidence framework you’ll use.  Annex B covers the general requirements of you dependability case report itself.  And Annex C is a checklist of points for assessing the evidence to confirm that it meets your needs.  A one-page Bibliography completes the document.

Now to get a copy.  You can order 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’re an authorized distributor of the IEC publications, so you will know that your copies of any standards purchased from us are valid and up-to-date, with free update notifications included.  And we have a wide range of services to make compliance easier.  Make Document Center your Standards Experts!

New AAMI TIR55 – Human factors and Medical device processing

February 24th, 2015

AAMI TIR55, “Human factors engineering for processing medical devices,” has just been released.  You can get a copy from Document Center Inc. in paper format, for pdf download and as part of our multi-user Standards Online subscription service.  This new release will help you understand the impact of human factors engineering during the full processing lifecycle of reusable medical devices.

Why should a medical device company be concerned?  Device usability and safety are essential features of products designed for the healthcare environment.  Using a standardized approach across your organization can facilitate successful strategies for instructions and training of personnel involved in the everyday use of your products.  And it can help encourage medical device design that includes processing requirements that can be implemented successfully in the real world.

What is a processing lifecycle?  This is the period from the point-of-use at the end of the patient procedure to the delivery to the point-of-use for the next patient.  As we have discovered from recent media coverage, failures during this cycle can bring unwanted outcomes and spread fear regarding the safety of various procedures and devices.

Where in the organization can the AAMI TIR55 have an impact?  The standard addresses human factors concerns in product design, in developing process instructions for use, for design of training programs, and the development, verification and validation of the device processing process itself.

What does this Technical Information Report actually cover?  You’ll get the usual scope and definition clauses at the beginning of the publication.  Then Clause 3 provides you with an overview of human factors engineering and the design controls approach that’s being used here for device processing.  Next come a series of clauses covering specific design requirements: the design of devices for processing, the design of the processing procedures, and the design of the processing instructions.

The last two clauses cover education, training and competency assessment tools, and validation.   Not only will you get a complete overview of the considerations essential to developing a system that promotes correct processing of your devices, but you’ll also get suggestions on how to confirm that your efforts are realistic and can be implemented successfully.  A one-page bibliography finishes the publication.

Now to get a copy for yourself and your team.  You can order 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’ve been working with companies like yours to help maximize your compliance efforts.  Make us your Standards Experts!

New IEC 62740 – Root Cause Analysis

February 23rd, 2015

There’s a new IEC 62740 available, and it’s titled “Root cause analysis (RCA).”  You can purchase your copy from Document Center Inc. in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  The standard addresses root cause analysis in general, so the publication can be used in any industry or setting.

Determining the causes of failure is an essential part of any quality process.  Root cause analysis is a way to systematically determine the factors that led to a particular event.  It’s used to identify systemic problems rather than symptoms.  And of course, once these types of problems have been unearthed, the goal is either to eliminate them or develop strategies for “defusing” their negative impacts.  While IEC 62740 does not specifically address safety or accident investigations, it certainly could be used for them.

The main clauses of the standard cover the first 11 pages of this 67-page standard (the true length of the document is 156 pages, including introductory material and the French language edition which covers the 2nd half of the publication.)  In these clauses, IEC 62740 describes a process for performing RCA along with an explanation of techniques you’ll use.  This means that after the usual scope, referenced documents and definition sections, the standard provides you with an overview, a detailed description of the process, and a section on the selection of techniques to be used.

However, the bulk of the information in this standard will be found in the Annexes A through E.  Here you’ll get the detailed data that will help you implement the concept.  Here’s a list:

  • Annex A, Summary and criteria of commonly used RCA techniques
  • Annex B, RCA models
  • Annex C, Detailed description of RCA techniques
  • Annex D, Useful tools for RCA
  • Annex E, Analysis of human performance

As you can see, this new release gives you a complete run-down of all the essentials to implement this tool.

Now, you need to get a copy!  You can order 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’re an authorized distributor of the IEC standards and have been working with customers like you since 1982.  Make us your Standards Experts!

New ISO/IEC 38500 2nd Edition

February 20th, 2015

ISO/IEC 38500, “Information technology — Governance of IT for the organization,” has just been updated.  The new 2nd Edition is available from Document Center Inc. in paper format, for pdf download, and as part of our multi-user Standards Online service.  The update replaces and cancels the previous 1st Edition from 2008 and is a technical revision.  It is intended for use by those in charge of IT (Information Technology) for organizations, from the Board level to those in charge of managerial oversight.  And auditors will also find it useful.

ISO/IEC 38500 is a high-level principles based standard.  It gives you a set of definitions and a model to use when evaluating, directing and monitoring the use of IT within your organization.  Since IT security, connectivity, and other issues are finding their way into the news these days,  those tasked with the oversight of IT operations will find this document particularly timely.

What is special about the approach of ISO/IEC 38500?  It is a vehicle for highlighting the business context of IT, allowing technical, financial, and scheduling aspects to then play a supporting role.  It will also help you understand the complex world of legal, ethical and regulatory obligations that affect your company’s use of IT.

How does the standard address the issue?  After the usual scope and definitions clauses, ISO/IEC 38500 provides you with Clause 3 on the benefits of good governance. It then outlines 6 guiding principles that will help you achieve your goals in Clause 4.  They are responsibility, strategy, acquisition, performance, conformance, and human behavior.  Further, this section suggests that you should govern IT through three main tasks.  This model is clearly illustrated in Figure 1.

Now to the heart of the matter.  In Clause 5, the nuts and bolts of how to implement this model is outlined.  Here you’ll receive the guidance you need to put the principles into practice, with specific information given for each of the 6 principles.  A brief 5-item bibliography completes the document.

FYI:  ISO/IEC TR 38502, “Information technology – Governance of IT – Framework and model,” was released last year.  And the ISO/IEC TS 38501, “Information technology — Governance of IT — Implementation guide,” is under development right now.  So there are additional standards to assist you with this area of responsibility.

Certainly the challenges of the fast pace of technological change can be difficult to keep up with.  Just remember, in the end the performance of the IT department and of IT deployment rests firmly at the top.  You cannot ignore the responsibility and you’ll want as many tools as possible to help you manage this aspect of your business.

So, now you realize you need a copy of this new standard.  You can order a copy online at Document Center’s 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’ve been selling standards to folks like you since 1982.  And we have a wide range of supporting services to assist manage your compliance documentation.  Make us your Standards Expert!

New ISO 13009 – Beach Resorts!

February 19th, 2015

As a long-time standards watcher, I love the unusual!  So when the new ISO 13009, “Tourism and related services – Requirements and recommendations for beach operation,” was released a couple of weeks ago, it really caught my eye.  It’s part of the expansion of management standards into tourist operations and it’s a good one!

The standard has been developed by ISO Technical Committee 228, which addresses tourism and related services.  It provides both requirements and recommendations for commercial beach operations.  It was developed in an effort to help these folks manage their natural resources effectively.  So it covers guidance on sustainable management and planning with an eye towards the development of both infrastructure and services that are safe with minimal negative ecological impact.

This means that ISO 13009 covers such issues as beach safety, cleaning and waste removal, communication with staff and patrons, and risk assessment.  Clauses cover general requirements and guidance for managing beaches, as well as specific information on infrastructure and services.  Five Annexes give you an overview of the concept of carrying capacity, bathing water quality, a checklist of minimum requirements for services and infrastructure, examples of beach shade materials, and lost and found people.  The 15-item bibliography completes the picture, including not only relevant standards but also data from various organizations like the WHO (World Health Organization) and the RNLI (Royal National Lifeboat Institution).

There are a wide variety of ocean-side beach resorts around the world and the development of a best-practices standard is sure to be of value to the industry.  As a guidance document, it allows for a benchmark that can be widely used by a variety of stake-holders.  These may include local governments interested in preserving natural resources while allowing for use, investors in resorts who want to minimize risk for their properties, and resorts that are interested in having a marketing tool that will assure potential patrons the property is world-class in every respect.

So here’s now I see it.  There’s a number of auditors and other compliance professions who I’m sure are contemplating retirement and yet want to keep their hand in the business.  Advising tourism industries on the benefits of standardization is a natural!  In addition to the ISO 13009, here’s a list of standards available on the topic:

  • ISO 13687, Tourism and related services – Yacht harbours – Minimum requirements
  • ISO 14785, Tourist information offices – Tourist information and reception services – Requirements
  • ISO 18513, Tourism services – Hotels and other types of tourism accommodation – Terminology

There’s plenty to be gained by helping these types of facilities improve and standardize their operations.

And how will you get your copies of these publications?  You’ll want to use an authorized distributor like Document Center Inc.  Just go to our webstore at www.document-center.com.  You can order online or work with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing customers like you with standards and support services since 1982.  Make us your Standards Experts!

 

New NQA-1 2015 Edition Available

February 18th, 2015

ASME NQA-1, “Quality Assurance Requirements for Nuclear Facility Applications,” has just been updated.  The new 2015 Edition is available from Document Center Inc. and is expected to start shipping late next week.  It is one of the most frequently used quality standards for the nuclear industry.

NQA-1 stands for Nuclear Quality Assurance 1.  The revised 2015 Edition replaces the previous 2012 Edition.  The document is actually on a two-year revision cycle, but expected release in 2014 was delayed to work through some of the issues that are facing the industry.  The next revision will occur at the beginning of 2017.

The NQA-1 addresses the need for a strong quality assurance program throughout the entire life-cycle of a nuclear facility.  The goal?  To assure the safe, reliable and efficient use of nuclear energy and the proper handling of radioactive materials.  It is used for certification purposes, with any of the editions from 2008 forward being acceptable for NRC requirements.

With over 300 changes, users of the publication will be interested in the main updates that are in this new release.  Introductions to the document and to Parts I, II, III and IV have been revised.  New terminology and definitions have also been added.  And terminology conflicts in Requirements 2, 18, and Appendix 18A-1 have been resolved.

However, you’ll be most interested in the guidance you’ll now receive regarding audits.   Audit frequency is addressed, for both internal and external audits.  And there’s also new material on an acceptable approach to classifying and handling various audit issues.  And Part I requirements for Lead Auditor qualification expiration and records has also been updated.

One reason for the delay in publication is the addition of a new Section 705 for Part III.  This new section on determining authenticity covers the timely topic of counterfeit or fraudulent goods and how to reduce the risk they pose.

The committee has also provided you with new information on software, including consolidated and reconciled software-related requirements.  Graphical tools and flowcharts to aid in the understanding of software aspects of the standard have also been added.

Lastly, you’ll be pleased to find a side-by-side comparison of the NQA-1 with ANSI/ANS 15.8 (the 1995 Edition).

Now to get your copy of this new release!  Head to Document Center’s webstore at www.document-center.com and order online.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll help you get your copy and notify you in the future as it changes.  Why leave compliance to chance?  Make Document Center Inc. your Standards Experts!

New J STD 020 Revision E Released

February 17th, 2015

IPC/JEDEC J STD 020 Revision E has just been released and is available now from Document Center Inc.  Titled “Moisture/Reflow Sensitivity Classification for Nonhermetic Surface Mount Devices,” the document is a joint publication of both IPC and JEDEC.  The new J STD 020E replaces the J STD 020D.1 Edition which is now obsolete.

The J STD 020 is used for nonhermetic surface mount devices (SMDs).  The standard provides the methodology to identify the classification level for SMDs that are sensitive to moisture-induced stress.  This allows for proper protocols for packaging, storing, and handling to prevent damage during assembly solder reflow attachment and/or repair operations.

What’s really at issue here?  Since solder reflow is a process of attaching electrical components to boards prior to the application of high heat, moisture within a package can lead to cracks and “popcorning” during the process.  The classification procedure in this standard informs users of the level of moisture sensitivity of the SMDs.

If you use this standard, you’ll want to know that the changes are from the old Revision D to this new Revision E.  Luckily, there’s an Annex B that provides you with a table of the major changes.  This table reviews clause by clause the areas where there are changes.  A description of the change is also included.  Of course, this is not a redline edition, so you’ll have to review the old copy against the new for a complete understanding of the implications of the new update.

When it comes to ordering the standard, you have two options from Document Center Inc.  You can purchase the IPC edition of J STD 020E, which is available in paper format, single user CD Rom, Kit, and site licensing options.  Or you can purchase the JEDEC edition which we have available as JEDEC J STD 020E.  The JEDEC edition has more flexibility, being available in paper, single user pdf and multi-user licensing options.

Order online at the Document Center webstore, www.document-center.com, or contact our staff.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ll work with you to determine the option that is right for you.  So make Document Center your Standards Experts!

New ISO Guide 33 – Reference Materials

February 16th, 2015

ISO Guide 33 has just been updated.  The new 3rd Edition, titled “Reference materials – Good practice in using reference materials,” not only cancels and replaces the 2nd Edition but also the now-obsolete ISO Guide 32, “Calibration in analytical chemistry and use of certified reference materials.”  Along with the new 3rd Edition of the ISO Guide 30, “Reference materials – Selected terms and definitions,” the document provides users with new definitions of RM (Reference Material) and CRM (Certified Reference Material).  This has a technical impact on the Guides that users will want to keep up with.

REMCO, the ISO committee on Reference Material that develops these Guides, introduced the new definitions to incorporate the concepts of both quantitative and qualitative analysis.  While the Guides 30 and 33 now are harmonized with the new terminology, ISO/IEC Guide 99 and JCGM-200 still need to be re-written with the new concepts in mind.

If you’re unfamiliar with the use of Reference Materials, they’ve been developed to use in testing.  They form a kind of “bench-mark” for calibration of equipment, allowing for a standardized level of acceptance that the testing samples can then be measured against.

As with any standardized concept or material, the use of a consistent set of terms and definitions is essential.  And a strict methodology for handling any physical items involved in testing is essential to providing consistent and valid test results.

ISO Guide 33 is broad in scope, covering many essential concepts and practices for those using RMs and CRMs.  The document not only starts with the usual scope, reference documents, and definitions sections, it also includes a clause on symbols and another on conventions.  Then it moves into the main topic with a clause on RMs and their role in measurement.  Next you’ll learn the proper way to handle RMs and CRMs, how to assess the precision, and the use of bias assessment.  The last four clauses cover calibration, assigning values to other materials, conventional scales and the selection of CRMs and RMs.  Three Annexes follow, with information on key characteristics of RM’s with respect to the applications, calibration models (as well as associated uncertainty models), and decision errors.  A 24-item bibliography finishes up the publication.

ISO Guide 33 and ISO Guide 30 (which provides definitions for the terms used for RMs) are essential for any testing lab that calibrates using these methods.  If you’re using the older editions, get your copies of the new releases now.  You can order 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’ve been working with standards since 1982.  Make us your Standards Experts!