New ISO/IEC TS 17021-5, Requirements for Auditing Asset Management Systems

April 23rd, 2014

There’s a growing number of management system standards and with each release, auditing and certifying to the standard becomes an essential activity.  The ISO/IEC 17021 series provides the core requirements for organizations that provide these services.  So the release of the new ISO/IEC TS 17021-5, “Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 5: Competence requirements for auditing and certification of asset management systems,” is welcome news.

Of course, both the certifying organizations and customers who rely on them for auditing services need some way to measure the competence of the folks that come in and do the work.  The ISO/IEC 17021 provides a generic model of needed competencies.  But for asset management systems, no specific requirements have been defined until now.

Following the principles of the ISO/IEC 17021′s Clause 4, the ISO/IEC TS 17025-5 standard provides detailed information in Section 5 for both the audit team and those individuals that comprise that team.  Covered are Asset Management terminology, practices and methodologies, relevant documentation, business practices, client business sector, and client products, services, processes and organization.  Section 6 briefly discusses competence requirements for other personnel that may be involved with the audit as well.

In addition to this new Part 5, the ISO/IEC 17021 series is comprised of the following documents:

  • ISO/IEC 17021 (to be renumbered Part 1 when the next revision is released), Conformity assessment — Requirements for bodies providing audit and certification of management systems
  • ISO/IEC TS 17021-2,  Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 2: Competence requirements for auditing and certification of environmental management systems
  • ISO/IEC TS 17021-3, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 3: Competence requirements for auditing and certification of quality management systems
  • ISO/IEC TS 17021-4, Conformity assessment – Requirements for bodies providing audit and certification of management systems – Part 4: Competence requirements for auditing and certification of event sustainability management systems

FYI:  The TS designates that the documents are Technical Specifications, which means that they are reviewed in three years, and then again in six years.  Eventually, they are either transformed into International Standards or withdrawn.

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New MIL-STD-1353 C for selecting electrical connectors

April 21st, 2014

The U.S. military has procurement challenges, perhaps larger challenges than some of the biggest U.S. companies.  And that procurement activity is under both legislative scrutiny and financial constraints!  So it’s not surprising that every aspect of the procurement cycle is constantly being reviewed to see where improvements can be made.  And the MIL-STD-1353, “Electrical Connectors, Plug-in Sockets and Associated Hardware, Selection and Use of,” is a good example of how this is happening.

MIL-STD-1353 was recently extensively updated.  The new Revision C provides the user with 348 pages of guidance on the DoD’s preferred list of electrical connectors, plug-in sockets and associated hardware.  No, it’s not a list of supplier part numbers.  Instead it’s a list of those military specs and standards that best define the components on which the military would like to standardize it’s procurement process.

Only those organizations that have to procure and maintain vast numbers of products can understand the savings that come from reducing the number of components used across the entire range of inventory.  So if you’d like your product to be purchased by the U.S. military, this is the type of standard you need to pay attention to.

The technical requirements are not lengthy — Only the first 17 pages are the standard itself.  It’s the various Annexes that really make up the “meat” of this document.  There’s six of them covering:

  • Printed wiring board connectors and test points,
  • Rectangular connectors,
  • Radio frequency connectors,
  • Circular connectors,
  • Audio connectors, and
  • Power connectors.

You’ll get information on the applicable specs for each, as well as tables showing the specification number, description, and configuration in many cases.  And these specifications also include the SMD drawings as well as the more familiar Mil DTL’s and other specs.

You can get your copy of this new Procurement Standard at the Document Center webstore, www.document-center.com.  Or you can contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll use us for your Mil Specs and Standards because of our superior notification service, providing you with email notifications when your documents are updated in any way.

Document Center has been supporting the military procurement cycle since 1982.  We have the expertise you need when collecting and using this type of documentation.  Be sure to make us your Standards Experts!

New IEC 62694 – backpack detectors for illicit radioactive material

April 16th, 2014

There’s a heightened awareness of the the need to address public protection from various radiation treats.  One tool that’s being used to detect radioactive materials being used in nefarious ways is the backpack-type radiation detector (BRD).  Like other radiation detecting equipment, these devices need to meet operational and performance requirements.  So the new IEC 62694, “Radiation protection instrumentation – Backpack-type radiation detector (BRD) for the detection of illicit trafficking of radioactive material,” was specifically written for this purpose.

IEC 62694 sets both performance and testing requirements for this equipment.  These cover radiation measurements to be taken, as well as the expected electrical, mechanical, and environmental conditions during usage.  The document is lengthy, comprised of 128 pages with the text in both English and French.

First you’ll find a section on general test procedures.  Then there’s the following general requirements:

  • Mass
  • Design requirements
  • Marking
  • Switches
  • Effective range of measurement (Energy)
  • Effective range of measurement (Count rate)
  • Operating parameters
  • Explosive atmospheres
  • Diagnostics
  • Power supply
  • Data format
  • Data storage
  • Communication interface
  • User interface

An equally exhaustive section on radiation detection requirements is then presented.  Shorter reviews of environmental requirements, mechanical requirements, electromagnetic requirements, and documentation are also included.

There are 4 informative Annexes in this standard.  They cover statistical considerations, expected progeny and impurities, fluence rate calculations, and calculation ambient dose equivalent rate.  The bibliography has 28 references for further review.

If you’re interested in this topic, you’ll also want to review my blog.document-center.com review of the New Standards on Radiation Protection for the 1st Quarter 2014.  I use the Document Center blog to highlight new releases on various topics of interest.

You can purchase this standard, and many others, 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).  We’ve been selling the IEC standards on the web since the 1990′s and in business since 1982.  We have a wide range of support services to help you identify the standards you need and maintain them once you start to use them.  Make Document Center your Standards Experts!

New FDA Guidance on Communication during MedDev Submissions

April 15th, 2014

The FDA Medical Device Guidance Documents provide a great way to keep up with administrative protocols, requirements, and other technical aspects of working within that regulatory framework.  If you’re in the medical devices field, you’ll welcome a newly released guidance.  It’s titled “Types of Communication During the Review of Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff .”  It replaces the earlier document, “Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.”  It provides FDA guidance on communication during MedDev submissions.

Four types of communication are reviewed:

  • Acceptance Review Communication (used for premarket notification submissions (510(k)s), original premarket approval applications (Original PMAs), Panel-Track PMA Supplements, and Pre-Submissions)
  • Substantive Interaction (for 510(k)s, Original PMAs, Panel-Track PMA Supplements, and 180-Day PMA Supplements)
  • Interactive Review,
  • Missed MDUFA Decision Communication (for 510(k)s, Original PMAs, and Panel-Track PMA Supplements)

For each type of communication, there’s discussion of why the FDA might want to communicate with you, when this type of communication might take place in the process, and what kind of data you can expect to receive.  There’s also notes on procedural issues that might delay processing, like missing fees and so on.

There’s also help with identifying how to best respond to some communications you may receive from the FDA during your submission process.  Further, the document will give you some examples of when you need to initiate communication with the FDA, either staff at CBER or CDRH.  And best of all, there’s information in this FDA guidance document how things you can do to help make the various steps in the process more effective.  Since time is money, and this process can be a daunting one, these hints are really helpful!

You’ll also want to review my blog.document-center.com today.  I’ve listed the new FDA Guidance Documents released during the 1st Quarter 2014.  Here you can find other publications that are appropriate for your business situation.

Order your copies through Document Center and you’ll  find that you’re notified when the standards are modified in any way.  This gives you security to know that if any critical changes occur, you’ll be aware that they’ve been made.

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New BS EN 1325 2014 Edition for Value Management

April 14th, 2014

Value Management is a hot topic these days, but it’s a concept that is not easy to understand.  It can be used to address the purchasing cycle — getting as much value from purchases by careful definition of minimum requirements and close attention to price.  Or it can be used as a tool to evaluate the essential value proposition of a company and align expenditures and activities to maximize this core value.  There are a number of European standards addressing this topic and two of them have been consolidated in the new BS EN 1325 2014 Edition.  Titled “Value Management. Vocabulary. Terms and definitions,” this new document replaces both the BS EN 1325-1,”Value analysis and functional analysis,” from 1997 and the BS EN 1325-2, “Value management, value analysis, functional analysis vocabulary.  Value management,” from 2004.

The new standard focuses on optimizing performance and productivity with the use of Value Management (VM).  It is intended to promote a common language for use in the development of European Standards and in the discipline at large as well.  Since VM is such a “soft art” there is a risk of terms being used inconsistently.  This standard provides a single source so that everyone can get on the same page.

There are a number of additional EN standards on this subject.  They are:

  • BS EN 12973, 2000 Edition, Value management
  • BS EN 16271, 2012 Edition, Value management. Functional expression of the need and functional performance specification. Requirements for expressing and validating the need to be satisfied within the process of purchasing or obtaining a product
  • CWA 15896-1, 2008 Edition, Value added purchasing management. General criteria
  • CWA 15896-2, 2008 Edition, Value added purchasing management. Accredited structure and process for certification bodies
  • PD 6663, 2000 Edition, Guidelines to BS EN 12973. Value management. Practical guidance to its use and intent

You can purchase any of these standards from Document Center Inc.  Just go to our webstore at www.document-center.com.  There you can search for and order the documents you need.  Or contact our staff via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been selling standards here in Silicon Valley since 1982.  Make us your Standards Experts!

New ISO/TR 12295 Ergonomics Technical Report Released

April 11th, 2014

Frankly, many activities in an organization involve physical tasks that have potential for injury.  The science of ergonomics addresses these concerns, so any time standards on human factors are released you certainly should pay attention.  The new ISO/TR 12295, “Ergonomics – Application document for International Standards on manual handling (ISO 11228-1, ISO 11228-2 and ISO 11228-3) and evaluation of static working postures (ISO 11226),” supports earlier ISO documentation for working postures and material handling.  It’s an application guide, offering a simple risk assessment methodology that can be used by small and medium enterprises.  And the annexes provide more detailed assessment methods for users at every level.

This means that the new technical report helps in two areas.  One, it can help “lay” users identify situations where the ISO 11226 and/or the ISO 11228 series can be applied.  And secondly, it offers a “quick assessment” technique that can be used for risk assessment of various activities within an organization.

Since this is a European standard, measurements are metric.  So you’ll need to do some converting to make use of the “quick assessment” questionnaires.  These questions, provided in tabular format, make up the actual standard itself.  You’ll use them to see if you need to refer to one or more of the following documents:

  • ISO 11226, 1st Edition, Ergonomics — Evaluation of Static Working Postures
  • ISO 11228-1, 1st Edition, Ergonomics – Manual Handling – Part 1: Lifting and Carrying
  • ISO 11228-2, 1st Edition, Ergonomics – Manual Handling – Part 2: Pushing and Pulling
  • ISO 11228-3, 1st Edition Reprint, Ergonomics – Manual Handling – Part 3: Handling of Low Loads at High Frequency

Of course, in doing your analysis you may determine that the tasks being assessed are acceptable as is.  This means that your risk assessment is complete!

The bulk of the document is contained in the 3 Annexes.  Each provides an application aid for one of the 3 parts of the ISO 11228 series.  You’ll find significant data in these Annexes, with plenty of flow charts, tables and figures illustrating the salient points of the analysis.  You’ll even get examples of how to input the data you’ll need to collect when doing your assessment.

This is a great companion document to the reference ISO standards.  If you need a copy, head to the Document Center webstore at www.document-center.com.  There you can search for and order the standards you need to support your engineering, quality, and other management requirements.  Or you’re welcome to contact us 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!

New ISO/TS 17988 covers corrosion tests for dental amalgam

April 10th, 2014

Dental amalgam restorative material is a mixture composed mainly of silver, tin and copper which is mixed with mercury for use in by your dentist when he repairs your teeth.  Since it includes a very pure form of mercury, it is essential that the material not corrode once it’s placed in your mouth.  The new ISO/TS 17988 provides a series of test methods meant to be used on a sample of mixed product to determine the resistance to various types of corrosion.  This is the first edition of the document, titled “Dentistry – Corrosion test methods for dental amalgam.”  It is intended to be used with ISO 24234, “Dentistry – Mercury and Alloys for Dental Amalgam.”

There are 3 basic types of tests included in this new technical specification.  They are:

  • Resistance to corrosion by the immersion procedure,
  • Corrosion by the potentiostatic procedure, and
  • Resistance to corrosion by the Hertzian-loading strength-reduction procedure.

For each laboratory test, details of the equipment needed, preparation of the test piece, reagents, test procedure, and analysis and reporting of the results are included as appropriate.  These tests are intended to show long term potential for corrosion by producing a measurable effect in a short period of time.

Please note:  The tests are not intended to be used for any biocompatibility claims.  And they should not be used for dental metallic materials that are covered by ISO 22674, “Dentistry – Metallic Materials for Fixed and Removable Restorations and Appliances.”

Your 29-page specification also includes a bibliography with 5 citations for further review.

Should you need a copy, you can order it at the Document Center webstore, www.document-center.com.  Or contact our staff via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  ISO standards are available in both paper format and for pdf download.  We have been an authorized distributor of the ISO documents since the 1990′s and can help you with copies of both current and obsolete editions.  Make Document Center your Standards Experts!

5 ISO Hemodialysis Standards Updated!

April 9th, 2014

Hemodialysis (AKA haemodialysis) is a proven therapy for renal (kidney) failure, with treatment facilities throughout the world.  Now the ISO committee for cardiovascular implants and extracorporeal systems has updated five standards relating to the fluids used in this process.  These five ISO hemodialysis standards are each discussed in today’s review.  All five updates are technical revisions, so if you rely on these standards, you’ll want the new copies.

ISO 11663, 2nd Edition, Quality of dialysis fluid for haemodialysis and related therapies

Since hemodialysis patients are exposed to a large volume of dialysis fluid, you can see that there’s a risk of contamination from the water and concentrates used to produce the dialysis fluid itself.  This standard provides minimum quality requirements for such fluids.

ISO 13958, 3rd Edition, Concentrates for haemodialysis and related therapies

Dialysis fluid is usually mixed at the treatment facility using a concentrate and water.  This standard covers concentrates in both liquid and powder form, as well as “spikes,” chemical additives that may be added to the final mix.  It is intended to primarily be used by concentrate providers, as well as mixing equipment manufacturers.

ISO 13959, 3rd Edition, Water for haemodialysis and related therapies

As you now understand, water is an essential component of the fluid used in this therapy.  You need the assurance of an adequate water supply, and a measure of purity as well.  This standard gives you the minimum chemical and microbiological requirements for your water supply.  And it covers when and how tests of the water supply should be done as well.

ISO 23500, 2nd Edition, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

Dialysis fluid quality is dependent on good process management for the healthcare workers actually delivering the therapy.  So this standard addresses the core principles involved in this activity.  First the 3 standards noted above are discussed.  Then some of the basics are reviewed:  the need to comply with local regulations, realization that the water supply may change from time to time, and so on.  Validation is covered — how to assign various responsibilities, determine your parameters, do your testing, etc.  Section 7 is a lengthy discussion of quality in all aspects of hemodialysis, while Section 8 addresses microbiological control.  Environment and personnel are also included, as well as 7 informative Annexes and a bibliography.

ISO 26722, 2nd Edition, Water treatment equipment for haemodialysis applications and related therapies

This standard is for equipment manufacturers and for the folks that actually specify various configurations for facilities.  While it was written with multiple users in mind, it can also be used in situations where there’s only 1 patient (home use).  So this standard focuses in on the mechanical aspects of the process — the affect that piping may have on the water supply, and so on.  It also reviews such things as the testing of the water and the fluid mixture so that the equipment used can support these types of tests.  Marking and product literature are reviewed too.

Anyone who uses these 5 ISO hemodialysis standards will also be pleased by the extensive information found in the Annex section in each.  The discussion of the Rationale for each provides you with better understanding of the differences between the U.S. (AAMI standards) and Europe (ISO-based standards).  And it defines the concerns that led to this standardization effort as well.

If you need any ISO standards, please go to the Document Center webstore at www.document-center.com.  You can search for and order the documents you need, either in paper format or for pdf download.  Need more personal attention?  Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing our customers with standards since 1982.  Make us your Standards Experts!

New ANSI H35.2 2013 Tolerances for Aluminum Mill Products

April 8th, 2014

As a follow-up to yesterday’s blog on the new ANSI H35.1 2013 Edition, today we’ll cover the companion ANSI H35.2 and ANSI H35.2(M) updates.  The ANSI H35.2, “American National Standard Dimensional Tolerances for Aluminum Mill Products,” covers measurements using the inch-pound systems.  The ANSI H35.2(M), “American National Standard Dimensional Tolerances for Aluminum Mill Products (Metric),” provides the same information in metric format.  Both have been updated with the recent release of the 2013 Editions.

Coverage is intended primarily for the U.S.  The documents provide users with the needed formulas for allowed standard tolerances in extruded and milled aluminum products.  This will be the plus-or-minus degree of accuracy needed in engineering drawings and contract fulfillment for various aluminum parts.  They’ll cover cross section/wall thickness, length, straightness, twist, and other aspects of physical dimensions.

Again, this new 2013 update for both editions of the standard replace the previous 2009 Editions of each.  Since it is essential that you use the latest edition of the standard in defining and producing products, you’ll want to be aware that changes have been made to the two documents.

There has been modification of the column headings for extruded and drawn pipe in order to harmonize with ANSI/ASME standards.   There are clarifications to the tolerance table for drawn tube as well.   And you’ll find clarification on tolerance calculation for wall thickness (eccentricity) of extruded tube in the new editions.

FYI:  The Aluminum Association has also reviewed and updated the balance of the H35 series as well.  Here’s the status of the remaining 3 standards:

  • ANSI H35.3, 2006 Edition Reaffirmed in 2013, Designation System for Aluminum Hardeners
  • ANSI H35.4, 2006 Edition Reaffirmed in 2013, Designation System for Unalloyed Aluminum
  • ANSI H35.5, 2013 Edition, American National Standards Nomenclature System for Aluminum Metal Matrix Composites

You can purchase these standards and many more 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 selling standards since 1982 and have a wide variety of services and products to support your use of these documents.  Make us your Standards Experts!

New ANSI H35.1 2013 Edition for Aluminum Alloys

April 7th, 2014

Aluminum is in the news as Ford is using the metal to lighten the frame of the F-150 truck line.  If you use the material, you’ll want to know that the entire H35 series of standards on Aluminum has been reviewed.  We’ll tackle the revisions of the various parts of the standard series this week.  First we’ll discuss the new ANSI H35.1, “American National Standard Alloy and Temper Designation System for Aluminum.”  The new 2013 Edition just released this month is a consolidated edition.  As you probably know, it merges the information from the old ANSI H35.1 and ANSI H35.1(m) documents.

Originally the publication (back in 1957) was a designation system for wrought aluminum alloys.  Over time, the standard has been expanded to include the U.S. temper designation system.  It has been used as the basis for the ISO 2107, “Aluminium and Aluminium Alloys – Wrought Products -Temper Designations.”  And there are also similarities between the U.S. standard and EN 515, “Aluminium and Aluminium Alloys. Wrought Products. Temper Designations,” the European norm.  However, you will still find differences in designations from country to country.

The previous revision of the ANSI H35.1 was in 2009, so you’re probably wondering what’s changed in this new edition.  First, the wrought alloy designation system has been expanded.  The requirement that an alloy variation be from a jurisdiction other than the U.S. has been eliminated.  There’s a new footnote that requires individual limits for the combination of elements in excess of 0.10%.  And there’s a new definition for O2 temper designation as a reserved temper to demonstrate response to annealing.

As I say, the balance of the H35 series has also been reviewed, with some parts undergoing revision and other reaffirmed.  If you need copies of the new documents, you can order them at our Document Center webstore at www.document-center.com.  Or you can contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be pleased to know that your purchase comes with our no-charge notification service, providing you with timely updates by email when your standards are modified.  Thousands of companies rely on Document Center — Make us your Standards Experts!