Having an organic Thanksgiving?

November 26th, 2014

Well, I love to talk about food and standards at this time of year, so I found myself wondering about organic food and that standards that ensure compliance.  Are you thinking about having an organic Thanksgiving?  You have a number of layers of standardization and regulation to depend on in order to make it so!

Firstly, the organic movement was a grass-roots (pardon the pun) effort, so early “standards” come from specific jurisdictions and common-interest groups.  As larger food producers got interested in the concept, more formalized standards-making has occurred.

There are two main sources of this standardization effort — the business itself (through trade associations) and government regulation.  For the first, you’ll find the current development of “harmonized standards” happening in such groups as United Fresh (organic produce standards) and IFOAM (International Federation of Organic Agriculture Movements).  These organizations support their standards development by certification.

However with the proliferation of “organic” products, regulatory agencies around the world have moved to set regional standards for such foodstuffs.  You’ll find extensive legislation and corresponding regulation in the U.S., Asia, Europe, and elsewhere.  This may be from the U.S. Department of Agriculture (USDA) with the NOP (National Organic Program) requirements.  Or the EU’s Commission Regulation 889/2008 for the production and labeling of organic products in support of EU laws.

In all cases certification is a keystone for the assurance of compliance to these standards.  This type of certification may be essential for export to various markets across the globe.  And it’s in the certification process where ISO standards are becoming more frequently referenced.  As we noted in last Thanksgiving’s post, the ISO 22000 series is the basis for food production.  But when it comes to certification, the use of ISO/IEC 17065 comes into play, providing the requirements for auditing bodies that offer certification services.

For this type of standardization, trade associations will usually continue to hold and update documents until there’s a strong business case for moving into a more traditional standards-developing process.  Some things that could move standards for organic foodstuffs into the ISO process, for example, might be the need for one standard internationally to harmonize market requirements.  Or there might be a need to reduce the costs of having a number of forums for holding these standards, thus making a consolidated document in the purview of one organization beneficial.

Meantime, when you do think of standards, think of Document Center Inc.  We’re here to help you find your way through the web of compliance information that affects your business!  Make us your Standards Experts and have a very happy and bountiful Thanksgiving!

New IWA 13 helps you assess environmental projects

November 25th, 2014

There’s a new IWA (International Workshop Agreement) available from Document Center Inc. that helps you assess the economic impact of large-scale environmental projects.  Titled “Multiple resource evaluation guideline,” this new IWA 13 provides you with a methodology for understanding how supplying one resource can actually negatively impact other resources.  The main contributors to the document come from Africa and the Near East, but this new publication is sure to be useful anywhere.

The type of projects that are being discussed are those that are labeled “Multiple-Resource Productivity (MRP) solutions.”  These are environmental projects that impact at least 2 resources (like water, energy or food/cropland) without apparently consuming others.  The question is: How do you assess a solution’s feasibility and develop your economic cost-benefit analysis?

The approach differs from the usual Life Cycle Analysis (LCA) and Environmental Impact Report (EIR) in that it looks at more than 1 material, element, or compound at a time.  The MRP process has been developed because of the complexity of renewable resources.  It’s used in order to determine a broader picture of how projects may affect other “assets” and impact sustainability.

There’s a number of examples of this given in the document:  The fact that food growth requires not only land, but water and energy for transport to market.  Or energy production requires land and perhaps water as well.  So when a project may seem to be focused on 1 resource, prudent development should take others into account as well.  In other words, a solution that promotes the development of 1 type of resource will surely consume another.

The bulk of the IWA 13 covers the MRP suggested methodology.  And after a review of the three main components used in the analysis (water, energy and food/cropland), detailed information is provided on how to determine how your project may increase or decrease each component.

Once you understand the methodology, Annex A will give you the algorithm needed for comparison of solutions.  There’s also an example which makes it clear how the process works.  A 53-item bibliography completes the publication.

Now you need a copy of IWA 13.  You’ll want to use an authorized distributor and there’s no organization better than Document Center Inc.  You can order at our 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 folks like you since 1982 and on the web since 1993.  Make Document Center your Standards Experts!

New EN 60601-1 Edition released

November 24th, 2014

Lately the EN 60601-1, “Medical electrical equipment. General requirements for basic safety and essential performance,” has been getting revised on a regular basis.  Part of the reason is that the source standard, IEC 60601-1, has been updated.  So the European adoption over time is republished to keep pace with the IEC changes.  Let’s talk about some of the recent updates, what they contain, and your purchasing options from Document Center Inc.

The latest edition of EN 60601-1 was released in 2006.  Your first update was in May of 2011, the implementation of IEC corrigenda December 2006 and December 2007 and the implementation of CENELEC corrigendum March 2010 (modification of CENELEC Foreword and Annexes ZA and ZZ.)

The second update was released in February of 2012.  This was the implementation of CENELEC amendment A11:2011, when Annex ZZ was replaced by Annexes ZZA and ZZB.

Then in December of 2012, IEC amendment 1:2013 was implemented with the released of CENELEC endorsement A1:2013.  Annex ZA was also replaced and Annex ZZ was added.

Now, the latest revision from this month (November 2014) implements the IEC corrigendum July 2014 (Figure 12 has been updated.)  And the CENELEC amendment A12:2014 has also been implemented.  This means Annex ZZ has been updated to Annex ZZA, with the previous Annex ZZA being deleted. And a new Annez ZZB has been inserted.  So, in this new edition your Annexes are:

  • Annex ZA, “Normative references to international publications with their corresponding European publications.”
  • Annex ZZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices.”
  • Annex ZZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices.”

FYI:  These Annexes comprise 31 pages of material at the beginning of the BS EN 60601-1 edition.

What are your purchasing options?  Here at Document Center Inc. we offer you two choices for ordering this new update.  In the BS EN 60601-1 edition, you’ll need to buy the entire document as a reprint, with all of your changes interfiled into one new publication.  With the SIS EN 60601-1 (the Swedish Edition in English), you can purchase just the amendment.  However, this means that you’ll only have the changes noted in your copy, so you’ll have to make pen and ink changes to your original edition by hand.  None-the-less, it is far less expensive to purchase just the amendment than the consolidated reprint from BSI.

You’ll be able to order the BS EN 60601-1 edition at our webstore, www.document-center.com.  You can also purchase the SIS EN 60601-1, but for the amendment only, you’ll first request a quote.  Our staff will confirm the price of the document and that you understand you’re purchasing just the amending material.  You might also want to consider contacting us directly by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with any conformance documentation issue you may have.  Make us your Standards Experts!

New ISO 8828 2nd Edition – Handling Orthopedic Implants

November 21st, 2014

Extreme care is taken during the production and shipment of medical implants — but what happens after delivery?  Setting up protocols to insure that implants are free from contamination or damage prior to surgical insertion is another critical link in the chain.  Guess what?  There is an ISO standard for this and it’s just been revised.  It’s ISO 8828, “Implants for surgery – Guidance on care and handling of orthopaedic implants,” and the new 2nd edition is available from Document Center now.

Yes, this standard has been written for all personnel involved in receiving and handling implants, including surgical staff (surgeons).  Nothing is more difficult as a patient than going through a surgery only to have an implant fail due to contamination.  So all staff members involved in receiving, storing, transporting, handling, cleaning and sterilizing implants need to be well trained in these recommended procedures.

What does this new revision cover?  After the usual scope and definition sections, the document reviews general guidance on such topics as the manufacturer’s instuctions, stock records and rotation, storage, modification and so on.  Then there are sections with additional guidance for polymeric implants, ceramic components, and products with rough surfaces or intrinsic porosity.  The bibliography provides you with information on 4 additional standards for more detailed data.

This is a technical revision of the ISO 8828 1st Edition from 1988, which is now withdrawn.

You’ll want to get a copy if your staff handles surgical implants.  Head off to the Document Center webstore at www.document-center.com and order it in either paper format or for pdf download.  You can also opt for multi-user licensed access using our Standards Online service.  Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

Standards like the ISO 8828 can help you set up procedures and processes to improve outcomes in what-ever line of business you’re in.  Rely on Document Center to help you identify and maintain your collection of this type of conformance information.  We’re your Standards Experts!

New AAMI TIR51 – Human Factors for Medical Devices

November 20th, 2014

For Medical Device developers and other healthcare professionals, one challenge is to understand how people interact with their products in a “real world” context.  Now AAMI has provided you with guidance for this challenge - AAMI TIR51, “Human factors engineering – Guidance for contextual inquiry.”  If you’re in the healthcare business, this new Technical Information Report can help you design devices, systems or instructions in a more informed manner.  Here’s more details about this new document.

The goal of this report is to help you expand your concept of human factors from an interview-based methodology to a broader process based on both interviews and observation.  This will help you bridge the gap between what people say they do and their actual actions.  The protocol is intended to help you develop a deeper understanding of both users and the environments the device will be used in.  You’ll also be using this system to spot problems with existing design.  And you’ll also be getting insight into both the viewpoint of users as well as their capabilities and limitations.

Sections in AAMI TIR51 cover research methodology, data analysis, and reporting (including the use of video).   It also covers how to integrate your analysis into the design of devices, facilities and/or processes.  It covers troubleshooting, since the process is different from market research, for example.  And it also has a sample story board format for this type of process from the University of Cincinnati.  A 15-item bibliography finishes up the document.

This new publication is available from Document Center Inc. in both paper format and for pdf download.  You’ll be able to order the AAMI TIR51 (and all current AAMI standards) at our webstore, www.document-center.com.  Need more information?  Check in with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping people like you with standards and standards questions since 1982.  Make us your Standards Experts!

ISO/IEC/TS 17021-7 – Auditors for Road Traffic Safety Systems

November 17th, 2014

The ISO/IEC 17021 series of standards provides guidance for those who do conformity assessment services.  Now there’s a new ISO/IEC/TS 17021-7, “Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 7: Competence requirements for auditing and certification of road traffic safety management systems.”  It’s used to provide the requirements for auditors for compliance to ISO 39001, “Road traffic safety (RTS) management systems – Requirements with guidance for use.”

ISO 39001 was released almost exactly 2 years ago.  It provides any organization with the requirements necessary to set up and maintain an RTS system as a way to improve road safety and reduce transportation-related injuries and deaths.  But with this type of standard — a management system conformity publication — there’s the need for qualified certification.

The ISO/IEC 17021 series provides the requirements for auditors and auditing bodies for a variety of ISO certification schemes.  This means that those who provide these services should be expected to meet the applicable series documentation.  As a customer, you’ll use the standards to insure that the organization you hire is up to snuff.

So far, there’s seven parts to the series.  Here’s the list:

  • ISO/IEC 17021 (will be renumbered ISO/IEC 17021-1 with the next revision), 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
  • 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
  • ISO/IEC/TS 17021-6, (not yet released), Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 6: Competence requirements for auditing and certification of business continuity management systems
  • ISO/IEC/TS 17021-7, Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 7: Competence requirements for auditing and certification of road traffic safety management systems

The series is essential for any organization that provides certification to various ISO standards, so you need to be aware of them and their requirements if you use a third-party service for ISO conformity certification.

And you’ll need to get your authorized copies of the standards themselves as well.  Choose Document Center Inc., a distributor of ISO standards since the 1980′s.  You’ll order on our webstore at 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 have options:  delivery in paper format, for pdf download or as part of our multi-user subscription service, Standards Online.  If you’re in the U.S. you can use a PO# on a net 30 basis or a credit card for your order.  There’s a number of different notification possibilities, from the free emails that come with the purchase of any standard to a nightly check provided by our premium service Standards Alert.  Our reporting services help you review the status of your collection and newly released standards in areas of interest to you.  And our Standards Audit can verify that your current collection is up-to-date.

Remember:  Here at Document Center Inc., we’re your Standards Experts!

FF-S-92 New Rev C – Machine Screws

November 14th, 2014

Have you ever wondered how come you can go to any hardware store and get the specific screw you need for the job or part you’re working on?  For those of us in the specifications business, it’s simple.  Standards!  But these types of publications can come from many sources.  Of course, industry trade groups have actually started to develop such standards for specific applications in their fields.  But another major source of these types of specifications is our U.S. government.  So the new FF-S-92, Revision C, “Screw, Machine, Slotted, Cross-Recessed or Hexagon Head,” is a good example of this.

First of all, you’re probably wondering why the title is so garbled!  This goes back many long years ago when the catalogs of standards were only available in paper format (yes, there was a time before the internet!).  There were indeed many government publications used for federal procurement, including the Department of Defense.  And finding the right specification or standard to call out in your contract was a challenge for government procurement agents.

There were two tools used to correctly find documents in those days.  The first was the catalog that indexed specifications according to the FSC (Federal Supply Classification) numbers.  You can do a similar search on the Document Center website in the left hand pull down menu.  The second was the alphabetical index.  Of course, finding screws based on a regularly written title would be challenging (the FF-S-92 would have read “Slotted, Cross-Recessed or Hexagon Head Machine Screw).  By putting the title basically backwards, the words move from the most general (screw) to most specific (slotted, cross-recessed or hexagon).  Thus, the mixed up title protocol was born!

A document like the FF-S-92 will have regularized sections, first the scope paragraph and then reference documents.  In this case, the requirements section comes next.  This will provide you with the details of the materials available, including a table showing you the mechanical properties of non-ferrous machine screws. This links the material with the applicable document, composition or class, condition, and so on.

Section 5 covers quality assurance requirements.  This reminds us that we’re looking at a specification used in procurement, where verification of quality for parts is an essential part of every transaction.  The document finishes off with packaging requirements and notes.  Here we learn that the changes from the previous edition (Revision B) are so extensive that lines have not been added to the margins where changes have been made.

Now you’ll want to get a copy.  You can go to the Document Center webstore at www.document-center.com and order it in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  And if you have questions, you are always welcome to contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New SAE J383 and J384 – Seat Belt Anchors

November 13th, 2014

When it comes to automobile safety, there’s one organization you’ll turn to — SAE International (formerly the Society of Automotive Engineers).  Now there’s two new updates for the J Standards on seat belt anchors – SAE J383, “Motor Vehicle Seat Belt Anchorages – Design Recommendations,” and SAE J384, “Motor Vehicle Seat Belt Anchorages – Test Procedures.”  They’re available from Document Center Inc. in both paper format and for pdf download.

These documents were both stabilized in 2013 and were not expected to be updated at all, let alone so soon.  However, as is sometimes the case, the act of putting a standard to bed causes last minute alerts to errors!  So both these documents have been updated to be compatible with FMVSS (Federal Motor Vehicle Safety Standards) requirements.  Changes to the SAE J384 also include the addition of the provisions of SAE J385, which has been cancelled as of July of this year.

The SAE J383 provides you with design recommendations for the location of seat belt assembly anchorages.  These locations are intended to properly transfer of occupant restraint forces on the strongest parts of the human anatomy to the vehicle or seat structure.

The companion document, SAE J384, specifies performance requirements and test procedures for the strength and location of seat belt assembly anchorages. It applies to seat belt anchorages attached to vehicle body structure or to seat assemblies in the vehicle.

Now to get your copies of these new revisions.  Head to the Document Center webstore at www.document-center.com.  You can search our database of over 500,000 different documents (and many more editions) easily and securely.  Order the items you need in the format you want.  If you have any questions, just get in touch with our staff.  We’ve been providing our customers with standards from our Silicon Valley location since 1982.  Make us your Standards Experts!

New AAMI TIR58 – Hemodialysis Water Testing

November 12th, 2014

ISO 13959 (aka ANSI/AAMI/ISO 13959) provides you with the allowable limits for chemical contaminants in water used for hemodialysis.  And FYI: both editions of this standard have been recently revised.  Still, you may need more information on the actual testing you should use.  Now the AAMI TIR58, “Water testing methodologies,” gives you up-to-date information on a variety of topics that will improve your facility’s ability to test the water used in this process.

What types of processes does this new Technical Information Report cover?  The AAMI TIR58 will provide you with information on:

  • maximum allowable levels of various contaminants
  • clinical symptoms in dialysis patients exposed to specific contaminants
  • toxic levels for these contaminants when available
  • substances that can interfere with testing results
  • how various contaminants can affect your equipment
  • new proven tests and techniques that have been developed more recently

The information is presented in the usual format at the beginning of the publication, the usual scope, applicability and use, and definitions sections.  But the bulk of the document is a table of the water testing methodologies themselves.  Section 4 provides you with a guide to using this table.

This lengthy Table 1 is set up in 5 columns:  Chemical element or contaminant, maximum allowable levels, clinical symptoms associated with exposure, effect of the contaminant of dialysis systems, and test methodologies.  These are all supported by a 95-item list of cited references, so you’ll have the various resources at your fingertips for the tests, etc., that are included in the table.  A two-page bibliography finishes up the document.

Since AAMI TIR58 is a copyright document, you’ll need to purchase a copy from an authorized dealer.  Choose Document Center and order yours at our webstore, www.document-center.com.  Or feel free to work with our staff personally by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  You’ll be able to choose delivery in paper format, as a pdf download, or as part of our multi-user annual subscription platform, Standards Online.  Make us your Standards Experts!

Does Anyone in China Pay Attention to Standards?

November 11th, 2014

Today I have a guest blogger, Dr. Tim Rodgers, who asks the question:  ”Does Anyone in China Pay Attention to Standards?

Over the past several years there’s been a growing number of high-profile incidents involving quality problems with Chinese suppliers and contract manufacturers. Earlier this year the venerable British car company Aston Martin announced a recall of 75% of the cars built since 2008 after discovering a Chinese supplier used fake materials in an accelerator pedal that was implicated in field failures. Incidents like this have plagued both small businesses with limited staffs as well as large multinational corporations with strong reputations and extended supplier management teams. Many companies are shifting production away from China to locations with higher labor cost in order to get better control over quality.

As someone who has lived and worked in China at a leading electronics manufacturing service for almost two years, I know from experience how hard it can be to maintain quality standards in that part of the world. I’m not convinced that this problem is unique to China, but it may seem worse because of the sheer number of suppliers competing on price with extremely small profit margins and very little loyalty on either side of the purchasing relationship. In this Darwinian setting, suppliers will look for any way to reduce their costs, and unfortunately that means some will violate standards, substitute materials, and skip testing or inspection.

Some people will look at this seemingly lawless environment and ask whether anyone cares about standards, and whether they should even bother communicating standards to their suppliers. If no one’s paying attention, what’s the point?

Do we still need standards? Of course we do. Let’s not confuse supplier performance problems with the value of setting clear expectations. Standards still provide a clear and unambiguous way to specify product requirements, testing procedures, and acceptance criteria. Regulatory agencies and review committees made up of your industry’s leading experts create standards that give you a proven, technically-sound basis for assuring reliable and safe products. They specify not just the quality characteristics of the supplier’s output, but in many cases also how that output should be produced.

Standards tell the supplier how you will measure their performance, and establish the criteria you will use to accept or reject their deliverables. Your supplier should already be familiar with your industry’s standards, and if they’re not, then they’re probably not the right supplier for you.

However, simply communicating the standard to your supplier is not enough to assure compliance. Purchasing customers have a responsibility here as well. You need to “trust but verify,” and regularly audit suppliers, which can include sampling incoming parts and inspecting the production factory and supporting processes. Suppliers need to understand that there are consequences for failures to meet standards, such as financial penalties and loss of business, and suppliers need to know that you’re monitoring their performance.

Yes, it’s frustrating when you discover a quality problem that can be traced to your supply chain, but that shouldn’t lead you to abandon standards. It can sometimes seem like the Wild West where anything goes, but without standards that clearly define your requirements and expectations you’re just contributing to the chaos.

Author:  Dr. Tim Rodgers

Editor’s Note:

Tim Rodgers, Ph.D., MBA, SSBB, PMP, is a senior engineering manager with many years of experience leading new product development, supply chain management, and quality engineering teams at large multinational firms, including Lockheed-Martin, Hewlett-Packard, and Eastman Kodak. Tim is currently in-transition, looking for an opportunity to join a growing firm with an entrepreneurial culture. He writes regularly on management and quality issues at his own blog “Managing in the 2000s” at http://timrodgers.wordpress.com