ISO 19649 is here for Mobile Robots!

ISO 19649, Mobile robots – Vocabulary, has just been released.  The new 1st Edition has 18 pages of information on terms used for these products.  As I often say, a vocabulary standard means that the groundwork is being laid for further standardization on a subject.  And yes, robots are being ever more ubiquitous in industrial and non-industrial settings.

ISO 8373 from 2012 gave us a vocabulary for robots in general (Robots and robotic devices – Vocabulary).  ISO 19649 expands on this work by addressing specific terms for mobile platforms and mobile robots.  These consist of “robots” that travel on a solid surface.  They can be used in either industrial or service applications.  Terms address the issues of mobility, locomotion, and other navigation definitions.

The standard is arranged in the usual format.  The first two sections cover the scope and the referenced documents.  Section 3 is strictly terms and definitions.  But it is divided into 6 sub-sections, each focused on a specific aspect of mobile robotics.  First is general terms, then locomotive structure, wheeled robots, legged robots, locomotion itself, and finally navigation.  Annex A provides examples in graphical or tabular format.  A 5-item bibliography completes the document.

In discussing the future of manufacturing, it is apparent that robotics is the future.  It is not surprising that a number of new robot standards are being released at any given time. If this is your field, you may want to take a look at our page devoted to robotics standards, Document Center List of Standards on Industrial Robots – Manipulators.  If you’d like to get a copy of ISO 19649, either go to our webstore at www.document-center.com or take a look directly at the order page for the ISO 19649 itself.

You may have additional questions.  If so, please get in touch with our staff by phone (650-591-7600) or email (info@document-center.com).  We’re based in Silicon Valley and have been working with standards since 1982.  You’ll find us to be knowledgeable and able to give you assistance with your compliance documentation requirements.  We have a range of support services as well.  Make us your Standards Experts!

ANSI Z80.20 2017 Updates Contact Lens Standard

ANSI Z80.20, Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements And Physicochemical Properties, has just been updated.  The new 2016 Edition is available from Document Center Inc.  It replaces the 2010 Edition which is now obsolete.

First, how can a 2016 Edition just be released in the spring of 2017?  It’s not uncommon for a standard that has been approved to take some time prior to actual public release.  So while the ANSI Z80.20 was approved on December 6, 2016, it wasn’t actually published until March 20, 2017.

What exactly does the ANSI Z80.20 cover?  While first of all, the document replaces the previous ANSI Z80.2 for rigid contacts and the ANSI Z80.8 for soft contact lenses.  So this standard covers tolerances for all contact lenses.  It also gives you the measurement methods to use for the parameters and properties needed for proper functioning and manufacture of contact lenses.  And it lays out the various conformance criteria you’ll need to meet during product tests.

That’s a lot of ground to cover and this standard is 109 pages of detailed information.  You’ll find the usual scope, referenced documents and definitions sections.  Then specific information for contact lenses are reviewed.  These include nomenclature and classification, tolerances, physicochemical properties, measurement methods, and the test report.  The Annexes cover conformance criteria, measurement systems, gauging consistency, determination of label back vertex power, and a 10-item bibliography.

Who develops the ANSI Z80.20?  The oversight for this standard is provided by The Vision Council (formerly the Optical Laboratories Association).  They convened a committee composed of government experts (FDA and VA), folks from related associations (like the American Academy of Optometry), and industry (the folks that design, manufacture and sell contact lenses).  Even though the standard is a U.S.-based ANSI standard, participants also represent links to the international level and ISO.  So this standard is broadly consensus-based.

If you’re part of this industry, you’ll need your copy now.  Use Document Center Inc. for your purchase.  We are an authorized distributor of many ANSI standards including those published by The Vision Council.  You can search for and order these publications at our webstore, www.document-center.com.  Here’s a direct link to the order page for ANSI Z80.20 for your convenience.

If you have additional standards questions or requirements, just get in touch with us.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  You’ll find us to be knowledgeable and available to work with you to provide your company with outstanding compliance documentation support.  Make us your Standards Experts!

ISO 8559 Updated – New ISO Standards for Clothing Sizes

ISO 8559 has been updated with the release of ISO 8559-1 and ISO 8559-2.  Between the two new standards, quite a number of older ISO clothing standards have been replaced.  What’s in the new documents?  Let’s take a look.

ISO 8559-1, 1st Edition, Size designation of clothes – Part 1: Anthropometric definitions for body measurement

Different populations have different sizes and shapes.  So clothing sizes must be tailored to the target customer base.  How can you go about creating valid sizes?  Making appropriate mannequins?  Developing stability in the clothing sizes you manufacture?

ISO 8559-1 provides an anthropometric basis for solving these problems.  It replaces the ISO 8559 from 1989, which is now obsolete.  In this standard, you’ll find the tools necessary to understand how to take these types of measurements.  And you’ll learn the principles of measurements needed, including the underlying anatomical and anthropometrical basis of these measurements.

The 90-page standard also includes an Annex A, which provides pictogram information, including widely used dimensions for developing clothing sizes.  Annex B covers standing and sitting requirements (including arm positions).  And Annex C reviews landmark and measurement mapping.

ISO 8559-2, 1st Edition, Size designation of clothes – Part 2: Primary and secondary dimension indicators

The new ISO 8559-2 replaces a myriad of other clothing standards:  ISO 3636, ISO 3637, ISO 3638, ISO 4415, ISO 4416, ISO 4417 and ISO 4418.  All are cancelled and the information in them has been technically revised by the new release.

The sizing system developed by this series of standards is a little different than we’re probably used to.  The critical dimensions provided are of the wearer, not the garment.  So this standard outlines the various primary and secondary dimensions of various types of garments that impact who can wear the item.  Using this system, your clothing label will include minimum and maximum sizes of the wearer’s body in these predesignated areas.  For example, for a men’s jacket, the label would have a primary dimension for a man’s chest and a secondary dimension of his height.

The 32-page standard covers over 25 different garment types along with the primary and secondary dimensions for men, women, boys and girls.  This is done with the use of both a table, and also a series of figures.  Additionally, label examples are included.

There is a third part to this ISO 8559 series that is still at the committee draft stage.  It is preliminarily titled Size designation of clothes — Part 3: Methodology for creating body measurement tables and intervals.  It looks like the committee is working on the first set of comments generated within the group.  When consensus is achieved, it should be ready for public review.

Clothing, like many other types of goods, is being impacted by the use of computers for design and manufacture.  And there is also the issue of a global market for such products.  The new structure of sizes reflects industry’s need to develop standards-based processes for sizing.  And to have a way to communicate this over a diverse customer base.

If you use these or other ISO standards, search for and order them at the Document Center Inc. webstore, www.document-center.com.  We have been authorized distributors of ISO standards for over 25 years.  You can order from our extensive collection of compliance documentation with confidence.  Here is a link to the list of ISO 8559 standards currently available.  Order the editions here that you need.

You may have additional questions.  Our staff is always happy to help.  Reach out to us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982.  Make us your Standards Experts!

 

2017 EN ISO 13485 Corrigendum

Sometimes you want to know only the changes that are made to an EN Edition.  The new 2017 Corrigendum for EN ISO 13485 is a good example.  You have the option of purchasing a consolidated edition to get this information (BS EN ISO 13485).  But you can also purchase the Corrigendum only if you like (SIS EN ISO 13485).  Why would you want to do that?  To make your gap analysis easier.

The EN ISO 13485 2017 Corrigendum makes changes to the Annexes only.  These changes are noted by symbols at the beginning and end of either added or deleted text.  In the Corrigendum, only the areas with the changes are included.  The balance of the text of the EN ISO 13485 2016 Edition is not included.

Why is a Corrigendum like this available as a stand-alone item in one Edition and not in the other?  Each country in Europe can provide the changes either way.  So this is strictly a national convention.  And you can use it as a way to make your life easier.

Document Center Inc. offers you a number of national edition choices when it comes to purchasing EN documents.  The ones we carry are usually in English.  The text of the EN standard itself is identical in all cases.  It comes directly from CEN or CENELEC, the two European regional standards bodies.  So there is no technical reason to choose one national edition over another.

So how will you make your purchasing decision?  Our customers decide which edition suits them best based on available formats, the price, and any preferences their auditors may have.  If you are uncertain what to do, just get in touch with us.  Our knowledgeable staff can assist you with the information you need to make up your mind. You can reach us by phone at (650) 591-7600 or by email at info@document-center.com.

To see what’s available, just search for the EN standard you’re interested in at our webstore, www.document-center.com.  The various acronyms at the beginning of each document number designate the country that has published that edition.  You’ll notice that there is never a price for the source EN edition itself.  EN’s are only available in each of the national editions.

More questions, please get in touch.  We are always glad to help you with your compliance documentation questions.  Make us your Standards Experts!

ANSI A1264.1 Updated – Workplace Safety

Workplace safety standards are among some of the most important standards for employers.  And ASSE, the American Society of Safety Engineers, is the right place to start when you want to know what’s available.  As an authorized distributor of the ASSE standards, Document Center Inc. is pleased to announce that the new ANSI A1264.1 2017 Edition is now available.  The standard is titled Safety Requirements for Workplace Walking/Working Surfaces and Their Access; Workplace, Floor, Wall and Roof Openings; Stairs and Guardrail/Handrail Systems.

This particular safety standard focuses in on protecting people in workplace or industrial settings where there’s a danger of either people or objects falling from elevated walking and work surfaces.  What kinds of situations might that be?  Well, the standard specifically mentions theaters as a location where both stage hands and performers may access certain areas that are high above the stage.

The 40 page standard reviews the various kinds of areas that can present a fall danger in work situations.  Formatted like many other ASSE standards, the text of the document is in a left-hand column.  Additional information and comments are located in a right-hand one.  This means that as you work through the document, you’ll be given clarifying material.

The standard also covers the important ways that such areas need to be designed and maintained.  So there is information on now to properly protect floor and roof openings and holes, for example.  Other safety concerns the standard addresses include protection of wall openings and holes; open-sided floors, roofs, platforms, runways and ramps; railing systems; stairways, and guardrails/handrails.  The document also gives you requirements for inspections and maintenance.

The 2017 Edition is a technical revision of the previous 2007 Edition.  The committee also notes that there are 2 new definitions and 4 new illustrations to help clarify text in the standard.

Now you need to get a copy, so head to Document Center Inc.’s webstore at www.document-center.com.  Here you can search for and order from our collection of over a million documents.  For your convenience, here is a link to the order page for the ANSI A1264.1 paper format standard and to the order page for the ANSI A1264.1 pdf download.

Have additional questions about standards?  Please get in touch with us.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982, so you’ll find us to be a knowledgeable resource.  And we have many additional services that can help you maintain your compliance documentation collection.  Make us your Standards Experts!

ISO 44001 – Business Collaboration Standard

ISO 44001, Collaborative business relationship management systems – Requirements and framework, has just been issued.  This is a new management system requirements document and follows the general schema of all of the ISO harmonized management system standards.  It is intended to provide the framework for such collaborative endeavors as consortia, alliances, joint ventures, and outsourcing.

ISO 44001 establishes a strategic lifecycle framework for collaboration between organizations of all sizes.  These relationships can be one to one, or a variety of situations with any number of partners.  And the processes of getting into and out of such relationships are discussed as well.

Your standard begins with the usual scope, references, and definition sections.  Then the following sections address issues familiar to those of you who have worked with management system standards before.  These include context of the organization, leadership, planning, support and operation. Sections 9 and 10 cover performance evaluation and improvement.

There are 7 informative Annexes.  They include a checklist, information on the relationship management plan, competencies, relationship maturity matrix, exit strategies,  business type descriptions, and application guidance.  A short bibliography completes this 70 page publication.

In actuality, you work in a collaborative fashion with many entities.  You look to both your suppliers and your customers for input on improving your business practices and products.  Should you choose to formalize any of these relationships, ISO 44001 provides a solid foundation.

You can search for and order all ISO standards (including many obsolete editions) from our Document Center Inc. webstore at www.document-center.com.  Here is a direct link to the order page for ISO 44001 for your convenience.

And if you comply with any of the management system requirements standards, you know that external assistance with maintaining your compliance documentation is a must.  Document Center Inc. has a variety of support services and products that can help you meet stringent documentation needs.  Just check in with our staff by phone (650-591-7600) or email (info@document-center.com) for more information.  Document Center Inc. has been working with customers like you since 1982.  Make us your Standards Experts!

ISO/IEC 17025 Draft for Testing Labs available now

ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, is one of our most widely-used standards here at Document Center Inc.  It is used to certify that a testing lab is able to correctly perform the various tests and calibrations you use it for.  The last update was the release of the 2nd Edition back in 2005.  Now the standard is being revised and you have a chance to look at the draft.

ISO and IEC release draft standards as part of the “public review” process.  In this case, you have until 3/22 to take a look at the proposed new 3rd Edition and send in your comments.  But you may also want to take a look at the draft to get a good idea where changes will be in the eventual updated publication.

Draft standards like this have the changed areas clearly marked.  For example, in the 2017 draft for ISO/IEC 17025, section 4.1 on impartiality and section 4.2 on confidentiality have been updated.  If there are a series of comments on this, it’s possible that the language could again be changed.  If so, another draft edition will be released in the future.  If not, the language will be adopted as is.

Other areas that are being considered for changes are section 6.2 on personnel, and section 7.9 on complaints.  Section 8.1 on options is also modified.  This is the best time to review the areas where changes will be made.  When the adopted final edition is published, it is likely that there will be no detailed information on where the exact changes are.

If you’d like a copy of the draft edition of the ISO/IEC 17025, please contact us.  We will verify that you understand that it is a draft edition with no legal standing and subject to change.  It’s available in either paper format or for pdf download at a price of $68.00 per copy.  Just get in touch with us by phone (650-591-7600) or email (info@document-center.com).  If you’d like to initiate the purchase using our webstore (www.document-center.com), here is a link to the order page for ISO/IEC DIS 17025 (the number of this draft).

Document Center Inc. has been selling standards since 1982.  We have an extensive catalog of standards available for  you to purchase.  And we have a number of services all geared to support your use of compliance documentation.  Make us your Standards Experts!

ANSI Z765 – Residential Housing Square Footage

I spotted a headline in the Wall Street Journal the other day.  It included the statement “With no national standard in calculating square footage…”  There’s a little something to get a standards professional’s dander up!  Of course, there is a national standard for residential housing square footage — The ANSI Z765 (aka NAHB Z765).  Titled Single Family Residential Buildings, Square Footage – Method of Calculating, it was originally issued in 1996.  Since that time, it’s been updated twice.  The 2013 Edition is the current revision.

So why would the WSJ pronounce the lack of a standard?  Further into the article, the reason is clarified.  It’s not the lack of a standard, its the lack of a uniformly implemented standard.  Yep, according to the WSJ author, a standard is not a standard if it is not universally applied.  And why is the ANSI Z765 not universally applied?  Because some states in the U.S. use other measurement practices in order to calculate square footage for property tax purposes.

And that’s the rub for voluntary standardization.  A standard can be created but it lacks a certain viability unless it is applied.  For the ANSI Z765, there are a lot of good reasons to use the standard and most real estate appraisers do.

First, using a standard reduces legal liability issues.  According to a great powerpoint presentation by Bryon Miller (presented in 2014 at a meeting of AI Connect), “One of the most common reasons appraisers & realtors get sued is over measuring disagreements.”  Being able to prove that a standard was used as the basis of a product, measurement or test provides “best practices” support of your position.

Second, using a standard provides a repeatable number.  And by using the same method for a variety of samples, you are then able to compare “apples to apples.”  This consistency of results is a major reason that organizations rely on standardization.

Third, standards are developed by a group of professionals.  Casting a wide net during the process of setting up a committee to do the work of standardization enhances the likelihood of an impartial result.  The Bryon Miller power point includes 12 well-respected organizations on slide 26 as a partial list of participants in the last update of the ANSI Z765.  Impressive!

So, that’s the challenge for Standards organizations.  The development of a standard is actually only half the battle.  Getting a standard implemented is the greater endeavor.  One pathway is to have standards embedded in regulatory rules.  This comes with its own set of issues.  Another is to have advocates like Mr. Miller educate the user base on the benefits of using a particular document.

For those of you new to standards, you’ll want help in learning to identify the documents that will offer benefit to your organization.  Let Document Center Inc. help you out.  You can search for and order standards at our webstore, www.document-center.com.  Here is a link to the order page for the ANSI Z765 for your convenience.

Or you may want to get in touch with us directly.  We can be reached by phone (650-591-7600) or by email (info@document-center.com).  We have been working with standards since 1982 and have a wide array of additional support services developed to make it easier to find and use the standards you need.  Make us your Standards Experts!

 

EN 15224 2016 – ISO 9001 for Healthcare

EN 15224, Quality management systems. EN ISO 9001:2015 for healthcare, 2016 Edition has just been released.  It replaces the previous 2012 Edition which is now obsolete.  Changes are extensive.  If you use this standard in your organization, you’ll want to get a copy of the new Edition right away.

EN 15224 is used to establish and certify quality management systems in healthcare organizations in Europe.  For those of you in the U.S., you may find the 88 page document to be an excellent addition to your compliance documentation.  It is an extensive review of the requirements for quality processes and performance in hospitals, nursing facilities, and the like.

The previous 2012 Edition was based on the previous edition of the ISO 9001.  This update supports the new 2015 Edition of the core QMS requirements standard.  To this end, changes are apparent with regards to risk management, a process approach, and the relationship between EN 15224 and the other management system standards.  The standard has been modified to make it easier to manage it within the context of the broader set.

What separates quality in healthcare organizations from the generic model of the ISO 9001:2015?  To me, a major difference is the inclusion of the WHO (World Health Organization) description of “health.”  This is defined by the five health components – body function, body structure, activity, participation, and environmental factors.  This gives a formal goal for quality efforts.  Additionally, the EN 15224 includes 11 basic quality aspects that have evolved from clinical experience.  They are:

  • Appropriate, correct care.
  • Availability.
  • Continuity.
  • Effectiveness.
  • Efficiency.
  • Equity.
  • Evidence/knowledge based care.
  • Patient-centered care.
  • Patient involvement.
  • Patient safety.
  • Timeliness/accessibility.

Many hospitals and other healthcare facilities are moving towards standards-based quality management systems to improve both patient outcomes and better use of resources.  And the processes of QMS have given many healthcare organizations a structure for real improvements in the delivery of services.  If you’re involved in improving your facilities performance, you’ll want a copy of this new standard.

Order from Document Center Inc., a leader in the distribution of compliance documentation.  You can search for and order standards at our webstore www.document-center.com.  For the EN 15224, you’ll need to purchase the standard in one of the national editions from Europe.  Currently, Document Center offers you two options: BS EN 15224 and SS EN 15224.  The DIN EN 15224 should be released soon.

If you need any assistance or would like information on other standards of interest, please get in touch with us.  We can be reached by phone (650-591-7600) or email (info@document-center.com).  We have been selling standards since 1982 and have an array of support services to improve your documentation protocols.  Make us your Standards Experts!

ISO 11138 Series Updated – MedDev Sterilization

The ISO 11138 series, Sterilization of health care products – Biological indicators, has just been updated.  All 5 parts in the series have been released as a new 2017 Edition.  These are important sterilization standards for the health care industry.  You’ll want to get your copies ASAP from Document Center Inc. so here is the order page for all 5 ISO 11138 Parts.

Biological indicators are inoculated carriers and suspension used for validating and monitoring sterilization processes.  The ISO 11138 series provides manufacturers and others with the requirements for production, labeling, test methods and performance requirements of these substances.  They are a vital part of insuring that sterile medical devices and products are used in health care settings.

The ISO 11138 series underwent a major revision back in 2006.  The original Parts 1, 2 and 3 were complimented by the release of Parts 4 and 5 at that time.  The 2017 updates represent the first change since then.  All 5 2017 Revisions are a technical update and so replace and withdraw the previous 2006 Editions.  Here’s more information about each document in the set.

ISO 11138-1, 3rd Edition, Sterilization of health care products – Biological indicators – Part 1: General requirements

This is the overview document, with the basic information common to all of the parts of the series.  You’ll get a wide range of information here, including quality considerations, the various test methods used, and so on.  Much of this 48 page standard is devoted to the Annexes.  A covers how to determine viable count, B is on growth inhibition, C and D contain D value determination methods, E reviews the survival-kill reponse, and F shows you the relationship between various biological indicator components.

ISO 11138-2, 3rd Edition, Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes

Part 2 is the Ethylene oxide sterilization standard.  It’s used to calculate the performance of sterilizers using this method.  The 14-page standard provides complimentary information to be used in addition to the basics found in Part 1.

ISO 11138-3, 3rd Edition, Sterilization of health care products – Biological indicators – Part 3: Biological indicators for moist heat sterilization processes

Part 3 has specific information on moist heat sterilizers.  Specific calculations are provided in this 16 page standard.

ISO 11138-4, 2nd Edition, Sterilization of health care products – Biological indicators – Part 4: Biological indicators for dry heat sterilization processes

The 16 page Part 4 gives you the additional requirements for biological indicators used in the dry heat sterilization process.

ISO 11138-5, 2nd Edition, Sterilization of health care products – Biological indicators – Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

The last Part 5 discusses specifics for low-temperature steam and formaldehyde sterilization process indicators.  It’s 14 pages in length.

ISO Technical Committee 198 is in charge of the ISO 11138 series of standards.  They have provided no additional information on where the changes have been made in the new updates.  The series has been widely adopted for use in a number of jurisdictions.  We should expect the changes to the core ISO set to ripple through the U.S. and European standards bodies shortly.  We’ll keep you informed as the ANSI/AAMI and EN editions become available, probably later this year.

How can you get your copies of the ISO standards now?  Head to Document Center’s webstore at www.document-center.com.  You’ll find all ISO standards available for purchase in a secure environment.  If you’d like assistance to determine if you need the ISO editions now or should wait for regional adoptions, just get in touch.  We can be reached via phone (650-591-7600) and email (info@document-center.com).  Document Center Inc. has been working with compliance documents since 1982.  Make us your Standards Experts!