ISO/IEC 29169 – Conformity Assessment for IT

ISO/IEC 29169, “Information technology – Process assessment – Application of conformity assessment methodology to the assessment to process quality characteristics and organizational maturity,” has just been released.  It’s a milestone in the ISO and IEC’s Joint Committee 1 (JTC 1) effort to promote conformity assessment in the world of IT (information technology).  The standard promotes the mutual recognition of accreditation, tests reports, certifications, and the registration of recognition of a supplier’s declaration of conformity.

The standard has been developed for the IT community.  However,  it is also an outstanding review of conformity assessment and the standards that support it.  That is, while the document focuses on process assessment as defined by ISO/IEC 33001 and ISO/IEC 33002, it uses the core principles of ISO/IEC 17000 and ISO/IEC 17020 which are applicable across industry.

The ISO/IEC 29169 begins with the usual scope, referenced documents and terms and definitions sections.  You’ll then get a thorough (and logical) review of the concepts, functional approach, and general scheme of conformity assessment.  As you move into the later sections, the reliance on the IT specific documentation then becomes clear.  You’ll see this in the details of Section 7 on requirements, Section 8 on planning and performing the assessment, Section 9 for review and attestation, and Section 10 on surveillance.  Section 11 specifically relates the general principles to the specific needs of IT in reviewing the requirements for the operation of the bodies actually performing the inspection.  The concluding 16 item bibliography provides information on closely related ISO/IEC standards and other publications.

For those of you in the IT industry as well as organizations who have an IT component in upir products, the ISO/IEC 29169 will be an invaluable aid to understanding what’s involved in conformity assessment of these types of products.  You’ll need a copy, and you’ll want to make sure that you get it from an authorized distributor like Document Center Inc.

Search for and order standards at our webstore, www.document-center.com.  Here’s a direct link to the order page for ISO/IEC 29169.  You’ll have the option of choosing delivery in paper format or for pdf download.  Want this standard in an enterprise platform for use by your entire organization?  Talk with our staff about our Standards Online cloud solution or the other premium services we offer.  You can reach us by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

ISO/IEC 17025 accredited labs

ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories,” is the go-to standard for certification of testing labs.  So when you’re learning about standards and how to use them, you may have questions on what the relationship is between testing labs and the ISO/IEC 17025.  There’s a great article in InCompliance magazine this month.  It’s titled “Specifying Accredited Calibration Services: A Review of Electrical Test Equipment.”  And it describes how you use the ISO/IEC 17025 certification to help you find a calibration lab for your product testing.

First of all, use of the ISO/IEC 17025 is one of two primary standards on calibration.  Along with ANSI-Z540.3, the successor for ANSI-Z540.1, it replaces the old MIL-C-45662 (later MIL-STD-45662), “Calibration System Requirements.” These standards are used by test labs the world over to make sure that testing is correct and reproduceable by correct calibration of the equipment used.

The article divides your process in getting an accredited calibration service into two primary activities:  Finding an appropriate lab and issuing the purchase order along with the receipt of the final results.  This is particularly helpful, since many folks don’t realize that accreditation is the way you the customer know that your test lab will provide you with valid results.

Finding the lab boils down to three major concerns.  First, is the lab accreditated by an ILAC signatory accreditation body?  This is your verification that a third-body certification organization has reviewed the processes at the test lab in question and that these meet the requirements of ISO/IEC 17025.  Secondly, you’ll want to confirm that the test lab has the expertise to work with your product.  Part of this is obviously confirmed by the scope of accreditation.  But you may also need to take into account such factors as location, since you may need to have your testers work on your premises rather than at their facility.  Lastly, you’ll want to review the accreditation to confirm that it is current (not expired).  You can do this at the accreditation body’s website in most cases.

Specifying the work by way of a purchase order is your assurance that the work that the lab does will meet your products needs.  Section 4.6.3 of ISO/IEC 17025 describes the technical content you’ll need to include.  And you’ll also want to make sure that you include enough detail to assure that any regulatory or other legal requirements can be fulfilled by the work the test lab does for you.

When you get back your report, check it out to make sure that the calibration certificate contains all the information requested on the PO.  And you may also have labelling requirements to verify as well.

The article then provides you with a sample process for obtaining an accredited calibration for an LPDA antenna.  This is particularly helpful for those of you with electrical equipment that needs to be tested.  You can follow this example when considering how to set up your procedure for certification of your electrical equipment in the future.

Meantime, good testing relies on both strong calibration procedures and using the proper standards for the testing.  When you need standards for these types of purposes, search for and order them on the Document Center Inc. website (www.document-center.com).  We’ve been working with standards since 1982 and have a detailed catalog of documents for you to choose from.  And should you have questions, our staff is here to help you!  Just reach out to us by phone (650-591-7600) and/or email (info@document-center.com).  We’re your Standards Experts!

New RR-C-271 Revision G

RR-C-271, “Chains and Attachments, Carbon and Alloy Steel,” has just been updated.  The new Revision G is available now from Document Center Inc. in both paper format and for pdf download.  It is a major revision, with changes too extensive to notate in the update.

The new RR-C-271 Revision G replaces the previous Revision F from 2011.  The document is used in Federal Procurement for the U.S. government.  As federal specification, it is also widely used in U.S. DoD contracts and across industry as well.  You’ll find that the specification covers carbon and alloy steel chain, commercial quality, and the attachments most often used with this type of chain.

Will you find all types, grades, classes and styles of this type of chain in this document?  No, just the ones that are used to meet Federal requirements.

How much information is in the RR-C-271?  There are 61 pages in  this document.  The publication starts with the usual scope and referenced documents sections.  Then follows a 35-page requirements clause with extensive tables and figures to define all of the many parts included in the document.  Quality requirements are reviewed next.  Then  Section 5 covers packaging, and Section 6 completes the document with various notes.  There are two appendices for your use.  Appendix A is on the PIN (Part Identification Number) system.  Appendix B covers the various material requirements (what kind of alloy is acceptable for eaach of the chains and attachments).

Why get your copy from Document Center Inc.?  Document Center offers you both “best in class” notifications of any changes to the standards that you purchase from us.  Our customers receive timely email notification when there are updates to the standards they use.  And should you want to talk with someone about any standard and how to use it properly, our knowledgeable staff is available to you via phone (650-591-7600) and/or email (info@document-center.com).  Search for and order standards online at our webstore, www.document-center.com.  Here’s the direct link to the order page for RR-C-271.  Make us your Standards Experts!

ASTM E384 2016 Edition Released

ASTM E384, “Standard Test Method for Microindentation Hardness of Materials,” has just been revised.  The new 2016 Edition is available in a variety of formats from Document Center Inc., an authorized distributor of the ASTM standards.  The new Edition replaces the 2011 Edition (with an editorial change from 2012), which is now obsolete.  This is a major revision and should be purchased by all users of this publication.

The ASTM E384 provides you with the details of performing both the Knoop and Vickers microindentation tests.  However, you will notice that the title has changed from the previous edition to focus back on the microindentation test itself, rather than to limit it to just Knoop and Vickers.  This is a test that involves the use of a diamond indenter and a calibrated machine that applies force to the  material in question using this indenter.  A hardness number is then determined using calculations provided in this document.

If you’re using the ASTM E384, you’re wondering what has changed in this new revision.  Let’s put it this way, what hasn’t changed?  There’s not 1 page of technical material that has not been revised.  In fact much of the technical information has been completely rewritten.  For this reason, you may want to purchase the redline edition of the document.  This will provide you with a clean copy of the 2016 Edition along with a “marked-up” copy of the previous 2011e1 Edition.

Now the next question is where to purchase your copy.  Use Document Center’s webstore at www.document-center.com to search for and order any ASTM standard.  Here’s a direct link to the order page for ASTM E384.  You’ll see that you can order both the paper format and a pdf download online.  If you’d like enterprise-wide access to any ASTM standard, check in with our staff for information on setting up a Standards Online service.  This allows you to access the standards you need on our cloud-based platform.  You can reach us by phone at 650-591-7600 or by email at info@document-center.com.

We’ve been selling standards since 1982 and have extensive knowledge on how you can best use this type of compliance information.  Make us your Standards Experts!

New ISO 16142-1 Safety Standard Selection for Medical Devices

ISO 16142-1, “Medical devices – Recognized essential principles of safety and performance of medical devices – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards,” has just been released.  This new standard (and it’s future Part 2 for IVD Devices) cancels and replaces the ISO/TR 16142 2nd Edition from 2006.  It is intended as a guide for both standards users and developers.

One of the reasons that this revision was initiated is that the essential principles (developed by the Global Harmonization Task Force, GHTF) were updated in 2012.  So the new ISO 16142-1 relies on these new principles, including a more thorough mapping of published reference standards to the GHTF criteria.

The previous document, ISO/TR 16142, was a “technical report,” having less legal weight than the status of the new ISO 16142-1, which is an International Standard.  It is expected that this change will make the document more useful to authorizities with medical device safety jurisdiction.  In the same vein, there is also an informative Annex D which maps the reference to essential principles by International Standards.  This should be used by writers of healthcare standards as a template when similar mapping is generated.

Another feature of this publication is the comprehensive description of standards usage as a tool in demonstrating that a medical device is clinically effective and can perform in a safe manner.  This is one reason that standards are so frequently used as a tool by both medical device designers and manufacturers as well as by regulators.  Clarification of this situation is a timely aspect of the document.

OK, so you’re a medical device manufacturer, a conformity assessment body, a standards developer or a regulator, and you need a copy of this new standard.  Remember, you’ll always want to use an authorized standards distributor like Document Center Inc. when you procure your documents.  You can search for and order standards from all corners of the world at our webstore, www.document-center.com.  Here is a direct link to the order page for the new ISO 16142-1.

Have additional questions or need to work directly with our staff?  Contact us by phone at 650-591-7600 or by email at info@document-center.com.  We have a range of services to improve your use of these compliance documents.  And our notification service is best-of-class!  (We just got a notification today from a competitor for a document that we issued an alert on two months ago!)  So remember Document Center Inc. and make us your Standards Experts.

ASTM B241/B241M updated

ASTM B241/B241M, “Standard Specification for Aluminum and Aluminum-Alloy Seamless Pipe and Seamless Extruded Tube,” has just been updated.  The new 2016 Edition is available from Document Center Inc. in both paper and pdf formats — it can be included in your enterprise solution, Standards Online, as well.  This is an extensive revision.  There is almost no section of the specification that remains untouched!

ASTM B241/B241M is used extensively throughout industry.  It covers aluminum and aluminum–alloy seamless pipe in a variety of alloys.  There are extensive tables with the details required.  Sizes of pipe are taken from the ANSI H35.2 and ANSI H35.2(M).  A new feature of the specification is the addition of seamless extruded pipe and tube for oil and gas transmission (formerly part of ASTM B354/B354M).

Why are the changes so extensive in this new 2016 Edition?  One of the alloys referenced in this standard has been deactivated by the Aluminum Association.  So it has been removed from all tables in the ASTM B241/B241M.  This means you’ll see new items in the referenced standards section, have new references in many of the various clauses, and a number of references removed as well.  Further, AMS 2772 has become the default heat treatment specification.

Another area of the standard with an extensive revision is the terminology section.  Changes also appear in Clause 4, ordering information, Clause 5, materials and manufacture, Clause 7, composition, Clauses 8, 10 and 11, all on heat treatment as noted above, Clause 9, tensile properties, Clause 13 on cladding, Clause 14 on dimensional tolerances, Clause 15 on general quality, Clause 16 on internal quality, and Clause 19 on identification marking of product.  Even Annexes A1 and A3 have been updated.  Whew!  Have I convinced you that you must have this new edition yet?

Just go to Document Center’s webstore where you can search for and order all ASTM standards.  It’s at www.document-center.com.  And here’s the direct link to the order page for ASTM B241/B241M.  If you’d like to set up a multi-user company-wide service, just get in touch with our staff.  You can reach them by phone at 650-591-7600 or by email at info@document-center.com.  Document Center Inc. has been an authorized ASTM Distributor since the 1980’s.  Make us your Standards Experts!

The QPD Database for QPL’s and QML’s

The QPD database has been set up as a replacement for the old QPL and QML publications.  Many of our customers still are referencing the old Qualified Products Lists, but you’ll find using this new database is the way to go.  Let’s take a look at this QPD database to understand how to use it when you need to purchase component parts.

The old QPL (Qualified Products List) system was set up to provide you with a way to find manufacturers that make a part that meet the requirements of a specific Mil Spec.  So if I wanted to include a universal joint in one of the products I’m making to fulfill a military contract, I’d want to know where I could buy joints meeting the requirements of MIL-DTL-6193 (formerly MIL-J-6193).  In order to do this, the QPL system was developed.  It is a list of manufacturers who have been certified as meeting the MIL-DTL-6193 requirements.  It maps the MIL part numbers to the product numbers of each manufacturer as well.

Of course, suppliers change and QPL’s have to be updated regularly in order to provide accurate information to users.  “Transforming” the data from a static publication to a dynamic database provides you with the level of accuracy you need at any given time.

Originally, these transformation notices linked to a URL that is no longer available.  The new location of the database is at http://qpldocs.dla.mil.  To search for the QPL (or QML) information for a give Mil Spec, you’ll use the search page at http://qpldocs.dla.mil/search/.  Just enter in the numeric part of your Mil Spec into the search field.  The result will be your original Mil Spec number.  You’ll quickly see that your result is actually a link.  This link takes you to the overview information for your spec.  You’ll then drill down to find the exact data you need.

So the next time you see a QPL or QML with a “Transformation Notice,” head to the QPD database page.  Here is where the information you need actually resides!

And when you need help with any Mil Spec or Standard, please let us know.  You can reach Document Center Inc. by phone at 650-591-7600 or by email at info@document-center.com.  Do search for and order standards at our webstore, www.document-center.com.  We’ve been providing folks like you with government specifications and standards since 1982.  Make us your Standards Experts!

ISO 14021 Updated – Environmental Labelling

ISO 14021, “Environmental labels and declarations – Self-declared environmental claims (Type II environmental labelling),” has just been revised.  The new 2nd Edition, dated 3/15/2016, replaces the 1st Edition from 1999 and its Amendment 1 (12/15/2011).  ISO has notified us that this is a minor revision.  It does not alter any legally required environmental information, claims or labelling.

The ISO 14021 is used for “self-declared” environmental claims.  This means that you’re going to use a label to communicate to consumers of your product.  This label may include statements, symbols or graphics.  Or it may be such information included in technical bulletins, advertising, and the like.  Since you are communicating a specific environmental aspect of your product (or packaging for example), its essential that it will hold up to verification, etc.

For this reason, the ISO 14021 provides you with the requirements you’ll need to meet when use use specific terms like “recycled content” and “degradable.”  It provides you with the correct usage information for various symbols and claims.  And it provides you with information on the relationship of this standard to ISO 14020 on environmental labelling in general.  Other useful features of this standard include Annex A, a simplified diagrammatic representation of a recycling system, and the comprehensive 68-item bibliography at the end of the publication.

If you use the ISO 14021 in your business, you’ll need to get a copy.  Of course it is essential that you use an authorized distributor like Document Center Inc. for your purchase to verify that copyright laws are met.  Search for and order all ISO standards at our webstore, www.document-center.com.  And here’s a direct link to the order page for ISO 14021.

Many folks have additional questions when they are working with this type of compliance information.  Here you’re in luck, for our staff has been working with standards for many years and can give you assistance with many of the issues standards users face.  Feel free to contact our staff by phone at 650-591-7600 or by email at info@document-center.com.  We’re your Standards Experts!

BS EN ISO 13485 Correction Issued

BS EN ISO 13485 2016 Edition, “Medical devices. Quality management systems. Requirements for regulatory purposes,” has just been reissued with a Corrigendum 1 (correction).  This updated edition is available from Document Center Inc. now.  If you use this publication, please get your corrected copy asap as it does contain changes that will affect your compliance requirements for Europe.

The BS EN ISO 13485 is the official English language edition of the EN ISO 13485.  You will note that other national editions contain the same text for the English edition as does the BS version.  So it is possible to meet your requirements with editions from Sweden, Germany or other jurisdictions.  The English text of the standard remains the same in them all.

The corrections to the BS version center on the preliminary material, that is the forward and the various Annexes.  Since the Annexes provide you with the specific information on what clauses of the standard meet the requirements of the various Directives referenced, they’re essential to effectively implementing the standard.  Other items of note include the official requirement to use the EN edition of the ISO 9001, for example.

For those of you who have already purchased your copy of the BS EN ISO 13485 from Document Center Inc., you can get the corrected edition for a nominal service charge to cover the costs of reprinting the entire document.  For those of you who haven’t gotten a copy yet, you’ll just purchased the corrected 2016 Edition that’s available at our webstore.

You can search for an order standards here at our Document Center website, www.document-center.com.  And here’s the link to go directly to the order page for the BS EN ISO 13485.  If you have questions and would like to talk with our staff, consider giving us a phone call at 650-591-7600 or contacting us by email at info@document-center.com.  We are an authorized distributor of EN Standards in a number of European National editions.  We’ll help you choose the best one for your purposes.  Make Document Center your Standards Experts!