New ISO/IEC TR 17026 – Certification of Tangible Goods

February 11th, 2015

ISO/IEC TR 17026 has just been released.  Titled “Conformity assessment – Example of a certification scheme for tangible products,” it supports the type 5 scheme of ISO/IEC 17067 (“Conformity assessment – Fundamentals of product certification and guidelines for product certification schemes.”)  You can get your copy now from Document Center Inc.  It’s available in paper format, for pdf download and as part of our Standards Online multiuser subscription.

What exactly is product certification?  It’s the process of having a specific product and it’s production verified to a specific standard by a third party organization.  It’s used by regulators, purchasers, industry, and others to confirm that a particular product meets requirements like safety, interoperability, performance and sustainability.  And it may be a requirement for offering a product for sale in specific jurisdictions.

What is a product certification scheme?  It is the methodology by which an organization selects the activities and data that prove adherence to the requirements of the standard to which they’ll certify.  There are a variety of product certification schemes.  You’ll use ISO/IEC 17067 to help you decide which is right for your product and situation.

What is Scheme Type 5?  Type 5 allows for conformance surveillance using either samples of the product at the point of production or from the market.  These samples are subjected to the tests, etc., that will confirm that the products meet the requirements.  It may also include periodic assessment of the production process and management system as well.

Is the use of the ISO/IEC TR 17026 limited to just Scheme Type 5?  No.  It is an informative document, with no requirements stated.  You can use it as a helpful guide even if your certification scheme is different from type 5.  However, the example given is type 5.

Why use ISO/IEC TR 17026?  You’re a manufacturer of a certified product, a certification body, or someone who uses or regulates a certified product.  You want to learn more about how product certification schemes are developed and used in practice.  And you want to better understand the functions, activities and elements that need to be considered.

Here’s what you’ll review in this new Technical Report.  First the usual scope, referenced documents and terms and definitions sections are included.  Then you’ll get a general description of the example (type 5) scheme.   Next the document covers the sequence of a certification cycle and the activities that this entails.

Next the publication covers the publicity that can be generated by the issuance of the certification, changes that may affect certification,  confidentiality, product liability, and complaints and appeals.  A series of Annexes and a bibliography complete the report.  Here’s what’s in the various Annexes:

  • Annex A is an example of the information provided with the application for product certification
  • Annex B is an example of information on the production process and the management system
  • Annex C is an example of what information should be included in your certificate of conformity
  • Annex D is an example of a licensing agreement for the use of the certificate and the mark of conformity (like the CE Mark).
  • Annex E is an example of the information included in a license for the use of the certificate or mark
  • Annex F is an example of the contents of a certification agreement

If you’re getting or giving a product certification, these examples can be invaluable.

Now to get your copy.  You can order online at the Document Center 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).  We’ll be able to help you get the standards you need and keep them current over time.  Make us your Standards Experts!

New ASTM A276/A276M released!

February 10th, 2015

ASTM A276 has been replaced by the new ASTM A276/A276M!  The new 2015 Edition, titled “Standard Specification for Stainless Steel Bars and Shapes,” now covers both feet and inches and metric measurements.  You’ll need a copy if you use this specification and you can get it from Document Center Inc.  Just choose delivery in paper format, for pdf download, or as part of our Standards Online subscription service.

This is a widely used ASTM specification.  It covers hot-finished or cold-finished bars (except bars for reforging).  It contains the various requirements, with the bulk of the information being provided by tabluar information presentation.  Table 1  covers Chemical Requirements.  This table lists your metals by UNS designation and type, and then gives you the specific chemical composition for each.  Table 2 lists the types and the mechanical requirements for each.  This includes such things as Brinell Harness, finish, condition, and so on.  There’s also a Table 3 for the Response to Heat Treatment.

If you use this standard, of course the most notable change is the modification to include both SI and feet-pound units of measurement.  But there’s also been the addition of two new UNS types (S31730 and S31266) and footnote A of Table 1 has also been revised.

FYI: If you’d like to see the history of this standard, please go to our ASTM A276/A276M Revision History page.

Now you’ll need a copy of this new specification.  You can order online at the Document Center webstore, 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).  We’ve been providing ASTM standards to our customers since the 1980’s.  Make us your Standards Experts too!

Solutions for Standards Management

February 6th, 2015

This is the third of our series on standards and compliance.  In this posting, I’ll review what has been covered so far and the Document Center solutions for standards management you’ll need moving forward.

Good practice for standards management requires work!  You’ve identified all the standards in your organization.  You’ve put them into two categories: Controlled (used for essential business purposes like product specifications and standards required for regulatory compliance) and Uncontrolled (used for one-time purposes only).

Now you need a way to do the following:

  • Provide access to the controlled set of standards to those individuals within the organization who need them for their job functions.
  • Monitor your document set for updates and changes
  • Notify document users that the new editions are available
  • Confirm that users have access to the updated documents.

In smaller companies, these processes are done manually.  Here’s what’s usually done and the Document Center tools that make it easier for a small business:

  • Procure individual standards in paper or pdf format for the use of the individual who needs access.  Sometimes small companies use a workstation or bookshelf as this type of library if more than one person will access the document set.  This solution depends on single user copies.
  • Use Document Center’s notification or Standards Alert services to monitor your document set.  You’ll choose your level of service based on how fast you need notification of changes.
  • When you receive a notification of change, purchase the new revision and make it available per your protocol.  You may want to set up a Standards Express standing order service to make this even easier.

In larger companies — those with a need for multi-user access (including multiple locations) — Document Center’s Standards Online subscription service can solve your monitoring and updating requirements.  This service allows for customized collections of standards to be available for clients across your company.  Your controlled collection is monitored and updated by Document Center Inc., a leader in standards sales and support.

What will you gain by using Document Center’s Standards Online service?

  • You reduce the risk of non-compliance that comes from using obsolete material.
  • There’s easy access to standards across the organization.
  • Standards can be viewed and used anywhere there’s internet connectivity.
  • Regulatory and certification requirements can be easily verified.

Want to learn more about how we can help you achieve regulatory and certification compliance?  Contact our staff via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Want to take a look at the standards we have available?  Head to our webstore at www.document-center.com.

Document Center Inc. has been selling standards and supporting the correct use of standards since 1982.  Make us your Standards Experts!

New Edition 2.0 for IEC 61010-2-101

February 5th, 2015

IEC 61010-2-101, “Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment,” has just been updated.  The new Edition 2.0 is an extensive revision of the original Edition 1.0 from 2002.  Document Center has it available in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  A redline edition is also available to assist you with your gap analysis.

The document itself applies to equipment intended for in vitro diagnostic (IVD) medical purposes.  This includes self-test IVD’s (equipment used by lay persons in a home environment.)  It contains a series of tests as well as other information.  You’ll find information on marking and documentation as well as the kinds of hazards the user needs protection from.  Risk assessment is also addressed.

Let’s discuss some of the changes you’ll find in this new edition of the IEC 61010-2-101.  First, general laboratory equipment has been excluded from the scope of the document.  This means that you’ll use IEC 61010-2-081 for general laboratory equipment and IEC 61010-2-101 for IVD equipment only. NOTE:  The IEC 61010-2-081 has also just been revised.

Requirements have been added to the following Clauses:

  • Clause 5 (in numerous areas)
  • Clause 7
  • Clause 8
  • Clause 13
  • Clause 15
  • Clause 16
  • Clause 17

Other changes include the deletion of Annex BB Instructions for use for self-testing IVD Medical Equipment (a reference is given to ISO 18113-5 in Clause 5.)  And Table 1 in Clause 5 has been updated with Biohazard and Lot symbols.

When you’re faced with so many areas of a standard that have been changed, the use of the redline edition can make the task of identifying critical updates much easier.  Since the two documents have already been compared to create the marked-up copy of the previous edition, every modification is there “in black-and-white.”  Or perhaps I should say in black and red!

Now you need your copy of the new update.  Go directly to Document Center’s website at www.document-center.com to place your order.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been providing folks like you with standards since 1982.  Make us your Standards Experts!

New AAMI TIR38, Medical Device Safety Case

February 4th, 2015

A new AAMI TIR38, “Medical device safety assurance case report guidance,” has just been released.  It provides you with information on how to meet the new additional FDA pre-market requirements for infusion pumps.  However, it can be widely applied to any medical device safety program.  You can get your copy now from Document Center in paper format, for pdf download or as part of our multi-user Standards Online subscription service.

The 65-page document is a Technical Information Report.  AAMI releases these TIR’s because of critical need within the medical device industry.  So a TIR does not go through the same adoption process as an AAMI standard would.  However, these publications can provide invaluable assistance when new issues face the industry.

In this case, the TIR was developed specifically to address the issue of developing safety cases for drug delivery systems (like infusion devices, etc.)  But the protocol and information can be used for any medical device and its design story.

Safety cases are an adjunct to risk management.  The concept stems from the nuclear industry, where failure is to be avoided at all costs.  In this application, it represents the totality of the documented information and arguments to prove that a nuclear facility is safe.  Additionally, it provides a written demonstration that all applicable standards have been met and that risks have been reduced as far as is reasonably practicable.

Now we’re starting to see the expansion of usage of this tool for medical device safety support.  This means a safety case can be used to provide a structured argument, supported by a body of evidence, that there is a compelling, comprehensible and valid case that a particular medical device is safe for its intended use.

The AAMI TIR38 provides you with a safety case development reference you can use for in this application.  It’s kind of a framework for distillating the experience and insight that went into your device’s design.  And it provides a way to systematically assure and document the safety that’s embedded in that design.  Further, it is intended for products that are already in existence and well understood.  You would not use this methodology for “new-to-the-world” products.

AAMI TIR38 has a strong tie to the ISO 14971 standard on medical device risk management.  Information that you generate for ISO 14971 compliance can be part of the data for your safety case.

Not only will you get a tutorial on the subject, but there’s also a number of Annexes that provide you with examples, tool selection considerations, and even lessons learned.

If you’re looking for additional tools to support your risk management efforts or want to meet emerging regulatory requirements, you’ll want a copy of the AAMI TIR38.  Head to the Document Center webstore at www.document-center.com to order your copy online.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to support your compliance program with standards and standards services.  Make us your Standards Experts!

ANSI Z358.1 2014 just released!

February 2nd, 2015

There’s a new 2014 Edition for ANSI Z358.1, “American National Standard for Emergency Eyewash and Shower Equipment.”  If your staff works in an environment where chemicals or caustics are present, you need this standard.  It is necessary for compliance with U.S. medical and first aid regulations (29 CFR Part 1910.151c).  And it is available now from Document Center Inc.

ANSI Z358.1 serves as a guideline for the proper design, certification, performance, installation, use and maintenance of emergency equipment.  This type of equipment provides adequate rinsing of a contaminant from the eyes, face and body in an emergency situation.  It should be installed no more than a 10-second walk of the hazard, and, in the case of eyewash stations,  should be able to deliver a 15-minute flush in the event of contact.  Compliant equipment is found in manufacturing and processing facilities, construction sites, laboratories, medical and healthcare offices, refineries and other workplaces.

ANSI A358.1 was first issued in 1981.  The new 2015 Edition replaces the previous 2009 Edition and all other earlier releases of the standard.  Topics include the minimum equipment performance criteria for water flow rates, water temperature, shut off valves, corrosion resistance, freezing and drenching patterns needed.  It also deals with the disposal of contaminated water.  You’ll also get guidance on setting up proper emergency response policies and practices as well as the proper way to set up inspection and maintain procedures.

Where can you get a copy?  Order at the Document Center webstore at www.document-center.com.  Or contact the Document Center staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with standards since 1982.  Make us your Standards Experts!

First Steps to a Compliant Standards Collection

January 30th, 2015

You’re responsible for documentation for your organization.  And you want to make sure your Standards Collection can meet the requirements of your regulatory and/or quality management programs.  Developing a Compliant Standards Collection takes work, but once put into place your company will benefit throughout the organization.

The first step in setting up a compliant standards collection is to identify any and all standards used within the company.  You’ll need to find them, sort them into controlled and uncontrolled classifications, identify them by number and revision level (date), and link them to products, divisions, and/or personnel.

Where can you find standards within your organization?  Many companies have relied on paper format collections over the years.  So there may be a central repository of documents that will provide you with your baseline collection.  But be aware!  There may be “rogue” copies floating around within your company as well.

To find these “strays” you may be able to do a physical inventory of standards stored at employees desks and on their computers.  But if your company is larger, you may need to enlist the assistance of all staff members.  They’ll need to self identify and surrender any copies of standards they possess.  Staff members can also be helpful in connecting various standards to regular processes and products of the company.

Why ask how a standard applies to your business processes?  You are going to need to make a distinction between those documents you use in the course of your business and those that have been obtained for “one-off” requirements.  Documents that you need because they are referenced in your procedures or are required by law or regulation are going to be “controlled.”  You’ll be monitoring them closely from here on out.

Uncontrolled documents are those purchased for other purposes, like evaluation of a technology, product development that did not get implemented, and so on.  And sometimes staff members have standards at their desks that they do not want to surrender.  You should mark these copies as “uncontrolled” so that users are responsible to check the status of the documents themselves.

Now we need to take the first steps in setting up a method for monitoring and retaining our controlled document set.  At the same time, we’ll develop a protocol for letting people know when a document is uncontrolled.  Why? An uncontrolled document may be out-of-date because it is not part of the set you’re keeping track of on a regular basis.

It’s most important to know that your controlled documents are current (the most recent revision).  So you’ll need to take an inventory and compare what you have to what’s correct.

Here, Document Center Inc. can assist you with our Standards Audit service.  For a small fee, we take the list of documents you have (including the dates on the cover of each) and compare them to our database of standards.  When your Audit is complete, you’ll get a list of the revisions you’ll need in order to get your core list of standards into compliant condition.

It is also helpful at this point to connect the standards you’re controlling to the places in your organization and your documentation where they are actually used.  Then as your standards are updated in the future, you’ll be able to notify the folks that use them of the changes.  This is essential for gap analysis and for compliance with quality and regulatory requirements.

It can be a daunting process to collect, categorize, and assess your documents.  But it is an essential first step in developing a compliant standards collection.  Starting off on the right foot reaps dividends later on down the road.

Next time we’ll discuss how you can procure the items you need to get your collection up-to-date and how you can provide access to your standards to the appropriate personnel.

Meanwhile, if you need help in managing your standards collection, contact Document Center Inc.  We’re on the web at www.document-center.com.  Or you can get in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with standards since 1982 and have a variety of programs that can assist in every phase of your collection management process.  Make us your Standards Experts!

New ASME Y14.2 2014 Edition

January 29th, 2015

There’s a new 2014 Revision for ASME Y14.2, “Line Conventions and Lettering,” and its due to be released on Valentines Day!  You can preorder your copy now from Document Center Inc.  It’s one of the Y14 series of basic engineering drawing standards, used by a vast array of companies world-wide.

The 24-page revision replaces the previous 2008 Edition, which is now obsolete.  It has been adopted by the U.S. Department of Defense for inclusion in military contract requirements.

The ASME Y14.2 establishes the line and lettering practices for use in the preparation of engineering drawing.  This includes the recognition of the requirements for Computer Aided Design (CAD) and manual preparation for their reduction and reproduction.

The document provides you with the usual scope, referenced documents and definition clauses.  Then it addresses line conventions, arrowheads and lettering.  You’ll find, however, that the many figures that compose the balance of the standard to be most helpful.  These cover such topics as line widths and types, arrowhead styles, and inclined and vertical letters.

Another important component of the standard is Table 6-1.  This table, Minimum Letter Height Proportions, is a frequently referenced part of this document.

Now you need to get a copy.  You can order at the Document Center webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re an authorized distributor of the ASME standards and have been helping folks like you procure and maintain their standards collections since 1982.  Make us your Standards Experts!

New EN 16679 – Tamper-proof packaging

January 28th, 2015

There’s a new EN 16679 that’s just been published.  Titled “Packaging – Tamper verification features for medicinal product packaging,” it’s available from Document Center Inc. now.  You’ll use this standard if you sell certain medicinal products in the Eurozone.

The standard itself provides you with the requirements for the packaging of medicinal products.   It also provides guidance for the application, usage and checking of tamper verification features.  You’ll see a wide variety of national editions for this publication as it gets adopted in each of the EU countries.

You’ll be glad to know that by using the EN 16679 you’ll meet the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU.  This is especially important since the amended directive requires that on the outer packaging or the immediate packaging of certain medicinal products need “a device allowing verification of whether the outer packaging has been tampered with” or not.

FYI:  You should also note that there will be no formal adoption of the EN 16679 as a harmonized standard.

You have a number of options when you purchase your copy from Document Center Inc.  Of course, you can always purchase the BS EN 16679 English language edition in paper format.  And the German adoption is expected to be released in March.  But you may prefer to use the SS-EN-16679.  The Swedish adoption is available in English and may be purchased in both paper format and for pdf download.  You’ll also be able to include it in our Standards Online multi-user subscription service.  And the price is significantly lower!

Just head to the Document Center webstore at www.document-center.com and place your order.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Should you have any questions about what edition is best for you, our staff can help you make that decision.  And if you need additional support services to improve your use of these compliance documents, we’re here for you on that as well!

Remember, Document Center has been selling standards since 1982.  Make us your Standards Experts!

 

New ISO/IEC 27040 – Security for Data Storage

January 27th, 2015

There’s a new document meant to help all of you challenged by keeping stored data secure in an ever changing IT environment.  It’s ISO/IEC 27040, “Information technology – Security techniques – Storage security,” and it’s available now from Document Center Inc.  You can get a copy in paper format, for pdf download or as part of our multi-user Standards Online subscription service.  The document is a set of guidelines for any organization’s storage security, particularly in meeting the requirements of ISO/IEC 27001 for ISMS (Information Security Management System).

Who should be using this standard?  Any IT manager and staff who are tasked with assessing the risk of data breaches and providing the organization with robust storage security controls.  You may even find it helpful when working with third parties.  And if you’re in the process of implementing ISO/IEC 27002, “Information technology – Security techniques – Code of practice for information security controls,” you’ll be able to use the extended guidance this standard provides with regards to your data storage concerns.

What is addressed in ISO/IEC 27040?  The standard is a detailed guide to how organizations can define an appropriate level of risk mitigation using a well-proven and consistent approach to all phases of securing data.  This including planning, documentation, and implementation issues.  And it covers a variety of devices and media as well as the entire life-cycle of information and the applicable storage devices.

The 118-page document is technical in nature, but still can be used by non-technical personnel.  It will provide you with an overview of the topic and concepts.  It will show you what threats, design and control aspects are associated with typical storage scenarios.  And it will help you understand the relationship of this standard to other documents appropriate to the issue of data storage.

Not only does ISO/IEC 27040 cover the basics but it also gives you a lengthy review of a multitude of storage control tools and architectures.  Clause 7 then reviews how to design and implement your storage security strategy with specific guidance on:

  • Storage security design principles,
  • Data reliability, availability, and resilience,
  • Data retention,
  • Data confidentiality and integrity,
  • Virtualization, and
  • Design and implementation considerations.

The standard is completed by the inclusion of 3 Annexes, one for media sanitization, one for selecting appropriate storage security controls, and one on important security concepts.  A 75-item Bibliography completes the document.

If you are directly responsible for the security of data in your organization or manage those who are, you owe it to yourself and your organization to review this document.  You can easily order it at the Document Center Inc. 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).  We’ve been working with folks like you to promote quality, health and safety, and engineering excellence through the use of standards since 1982.  Make us your Standards Experts!