Category: Hot Topics in Standardization

News and Views from the World of Standards

MIL-C-81904, Coating Compound, Thermal-Insulation, Ablative, renumbered MIL-PRF-81904 with the release of new Revision C

MIL-PRF-81904 Revision C, titled “Coating Compound, Thermal-Insulation” has just been issued.  It is the replacement for MIL-C-81904 Revision B (“Coating Compound, Thermal-Insulation, Ablative,”) from 1991.  This specification covers asbestos-free, thermal-insulating coating compound.  The thermal protection coating is used for the exterior surfaces of aircraft ordnance to delay cook-off during exposure to a liquid fuel fire.

Marginal notations are not used in this 27-page revision to identify changes with respect to the previous issue due to the extent of the changes.

The change of the document identifier MIL-C-81904 to the new designation MIL-PRF-81904 reflects one of the many changes to military specifications and standards during mil spec reform in the mid-1990’s.  Because the military was directed to reduce dependence on internally generated documentation and move to industry standards where-ever possible, there was a need to identify those items that were unique to the military and needed to be maintained in the new regulatory environment.

It was determined that essential military specifications would be segregated into two types of documents:  Performance Specifications and Detail Specifications.  The detail specification would provide instructions on manufacturing something to an exact blueprint (e.g., uniforms).  Whereas performance specifications would define the performance requirements needed for a particular item and leave it up to the manufacturer to determine how to meet those requirements (for example, development of a sleeping bag to be used in extremely cold weather).

When a document number is modified to show that it is either a performance specification (MIL-PRF-) or a detail specification (MIL-DTL-), it then can be called out in military procurement with confidence that the document is valid in the post-mil spec reform world.

All military specifications and standards, both current and many obsolete) can be purchased on the Document Center Inc. website, www.document-center.com.  Or you may want to call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.c0m).  The many changes to DoD documents can be challenging.  We’d be happy to help you understand them.

 

 

ESD Association document types and our list of ESD Standards

Understanding the various document numbering schema from Standards Developing Organizations (SDO’s) can be challenging for the beginning Standards Specialist.

In reviewing the standards available for Electronic Discharge Control, standards from the ESD Association top the list.  What are the different designations for these ESD standards and what do they mean?  Here’s the definitions:

  • Standard (S): A precise statement of a set of requirements to be satisfied by a material, product, system or process that also specifies the procedures for determining whether each of the requirements is satisfied.
  • Standard Test Method (STM): A definitive procedure for the identification, measurement and evaluation of one or more qualities, characteristics or properties of a material, product, system or process that yield a reproducible test result.
  • Standard Practice (SP): A procedure for performing one or more operations or functions that may or may not yield a test result. Note, if a test result is obtained it is not reproducible.
  • Technical Report (TR): A collection of technical data or test results published as an informational reference on a specific material, product, system or process.

Our webpage, Some of our best selling Electrostatic Discharge Control (ESD) Standards (with Links to the Current Document), contains a list of the ESD standards we commonly sell.  You can easily link from the page to each individual document to check the status of the document and order if needed.

Or consider looking up a document you need to order directly on our website, www.document-center.com.  You can also contact us by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  We’re here to help you with all your standards needs.

What is ISO 9000? Why do I use ISO 9001?

Since we’ve been selling standards since 1982, we’ve seen the business of standards-based quality schemes (like 6 Sigma, TQM, etc.) really take off .  And the certification for ISO 9000 has been the most successful of all of these programs.  ISO states that ISO 9001:2008 is implemented by over a million organizations in 176 countries.  But for the new-comer to the standard, there are any number of questions that always come up.

The first issue that new customers have is understanding why they need to purchase ISO 9001 when they are going for ISO 9000 certification.

This is because ISO 9000 really refers to a family of standards.  The ISO 9000:2005 is an overview document, covering “Quality management systems — Fundamentals and vocabulary.”  The document number is ISO 9000, the 2005 refers to the year that it was published.

An organization actually certifies to the ISO 9001 standard.  It is called out as ISO 9001:2008, even though it was corrected and reprinted in 2009.  This document, “Quality management systems — Requirements,” provides for the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.  It specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes.  This means that when an organization is certified to “ISO 9000,” it is actually judged against the requirements of ISO 9001.

There are additional offspring of ISO 9001 for various industries.  So, you may prefer to be certified to AS 9100, “Quality Management Systems – Requirements for Aviation, Space and Defense Organizations,” ISO/TS 16949, “Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations,” or ISO 13485, “Medical devices – Quality management systems – Requirements for regulatory purposes.”

If you’d like to take a look at the documents that make up the ISO 9000 family, take a look at our ISO 9000 Compendium page.  It offers a listing of the ISO 9000 standards family as of the date of the last published ISO compilation of the documents.

As always, the standards mentioned are available for sale at our Document Center Inc. website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re open from 8 am to 5 pm California time to assist you with all your standards requirements.

How does Document Center audit your standards collection?

Document Center Inc. has been in the business of monitoring and selling standards since 1982.  With this much experience, we know standards better than almost anyone else around!  So when customers ask, “Who can audit my standards collection?” Document Center is the answer.

When our customers are facing compliance-driven certification audits, they want to minimize the risk of discovering their standards are out-of-date.  Asking staff members to look up the various documents they use is time-consuming and error-prone.

But Document Center Inc. is getting information on new releases every day.  And we keep all this information in our in-house database of standards that monitors over 750,000 different items.

By handing over your list of standards to Document Center to review, you know that you’ll be aware of the current edition of every item on your list, including amendments, correction sheets, and other add-on components that can elude the standards novice.

A Document Center Audit is quick, taking anywhere from 1 day to 1 week depending on the number of standards to review.  Its also frees up your staff to concentrate on other activities to prepare for your conformance review.

You’ll get a complete list of the items you need to bring your collection into current status.  And if you additionally request us to monitor the list for you in the future, you can get timely notification of all changes to the conformance standards you depend on in your business.

Contact our sales staff at (650) 591-7600 or email us at info@document-center.com.  We’ll be happy to work with you to get you in tip-top shape for your upcoming review.

Guides for ISO 31000, Risk management – Principles and guidelines

ISO 31000:2009, “Risk management – Principles and guidelines,” is the essential standard on enterprise risk management (ERM).  Adopted by a number of countries both as direct adoptions (such as AS/NZS ISO 31000 (Australia) and CAN/CSA ISO 31000 (Canada)) and as embedded adoptions (ANSI/ASSE Z690.2 (United States)), the standard establishes a common framework and reference points for risk.

ISO 31000 grew from the work of Alcoa of Australia in the 1990’s that was the basis of the 1995 release of the AS/NZS 4360 standard, “Risk Management.”  The ISO standard is separated into three areas:

1. Risk Management principles (11 principles for managing risk)
2. Risk Management framework (5 components to the framework for managing risk)
3. Risk Management process (5 processes for managing risk)

There are a number of guides written to provide assistance to organizations in the process of adopting this ISO standard.

BS 31100, 2011 Edition from 6/2011, “Risk management. Code of practice and guidance for the implementation of BS ISO 31000,” from the United Kingdom.

Created by UK risk management experts, BS 31100:2011 gives you practical and specific recommendations on how to put the key principles of effective risk management into place in your organization using real life case studies.

HB-158, 2010 Edition, “Delivering assurance based on ISO 31000:2009 – Risk management – Principles and guidelines,” from Australia.

This Handbook is a guide for internal auditors and any other assurance provider such as External auditors; Information system control professionals – internal or external auditors, security professionals; Safety, health and environmental auditors; and Quality auditors.
This Handbook draws on the revised HB 436 and the IIA’s ‘International Professional Practices Framework’ (IPPF) with respect to using and assuring the ISO 31000:2009 risk management process. In particular, it describes how to use the risk management process to:
Develop a risk-based assurance strategy and program;
Plan an assurance engagement;
Report the assurance program; and
Design controls.

CSA Q31001-11, 2011 “Implementation guide to CAN/CSA ISO 31000, Risk management – Principles and guidelines,” from Canada.

Provides principles and generic guidelines on risk management.

All of these documents can be purchased from Document Center Inc. by way of our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re ready to assist you with any questions you may have.

 

European Risk Management Standards center on Medical Devices

Looking for European Standards on risk management?  If you’re interested in EN standards specific to the region, you’ll find most are focused on medical devices and laboratories.  And they’re almost all adoptions of ISO and IEC standards as well!

Here’s a list with links to the existing Official English language editions of the EN standards on Risk Management:

EN 31010:2010 Risk management – Risk assessment techniques,

CEN ISO/TS 22367:2010 Medical laboratories – Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009),

EN ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) – Includes Corrigendum 1,

EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007),

EN ISO 14971:2009 Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01),

EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities,

EN ISO 17666:2003 Space systems – Risk management (ISO 17666:2003),

EN ISO 15743:2008 Ergonomics of the thermal environment – Cold workplaces – Risk assessment and management (ISO 15743:2008),

EN 15975-1:2011 Security of drinking water supply – Guidelines for risk and crisis management – Part 1: Crisis management, and

EN 62305-2:2006 Protection against lightning – Part 2: Risk management.

EN standards are not available as stand-alone items, but only as reprints by each country in the European Union, released as the EN is adopted.  The official English language editions and other national issues are all available from Document Center Inc. at our website, www.document-center.com.  You may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here from 8 am to 5 pm Monday through Friday California time to help you with your standards requirements and questions.

93/42/EEC – The Medical Device Directive and it’s Harmonized Standards

When Medical Device companies do business in Europe, they are required to conform to the EU’s Medical Device Directive, 93/42/eec.  One important way to comply is to use the applicable standards from the Harmonised List for Medical Devices.

What is a European Directive?  It’s a legislative act, rather than a regulation, that requires a specific outcome but does not dictate how that outcome is to be achieved.  Countries are given a specific timetable for conformance with the directive.    The Treaty that created the functioning of the  European Union states,  “A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods.”

With the adoption of the New Approach methodology for directives, there is the ability to create a directive that is not based on specific limits or tests, but on “essential requirements.”  This allows for the European market itself, through the mechanism of the EN Standards, to set the details of limits and tests rather than through specific language in the directive itself.

So for a limited number of directives, there are lists of Harmonized Standards that define the requirements for each.  These European Standards are created at the regional level and then adopted as national standards in each member country.  However, the standards are not mandatory — their use is still considered voluntary.  So in principle an alternative means of proving compliance with the safety requirements of the directives is possible.

This is the case with the Medical Device Directive, 93/42/eec.  The MedDev List of Harmonized Standards provides the easiest way to meet the requirements of the directive.

One last question to answer — How are directives amended?  Due to the way in which directives are generated, it takes a directive to modify a directive.  So 93/42/eec has been amended 5 times, by 98/79/EC, 2000/70/EC, 2001/104/EC, 2003/32/EC, and 2007/47/EC.  Luckily, there is a consolidated reprint of the Medical Device Directive, issued in 2007, that consolidates the original text with these 5 amendments.

The Directives and European Standards are all available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (+650-591-7600), fax (+650-591-7617) or email (info@document-center.com).  Our expert staff is available Monday through Friday, 8 am to 5 pm California time, to help you with your Standards needs.

IEC 60812, BS EN 60812, FMEA, and SAE-J1739 — Four important FMEA Standards (Failure Mode and Effects Analysis)

IEC 60812 Edition 2.0, BS EN 60812:2006, AIAG’s FMEA Standard, and SAE-J-1739 all provide standards users with information on how to identify the potential for system elements to fail.  Failure is the loss of the ability of an item to provide its required function. By using a FMEA standard, the designer may be able to eliminate the causes, or mitigate the failure effects to avoid undesirable consequences on the system.

Failure mode and effect analysis is a logical process aimed at identifying the potential failure modes of the elements of a system; the respective causes of failures; and the failure effects, initially on that element and then on its particular part of the larger system. A failure effect at a lower level may then be a failure cause for an item in the next higher level, hence the end effect on the system as a whole may be identified.

IEC 60812 Edition 2.0 from 2006, “Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA),” describes failure mode and effects analysis (FMEA) and failure mode, effects and criticality analysis (FMECA), and gives guidance as to how these techniques may be applied to achieve various reliability programme objectives, by:

  • outlining the basic principles
  • identifying appropriate terms, assumptions, failure modes, and criticality measures
  • providing the procedural steps necessary to perform an analysis
  • providing examples of the typical forms used.

BS EN 60812:2006, “Analysis techniques for system reliability. Procedure for failure mode and effects analysis (FMEA),” is the European adoption of the IEC 60812 2006 Edition.

SAE J1739, “Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (Process FMEA),” describes Potential Failure Mode and Effects Analysis in Design (DFMEA) and Potential Failure Mode and Effects Analysis in Manufacturing and Assembly Processes (PFMEA). It is geared for the ground vehicle community and assists users in the identification and mitigation of risk by providing appropriate terms, requirements, ranking charts, and worksheets. As a Standard, this document contains requirements (must) and recommendations (should) to guide the user through the FMEA process.

AIAG’s FMEA 4th Edition, “Potential Failure Mode & Effects Analysis,” is a reference manual to be used by suppliers to Chrysler LLC, Ford Motor Company, and General Motors Corporation as a guide to assist them in the development of both Design and Process FMEAs. The manual does not define requirements; it is intended to clarify questions concerning the technical development of FMEAs.

These standards, and all IEC, BS, SAE and AIAG standards, are available from Document Center Inc.  Purchase them at our webstore, www.document-center.com.  Or call us (650-591-7600), fax us (650-591-7617) or send us an email (info@document-center.com).  We’re here to assist you with your standards requirements and questions.

How to get the EMC Directive Standards on Electromagnetic Compatibility for Europe

Document Center’s List of the EMC Directive Standards for Electromagnetic Compatability is a handy way to review and order the EMC Standards you need for products intended for the European market.  The list includes all the standards that are part of the New Approach Directive 2004/108/EC for EMC requirements.  You can review the list and use the links for each standard to order the documents you need from us.

The “New Approach”  refers to the fact that legislation only provides for the Essential Safety Requirements that products must meet, with the goal of promoting  free  movement  within the  European Market. The technical specifications of  the  products are laid down in the harmonized  standards, whose application is indeed not mandatory but confers nonetheless to the products the presumption of conformity to the Essential Safety Requirements set out in the Directive.

Use of the standards on the Harmonized List for any of these New Approach Directives can save a great deal of time and money, as well as reduction of liability issues, when developing or marketing product into the European Union.

For other lists of standards that might be of interest to you, please see our webpage on Industry Standards.  Any documents you need can be purchased on our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) with your orders or questions.

ICS (International Classification for Standards) Codes can help you identify the standards you need

The ICS (International Classification for Standards) Codes are intended to serve as a structure for cataloging standards by subject area.  It is similar to the Dewey Decimal system for books in the library.  They’re used by standards bodies at the International Level (ISO and IEC), the regional level (CEN and CENELEC in Europe) and at the national level (ASTM International for example).   Understanding the ICS schema can help you find the standards you need to maintain the use of best practices in your organization.

The scheme is made up of 3 levels, each divided by a period.  The first level is a two digit number that specifies one of forty specific areas of standardization.  Some examples are 11 (for Health Care Technology), 25 (for Manufacturing Engineering) and 29 (Electrical Engineering).

Each of these area is then divided into 392 groups for level 2, this time a three digit number.  So for Health Care Technology, the 11.040 covers Medical Equipment, 11.060 is for Dentistry, and 11.080 is for Sterilization and disinfection.  For section 25, 25.040 is Industrial automation systems, 25.060 is Machine tool systems, and 25.200 is Heat treatment.  And in section 29, 29.020 is Electrical engineering in general, 29.030 is Magnetic materials, and 29.045 is Semiconducting materials.

Many of these level two designations still are rather broad, so there is a possible level three (for 144 of the 392 level two groups), again separated by a period.  Some examples would be 11.040.40, Implants for surgery, 25.040.30, Industrial robots, Manipulators, or 29.060.01, Electrical wires and cables in general.

You can find the documents you need by drilling down using the links to StandardsCatalog.com above which direct you to lists sorted by the ICS Code numbers.   Or you can use the references in StandardsCatalog.com to specific documents like ASTM B633 and use the link found towards the bottom of the page in the section “To find similar documents by classification.”  In the case of ASTM B633, the ICS Code is 25.220.40 (Metallic coatings).

Should you find documents you like to purchase, they are available from us at our www.document-center.com website.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Remember, we’re happy to answer any questions you might have about this or any standards-related topic.