ISO/IEC TS 33073 – Process Assessment

ISO/IEC TS 33073 has just been released to help you set up a quality management process assessment model (PAM).  This is a set of indicators for process performance and process capability.  They are to be used to collect objective evidence for your assessor.  The PAM supported by this standard meets the requirements of ISO/IEC 33004.  It is available now from Document Center Inc.

The standard is titled Information technology – Process assessment – Process capability assessment model for quality management.  It is designed to support self-assessment for process quality.  You’ll use it as the basis for your on-going improvement cycle.  And it provides you with a methodology for an actual process rating.

No matter the size of your organization or the types of processes you use, you’ll find the ISO/IEC TS 33073 to be applicable.  The 308-page standard begins with the usual scope, referenced documents and definition sections.  Section 4 reviews the process assessment model (PAM) itself.  You’ll get an overview of the structure of a PAM, the assessment indicators, and measuring process capability.

Section 5 covers various process performance indicators, divided into types.  COM.01 through COM.11 are administrative (like management review and operational planning).  ORG.01, ORG.02, and ORG.03 cover asset management, measurement resource management and supplier management respectively.  The 11 TEC indicators deal with configuration and product/service issues.  A final TOP indicator is on leadership.  Each of the indicators is presented as a table, featuring critical features of each.

Section 6 provides you with information on process capability indicators.  This time they’re organized by levels, from zero to five.  Information is presented in a combination of text and tables.  You’ll see how to define your requirements, identify and establish objects and measurements, create documentation, and so on.  Overview tables of the processes and attributes will supply you with visual support.

The ISO/IEC TS 33073 contains 3 informative Annexes.  Annex A is on conformity of the PAM, Annex B covers input and output characteristics, and Annex C reviews the relationship between this standard and the ISO 9001 requirements.  An 11-item bibliography completes the standard.

You can purchase your copy of this new edition now at Document Center Inc.’s webstore, www.document-center.com.  Here is a direct link to the order page for ISO/IEC TS 33073 for your convenience.  If you are ISO 9000 certified, you’ll want to learn more about our support services.  Check in with our staff by phone (650-591-7600) or email (info@document-center.com).  We have a range of products and services to help every size business improve document compliance outcomes.  Find out why so many companies make us their Standards Experts!

ISO 14644-15 – New Cleanroom Standard

The ISO 14644-15 Cleanroom Standard has just been released.  It’s title is Cleanrooms and associated controlled environments – Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration.  It’s intended to be used with ISO 14644-8.  You can get your copy now from Document Center Inc. in either paper format or for pdf download.

The ISO 14644 series of standards on cleanrooms is widely used throughout industry.  There are many manufacturing situations where a clean environment is essential.  Some involve classifying the cleanliness level by the concentration of chemicals in the air.  The ISO 14644-15 has been developed to assist users using this method.

One issue for those in charge of cleanrooms is the impact of bringing in “foreign” materials into the cleanroom environment.  Now the ISO 14644-15 gives you a methodology for controlling contamination.  It specifically addresses evaluating equipment and materials that will be introduced into your cleanroom.  This evaluation is for the chemical airborne cleanliness of these items.  If you determine cleanliness classes by chemical concentration per ISO 14644-8, this will be immensely valuable.

The new standard begins with the usual scope, referenced documents, and definitions sections.  Nine additional sections cover symbols, test setup, representative mode, visual inspection, a description of the test, calculation of the measured concentrations, calculation of the specific emission rate, the assessment itself, and your documentation.  There are also 3 informative Annexes and a 19-item bibliography.  The Annexes can help you evaluate such items as flooring and wallpaper.

To get your copy of this and any of the ISO 14644 standards, use the Document Center Inc. webstore at www.document-center.com.  We are an authorized distributor of the ISO standards so you can purchase with confidence.  Here is a direct link to the order page for ISO 14644-15 for your convenience.

We have a number of services that allow for company-wide cloud access to standards, monitoring of your essential documentation, and reports to support the document control function.  To learn more, please get in touch with our staff.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Learn why so many companies make us their Standards Experts!

 

ANSI Z535.1 2017

ANSI Z535.1, Safety Colors, is being updated and the new 2017 Edition is due in mid-December.  This new Edition will also impact the ANSI Z535 set of the 6 standards in the series.  Remember, if you have purchased the entire set, only the Z535.1 will be updated in December.  The new revision will be available from Document Center Inc. at that time.

ANSI Z535.1 includes the technical definitions, color standards, and color tolerances for safety colors. These are the colors that are used in safety signage and other warning material.  It provides a consistent way to communicate hazardous situations and environments visually.

The standard is widely used throughout industry.  It has even been adopted by the U.S. Department of Defense.  The standard was last updated in 2006, with reaffirmation of the contents in 2011.  So this new update will be important for many businesses and other organizations.

There’s no preview available for the new ANSI Z535.1 2017 Edition at this time.  So I’m unable to give you concrete information on the up-coming changes.  I will note however that the ANSI-Z535.4 is also under review.  So a new edition of that standard could also appear soon.

Now to get your copy of the new edition.  It’s available for pre-order now at our Document Center Inc. webstore, www.document-center.com.  Here is a direct link to the order page for the ANSI Z535.1 for your convenience.  Please note:  As I stated before, this new edition will also update the information for the Z535 set.  If you already own all 6 standards, you’ll only need to get the updated Part 1 in order to remain current.

Have additional questions?  Need to purchase other standards?  Want more information about all our support services?  Just get in touch.  We can be reached by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982.  We’re your Standards Experts!

BS EN 55011 Corrected

BS EN 55011, the English language copy of the EN adoption of CISPR 11, has just been corrected.  The standard is titled Industrial, scientific and medical equipment – Radio-frequency disturbance characteristics – Limits and methods of measurement.  It was recently updated as the 2016 Edition with Amendment 1 from 2017.  An additional corrigendum (correction sheet) has just been released.  It is available from Document Center Inc. now.  If you already purchased the previous edition from us please let us know.  We offer a special deal for corrigendums for those of you who bought the standard from us.

This is not an unusual situation.  Most times the editorial review of a standard will catch mistakes prior to publication.  But occasionally, an error or two will make it into the final document.  Of course, usually the first users of the standard will spot a mistake and the standard is fixed.  However, we have had examples of customers finding errors years after a standard was formalized.

If you use BS standards, you’ll want to understand how to spot the revision history.  Look inside the front cover of the document.  There you’ll find a table at the bottom of the page labeled “Amendments/corrigenda issued since publication.”  For the BS EN 55011, you’ll see the implementation of the Amendment 1 on July 31, 2017.  And you’ll see the listing for the correction on October 31, 2017 as well.

A lovely feature of this table is that you’ll get information on each update.  For the corrigendum, it says “Supersession details in national foreword corrected.”  The bad news is that there is no further detail about what this means.

So in this case, you’ll look for the National foreward, which is on the same page as the table.  You’ll soon realize that the correction is very important.  In the 2016 Edition with Amendment 1, the standard correctly replaces the 2016 Edition.  But it also says that the 2016 Edition has been withdrawn.  Now in the corrected edition it shows that the 2016 Edition will be withdrawn on April 21, 2020.  This gives you additional time to make the transition from one edition to the next.

I hope you can see that corrigendums and other correction sheets can contain information critical to your proper use of a standard.  And if you’re using the BS EN 55011, you’ll want to get your copy now to keep your compliance documentation current.  Use the Document Center Inc. webstore at www.document-center.com to purchase your authorized copy.  Here is a direct link to the order page for BS EN 55011 for your convenience.   We are authorized distributors of the BS standards collection, so you can buy with confidence from us.

We also have a number of services that can help your organization improve your documentation protocols.  Just reach out to our staff for more information.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  We have been working with standards since 1982, so you’ll find us to be knowledgeable about many of the questions you have.  Make us your Standards Experts!

AS 478 P – Identification Marking Methods

AS 478, Identification Marking Methods, has just been revised.  The new Revision P cancels and replaces the previous Revision N from 2007.  It’s an SAE Aerospace Standard.  The updated publication is available from Document Center Inc. now.  You can get your copy in paper format, for pdf download, or as part of our enterprise cloud access service, Standards Online.

AS 478 is widely used in the aerospace industry.  It provides you with a number of useful requirements.  These cover definitions of marking terms, symbols for marking locations, rules and restrictions for permanent markings, and types of marking methods.  It also contains the rules for designating marking methods and a table with a list of marking methods.

Of course, many of you use this standard to specify your marking methods on engineering drawing of parts and assemblies.  So you’ll want to know where the changes in the 15-page standard have occurred.  The SAE committee in charge has put black lines in the margins of the standard so you can find the updated areas easily.

They also confirm at the beginning of the document that the following areas have been revised:

  • Section 6 (on the rules for designating marking methods)
  • Table 1, Method 1C (correcting a mistake in the maximum depth)
  • General editorial revisions

Now to get your copy.  Of course, you’ll use an authorized distributor like Document Center Inc. to confirm that you’re complying with the rules of copyright.  You can search for and order SAE standards with confidence from our web store, www.document-center.com. Here is a direct link to the order page for the AS 478 for your convenience.  And if you’d like to see the history of this publication, here is a link to the Revision History for AS 478.

Standards users prefer to get their compliance documentation from Document Center because of our superior notification service and our wide range of support services.  To learn more about how Document Center can help your organization, just reach out to us by phone (650-591-7600) or email (info@document-center.com).  You’ll soon find out why so many folks make us their Standards Experts!

Redlines Available – IPC-A-610G and IPC-J-STD-001G

Redlines Available!  Yes, there are Redline Editions available now for the new IPC-A-610 Revision G and the IPC-J-STD-001 Revision G.  So for all of you in the electronics industry, this is exciting news!  Redline editions make it much easier to do the gap analysis needed to stay current with the requirements of these standards.

The IPC-A-610 is titled Acceptability of Electronic Assemblies.  IPC-J-STD-001 is Requirements for Soldered Electrical and Electronic Assemblies.  They are widely used throughout the electronics industry worldwide.

These are the first authorized IPC redline editions that I can remember.  They are available now from Document Center Inc. in pdf single-user format only.  Remember, IPC pdf’s have the print function turned off, so you will only be able to use the pdf — No printing allowed.  However, it is normal for only 1 person in an organization to be tasked with reviewing a new revision of a standard.  If this person is you, get the redline now!  Since all changes are clearly marked in the text, it will be much easier for you to spot and evaluate the changes.

Since the IPC-A-610 and the IPC-J-STD-001 are two of Document Center’s most popular electronic industry standards, we’re looking forward to seeing broad usage of this new format.  I reviewed the new Revision G for IPC-A-610 just the other day — Here is my post for IPC-A-610G.  At that time, the revision was on pre-order.  But it is here now and shipping from Document Center Inc.

I expect to review the new IPC-J-STD-001G soon.  It too is shipping and readily available from us.  Again, it is an essential standard for many of our customers.  So understanding the revisions can be very helpful.

Now you need to get your copies.  Of course, you can search for and order from our extensive standards catalog at www.document-center.com.  But here are direct links to the order pages for the IPC-A-610G Redline Edition and the IPC-J-STD-001G Redline Edition.  The regular editions are available in both paper format and for pdf download.  You can even get site licensing.

Just check in with our staff to learn more about your options for IPC standards.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Since we have been working with standards users since 1982, we have the experience you need to help you with your many questions and requirements.  Find out why so many professionals make us their Standards Experts!

How did you become a Standards Professional?

I was one of the mentor’s at ANSI’s Standards Simulation contest at San Jose State University last week.  And one of the questions students asked me was “How did you become a Standards Professional?”  In fact, ever since I have become involved in the standards community at large, this is a frequent question.  People want to know what career path leads to participation in standards activities.

Now the Asia-Pacific Economic Co-operation group APEC is going to find out!  Their Sub-Committee on Standards and Conformance (SCSC) is conducting a survey on this very question.  And best of all, if you take the survey, you’ll get a free copy of the results.

What is APEC’s Sub-Committee on Standards and Conformance?  The SCSC was established in 1994 to promote understanding and usage of standards in the Asia-Pacific region.  It was developed for a number of reasons.  First, this region has been very interested in using standards to facilitate international trade.  Second, Asia has been increasing participation in International Standards activities (ISO, IEC, and ITU).   Why?  For the sake of harmonization of standards in this area with international norms.  So a focal point for educational activities is warranted.  And lastly, greater reliance on standards promotes improved production integration with global partners.  All these activities have helped improve the economies of the APEC member countries.

What is the SCSC survey about?  The survey (located at https://ko.surveymonkey.com/r/WDKW3K8) is a questionnaire for standards professionals in both industry and in Standards Developing Organizations.  It aims to identify both the career path of standards professionals and map the reults.  It also asks about skills and the knowledge base required for those in the standards community.  In the end, the survey will be used to create recommendations for SCSC projects to inspire folks in the region to enter this field.

Who should take this survey?  Anyone who is a standards professional!  But you’ll need to act prior to December 15, 2017.  When the survey is complete you’ll get a copy of the survey summary results.  Since the company and individual information will not be publicly available, this is one of your few chances to gain access to this critical information.  It should be completed around March of 2018.

Hats off to APEC’s SCSC for undertaking this survey.  And also to Donggeun Choi from KSA (the Korean Standards Association) for taking the lead on the project.  We’re very interested in seeing the results of this work on “Inspiring the Next Generation of Standards Professional Development – Phase 2: Developing Career Path and Career Map.”  It is a great adjunct to other educational efforts like the ANSI Standards Simulation Competition that I participated in last week!

ISO 17664 Updated – Medical Device Sterilization Instructions

ISO 17664 has just been updated.  The new title of this 2nd Edition is Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices.  Previously, it focused on Sterilization of medical devices so you can see the scope of the standard has been expanded.  The 1st Edition from 2004 is now obsolete.  You’ll need to be using this new update and you can get it now from Document Center Inc.

ISO 17664 provides manufacturers with requirements for the instructions that accompany their medical devices and other health care products.  These instructions center on the processing required to make these products ready for use.  This may include an initial sterilization or other processing.  Or it may be processing needed for the reuse of the product.

This update of the ISO 17664 was generated by technical advances in sterilization technologies.  With products becoming more complex, the techniques to clean them are coming under greater scrutiny.  Comprehensive instructions on processing utilizing available equipment is essential.  Additionally there may be critical requirements during the inspection and testing phase performed after a device is cleansed.

As noted, the 32-page 2nd Edition cancels and replaces the 1st Edition.  It is a technical revision, with an expanded scope.  Now the standard covers devices that need both sterilization (as before) and/or disinfection (added) prior to use.

Document Center Inc. customers have already been notified that the new Edition has been released.  We’re filling orders placed at our webstore, www.document-center.com, now.  Here’s a direct link to the order page for ISO-17664:2017 for your convenience.  It’s available in paper format and for pdf download.

All ISO standards are also available as part of our Standards Online cloud access service.  This allows you to set up a subscription for the standards critical to your business in a company-wide environment.  To learn more, check in with us by phone (650-591-7600) or email (info@document-center.com). We have been working with standards since 1982 and offer a wide range of products to support your compliance requirements.  Make us your Standards Experts!

NFPA 101 2018 – Life Safety Code

The Life Safety Code, NFPA 101, has just been updated and the new 2018 Edition is available from Document Center Inc. now.  You can purchase your copy either in softcopy format or for pdf download.  This is one of the most important Codes that NFPA produces.  It provides requirements for occupant fire safety throughout the life of a building.  The new 2018 Edition contains major changes and an expanded scope.

What are the areas the NFPA 101 addresses?  Egress, sprinklers, alarms, emergency lighting, smoke barriers, special hazard protection and other concerns are all included in this Code.  So it is appropriate for use both by architects and engineers during the design phase and by building owners and managers during the occupancy phase.  Other facilities professionals like hospital administrators should also use this standard.

The new Code has been expanded to include  hazardous materials emergencies, injuries from falls, and emergency communications.  It continues to be applicable in situations where new materials are being used.  And it can be adapted for buildings that are being used in non-traditional ways.

NFPA has noted the following major changes for the 2018 NFPA 101:

  • New requirements for hazardous materials protection of other than fire-related hazards (Chapter 8)
  • A new reference to NFPA 4 for integrated fire protection and life safety system testing, and new provisions for risk analyses for mass notification systems (Chapter 9)
  • Animal housing facilities added as special structures (Chapter 11)
  • Added requirements for carbon-monoxide detection in new assembly occupancies and new residential board and care occupancies (Chapters 12 and 32)
  • Added criteria for door locking to prevent unwanted entry in educational, day care, and business occupancies (Chapters 14-17, 38, and 39)
  • A mandatory sprinkler requirement for all but very small new educational occupancies (Chapter 14)
  • New provisions that permit health care and ambulatory health care smoke compartments up to 40,000 ft2 (3720 m2) in area (Chapters 18 and 19)
  • Added requirements for bathtub and shower grab bars, which are then referenced by numerous occupancy chapters (Chapter 24)
  • Added requirements for attic protection requirements that impact certain new hotels and dormitories and apartment buildings (Chapters 28 and 30)
  • A new reference to NFPA 99 for medical gases in business occupancies (Chapters 38 and 39)
  • A new Annex C that offers guidance on several NFPA hazardous materials standards to assist users with the new hazardous materials protection requirements

If you use the NFPA 101, you’ll want this new edition now.  Purchase your copy from Document Center Inc., an authorized distributor of the NFPA standards.  You can search for and order them at our webstore:  www.document-center.com.  Here is a link to the order page for the NFPA 101 for your convenience.

All purchases include our “best-in-class” notification service at no additional charge.  Because this Code is updated on a three-year cycle, you’ll be informed in 2021 when the next edition is issued.  Other Document Center services including reporting and monitoring, perfect for organizations with compliance requirements.  To learn more, just get in contact with us.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Make us your Standards Experts!

ANSI Standards Simulation Contest

ANSI’s 2nd Standards Simulation Contest will be taking place tomorrow and I will be mentoring one of the teams.  The contest is sponsored by John Deere and is held under the auspices of the ANSI (American National Standards Institute) Committee on Education (COE).  It’s a training activity for university students to support standards and standardization education.

The contest focuses on two skill sets.  The first is the ability to define the performance and other requirements for a sample standard.   This year’s competition is unusual in that the “standard” the students will be developing will contain minimal text.  This means that it will be composed almost entirely of graphical elements.  Luckily, the subject of this year’s standard is vehicle-to-vehicle communication.  So the use of icons and other graphical elements should make for interesting presentations!

Next, the students will have to try to persuade other teams to support their unique requirements.  Each team represents a different user profile (manufacturer, government player, technology company, and so on).  And there will be two competing technologies that are incompatible.   Negotiating and people skills will come to the forefront during this portion of the competition.

In the last part of the Standards Similation, the teams will attempt to gain consensus in the final negotiations.  For all of us in the standards business, this is really fast-track!  Industry experts from the ANSI membership will choose the winning team.  Judging criteria are based both on the proposed standard each team develops and on their leadership and negotiating skills in achieving their assigned objectives.

The standards community has been focused on fostering greater awareness of standards in the world at large and on more exposure to standards and standardization in educational settings.  The ANSI Committee on Education is at the forefront of this effort.  You’ll find more information on them on their ANSI COE homepage.

As an additional note, San Jose State University (SJSU) is right in Document Center’s backyard.  Representatives of the institution have been particularly active in the COE and other ANSI activities.  In fact, Tiana Ashley Khong, an SJSU student, was the winner of this year’s World Standards Day Student Paper competition with her “The World in 2050: Safety by Design.”  Congratulations to the faculty and students of SJSU for their participation in these standardization events.  I’m looking forward to tomorrow’s event!