Category: General Standards Questions

What are these AAMI TIR Reprints?

We just added 32 AAMI TIR Reprints into our database and we know it’s sure to cause some confusion.  After all, usually AAMI (the Association for the Advancement of Medical Instrumentation) updates include important changes to technical data that the medical device industry relies on.  However, these reprints represent an administrative change which has little to no bearing on the use of these publications.  So here’s what!  Let’s take a look at these reprints and learn what it all means.

First of all, we need a quick review of what an AAMI TIR (Technical Information Report) is.  Unlike AAMI standards and recommended practices, these documents do not go through the usual rigorous development process as required by ANSI (the American National Standards Institute) for adoption.  They are created specifically to meet a critical industry need.  In particular, the requirement for review every 5 years for either reapproval or updating is not mandatory for TIR’s.  They may be left in place if the authoring committee deems the information either to still be valid or to be of historial value.

So, all the documents that have been issued as reprints are actually adoptions of ISO/TR or IEC/TR publications.  AAMI has the right to republish these Technical Reports (TRs) because of its participation in international standards development at the behest of ANSI.  However, at the International level, similarly to the TIR, the TR is not subject to the same rigorous review process as the other publications.  This means they do not meet ANSI administrative process requirements that are critical to release as an ANSI adopted document.

When the 32 AAMI TIRs were originally published, they were given a numerical designation that included “ANSI” in the number.  However, as  you can see above, these reports didn’t actually meet the criteria needed for ANSI approval.  This error in numbering has been brought to AAMI’s attention and has just now been fixed.  Thus, the 32 reprints!

And the changes are (administrative only):

  • “ANSI” was removed from the designation of all 32, including in the footer
  • The title page of each has been updated to read “Registered” by ANSI, rather than “Approved”
  • The text before the table of contents has been revised

There is no change to the guidance within the documents or the page counts at all.

Do you need to purchase these reprints?  The AAMI TIR reprints are administrative in nature.  There is no change to the technical content.  So getting a copy of the reprint is not necessary if you are interested in technical changes only.  However, in cases like this where the document has some type of physical change (for example, reprints with reapproval dates only), some auditors do require companies to have the most current information.  You should review the situation with your company’s compliance staff if you are uncertain how to proceed.

In the meantime, you’ll want to purchase your copies from an authorized AAMI distributor like Document Center Inc.  You can search for and order all the standards you need at our webstore, www.document-center.com.  An easy way to check which items have been revised is to search for “AAMI/IEC TIR” and/or “AAMI/ISO TIR”.  And if you’ve purchased copies of any of these 32 recently reprinted TIR’s from Document Center Inc., you’ll soon get your notification(s).

Need more information?  Want to order directly from Document Center Inc.?  Just contact our staff by phone (650-591-7600) or email (info@document-center.com).  We’ve been working with standards since 1982 and have the knowledge you need to make the most of this type of compliance documentation.  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!

What are FDA Guidance Documents?

What are FDA Guidance Documents?  Why should we use them?  Do they have any legal weight?  These are questions that many organizations have when trying to understand FDA compliance and how the FDA works.  Since FDA Guidance Documents contain a wealth of information that many of our Document Center customers find to be very helpful, I’m going to discuss these publications in general today.  My goal?  To give you a better idea of when and how to use them to improve the way you interact with the FDA.

Guidance Documents are published by the FDA on a regular basis.  They are a methodology they use to communicate information about FDA processes and regulatory requirements.  These publications do not have any legally binding status.  They just are a way for the FDA to let you know what their current thinking is on a topic or how they deal with certain issues or about new processes that you’ll be asked to meet.

One area that FDA guidance documents cover is submissions: how to make your submissions, how your submissions will be reviewed, what they should contain, and so on.  If you’re unfamiliar with what documentation you  need to provide and how it will be processed, guidance documents can explain this to you in general terms.  And occassionally you’ll even get an overview of a specific issue for submissions, as when the “Refuse to Accept Policy for 510(k)s – Guidance for Industry and Food and Drug Administration Staff” was recently released.  This document covers a specific situation for submissions, what it means and how to deal with it.

Another area that’s addressed is compliance, inspection and enforcement.  For anyone with FDA regulatory requirements, understanding how an inspection can take place and what the inspector(s) will be looking for is critical.  Promoting compliance with regulatory requirements over time is an important aspect of the FDA’s mission.  So you’ll find such publications as “Unique Device Identification System: Small Entity Compliance Guide – Guidance for Industry and Food and Drug Administration Staff” available to help you in this regards.

And the other main area that’s covered by guidance documents are about the regulated products or processes themselves.  You’ll find information in these publications on design, production, labeling, promotion, manufacturing, and testing.  They’re a critical communications tool for the FDA.

Some are issued for products that are “hot” as when there was some concern over sterility processes for endoscopes recently.  The FDA issued an update for it’s publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff” to help resolve this issue.  And alongside the FDA’s guidance release, standards organizations also looked to improve processes defined by standardization for this topic.

Others are issued when the FDA or industry perceive that additional information is required to get the desired level of safety and reliability necessary for the public’s well-being.  These can be about very specific topics or more general, like the recent “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings – Guidance for Industry and Food and Drug Administration Staff.”

So, as we mentioned before, FDA Guidance Documents are not a requirement, but they can offer medical device developers and manufacturers a wealth of information to improve the way that you interact with the Administration.  If you’re in this industry, you should monitor these publications on a regular basis.  One easy and effective way to do so is to review the blog.document-center.com on a regular basis.  Just yesterday, I posted the new Medical Device Guidance Documents that were released during the 4th quarter of 2016!  Check it out.

And don’t forget:  Document Center Inc. not only provides you with the standards you’ll need but also gives you access to regulations and supporting documentation necessary to achieve compliance and safety in your product line.  Order the material you need at our webstore, www.document-center.com.  Or if you have additional questions, reach us by phone (650-591-7600) and by email (info@document-center.com).  We’re here to support your quality and compliance requirements!  Make us your Standards Experts!

What is an NSB?

Acronyms are a fact of life in the standards business, but many times they are used without adequate definition.  So as part of my on-going efforts to educate you, the standards user, here’s information on “What is an NSB?”

NSB stands for “National Standard Body” and is the way to describe standards organization that have countries as their jurisdiction.  So some examples would be ANSI (the American National Standards Institute) here in the U.S., BSI (the British Standards Institute) in the U.K. and JISC (the Japanese Industrial Standards Committee) in Japan.

NSB’s usually are an arm of a particular government.  This is because standardization developed in many countries as part of the legal and regulatory structure.  Our U.S. system, with a large number of standards developing organizations (many of them trade associations), is not the norm.  Most NSB’s are quasi-governmental organizations with varying degrees of integration into other government structures.

Let’s take a look at a couple of the larger ones.  DIN (the German Institute for Standardization — Deutsches Institut für Normung) is a private, non-profit organization.  It was founded in 1917 as the “Standards Association of German Industry.”  In 1975 DIN entered a public-private partnership with the German Federal Republic by signing the Standards Agreement.  This makes it the acknowledged national standards body that represents German interests in European and international standards organizations.  It has a wide range of mandates.  The sales of standards provide the Institution with it’s primary income (about 70%.)

Another NSB you should be familiar with is BSI, the British Standards Institute.  Originally established as the British Engineering Standards Association, it is a private company incorporated by Royal Charter (first issued in 1929.)  This Charter sets out the purpose of BSI and defines in broad terms its range of activities.  These include its functions as a standards body, as well as serving as a training, testing and certification services facility.  This means that BSI not only develops standards and participates in standards development on a regional and international level, it also certifies products to the standards it publishes.

How does ANSI, as the U.S. NSB, differ from these other organizations?  ANSI does not write standards.  Instead, it adopts standards produced by other organizations within the U.S.  So many “ANSI” standards are actually written by such groups as ASME, OPEI, AWWA, and so on.  And while ANSI “represents” the U.S. in regional and international standardization efforts, many times this is achieved by authorizing one U.S. standards body or another to oversee participation.  So there is a degree of separation here in the U.S. not found in most other jurisdictions.  Or to put it another way, standardization is more of a “grass-roots effort” here than elsewhere.

One easy way to determine what organization is the NSB for any given country is to check out the list of members and affiliate members of ISO, the International Organization for Standardization.  Since ISO is solely comprised of NSB’s, the list will often help you to determine who’s who in standards.  Here is the link to the ISO List of Members page: http://www.iso.org/iso/home/about/iso_members.htm.  There are a few countries that are not represented in the list.  But with a total of 162 members, its pretty comprehensive!

Of course, it’s not easy to keep track of 162 national bodies, plus the 450+ standards developers in the U.S., various International Standards Bodies, and the many other standards developers around the world.  Most standards users find it advisable to choose an authorized distributor like Document Center Inc. to manage their collections.  Why?  Because a standards aggregator like Document Center Inc. has information coming in daily about new and revised publications.  Only a professional organization like Document Center can deal with the sheer volume of data generated daily.

Search for standards at our webstore, www.document-center.com.  There you’ll find a consolidated catalog of standards from around the world.  Order the documents you need, then depend on our superior notification service to keep you informed of changes moving forward.  Remember:  Document Center Inc. has been helping folks like you since 1982.  Make us your Standards Experts!

AHRI and Document Center Inc. sign Distribution Agreement for Standards

AHRI and Document Center Inc. have just signed a new distribution agreement for the AHRI standards.  This adds AHRI standards in both pdf single copy format and as multi-user subscriptions to Document Center’s rapidly expanding catalog.  For those of you in the air-conditioning, refrigeration, and heating industry, you’ll appreciate the extension of our services for the AHRI standards set.

What is AHRI?  AHRI is the Air-Conditioning, Heating and Refrigeration Institute.  The organization has a long history, starting with the Refrigeration Equipment Manufacturers Association and the Air-Conditioning and Refrigerating Machinery Association.  These two entities merged in 1953 to form the ARI, Air-Conditioning and Refrigeration Institute.  So many of you know this standards set as the ARI standards.

In 2008 ARI then merged with GAMA, the Gas Appliance Manufacturers Association, thus forming AHRI as we know it today.  The Institute maintains over 115 Standards as well as approximately 16 Guidelines (some are published both in inch-pound and metric formats).   And the number of these publications continues to grow each year.

You’ll also be interested to know that it is part of AHRI’s mission to promote HVACR Industry issues both at the U.S. federal level and with various states around the country.  This involves an active advocacy program as well as education, training and regulatory support.  AHRI considers the HVACR community to be an essential component for meeting energy conservation goals around the world.  In particular, it’s workforce training program is geared to help develop the 57,000 skilled workers needed for this critical industry.

Where does Document Center Inc. come into all this?  Here at Document Center we have a clearinghouse of standards from around the globe.  Our customers can use our catalog at www.document-center.com to search for and order standards from a wide selection of standards developing organizations.  The addition of AHRI standards in pdf format and as part of our Standards Online multi-user platform will be of value to our customer base and to the standards community at large.

We’re pleased to have AHRI join our family of standards developers.  The new agreement for AHRI and Document Center will mean your standards purchasing options have been expanded.  Here at Document Center we look forward to providing you, the AHRI standards user, with the services and formats you need when you’re making the standards purchasing decision.  Remember, Document Center Inc. has been working with standards since 1982.  Make us your Standards Experts!

What is the ANAB?

What is the ANAB?  This is a question that comes up when our Document Center  customers are getting ready for management system certification.  If you’re interested in certification and want to know about the ANAB, today I’m posting an overview of the organization.  If you’ve been ISO certified and want to know what happened to the old RAB (Registrar Accreditation Board), I’ll answer that question too.

ANAB is a jointly owned non-profit NGO co-owned by ANSI and ASQ.  There are three main “brands” that have recently been integrated into one service.  They are ACLASS for medical laboratories, ANAB for management systems, and FQS for forensic test labs.  The services of the former RAB (Registration Accreditiation Board) now fall under the umbrella of the rebranded ANAB.

The organization began with the establishment of the RAB in 1989.  Run by ASQ (American Society for Quality), it provided auditor certification for such programs as the ISO 9000 quality and the ISO 14000 environmental management systems.  In 2005, the RAB was transferred to a joint ANSI-ASQ National Accreditation Board (called the ANAB) which included both certification and training.

During the last few years, the joint board acquired a number of other certification accreditors.  With so many different types of accreditation available, ANSI and ASQ decided to consolidate their services this year under the umbrella designation ANAB, American National Accreditation Board.  This means that a wide range of registration services are now covered by the ANAB.  Included in the ANAB portfolio are the following types of certificiations:

  • ISO 9001 quality management systems
  • ISO 14001 environmental management systems
  • ISO 13485 medical device quality management systems
  • ISO/IEC 20000-1 information technology service management systems
  • ISO 22000 food safety management systems
  • ISO/IEC 27001 information security management systems
  • ISO 28000 supply chain security management systems
  • ISO 50001 energy management systems
  • ISO 55001 asset management systems
  • ISO 20121 event sustainability management systems
  • ANSI/AIHA Z10, CSA Z1000, and BS OHSAS 18001 occupational health and safety management systems
  • Aerospace ICOP
  • TL 9000 quality management systems
  • Recycling Industry Operating Standard
  • e-Stewards Standard
  • Responsible Recycling
  • AS5553 and AS6081 for avoidance of counterfeits
  • IECQ QC 08000 hazardous substance process management
  • ASIS SPC.1, ASIS/BSI BCM.01, BS 25999-2, and NFPA 1600 PS-Prep and preparedness
  • Sustainable Forestry Initiation
  • American Tree Farms System
  • BA 9001 body armor quality management systems
  • SQFI Ethical Sourcing
  • Private security company management systems

And services for DoD Environmental Laboratory Accreditation Program (ELAP) and IFS Food Store Inspection Accreditation have just been added.

The ANAB itself is accredited to ISO/IEC 17011.  This means that every 4 years the processes and practices of the NGO are reviewed and certified.  Additionally, ANAB has links to the International Accreditation Bodies ILAC (International Laboratory Accreditation Cooperation) and APLAC (Asia Pacific Laboratory Acceditation Cooperation.)  So many times your certification by a U.S. organization that is ANAB registered will be recognized in other jurisdictions.

Why might ANAB registration be important to you?  With ANAB registration, your certification provider shows you that they can meet their requirements in just the same way that you’ll be expected to.  It’s like knowing that your doctor is board certified!  Also, by using the list of organizations that have the ANAB registration, you may be able to get competing quotes for your certification in order to find the organization that will work best for you.

To look for an organization that has been accredited by the ANAB, check out this Link to the Certified Bodies Directory.  Need an accredited Test Lab?  Here’s the Link to the Accredited Companies.  Once you’ve determined that you’re interested in certifying to a specific management system or testing lab specification, you’re going to need standards in order to support your process.  Turn to Document Center Inc. for the compliance documents you’ll need.  You’ll find us on the web at www.document-center.com.  We’re your Standards Experts!

What’s the difference between ISO 10012 and ANSI Z540.3?

“What’s the difference between ISO 10012 and ANSI Z540.3?”  This is a question that gets raised when folks are trying to determine which calibration standard is best for them.  And it’s also generated by those of you trying to decide what standard is your best replacement for the old MIL-STD-45662.  Let’s take a look at each of these important calibration standards to see how they’re similar and different from each other.

First of all, let’s review the ISO 10012, “Measurement Management Systems – Requirements for Measurement Processes and Measuring Equipment.”  This standard provides “generic requirements and … guidance for the management of measurement processes and metrological confirmation of measuring equipment…”  You’ll use it to show that your equipment complies with specific tolerances (metrological requirements) and that your management system supports your calibration system.

The ISO 10012 covers the topics of management responsibility, resource management, metrological confirmation and realization of measurement processes and the analysis and improvement of your measurement management system.  There’s also an informative Annex A that gives you an overview of the metrological confirmation process.  The 26-page document also includes specific guidance throughout the body of the text, boxed information that clarifies various procedures.

The ANSI Z540.3, “Requirements for the Calibration of Measuring and Test Equipment,” is much more focused on calibration itself rather than the management of the same.  So your sections (apart from the usual scope, referenced documents and definitions that both standards have) include information on:

  • General Requirements
  • Calibration system implementation
  • Calibration system assessment and improvement

Detailed information is provided on such topics as records and data control, competence and training, calibration equipment and personnel, and so on.  And as a final note on the document, the ANSI Z540.3 is the successor document to the old ANSI Z540.1.

Now we’ve taken a look at both the ISO 10012 and ANSI Z540.3.  To wrap the discussion up, the ISO 10012 standard is more of a management overview of one’s calibration system whereas the ANSI Z540.3 is a focused document with specific requirements for the control of accuracy for calibrating measuring and test equipment.  Either or both will make suitable replacements for the MIL-STD-45662, the old Mil Standard on calibration.  You’ll want to choose between them based on your specific needs.

And where can you get your copies of either of these standards?  From Document Center Inc., of course!  We’re an authorized standards distributor based in Silicon Valley with over 30 years of  experience in working with this type of conformance information.  Use our online webstore, www.document-center.com, to order your standards publications when you need them.  And here’s a link to the order page for ISO 10012 and the order page for ANSI Z540.3.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) when you need assistance.  We’re your Standards Experts!

 

Formats for IPC standards

When you order IPC standards from Document Center Inc., you have a number of choices when it comes to delivery formats.  Let’s review your choices and the pros and cons of each.

IPC standards in paper format.  IPC standards can be purchased in paper format.  These are copyright editions, so further replication is prohibited.  However, for the paper copies of IPC standards, you can share a copy with multiple folks as long as you use the IPC original copy.  Document Center Inc. sells the paper copies of IPC standards for the same list price as you’ll receive from IPC.  If you’re a member of the organization, Document Center will honor the member discount.  Just let us know when you place your order.

IPC standards in pdf format.  IPC standards can also be purchased in pdf format.  This results in faster delivery than paper and reduced shipping costs.  However, the IPC pdf format standards are copyright and sold as single user editions.  This means that they are for the use of 1 person on 1 computer only, not on a network.  Also, the print function has been suppressed so you will not be able to print any of the publication.  As with the paper copies, Document Center Inc. sells the pdf editions for the same price as IPC and will honor the IPC member discount if requested.

IPC standards in CD Rom format.  IPC standards are also available as CD Rom copies.  These CD’s are single user editions, not for networking.  They also have their print function suppressed, so you will not be able to print any paper copies from these CD’s.  Prices are as above — List price or member price with confirmed membership in IPC.

IPC standards in Kit format.  The Kit editions of IPC standards offer you discounted pricing for 2 copies of your standard — One paper format copy and one CD Rom edition.  This allows for the benefits of both formats since the CD Rom can be used on a computer, but the paper copy has the flexibility of being portable.  Prices are again the same as you would receive from IPC, since Document Center Inc. is an authorized distributor of these publications.

So the next time you need an IPC standard, look to Document Center Inc. and the variety of formats available from us.  You’ll be able to search for and order your copies online at our webstore, www.document-center.com.   If you have any questions, just get in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with all your standards questions.  Make us your Standards Experts!

First Steps to a Compliant Standards Collection

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!

Standards and Compliance

Compliance is an increasing issue for many of our Document Center customers.  And for us Standards and Compliance are the focus of many of our products and services.  Why?  We’re here to promote and assist our customers’ quality programs, contract and compliance requirements, and the use of best practices through the use of standards.

Of course, for many people the first question is “How do standards fit into a compliance program?”  Many times standards are used in product definition and contract fulfillment.  Or they may be an essential part of meeting regulatory and legal requirements.  And as part of many certification programs, there needs to be a way to manage these publications.

Over the coming weeks, I’ll be reviewing how to set up a program to identify and control the standards you use in your business.  And I’ll be providing you with information on the services Document Center provides to make this program as easy as possible for your organization.

Here’s the steps that need to be taken in order to set up a document control system for the standards you use (and should use) in your business:

  1. Identify those standards that need to be controlled (managed) and who needs to use those documents as part of their job function.
  2. Assess the status of the documents you currently have.
  3. Procure the correct editions for your controlled set.
  4. Make the current editions of your controlled set available to the appropriate personnel.
  5. Monitor and update your standards as necessary.
  6. Notify users when “their” documents change.
  7. Provide a methodology for gap analysis when new revisions are issued.
  8. Have a system for spotting newly released standards not on your controlled list that may affect your business.

Document Center has a wide range of services that make achieving compliant document control possible.  We have auditing and notification services, multi-user site licensing for standards,  online access to standards, and current-awareness programs available.  You’ll use our suite of products to set up a system that is appropriate to your business.

Document Center’s customers rely on us as a critical component of their solution for standards and compliance.  With over 30 years experience in this field, we have the expertise to solve the problems that come with any standards collection.  Check us out at our website, www.document-center.com.  Or contact our staff for more information.  You can reach us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!