What is World Standards Day and Why Should Life Scientists Care?


world-standards-dayFocusing on the importance of standards

World Standards Day (WSD) is an international celebration that is meant to draw attention to the importance of written standards in the global economy, and to raise awareness about how standards are developed. The date is said to be chosen as the anniversary of the first pre-ISO meeting for world standardization, which was held in London on October, 14th, 1946. The event is sponsored by a variety of international standards bodies, including ISO (the International Organization for Standardization), IEC (the International Electrotechnical Commission), and ITU (the International Telecommunication Union).   In the US, there’s a whole week of celebratory events co-chaired by ANSI (the American National Standards Institute), and NIST (the National Institute of Standards and Technology).

Why should we care? Because standards build trust

Most people take standards for granted, but many of our everyday experiences couldn’t happen without them. For example, suppose it’s Saturday and you are going to the lake. The car that takes you there is built on thousands of standards: airbags, crash testing, paint, steel, upholstery, seatbelts, tires, etc. There are even standards for eliminating radio interference from the spark plug wires.  We can listen to the radio and drive at the same time! All of these standards work together to make the car comfortable, reliable and safe, and all of them are built to conform to written standards.

Suppose that you stop at the convenience store for gas. The octane numbers (87, 89, etc.) are measured by standard test methods.  The pump will be calibrated using a standard method, and have a current inspection sticker.  This inspection sticker is a trust mark, and the supporting written standards provide confidence that the correct amount of the expected product is delivered to your tank.  In other words, standards ensure that you’re getting what you paid for.

In the medical world, standards are even more critical. The typical surgery will involve thousands of standards: anesthesia, sterilization, gloves, gowns, masks, medical implants, antibiotics, preparation solutions, lighting, and so on. The good news is that we don’t have to even think about these things, because all these pieces are built to conform to standards covering their safety and effectiveness.  We can trust that the routine supplies and equipment will work, and focus our efforts on supporting the patient.

For life scientists, the obvious benefits of standards include better quality data for more reproducible and reliable results, as well as the ability to compare results from lab-to-lab across the globe. Recent initiatives like the Microarray/Sequencing Quality Control Consortium (MAQC/SEQC)  and the new Antibody Validation Initiative  sponsored by the Global Biological Standards Institute (GBSI)  come to mind.

At the end of the day, standards build trust—which just happens to be this year’s WSD theme.

How are standards made and who makes them?

The quick answer is—you and people like you.

Standards are developed by volunteers who either have a specific expertise or concerns related to a given topic—basically, anyone with knowledge in a field, and interest, can contribute to the process. These volunteers come from a range of different perspectives, and can be the producers of products and services, users, consumers, government regulators, and consultants. Standards for consumer products often focus on safety; and it is in participation in developing these standards where consumer groups play an especially important role.

One of the guiding principles of standards development is openness, which means that barriers to participation in the development should be low – hence ensuring that the standards are applicable and valuable in the real world. In most cases, membership fees are small or non-existent; and with email and the internet, it is possible to participate by web conferencing, phone conference, or by providing written comments and opinion.

How often do standards change?

Standards are evolving continually. There are thousands of new standards under development at any given time, and each published standard is subject to periodic review, which is typically every five years.  However, standards development committees don’t need to wait for a full review cycle and can revise standards whenever there is a need. Changes to standards occur by first establishing a need, and then assigning that need to a “task group” or “working group,” which makes the edits.  The revised document comes back to a technical committee for review and approval.

Here are a few of the different standards projects related to lab equipment that are currently under development or implementation:

ASTM E617 “Standard specification for laboratory weights and precision mass standards” is being revised to clarify a few key technical requirements. This is an example of how, after a major revision in 2013, users had questions and requested greater specificity. This standard provides laboratory users with specific criteria for evaluating weight calibration services, and will result in more accurate weights for all laboratory users.
“Piston-operated volumetric apparatus” is a seven-part series covering pipettes, burettes, dilutors and dispensers. The series is being revised to include specific test methods for motorized electronic pipettes. Motorized pipettes can be programed to operate in the normal pipetting mode, but can also be operated as repetitive dispensers and other modes. This revision will include enhanced testing protocols for motorized pipettes, which are an increasingly important tool in life sciences laboratories.
ISO IWA 15 “Specification and method for the determination of performance of automated liquid handling systems” was published in 2015 and is currently being implemented by a number of equipment manufacturers and laboratories. ISO IWA 15 provides a common language, common statistics and defined test methods. This document provides users with a common framework for specifying volumetric performance and for making comparisons across various vendors. The end result will be more efficient application deployment and better analytical data quality.
CLSI (the Clinical and Laboratory Standards Institute) is completely revising their laboratory equipment guide. This new document, designated QMS23, should be published in 2017. Users of this guide will find specific recommendations for proper selection, qualification, calibration and maintenance of general purpose laboratory equipment, including timers, centrifuges, incubators, and much more. This will be a real time saver for users who are looking to establish or bench-mark their equipment management practices.
EURAMET project 1295 research is ongoing, and will eventually be published along with an extensive and detailed calibration guide for handheld pipettes. This is likely to be the first standard guideline to address topics of major practical importance, such as how to handle pipetting of fluids with different physical properties.

How will I be celebrating WSD?

Being a metrologist, WSD is very important to me! On the Tuesday and Wednesday before WSD, I’ll be attending a two-day workshop and meeting on current and future standards activities within pharmaceutical and biopharmaceutical manufacturing.  This workshop and meeting is being jointly organized by the US FDA and the ASTM (American Society for Testing and Materials) E55 Committee for the Manufacture of Pharmaceutical and Biopharmaceutical Products.

On Thursday, I’ll be speaking on the topic of standards in laboratory automation to the Laboratory Robotics Interest Group in Boston.

Then on Friday, the actual WSD, things should be pretty low-key. I’ll drive home from Boston on a standardized and reliable roadway during the day (of course there are standards for asphalt, concrete and bridges).  And, if the weather is clear and cool on Friday evening, I’ll light an NFPA-compliant fire in the patio fire pit, and enjoy an American standard 12-ounce can of Stowaway IPA.

Additional Resources

About the Author

George Rodrigues, Ph.D.

George Rodrigues, Ph.D., is Senior Scientific Manager at Artel, the global leader in liquid delivery quality assurance. Rodrigues is responsible for developing and delivering communications and consulting programs designed to maximize laboratory quality and productivity through science-based management of liquid delivery. Rodrigues is Artel’s chief representative to key commercial clients, government regulatory bodies and industry organizations. His speaking and teaching engagements, along with his publications, build awareness of the challenges and solutions for laboratories in maintaining data integrity and confidence in their testing protocols. He plays a key role in developing the manufacturing and quality assurance processes for Artel products and organizes programs to assist pharmaceutical, biotechnology and clinical laboratories in improving their liquid delivery quality assurance and analytical process control. Rodrigues earned his BS in Chemical Engineering at the U.C. Berkeley, and a PhD in Chemical Engineering at the University of Wisconsin.