The pipette is the most universally important laboratory instrument, and liquid delivery handling is arguably one of the most critical skills for all laboratory technicians. No matter how accurate a lab’s instrument is, if technicians are not pipetting the desired volumes accurately and precisely, the ramifications could be even more serious than incorrect data, damaged samples or wasted reagents – people’s lives might be put at risk through disease misdiagnosis.
Since laboratories are focusing so heavily on automation these days, it is easy to lose sight of the most important aspect of productivity: laboratory personnel. We have become used to calibrating instruments and running extensive quality control tests to measure their performance, however when it comes to assessing the accuracy and precision of laboratory technicians, we may be falling short.
Colleges and universities across the country are charged with training the next generation of laboratory technicians, but while liquid handling is one of the most important laboratory procedures, not all programs dedicate sufficient time and resources to teaching proper pipetting technique.
The School of Medical Technology program at a hospital located in Shreveport, Louisiana aims to change this by instructing students on proper pipetting technique, and verifying their performance. It is a program that has already yielded impressive improvements in the students’ ability to pipette correctly, and is helping to usher a new generation of well-trained medical and clinical lab technicians into the workforce.
Vanessa Johnson directs the School of Medical Technology Program at the hospital. For over ten years she has been working directly with students to improve their laboratory skills and capabilities. The program requires an intensive full-time commitment for students and consists of a year of clinical rotations, with classes held five days per week. A significant portion of Johnson’s Orientation & Management program is dedicated to training on automated liquid handling devices and proper manual pipetting technique.
“You would think it’s a minor point, but improper pipetting could be very dangerous for laboratories,” said Johnson. “Honestly, it’s a pandemic in the medical laboratory industry.”
Improper technique could potentially lead to inaccurate and imprecise results, wasting time and money and, in the worst case scenario, result in misdiagnosis, she said.
Johnson fears the teaching of correct pipetting technique is not adequately addressed at the university level, and that not all graduates are exposed to the full range of sophisticated pipettes that they will encounter when they enter the workforce. “We need to make sure students are prepared to work in laboratories, and that they are trained on the right tools. Our goal is to have them better understand how to use equipment and deliver quality results in the real world,” Johnson continued.
Recently, Johnson made a discovery at the American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Expo that would change her curriculum forever. Artel, the global leader in liquid handling quality assurance, was exhibiting at the show and holding a competition at the booth called the Artel Pipetting Challenge. During the event, each participant used a manual pipette to dispense the same target volume of liquid five times, and was scored on the level of precision (i.e. repeatability) with which the volumes are dispensed.
The Pipetting Challenge employs the Artel PCS® Pipette Calibration System to measure the accuracy and precision of the volumes of liquid dispensed by each participant. The PCS uses ratiometric photometry, which measures light absorption to verify volume, to instantly measure and document the accuracy and precision of volumes dispensed from handheld pipettes. To prompt interest and generate some fun and excitement, Artel awards medals for exemplary performance.
Fun aside, the competition clearly demonstrates how poor pipetting technique can cause serious variation in dispensed volumes.
“Improper pipetting technique is a major source of error in laboratories,” said Dr. George Rodrigues, Artel’s Senior Scientific Manager. “The Pipetting Challenge gives users a hands-on training experience that’s designed to improve pipette operator competence in laboratories.”
One of the major reasons the medical center purchased a PCS was to measure its students’ ability to pipette correctly. By using the PCS, students can gauge quickly and easily how well they are pipetting and see firsthand the impact pipetting technique has on the volume of liquid dispensed – especially when pipetting small volumes.
With the installation of the PCS, an Artel Technical Service representative trained laboratory personnel on how to use the instrument and also on best practices in manual pipetting. This training included guidance on proper pipetting technique, pipetting ergonomics and provided hands-on technique training with the PCS to quantitatively show the difference in results when pipetting properly versus improperly. Johnson now uses this same data-driven approach to teach her students.
Artel also provides a list of Ten Tips to Improve Your Pipetting Technique, which has been developed as a brief introduction to the manual pipette technique training service Artel offers to laboratory professionals. Johnson, who won a gold medal while participating in the Pipetting Olympics, took these tips back to Shreveport with her, and to this day uses them to teach her class about proper pipetting technique.
Artel’s Ten Tips include recommendations such as pre-wetting pipette tips to increase the humidity within the tip and reduce evaporation. Another recommendation is immersing pipette tips at just the right depth; too little immersion can lead to aspiration of air, while too much can cause liquid to cling to the outside of the tip, both affecting volume and therefore data integrity. The Ten Tips and the PCS are now a large part of the program’s curriculum, and Johnson calls them the “perfect teaching tools.”
“Students come into our program with little or no knowledge of using modern pipettes, and by going through our training we’ve seen dramatic improvements,” said Johnson. “Because of the PCS we are able to train students better, and the skills they learn in class transfer directly to the labs in the field.”
The curriculum starts with an introduction to how pipettes are used in the lab, and includes instruction on a pipette’s mechanical function and the variables that can affect its accuracy and precision. Once a basic level of knowledge has been established, Johnson asks the students to pipette into the PCS to get a baseline reading of their skill level prior to training. Instructors then walk students through the Ten Tips so they learn to operate the pipette correctly and use the PCS to continually verify performance.
“Between teaching the Ten Tips and using the PCS to quantify performance, we’ve seen a major improvement in pipetting technique with our students,” said Johnson. “The PCS also allows me to demonstrate the impact certain factors have on pipetting. If I spot students not pipetting correctly while conducting assays, I show them the volume measurement on the PCS and they can instantly see for themselves the effect their technique has on their results.”
In addition to training, the laboratory also uses the PCS to calibrate the many pipettes that circulate throughout its departments. Regular calibration is essential to ensure the devices are functioning properly and delivering volumes according to accuracy and precision specifications. The PCS can rapidly verify pipette performance and uses a sophisticated software package, Artel Pipette Tracker™, to keep track of each individual pipette. It keeps a log of which department each pipette belongs to, all historical calibration data for each pipette, immediate pass/fail results during calibration based upon user-defined requirements, and sends email reminders when re-calibration is due.
“The PCS allows me to follow the path of each and every pipette we have in our entire laboratory,” said Johnson. “It gives me an inventory so I know if there’s a pipette missing. Now I know exactly where each individual pipette is being used, and if it has been calibrated.”
For Johnson, Artel’s technology and know-how have made important improvements to her program and enabled her to manage a critical part of her inventory better. It has also enabled her to enhance the School of Medical Technology program’s curriculum, and the training offered to her students such that the next generation of medical laboratory technicians will be better able to conduct critical disease diagnosis assays.
With a focus on ensuring that Artel delivers meaningful and measurable value to the company’s customers—whether that’s accelerating time to market, delivering cost savings, or driving intellectual property creation—Rosario approaches his role as Vice President of Business Development as one of partnership and collaboration.
He has spent his career bringing complex technologies to scientific and medical professionals and has found success through close engagement with customers. By truly listening and understanding his constituents’ needs, Rosario is able to translate a technology’s value into measurable and sustainable benefits. Newly part of the team, he is already making an indelible mark both in-house and with the users of Artel technology.
When not focusing on customer success or being corralled by colleagues into proofreading their documents (that’s what an inborn commitment to excellence gets you), Rosario brings joy to his friends and family in the form of cooking and opera singing.
“Strive not to be a success, but rather to be of value.” – Albert Einstein
A sales manager responsible for leading a team of skilled account managers, distributors and consultants, Tanya brings together a deep understanding of Artel technology and customer needs to drive success for her team and for Artel’s customers.
Her insight into the benefits provided by Artel technology is based on her experiences as part of the original R&D team that developed the MVS. With the belief that technology untethered from customer needs is ineffective, she moved into marketing to learn how the system she helped develop can enable Artel’s customers to achieve their goals. Now as a sales manager, Tanya is focused on expanding the number of life science teams that Artel can help, whether they are developing and manufacturing tomorrow’s cures or ensuring health through accurate assays.
Like many at Artel, Tanya likes to enjoy the great Maine outdoors with her family when not at work, by camping and traveling to the many wonderful state parks.
“Precision is, after all, not a form of responsibility and a kind of pleasure, but an instrument of compassion. To be precise requires care, time and attention to the person, place or process being described.” – Marilyn Chandler McEntyre
Morgane’s mission is to enable customers and potential customers to quickly and easily understand how Artel’s technology can help them optimize their assay workflows by clearly communicating everything Artel. From how the technology works in specific applications to challenging set up of liquid handler processes and tuning in of complex assays, Morgane is making Artel’s technology understandable and accessible to all.
Having been both hands-on at the bench and with scientific project management, Morgane understands the ins and outs of customers doing research and providing scientific services. She looks forward to satisfying her innate curiosity by learning about the needs of all of Artel’s many types of customers.
When not translating Artel technology into easy-to-grasp communications, Morgane relaxes by folding herself into knots practicing and teaching yoga, traveling back to her native France, expanding her proficiency at a variety of arts, and marveling at how all of these activities feed back on and are driven by the nervous system.
“After a certain high level of technical skill is achieved, science and art tend to coalesce in esthetics, plasticity, and form. The greatest scientists are always artists as well.” – Albert Einstein
Bernadette is the driving force (and friendly face) behind Artel’s content-heavy and customer-centric approach to marketing. She develops marketing/branding strategies and communications campaigns, and leads program execution and analysis by coordinating internal and external efforts, managing budgets, and ensuring consistency and adherence to Artel’s high standards.
Bernie’s strength lies in her ability to reach across all disciplines at Artel—scientific, engineering, metrology, technical support, product development, production, sales, and field support—to make sure that customers are getting the valuable information they need.
Bernie’s passion for detail, quality, and authentic content is expressed in her extraordinary culinary skills, whether the cooking is for an (extensive) family gathering or making a meal for the local community teen center.
“What people do with food is an act that reveals how they construe the world.” Marcella Hazan
Wendy puts her years of experience in the laboratory and her passion for helping people and problem solving to good use as Artel’s Technical Services Manager. Her background has given her hands-on knowledge of customers’ tests and assays, enabling her to understand their pain points since she has experienced them herself. Her goal is to ensure that first-class service is provided by Artel’s customer-facing team, whether it’s directly interacting with customers or through her management of the team. Through hiring, training and guiding her team, she nurtures productive, long-lasting customer relationships.
Wendy’s focus on customers also makes her an excellent internal customer representative to Artel’s teams, where she provides input on product development to the R&D team and communicates any quality issues with Artel products and services to the operations team.
Wendy’s drive to help others resolve problems is not limited to Artel but is evident in all aspects of her life, especially with her children. When not assisting customers, Wendy likes to stay active by biking, boating, and taking long walks in beautiful Maine.
“Nobody cares how much you know until they know how much you care.” commonly attributed to Theodore Roosevelt
Keeping a continual focus on optimizing laboratory productivity, particularly in an increasingly global environment, Bjoern has been contributing to the development of international standards for over 10 years. He is a technical expert contributing to the efforts of standards development committees of ISO (International Standards Organization), ASTM International (formerly the American Society for Testing and Materials), and CLSI (Clinical and Laboratory Standards Institute).
Filling a void in testing guidance for users of automated liquid handling systems, Bjoern was one of the industry experts who proposed the development of the ISO International Workshop Agreement (IWA) 15 “Specification and method for the determination of performance of automated liquid handling systems,” serving as project leader and technical editor for the development of this ISO document. He is currently the project leader and technical editor for the development of a series of ISO standards (ISO 23783 parts 1, 2, and 3) slated to succeed ISO/IWA 15.
Bjoern has been contributing as technical expert to the revision of the ISO 8655 series of standards, serving as lead author and project leader for the new Part 8 “Photometric reference measurement procedure for the determination of volume” and project leader and technical editor for the revision of Part 7 “Alternative measurement procedures for the determination of volume.” He is the co-proposer, lead author, and project leader for the development of the new Part 10 “User guidance and requirements for competence, training, and POVA suitability.”
Key Roles:
Project leader for development or revision of:
– ISO 8655-7
– ISO 8655-8
– ISO 8655-10
– ISO 23783-1, -2, and -3
– ASTM E1154
– ISO/IWA 15
Technical expert in:
– ISO/TC48/WG04
– ISO/TC48/WG05
– ANSI US TAG to ISO/TC48
– ASTM E41 and E13
– CLSI
Heidi contributes almost 40 years of Regulatory Affairs and Quality Assurance experience to the Standards Leadership team. Having worked for decades in FDA-registered companies, she is well-versed in FDA regulations, audits, and inspections. As a Certified QMS Auditor, she has been responsible for all aspects of Artel’s ISO 9001 certification and ISO 17025 accreditation processes, as well as the corresponding internal audits. Additionally, she is an expert in industry-specific regulatory requirements, and ensures Artel’s continuous compliance with all applicable regulations and international standards.
Heidi serves as the secretary to the ISO working group responsible for the development of a series of new ISO standards for Automated Liquid Handling Systems, after having provided significant support to the development of ISO/IWA 15. Her standards development expertise is further applied in handling the balloting process of ISO and ASTM standards for the relevant technical committees in the US.
Key Roles:
– ISO/TC48/WG05 – Secretary
– ANSI US TAG to ISO/TC48 – Vice Chair
Responsible for:
– FDA regulations
– ISO 9001 certification
– ISO 17025 accreditation
– Internal audits
– Compliance to RoHS, REACH, TSCA, and others
Richard has been applying his scientific expertise to the development of international standards for over 25 years. He proposed and authored ISO 8655-7:2005 and ISO/TR 16153, based on the ratiometric photometric method for volume determination.
He was an active member in the ASTM International (formerly American Society for Testing and Materials) committee on laboratory apparatus, as well as in NCSL International (formerly National Conference of Standards Laboratories) through the 1990’s. In 1995, he became involved in the revision of DIN 12650 series of standards related to pipettes and other piston-operated apparatus, which led to the development of the ISO 8655 series of standards.
The co-founder of Artel, Richard was company’s original member delegate to the NCSLI – an international metrology association founded at the request of the US National Institute of Standards and Technology (NIST). This close engagement with metrology and measurement excellence was formative in the development of Artel’s measuring systems and laboratory capabilities.
He authored numerous papers and presentations on the topic of pipette calibration, which are referenced in compliance standards, such as the checklists issued by CAP (College of American Pathologists).
Key Roles:
Author of:
– ISO 8655-7:2005
– ISO/TR 16153:2004
– Performance verification of manual action pipettes, Am Clin Lab 1994
– Referenced in CLSI GP-31 A
– Referenced in CAP checklists
– NCLSI member delegate and appointing officer
– ASTM E41 member since mid-1990’s
George has been engaged in international standards and metrology for more than 20 years – working with colleagues at ISO, ASTM International (formerly the American Society for Testing and Materials), CLSI, and NCSL International (formerly the National Conference of Standards Laboratories).
He chairs the ISO working group responsible for the development of the new standard for Automated Liquid Handling Systems, after having co-proposed and chaired the development of ISO/IWA 15, which was published in 2015. He is the former chair of the ISO working group responsible for pipettes and other piston-operated apparatus, where he proposed the development of a new ISO standard for the “Photometric Reference Measurement Procedure for the Determination of Volume” (ISO 8655-8). George is also a technical expert in the revision of all parts of the ISO 8655 series of standards and proposed the development of the new ISO standard on Operator Training and Pipetting Technique.
His deep expertise in metrology is applied in the current revision of the ISO technical report on the estimation of uncertainty for the photometric reference method, numerous articles, as well as across Artel’s product line.
Serving as chair of the US technical advisory group to the ISO technical committee responsible for laboratory equipment, George is responsible for achieving consensus among US experts and articulating this US consensus positions the ISO international technical committee.
George chairs the ASTM sub-committee on laboratory apparatus and serves as secretary to the parent main committee. His metrology expertise was applied in the revision of the balance calibration standards ASTM E898 and E617, which is referenced in the USP (United States Pharmacopeia).
He co-authored the chapters about pipettes and liquid handling processes in the current edition of CSLI QMS-23.
Key Roles:
– Co-author of:
– ISO 8655-7
– ISO 8655-8
– ISO/TR 16153
– Proposer of ISO/IWA 15
– Proposer of ISO 23783-1, -2, -3
– CLSI QMS-23 – Contributing Author
– ISO/TC48/WG05 – Convenor
– ISO/TC48/WG04 – Former Convenor
– ASTM E41 – Secretary
– ASTM E41.06 – Chair
– ASTM E898:2020 – Revision Participant
– ASTM E617:2018 – Revision Participant
– ASTM E1154 – Technical Contact
– ANSI
– US TAG to ISO/TC48 (Laboratoy Equipment) – Chair
– ANSI International Forum – Participant
– NCLSI – Member Delegate & Healthcare Metrology Committee
Kathleen extends Artel’s commitment to using innovative processes for error-free results to Artel’s finance-related activities. Responsible for financial planning and analysis, evaluating strategic opportunities, budgeting, benefits, and compensation, Kathleen uses her long history of doing mergers and acquisitions from a consulting and business side to bring analytical excellence to strategic evaluations, and her experiences at larger companies to advance established processes.
When not at Artel, Kathleen uses all her experience in efficiency and productivity to care for her two daughters and their cat, dog, and horse and, in the very little time left over after that, enjoys travelling to other countries, meeting new people and learning about other cultures.
“Live life as if you were to die tomorrow. Learn as if you were to live forever.” Mahatma Gandhi
John keeps one eye on the latest technologies and another on the challenges facing today’s life science labs. He and his team of eagerly engaged scientists and engineers test new ideas to enhance Artel’s current products and build out tomorrow’s solutions.
Like many Artelians, John is driven by a lifelong curiosity in the physical world around him. He has turned his fascination with spectroscopy and understanding how light interacts with molecules into products that solve real-world productivity and quality challenges for scientists. He was part of the original team that created the MVS and has been involved in product development at Artel since he walked through the front door.
Descended from a family whose motto is probably best expressed as “do a job right, do it completely, and don’t let go until it’s done,” John embodies this philosophy during the day at Artel. He propagates that motto to his kids through gardening, tapping Maple trees and exploring the great backwoods and waterways of Maine.
“It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so.” – something Mark Twain may, or may not, have said…probably
Richard combines his scientific education, love of learning, curiosity, and passion for making things work better to build products that help life science labs meet quality and productivity goals. His favorite challenge is finding the bullseye at the intersection of corporate strategy, market need and available technology, and then figuring out how to create a product which hits that target. His leadership has been instrumental in shaping Artel’s products and services into the effective, easy-to-use, and quality-focused offerings that they are today.
When not creating tools and knowledge to help life science labs get the right answers every time, Richard enjoys the great Maine outdoors—canoeing, camping, and gardening—as well as woodworking (usually in the great Maine indoors).
“When you have eliminated every possibility for inaccuracy, then accuracy remains your only option.”
With years of pharmaceutical industry experience centered around analytical chemistry, automation, and new technologies, as well as a background in teaching assay development and validation, Nat’s a natural in his role at Artel as the primary driver and chief communicator of product applications. From optimizing assays, processes, and workflows to pipette user training and calibration, Nat communicates to customers how Artel products and services can improve quality and productivity.
At the same time, he keeps track of key assay trends and applications to inform new product development and strategic guidance for business development, partnering, and collaborative opportunities.
While typically a casual and friendly person at Artel and at home, Nat’s aggressive commitment to quality comes out when he homebrews beer and other fermented beverages and he’s even been known to kick people out of the kitchen to avoid contamination.
“Fast is fine but accuracy is everything.” Wyatt Earp
As a co-founder and President, Kirby’s role at Artel is similar to that of an orchestra conductor—he melds the different elements of the company into a powerful whole, bringing out the best in his colleagues and creating synergies that together overcome customer challenges in liquid handling, quality, and regulatory compliance.
Through a combination of curiosity and discipline, creativity and precision, he works with his fellow Artelians to build outside-the-box solutions that are efficient, easy-to-use, highly effective and based on science. Their goal: to ensure that each customer finds new opportunities and executes new solutions to achieve productivity and compliance objectives.
When not at Artel, Kirby takes up his own instruments, the saxophone and piano, playing for the approval of Charlie Parker and Gabriel Faure.
“Music is your own experience, your thoughts, your wisdom. Master your instrument, master the music. If you don’t live it, it won’t come out of your horn.” Charlie Parker
As the Production Manager, Jim maximizes Artel’s productivity and quality by ensuring that all supplies and components are in place, providing proper training for production personnel, maintaining effective processes, and supporting an overall positive, sound and safe working environment.
Driven by a desire to help others, Jim uses his 30-plus years of experience in the photometric instrument field to ensure that customers know they can rely on Artel, answering questions, solving problems, and guiding them through to complete resolution of any issues they have with their lab’s systems.
Like many at Artel, Jim enjoys cooking and home renovation, and is currently combining his helpfulness and home renovation skills by working on his daughter and son-in-law’s house.
“Seek first to understand, then to be understood.” Stephen R. Covey
An important part of building high-quality products, and providing services that rely on those products, is ensuring that the components and supplies are also high-quality and readily available. Which is why Jack focuses on keeping supply-side relationships top notch. Responsible for the extended supply chain—procurement, purchasing, inventory control, warehousing, shipping, and trade compliance—as well as Artel’s facilities and physical plant, Jack ensures quality by being both a good customer and delivering good customer service.
Jack’s adherence to high standards, quality, and attention to detail are a great fit for his work at Artel and can also be seen in the years-long home renovation project he and his wife have been undertaking. When not at Artel, Jack is an avid traveller, gardener, and connoisseur of cinema and literature.
“No one knows the cost of a defective product – don’t tell me you do. You know the cost of replacing it, but not the cost of a dissatisfied customer.” W. Edwards Deming
Officially, Graham is responsible for overseeing sales, strategic marketing, business development, and applications of Artel’s technology. In practice, this means listening to customers and leveraging his broadly eclectic scientific and business background to identify technological solutions that improve data quality and productivity.
Initially trained as a molecular biologist/protein biochemist, his many years troubleshooting misbehaving assays and analytical methods make him particularly well-suited to a role helping customers with their data quality. The many years at the bench have given Graham a deep appreciation of the importance of reducing sources of noise and variability which, together with experimental controls, can help save weeks and even months of wasted time.
When not at work, Graham’s total embrace of the experimentalist’s spirit is evident in his approach to cooking and baking, also known as “the experiment you get to eat,” which requires precision and tight QC of the ingredients as well as exact execution of the recipe steps to get the desired tasty outcome.
“I often say that when you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind.” Lord Kelvin
With a specialization in metrology and a lifelong interest in both science and engineering, George is ideally suited for his role as Artel’s representative to metrology and standards organizations, laboratory accreditation bodies, and government regulators, where he helps shape regulatory frameworks around liquid handling processes.
These activities give George a deep understanding of regulatory compliance which, coupled with his metrology and quality expertise, he uses to help customers improve data quality and efficiency while maintaining regulatory compliance. This help is especially critical for customers making process improvements, as change can be challenging in regulated environments.
George’s interest in metrology and standards extends beyond his work at Artel (see how he celebrated World Standards Day in 2016). For example, in George’s words, “Deflategate could have been avoided with a properly defined and validated measurement process. With no stated reference temperature, the NFL cannot possibly regulate ball pressure to plus or minus 0.5 psi. A game of inches and seconds, $15 billion annual revenue, and zero metrologists!”
“Every system is perfectly designed to get the results it gets.” Often attributed to W. Edwards Deming, but more likely from Paul Batalden.
As the person in charge of Artel’s Quality Management System, Cary plays a critical role in making sure that Artel’s commitment to quality is always being met. By training employees and keeping all quality processes and procedures well-documented and up-to-date with current regulatory standards she ensures regulatory compliance, and by assessing and evaluating performance both internally and externally (Suppliers) and customer feedback, she supports overall productivity and effectiveness to ensure we meet our customers’ expectations.
When not working closely with her team members to maintain Artel’s quality management processes, Cary enjoys the peace found hiking in the beautiful Maine outdoors.
“Nature does not hurry, yet everything is accomplished.” Lao Tzu
“Random is not one of my strengths.” Doreen Rumery
With a strong work ethic, thorough attention to detail, inquisitive mind that needs to know why things work (or don’t work), and passion for standardization, Doreen is exactly the right kind of person to manage Artel’s chemistry and calibration labs. She’s responsible for making sure the labs run smoothly, ensuring product and instrument quality, calibrations, regulatory compliance, lab personnel training, timely delivery of products, troubleshooting, and process improvements.
Doreen’s need for standardization is apparent even in her home life where spreadsheets and planning tools are used to ensure the household runs smoothly. When not at Artel, Doreen likes to spend time with her family (some of whom she also sees at Artel), gardening, and travelling with her many sisters and brother.
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives.” William A. Foster
Table 1. Regulations that require demonstration of pipette competency training and/or assessment
ISO Standards | |
ISO/IEC 17025:2005 | General Requirements for the Competence of Testing and Calibration Laboratories |
ISO 15189:201 | Medical Laboratories; Requirements for Quality and Competence |
ISO 15195:2003 | Laboratory Medicine; Requirements for Reference Measurement Laboratories |
FDA cGMP regulations (current Good Manufacturing Practice) | |
21 CFR Part 211 | cGMP for Finished Pharmaceuticals |
21 CFR Part 225 | cGMP for Medicated Feeds |
21 CFR Part 820 | Quality System Regulation for Finished Devices for Human Use |
21 CFR Part 1271 | Human Cells, Tissues, and Cellular and Tissue-based Products |
GLP (Good Laboratory Practice) | |
FDA: 21 CFR Part 58 | GLP for Non-clinical Laboratory Studies |
EU: Directive 2004/10/EC | Principles of Good Laboratory Practice 1997 (Part 1), from the Organisation for Economic Cooperation and Development (OECD) |
GCP (Good Clinical Practice): | |
International Conference on Harmonization (ICH) E6 | Good Clinical Practice – Consolidated Guidance 1996 |