PJLA Blog

Who Should Consider ISO 15189?

Medical testing laboratories that aim to ensure the highest quality and reliability of their services should consider ISO 15189 accreditation. This standard is particularly crucial for laboratories involved in medical testing, diagnostic services, and clinical research. Whether you are a small lab serving a local community or a large facility supporting multiple healthcare providers, ISO 15189 provides a framework for excellence. Laboratory managers, quality assurance professionals, and healthcare administrators should explore the benefits of this accreditation to enhance their operational standards and trustworthiness.

What is ISO 15189?

ISO 15189 is an international standard that specifies the requirements for quality and competence in medical laboratories. Developed by the International Organization for Standardization (ISO), it is designed to improve the quality and reliability of medical laboratory services. The standard covers essential aspects such as laboratory equipment, personnel qualifications, process management, and quality control procedures. By adhering to ISO 15189, laboratories can demonstrate their commitment to delivering accurate and timely test results, which are critical for patient care and clinical decision-making.

Where to Find Out More?

For more detailed information on ISO 15189 and how it can benefit your medical laboratory, visit Perry Johnson Laboratory Accreditation, Inc. (PJLA). As a leading accreditation body, PJLA provides comprehensive resources, expert guidance, and professional support to help laboratories achieve and maintain ISO 15189 accreditation. Our team of experienced assessors is dedicated to ensuring that your laboratory meets all necessary requirements. You can learn more about our services and get started on your accreditation journey by visiting our website at www.pjlabs.com.

When Was ISO 15189 Established?

ISO 15189 was first published in 2003. It was developed in response to the growing need for a standardized approach to quality and competence in medical laboratories. Since its inception, the standard has undergone several revisions to stay current with advancements in medical technology and evolving industry practices. The most recent version ensures that laboratories can consistently deliver high-quality services that meet international benchmarks.

Why Should Medical Testing Laboratories Consider ISO 15189 Accreditation?

1. Enhanced Credibility and Trust:

ISO 15189 accreditation signals to patients, healthcare providers, and regulatory bodies that your laboratory adheres to internationally recognized standards. This enhances your laboratory’s reputation and fosters trust in your services.

2. Improved Quality and Efficiency:

The accreditation process helps identify areas for improvement, leading to more efficient operations and higher quality test results. It encourages a culture of continuous improvement and excellence within the laboratory.

3. Regulatory Compliance:

Many regions and healthcare providers require or prefer laboratories to be ISO 15189 accredited to ensure that they meet rigorous quality and competence standards. Achieving this accreditation helps laboratories stay compliant with local, national, and international regulations.

4. Risk Management:

Implementing ISO 15189 standards enhances the laboratory’s ability to manage risks associated with medical testing, thereby reducing the likelihood of errors, and improving patient safety.

5. Competitive Advantage:

Accreditation can differentiate your laboratory from competitors. It demonstrates a commitment to quality that can attract more clients and partnerships with healthcare providers who prioritize accredited laboratories.

By choosing ISO 15189 accreditation through PJLA, laboratories can not only meet but exceed the expectations of patients and healthcare providers. Our expert team is here to support you every step of the way, from initial assessment to maintaining your accreditation status.

For further information on how PJLA can help your laboratory achieve ISO 15189 accreditation, visit our website at www.pjlabs.com. Let us partner with you in your journey towards excellence in medical laboratory services.

June 9th marks a significant day in the world of quality and standards—World Accreditation Day. This international initiative, established by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), is dedicated to raising awareness about the critical role of accreditation across various sectors. At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we are excited to join the global community in celebrating this important occasion and exploring this year’s theme: “Empowering Tomorrow and Shaping the Future.”

The theme underscores the transformative power of accreditation in our evolving world. As we navigate through rapid technological advancements, environmental challenges, and shifting societal needs, accreditation provides a stable foundation for progress and innovation. At PJLA, we are proud to contribute to the global mission of accreditation by providing top-tier accreditation services. Our role is to ensure that organizations operate at the highest levels of quality and integrity, fostering trust in their results and services.

As we celebrate World Accreditation Day 2024, we reaffirm our commitment to empowering our customers and shaping a better future. We believe that through continuous improvement, innovation, and adherence to the highest standards, we can contribute to a world where quality and trust are paramount. PJLA invites you to join us in celebrating this special day and recognizing the indispensable role of accreditation in our lives.

Happy World Accreditation Day 2024!

---

For more information about PJLA and our accreditation services, please visit our website at www.pjlabs.com.

---

As the warm days of summer approach, families and friends look forward to backyard barbecues, dazzling fireworks displays, and festive picnics. At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we understand that these joyful moments are built on a foundation of safety and quality. The unseen heroes behind your summer festivities are the laboratories that safeguard the products we rely on for these summer traditions.

Imagine firing up your grill on a sunny afternoon, the aroma of sizzling burgers and hot dogs filling the air. But before these grills reach your backyard, they undergo extensive testing. Labs evaluate the safety, performance, and durability of grills, checking for potential hazards such as gas leaks, electrical issues, and structural weaknesses. By ensuring that grills meet stringent safety standards, they help prevent accidents and ensure that your barbecue is a success.

A summer celebration is incomplete without a stunning fireworks display. Yet, the beauty of fireworks comes with inherent risks. Laboratories play a crucial role in testing fireworks for safety and compliance with regulatory standards. They assess factors such as explosive strength, stability, and packaging integrity.

Summer picnics are a beloved tradition, filled with delicious foods from fresh fruits to savory snacks. Ensuring that these foods are safe to consume is a critical task handled by labs. From pesticide residue testing on fruits and vegetables to microbiological testing on meats and dairy products, accredited labs verify that your picnic foods are free from harmful contaminants. This rigorous testing helps prevent foodborne illnesses and ensures that your outdoor feast is both tasty and safe.

At PJLA, our mission is to promote confidence in products and services through accreditation. We achieve this through meticulous assessment and continuous oversight, ensuring that labs maintain the highest standards of excellence.

As you enjoy your summer celebrations, remember the critical role that laboratories play in ensuring your safety and enjoyment. Whether it’s a grill, a firework, or picnic food, you should be confident that your favorite products have undergone thorough testing and calibration to ensure your safety. Here’s to a summer filled with safe and joyful celebrations!

This week, we are excited to provide a behind-the-scenes look into the daily life of a PJLA assessor. Have you ever wondered what it takes to ensure laboratories meet the highest standards of quality and competence? To shed light on this crucial role, we sat down with Rae Cote, one of our dedicated PJLA assessors, to discuss the unique challenges and rewarding experiences she encounters during assessments.

Rae’s insights offer a fascinating glimpse into the meticulous and dynamic world of laboratory accreditation. Let’s dive in!

1. Can you provide a brief overview of what your role entails?

Primarily, being organized. In general, my role is to coordinate with the labs and PJLA to ensure the customers are getting what they need: a reassessment, an initial assessment, or whatever it may be. Scheduling on-site with travel or an offsite review or remote assessments all have a different agendas. Travel is a big part of my job. The actual assessment is interesting as you don’t know what you’re walking into. Some labs I’ve been to before, but others I may not know the facility, people, or even the area. And certainly, working with different people every assessment can be fun, but also challenging. I must be flexible. We are assessing labs during their regular business hours so as in any business, anything can happen at any time… and usually when an assessor is on site, it does!

2. What qualifications and experience are typically required to become an assessor?

At a minimum, a BS degree in the area you are assessing and experience is critical when assessing. I have a Bachelor of Science degree in Biochemistry with a minor in Organic Chemistry and several courses in Microbiology allowing me to assess in many testing areas for ISO/IEC 17025:2017. I also worked and went to graduate school in Pathology which qualifies me to work with ISO 15189. Having an excellent understanding of the standard and quality systems, as well as lab experience and expertise, makes for a great assessor.

3. What are some of the key responsibilities you have during an assessment?

To be professional and open to what the lab is doing and saying. To be a detective and observe what I am seeing and not seeing. To hear what I’m being told and not being told. I must complete all required paperwork and return it to PJLA promptly. Also, to refrain from providing any consultancy during an assessment. It’s also my responsibility to ensure we adhere to the schedule in the time we are given for the assessment.

4. How do you prepare for an assessment before visiting a laboratory?

So many things, starting with reviewing the lab documentation, the website, and logistics of the lab. I prepare all my paperwork to the extent that I can. I plan my travel and try to stay as close to the facility as I can.

5. Can you share any interesting or challenging experiences you’ve encountered during assessments?

I’ve had a few challenging assessments. I can quickly tell when a lab is hiding something, or outright lying about things. It happens, but most of the labs I assess are fantastic and want to improve so they are glad I’m there.

6. What tools or resources do you utilize during the assessment process?

My main resource is the standard to which I’m assessing to (i.e. ISO/IEC 17025 or 15189). I keep the PJLA website open to look for certificates when needed for a lab using a company for calibrations or lab comparisons. I look at the certificate before I ask the lab anything. I try not to ever ask a question that I don’t already know the answer to.

7. What do you enjoy most about being as assessor?

I love being at a different lab location every week and meeting different people. If we hit it off, it’s nice to know I might see them again next year. And if not, I continue with my task and keep it professional. I don’t like doing the same thing every day, so being an assessor puts me in many locations and many types of labs with many different people. I also assess to two standards, which definitely keeps each week a little different.

8. What advice would you give to laboratories aiming to achieve or maintain accreditation?

Listen to your assessor and accreditation body – you are paying us! Get a pre-assessment. I find that most labs that utilize a pre-assessment are far more ready than those who do not. And always look to improve. A lab doesn’t get better by doing things the way they always did them. Use your risk assessment, improve, and grow. Assessors notice these things.

---

Would you like to join PJLA’s team of professionals who are dedicated to providing the best accreditation experience possible? Click Here to apply today.

---

Today, Perry Johnson Laboratory Accreditation, Inc. (PJLA) proudly joins the global community in celebrating World Metrology Day 2024. This year’s theme, “Sustainability,” underscores the pivotal role of precise measurements in nurturing a sustainable global economy and environment.

From measuring energy use in industries, buildings, and transportation to managing resources in agriculture and forestry, metrology is at the heart of sustainable development. Accurate measurements are essential for:

• Identifying pollution sources
• Setting and achieving environmental protection targets
• Ensuring regulatory compliance in vehicle emissions and fuel consumption
• Designing sustainable transportation solutions
• Improving environmental stewardship through efficient manufacturing and waste management

At PJLA, we are committed to advancing the science of measurement to foster innovation and sustainability. Our accredited laboratories ensure that measurements meet the highest standards of accuracy and reliability, supporting efforts to build a greener, more sustainable world.

Join us in celebrating the power of precise measurements and their crucial contribution to sustainability. Together, let’s measure for a better future!

Let’s delve into the realm of ISO/IEC 17020, shedding light on its significance, purpose, and impact on inspection bodies worldwide.

Who? ISO/IEC 17020 is a standard developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). It pertains to the competence of bodies performing inspection activities. These bodies, known as inspection bodies, can encompass a wide range of entities, including governmental agencies, commercial enterprises, and independent organizations.

What? ISO/IEC 17020 outlines the general requirements for the operation of various types of bodies performing inspection. It sets forth criteria for impartiality, competence, consistency, and reliability in conducting inspections. Compliance with this standard ensures that inspection bodies operate with integrity and adhere to internationally recognized practices.

The standard covers a multitude of aspects, including:

1. Organization and Management: Establishing a robust organizational structure, management system, and quality policy to support the inspection activities.
2. Personnel Competence: Ensuring that personnel possess the necessary skills, knowledge, and training to perform inspections competently and impartially.
3. Inspection Process: Defining procedures for planning, conducting, and reporting inspections, including the handling of samples, data, and records.
4. Equipment and Facilities: Providing and maintaining appropriate equipment, facilities, and resources to support inspection activities.
5. Impartiality and Confidentiality: Upholding impartiality and confidentiality throughout the inspection process, thereby maintaining trust and integrity.

Where? ISO/IEC 17020 applies to inspection bodies operating in various sectors, including manufacturing, construction, healthcare, environmental management, and consumer product safety. Whether it’s assessing the quality of manufactured goods, verifying compliance with regulatory standards, or ensuring environmental sustainability, ISO/IEC 17020 provides a framework for consistent and reliable inspection practices globally.

When? ISO/IEC 17020 was first published in 1998 and has since undergone revisions to address evolving industry needs and advancements in inspection practices. The most recent version, ISO/IEC 17020:2012, sets the current benchmark for accreditation of inspection bodies. Regular updates and revisions ensure that the standard remains relevant and reflective of best practices in the field of inspection.

Why? The importance of ISO/IEC 17020 cannot be overstated. Accreditation to this standard provides numerous benefits to inspection bodies, regulatory authorities, consumers, and the broader marketplace:

1. Enhanced Credibility: Accreditation demonstrates the competence and reliability of inspection bodies, instilling confidence in the quality and integrity of their services.
2. Global Recognition: Accreditation to ISO/IEC 17020 facilitates acceptance of inspection results across international borders, promoting trade and market access.
3. Risk Mitigation: By adhering to standardized inspection practices, ISO/IEC 17020 helps identify and mitigate risks associated with product quality, safety, and compliance.
4. Continuous Improvement: The standard encourages a culture of continuous improvement, driving inspection bodies to refine their processes, enhance their capabilities, and adapt to changing industry dynamics.

ISO/IEC 17020 serves as a beacon of quality and professionalism in the realm of inspection. At PJLA, we are committed to supporting inspection bodies in their journey towards accreditation, ensuring that they meet and exceed the rigorous requirements set forth by this esteemed standard. Join us in our quest for excellence and integrity in inspection practices, as we navigate the intricate landscape of ISO/IEC 17020 together.

Perry Johnson Laboratory Accreditation, Inc. (PJLA) was honored to host the NCSL International Michigan Section Meeting 2024 at the Troy Michigan Community Center on May 8th, 2024. The event brought together professionals and experts from the calibration field for a day of insightful presentations, networking opportunities, and knowledge exchange. The agenda was meticulously crafted to cover a wide array of topics relevant to the calibration industry, ensuring attendees left with valuable insights and perspectives.

The opening remarks, delivered by the NCSLI Section Coordinator, set the stage for the day ahead, providing updates on the latest developments within NCSLI and the broader field of measurement science. Attendees were then treated to a thought-provoking presentation by Sandeep Nair from MetQuay, who delved into the intricacies of navigating the digital transformation of calibration labs in his talk titled “Revolution or Risk?”

Following a brief networking break, Cees Veth from HPV, The Netherlands, took the stage to present on “CCPG Highest Calibrated ISO/IEC 17025:217 Accredited Pressure Calibration in the World Today,” shedding light on the cutting-edge practices in pressure calibration.

Lunch provided attendees with an opportunity to recharge and engage in informal discussions, further fostering connections within the measurement science community. The afternoon sessions commenced with Dilip Shah from E=MC3 Solutions delivering insights on “Making Statements of Conformity on a Calibration Report,” addressing a crucial aspect of calibration documentation.

Roman Lotus from Additel then captivated the audience with his presentation titled “Evaluation of Dry Well Calibrator and Calibration Uncertainty Budget using Dry Well Calibrator,” offering valuable perspectives on calibration methodologies and uncertainty assessment.

The penultimate session of the day, led by Michael Kramer from PJLA, explored “ISO/IEC 17025 Auditing Fundamentals,” providing attendees with essential insights into the auditing process and compliance standards.

As the day drew to a close, attendees eagerly participated in the distribution of door prizes, adding an element of excitement to the event’s conclusion. Closing comments reiterated the value of collaboration and knowledge sharing in advancing the field of measurement science.

PJLA extends its heartfelt gratitude to NCSL International for giving PJLA the chance to host their excellent event. PJLA looks forward to continuing its support for initiatives that promote excellence in measurement science and calibration practices. For more information about upcoming events and accreditation services, please visit Perry Johnson Laboratory Accreditation, Inc.

About NCSL International: NCSL International is a member-based, volunteer-driven professional trade organization dedicated to promoting measurement education, skill development, and collaboration within the field of measurement science. Since 1961, NCSLI has been at the forefront of advancing measurement practices through networking, information exchange, and the promotion of conferences and training events. Membership is open to any organization or individual with an interest in measurement and its applications across various sectors.

In the bustling city of Nashville, Tennessee, the manufacturing community recently converged for a leading event – The Quality Show South 2024. This inaugural gathering, presented by Quality Magazine, aimed to foster connections among southern manufacturing professionals and provide a platform for interaction with premier suppliers and industry experts. Among the attendees this year was Courtney Smith, representing Perry Johnson Laboratory Accreditation, Inc. (PJLA).

For PJLA, an organization dedicated to providing accreditation services to laboratories worldwide, events like The Quality Show South are invaluable opportunities to engage with the industry and showcase their commitment to quality and excellence.

Courtney Smith, equipped with her expertise and enthusiasm, navigated through the event, immersing herself in the vibrant atmosphere of innovation and collaboration. As a representative of PJLA, Courtney’s primary objective was to connect with professionals from various sectors, share insights on accreditation processes, and explore potential collaborations.

During her time at The Quality Show South, Courtney had the pleasure of running into one of PJLA’s esteemed clients, Holts Precision, Inc. Holts Precision, Inc. holds ISO/IEC 17025 accreditation, a testament to their dedication to quality and precision. PJLA has been privileged to accredit Holts Precision, Inc. for many years, fostering a relationship built on trust and mutual respect.

With events like these paving the way for collaboration and innovation, the future of manufacturing looks brighter than ever.

April 24, 2024, marks the celebration of National Administrative Professionals Day, a day dedicated to honoring the invaluable contributions of administrative professionals across various industries. At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we recognize the importance of our administrative professionals in keeping our operations running smoothly. They are the unsung heroes who form the backbone of our efficiency, and today, we want to express our deepest gratitude for their hard work and dedication.

In every organization, administrative professionals play a pivotal role in ensuring seamless day-to-day operations. From managing schedules and appointments to coordinating communications and providing vital support to staff, their responsibilities are essential.

At PJLA, our administrative professionals go above and beyond to support our mission of promoting quality and excellence in laboratory accreditation. They are the friendly voices on the other end of the phone, the meticulous organizers behind the scenes, and the problem solvers who keep things running like clockwork. Their attention to detail, organizational skills, and unwavering commitment are instrumental in upholding the high standards we are known for.

“To all of the PJLA administrative staff, I’d like to extend my heartfelt thanks and recognition for your invaluable contributions. You are essential to the smooth functioning of our organization. Happy Administrative Professionals’ Day!” – Tracy Szerszen, PJLA President

As we commemorate Earth Day, we are reminded of the collective responsibility we bear towards our planet and the imperative need to protect and preserve it for future generations. At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we are committed to promoting sustainability and environmental stewardship not only within our own organization but also among the countless businesses and laboratories we accredit worldwide. Today, we extend our efforts beyond accreditation standards to share actionable steps that organizations can implement to contribute to a greener world.

1. Embrace Renewable Energy: Transitioning to renewable energy sources such as solar, wind, or hydroelectric power can significantly reduce carbon emissions and environmental impact.
2. Reduce, Reuse, Recycle: Implementing effective waste management practices is essential in minimizing environmental footprint. Encourage employees to reduce paper usage, recycle materials, and invest in reusable products.
3. Adopt Sustainable Procurement Practices: Choose suppliers and vendors who prioritize sustainability in their operations.
4. Invest in Energy-Efficient Technologies: Upgrade to energy-efficient appliances, lighting systems, and HVAC systems to conserve energy and reduce operating costs. Implementing smart building technologies and energy management systems can optimize energy usage and enhance sustainability performance.
5. Support Environmental Conservation Initiatives: Engage in corporate social responsibility initiatives that support environmental conservation efforts. Partner with nonprofit organizations, participate in tree planting campaigns, or organize community clean-up events to contribute to local environmental preservation.

At PJLA, we stand ready to support organizations in their journey towards sustainability through our accreditation services and commitment to environmental stewardship. Together, let us pave the way towards a brighter and more sustainable tomorrow.

Happy Earth Day from the team at Perry Johnson Laboratory Accreditation, Inc. (PJLA)!