PJLA Blog

At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we take pride in being a leader in accreditation services, including ISO 17034 accreditation for Reference Material Producers (RMPs). Today, we delve into the “5 Whys” of ISO 17034 accreditation to highlight its significance, benefits, and the journey towards achieving it.

Who Benefits from ISO 17034 Accreditation?

ISO 17034 accreditation benefits a wide range of organizations:

• Reference Material Producers (RMPs): Accreditation enhances their credibility and ensures the quality of their reference materials, which are essential for calibration, method validation, and quality control processes in laboratories worldwide.
• Testing and Calibration Laboratories: These laboratories rely on high-quality reference materials to ensure the accuracy and reliability of their results. ISO 17034 accreditation guarantees that the reference materials meet stringent quality standards.
• Regulatory Bodies and Industry Sectors: Consistent and reliable reference materials are critical for compliance with regulations and industry standards. Accreditation ensures that these materials support regulatory requirements and industry best practices.
• End-Users: From pharmaceutical companies to environmental testing labs, end-users benefit from the assurance that accredited RMPs provide high-quality reference materials, leading to more accurate and reliable testing outcomes.

What is ISO 17034 Accreditation?

ISO 17034 accreditation is a globally recognized standard that specifies the general requirements for the competence of reference material producers. It encompasses a comprehensive set of criteria that RMPs must meet to demonstrate their ability to produce reference materials of consistent and reliable quality. Key components of ISO 17034 include:

• Technical Competence: Ensuring that RMPs have the necessary expertise, equipment, and processes to produce high-quality reference materials.
• Quality Management: Implementing a robust quality management system to maintain the integrity and traceability of reference materials.
• Metrological Traceability: Ensuring that reference materials are traceable to SI units or other internationally accepted standards.

Where Can Organizations Turn to for ISO 17034 Accreditation?

Organizations seeking ISO 17034 accreditation can turn to Accreditation Bodies (ABs) like PJLA. As an internationally recognized accreditation body, PJLA offers comprehensive accreditation services, guiding RMPs through the process to achieve and maintain compliance with ISO 17034. Our experienced assessors and technical experts work closely with RMPs to ensure they meet the stringent requirements of the standard.

When was ISO 17034 Created?

ISO 17034 was first published in 2016 by the International Organization for Standardization (ISO). It replaced ISO Guide 34, which was previously used for the accreditation of reference material producers. The creation of ISO 17034 marked a significant step in standardizing the requirements for RMPs, providing a more robust framework for ensuring the quality and reliability of reference materials.

Why Should RMPs Consider Becoming Accredited?

• Enhanced Credibility: Accreditation demonstrates a commitment to quality and competence, enhancing the RMP’s reputation in the market.
• Market Access: Many industries and regulatory bodies require the use of reference materials from accredited RMPs, opening up new opportunities and markets.
• Customer Confidence: Accreditation provides assurance to customers that the reference materials they purchase are reliable, consistent, and of high quality.
• Continuous Improvement: The accreditation process encourages continuous improvement, helping RMPs to refine their processes and maintain high standards of quality.

ISO 17034 accreditation is a vital component for Reference Material Producers aiming to ensure the quality and reliability of their products. At PJLA, we are committed to supporting RMPs on their journey towards accreditation, providing the expertise and guidance needed to achieve and maintain compliance with ISO 17034. By becoming accredited, RMPs not only enhance their credibility but also contribute to the accuracy and reliability of testing and calibration processes worldwide.

Organizations seeking ISO 17034 Accreditation may apply online through our easy FREE Quote request form.

From July 13 to July 18, 2024, Perry Johnson Laboratory Accreditation, Inc. (PJLA) had the privilege of attending the Asia Pacific Accreditation Cooperation (APAC) Annual Meeting in the vibrant city of Dubai, UAE. This year’s event, hosted by the GCC Accreditation Center (GAC), the Emirates International Accreditation Centre (EIAC), and the Emirates National Accreditation System (ENAS), proved to be an exceptional gathering of global accreditation leaders, fostering collaboration and advancing the quality of conformity assessment services across the region.

APAC’s mission is to manage and expand mutual recognition arrangements (MRAs) among accreditation bodies. These MRAs are crucial for facilitating the acceptance of conformity assessment results, enhancing trade, and ensuring public safety.

As a leading accreditation body, PJLA is dedicated to upholding the highest standards of quality and integrity in conformity assessment. Our participation in the 2024 APAC Annual Meeting underscores our commitment to staying at the forefront of accreditation advancements and contributing to the global accreditation community.

As we return from Dubai, we are invigorated by the collaborative spirit and shared vision of our peers. We remain committed to advancing the field of accreditation and ensuring that our clients receive the highest level of service and support. Thank you to the GCC Accreditation Center, the Emirates International Accreditation Centre, and the Emirates National Accreditation System for hosting such a successful and impactful event.

The Environmental Measurement Symposium (EMS) is a cornerstone event for professionals in the environmental sector, and Perry Johnson Laboratory Accreditation, Inc. (PJLA) is excited to be a part of it. This year, EMS will take place from August 5-9 at the Hyatt Regency Orange County in Garden Grove, California. The symposium combines the National Environmental Measurement Conference (NEMC) and the Forum on Environmental Accreditation, making it a comprehensive gathering for environmental experts.

The 2024 symposium focuses on the importance of reliable data in making informed decisions that impact our environment. As we face increasing environmental challenges, the need for precise and dependable data becomes ever more critical.

PJLA is thrilled to announce that Matthew Sica, one of our esteemed experts, will be presenting a session titled “Leveraging Technology to Improve Laboratory Quality.” This presentation will delve into how modern technological advancements can enhance the quality and efficiency of laboratory operations, ensuring more accurate and reliable data.

EMS 2024 is set to be a pivotal event for anyone involved in environmental measurement and accreditation. We encourage you to join us in Garden Grove to gain valuable insights, explore new technologies, and network with industry leaders.

Register Now: Event Registration

In the sparkle of fireworks, lighting up the night,
Behind every burst, there’s a lab’s guiding light.
Accredited hands ensure safety’s embrace,
Testing each firework, for the thrill in its place.

From barbecues sizzling, where families convene,
To food on our tables, tested pure and clean.
Our labs check the waters, where children will play,
Ensuring each splash is safe every day.

With standards so high, and rigor so true,
They safeguard the joys that July Fourth brings you.
From sparklers to skies, and food that’s delight,
PJLA ensures your celebration is right.

So, as you enjoy, with hearts full of cheer,
Remember our role, quiet but clear.
For in every test, and every review,
PJLA’s promise: to keep safe, all of you.

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In observance of Independence Day, Perry Johnson Laboratory Accreditation, Inc. (PJLA) will be closed on Thursday, July 4th. We will resume normal business hours on Friday, July 5th.

Wishing everyone a safe and joyous Fourth of July celebration!

The Westin Lake Las Vegas Resort & Spa in Las Vegas, Nevada hosted the 2024 Analytical Services Program Workshop from June 25-27, 2024. This event was a significant gathering for industry professionals, and Perry Johnson Laboratory Accreditation, Inc. (PJLA) was proud to be part of it.

Engaging Topics and Expert Discussions

The workshop’s agenda was packed with essential topics and updates, like:

• QSM v6.0 Rollout and Implementation Challenges
• Continuing the Role of the Observer
• Radiochemistry Data Validation
• PFAS Updates

Our very own Matt Sica, PJLA Technical Program Manager, contributed to the event. Matt presented on the “Commonalities between HRMM and Risk-Based Thinking (RBT),” offering valuable insights into how these methodologies intersect and support robust quality management systems.

Panel Discussion on QSM v6.0

Matt also participated in a panel discussion titled “Assessing to QSM v6.0”. The session provided an excellent platform for exploring the practical challenges of implementing the new standards.

Panel Discussion Overview

The panel addressed several pertinent questions:

1. What is your number one challenge?
2. How many Assessors do you have for DOECAP-AP?
3. Are you looking for new assessors? What are their requirements?
4. What issues or concerns do you have regarding the changes in the QSM?
5. Will DOE need to reinstate “Technical Advisors” to assist in future radiological assessments?
6. How would you improve upon the accreditation process?

The panel featured representatives from various Accreditation Bodies (ABs), including ANAB, A2LA, PJLA, and IAS. The discussion was moderated by Alyssa Wingard, DOE – EHSS, Environmental Protection Specialist – Chemist, who guided the conversation through these critical topics, highlighting the collective effort needed to adapt to the new QSM standards.

Looking Forward

We are pleased to announce a complimentary webinar titled “A Summary of Changes of the DoD/DOE ELAP QSM Version 6.0 and PJLA Transition Requirements.” This webinar will be presented by Matthew Sica on Wednesday, July 24, 2024, at 1:00 PM ET. It will offer a comprehensive overview of the recent changes and provide guidance on the transition requirements for PJLA. Register on our website by Clicking Here.

Conclusion

Our participation in the 2024 Analytical Services Program Workshop underscored PJLA’s commitment to staying at the forefront of industry developments and maintaining the highest standards of accreditation. We are excited about the future and look forward to continuing our collaborative efforts to advance quality and compliance in laboratory accreditation.

Stay tuned for more updates and join us for the upcoming webinar to deepen your understanding of QSM v6.0!

On May 31, 2024, the FDA announced that sufficient laboratory capacity has been achieved for mycotoxin testing under the LAAF program. This marks a pivotal step forward in ensuring the accuracy and reliability of food testing for imports, particularly concerning the detection and analysis of mycotoxins.

The LAAF program was established by the FDA to enhance the quality and consistency of food testing through stringent standards and rigorous oversight of accredited laboratories. The program requires owners and consignees of specific foods to use LAAF-accredited laboratories for testing, particularly for activities such as removing a food item from import alert or addressing specific food safety concerns.

However, the implementation of this requirement was contingent upon reaching sufficient laboratory capacity capable of conducting these critical tests. The recent announcement confirms that this capacity has been reached for mycotoxin testing, ensuring that laboratories are well-equipped to meet the demand for accurate and reliable analyses.

Starting December 1, 2024, importers and consignees of foods subject to the LAAF regulation must utilize LAAF-accredited laboratories for mycotoxin testing. This mandate underscores the FDA’s commitment to upholding food safety standards and protecting public health through meticulous and standardized testing procedures.

At PJLA, we are proud to be part of this transformative journey towards enhanced food safety. Our role as an accreditation body is to ensure that laboratories meet the highest standards of accuracy and reliability. We are committed to supporting laboratories through the accreditation process and ensuring they are equipped to meet the demands of the LAAF program.

The FDA’s announcement is a testament to the collaborative efforts of regulatory bodies, accreditation organizations, and laboratories working together to safeguard public health. We anticipate further updates as the LAAF program continues to expand its capacity for other critical food testing scenarios.

We encourage all stakeholders to stay informed and engaged as we collectively advance towards a safer, more reliable food supply chain. PJLA remains dedicated to providing the support and expertise necessary to navigate these regulatory changes and uphold the highest standards of laboratory excellence. Contact us today for more information!

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!

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

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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.

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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.

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