PJLA

Correction vs. Corrective Action is a common topic in quality management, yet many Conformity Assessment Bodies struggle to differentiate between the two. According to George Anastasopoulos, PJLA’s Technical & International Business Development Manager, understanding this distinction is essential for compliance with the ISO 17000 series.

A Correction is an immediate fix that addresses a detected issue. It solves the problem temporarily but does not prevent it from happening again. For example, if a machine produces defective parts, reworking or scrapping them is a correction. If an employee makes an error in a document, fixing the mistake without identifying why it happened is also a correction.

Corrective Action, however, eliminates the root cause of the problem. It prevents future occurrences and supports long-term quality improvement. For instance, if defective parts result from incorrect calibration, a corrective action would involve updating maintenance procedures. If employees frequently make data entry mistakes, corrective action could include training or process automation.

ISO 17000 standards require corrective actions to resolve nonconformities. Organizations that rely only on corrections risk repeating the same issues, leading to inefficiencies. By prioritizing corrective actions, Conformity Assessment Bodies foster continuous improvement, maintain compliance, and enhance operational reliability.

Incorporating both corrections and corrective actions strengthens quality management systems. While corrections provide quick fixes, corrective actions ensure lasting solutions. Understanding this distinction helps organizations maintain compliance, improve efficiency, and drive long-term success.

Read George Anastasopoulos’ full insights on LinkedIn.

At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we understand that quality is no accident. As George Anastasopoulos, our Technical & International Business Development Manager, recently shared: “Quality is a result of intelligent effort!” This statement perfectly encapsulates our commitment to helping organizations achieve and maintain the highest standards through intentional and systematic processes.

Achieving and sustaining quality involves much more than simply meeting baseline requirements. It requires deliberate planning, systematic execution, and a continuous focus on improvement. At PJLA, we work closely with organizations to implement and uphold robust quality management systems that are designed to prevent errors, improve operational efficiency, and consistently meet customer expectations.

Intelligent effort goes beyond correcting mistakes after they occur. It emphasizes the importance of identifying inefficiencies, eliminating waste, and refining workflows. By focusing on prevention rather than reaction, organizations can reduce costs while enhancing the reliability of their processes and results.

Our accreditation process is built on this philosophy. We guide businesses through identifying potential risks, establishing preventive measures, and continuously improving their systems. This proactive approach not only ensures compliance with ISO/IEC 17025 and other relevant standards but also fosters a culture of quality that drives long-term success.

Quality improvement is not a solo endeavor. It requires the involvement of skilled personnel and dedicated management. Training, experience, and a commitment to continuous learning are crucial in maintaining and enhancing quality standards. At PJLA, we recognize the value of empowering teams with the knowledge and tools needed to uphold excellence.

Through our free workshops, webinars, and accreditation services, we help organizations instill a mindset of continuous improvement. This includes fostering open communication, encouraging feedback loops, and supporting innovation to drive better outcomes.

As George emphasized in his post, “Quality isn’t just about working harder—it’s about working smarter.” This mindset aligns perfectly with our mission at PJLA. By focusing on intelligent effort, organizations can achieve superior quality outcomes while optimizing resources and processes.

We encourage organizations to reflect on their approach to quality. Are you embracing a proactive, intelligent effort to drive improvement? Or do you face challenges in making quality a true priority? PJLA is here to support you however you need. Contact us today to learn how our expertise can help you achieve and sustain the highest standards in accreditation.

We are excited to announce our upcoming in-person training event: “PJLA Accreditation, Enhancing Laboratories Competitiveness.” This exclusive training will be presented by George Anastasopoulos, PJLA’s Technical and International Business Development Manager.

Event Details:

• Course Title: PJLA Accreditation: Enhancing Laboratories Competitiveness
• Presenter: George Anastasopoulos, Technical and International Business Development Manager
• Date: Thursday, April 24, 2025
• Time: 14:00 – 18:00 Hrs
• Location: Holiday Inn Mumbai International Airport, Sakinaka Junction, Andheri Kurla Road, Andheri East, Mumbai, India, 400072
• Cost: Free!

This in-depth training is designed to provide valuable insights into PJLA accreditation and its importance for laboratories, inspection bodies, and certification organizations. Whether you are new to the accreditation process or seeking to enhance your existing knowledge, this course is tailored to meet your needs.

What You Will Learn:

• The significance of PJLA accreditation and how it enhances laboratory competitiveness
• Key steps and requirements of the accreditation process
• Benefits of PJLA accreditation for testing and calibration laboratories, inspection bodies, and certification organizations
• Ensuring compliance with international standards (ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17065, and more)

Bonus: All attendees will receive a certificate of completion at the end of the course!

Don’t miss this opportunity to gain expert insights and practical knowledge from a leader in the field. Space is limited, so secure your spot today!

For more information and to register, visit our website.

The medical device industry operates in a highly regulated environment where compliance with safety and performance standards is critical. To streamline the testing and approval process, the U.S. Food and Drug Administration (FDA) established the Accreditation Scheme for Conformity Assessment (ASCA) Program. This voluntary initiative aims to enhance the efficiency of regulatory submissions for medical devices by leveraging accredited testing laboratories. Perry Johnson Laboratory Accreditation, Inc. (PJLA) is proud to be an FDA-recognized Accreditation Body that plays a vital role in supporting this program.

What is the ASCA FDA Program?

The ASCA FDA Program is designed to ensure that medical device testing follows FDA-recognized consensus standards. By working with accredited laboratories, device manufacturers can improve the consistency of testing, minimize regulatory delays, and facilitate a smoother premarket review process.

Scope of the ASCA Program

The ASCA program primarily covers two critical areas of medical device testing:

• Biocompatibility Testing – Ensures that materials used in medical devices are safe for patient contact.
• Electrical Safety Testing – Evaluates the safety of electrical medical devices to prevent hazards such as electric shocks or malfunctions.

Key Aspects of the ASCA Program

• Accredited Laboratories: Only laboratories accredited by FDA-recognized Accreditation Bodies, such as PJLA, are eligible to conduct ASCA testing.
• Standardized Testing: Ensures consistency in test results by adhering to FDA-recognized consensus standards.
• Faster Regulatory Review: Device manufacturers using ASCA-accredited laboratories benefit from a more efficient FDA submission process, reducing the need for redundant testing or additional evaluations.

Benefits of ASCA Accreditation

• Reduces the Burden on Manufacturers: By using ASCA-accredited test results, manufacturers can avoid re-evaluation of test data, saving time and resources.
• Enhances Confidence in Test Results: FDA recognition of ASCA accreditation reinforces the reliability and credibility of testing laboratories.
• Speeds Up Market Access: A more predictable and streamlined regulatory process allows manufacturers to bring medical devices to market faster.

PJLA: A Recognized Accreditation Body for ASCA

PJLA is one of the FDA-recognized Accreditation Bodies responsible for evaluating and accrediting laboratories under the ASCA Program. We ensure that testing laboratories comply with the stringent requirements of ISO/IEC 17025, which outlines the general requirements for the competence of testing and calibration laboratories.

How to Obtain ASCA Accreditation with PJLA

Testing laboratories interested in ASCA accreditation must undergo an assessment process to demonstrate compliance with FDA-recognized standards. The accreditation process with PJLA involves the following steps:

1. Application Submission – A laboratory applies to PJLA for ASCA accreditation.
2. Evaluation Process – PJLA assesses the lab’s compliance with ISO/IEC 17025 and ASCA-specific requirements.
3. Accreditation Approval – Upon successful evaluation, the lab receives ASCA accreditation and is recognized as an authorized testing facility.
4. Conducting ASCA Testing – Accredited laboratories can then perform ASCA testing under FDA-recognized standards, helping manufacturers streamline their regulatory submissions.

FDA Oversight and Compliance

The FDA maintains an active role in overseeing the ASCA program. It maintains a list of ASCA-recognized Accreditation Bodies and Testing Laboratories, conducting periodic assessments to ensure continued compliance with program requirements. This oversight reinforces the credibility of ASCA testing and ensures that accredited laboratories maintain high-quality testing standards.

Why Choose PJLA for ASCA Accreditation?

PJLA brings years of expertise in laboratory accreditation, offering a streamlined and efficient process for laboratories seeking ASCA recognition. Our dedicated team of assessors ensures that labs meet the highest standards of quality and compliance, ultimately supporting medical device manufacturers in their journey toward FDA approval.

For more information on how PJLA can assist with ASCA accreditation, contact us today and take the next step toward achieving regulatory excellence.

Operating a successful testing laboratory requires a blend of technical expertise, operational efficiency, and strong business acumen. Many laboratories adhere to ISO/IEC 17025, the globally recognized standard that ensures competence and reliability in testing operations. However, the technical language of ISO/IEC 17025 can be overwhelming for many professionals.

With years of experience in the conformity assessment market, PJLA’s Technical and International Business Development Manager, George Anastasopoulos, recently simplified the key elements necessary for running a successful testing laboratory. Here’s a structured approach to help labs maintain compliance, efficiency, and credibility.

1. Implement a Robust Quality Management System (QMS)

A well-functioning QMS is the backbone of any laboratory. To ensure quality and compliance:
• Implement ISO/IEC 17025 standards.
• Conduct regular internal audits.
• Develop and enforce documented procedures for all testing processes.

2. Hire and Train Competent Personnel

Your team is the foundation of a successful laboratory. Ensure that you:
• Hire qualified scientists, technicians, and analysts.
• Provide ongoing training on new technologies and regulatory updates.
• Foster a culture of accuracy, accountability, and professional growth.

3. Maintain Reliable Equipment & Calibration

State-of-the-art equipment ensures accurate test results. Best practices include:
• Investing in high-quality instruments and maintaining them properly.
• Regularly calibrating and verifying equipment.
• Establishing preventive maintenance schedules to prevent unexpected failures.

4. Strengthen Sample Management Systems

Proper handling of samples ensures the validity of test results. Labs should:
• Implement a Laboratory Information Management System (LIMS) for efficient tracking.
• Use proper storage and handling techniques to prevent contamination.
• Maintain chain-of-custody procedures for regulatory and legal compliance.

5. Enforce Strict Quality Control (QC) & Quality Assurance (QA)

Quality control is critical for maintaining credibility. Laboratories should:
• Use standard reference materials and participate in proficiency testing.
• Establish control charts and set acceptance criteria for test results.
• Implement corrective and preventive actions (CAPA) for non-conformities.
• Engage in external proficiency testing and interlaboratory comparison programs.

6. Enhance Workflow Efficiency & Productivity

Operational efficiency helps laboratories stay competitive. To improve workflow:
• Optimize lab layout for smooth movement and sample processing.
• Reduce turnaround time by streamlining processes.
• Introduce automation such as robotic sample handling and AI-driven analysis where possible.

7. Ensure Data Integrity & Cybersecurity

Data security and integrity are essential in modern laboratories. Best practices include:
• Maintaining accurate and traceable records.
• Using secure LIMS and implementing backup systems to prevent data loss.
• Establishing strict access control for sensitive information.

8. Prioritize Customer Focus & Communication

Customer satisfaction drives business success. To enhance client relations:
• Provide clear, timely, and detailed test reports.
• Offer excellent customer service and technical support.
• Gather and incorporate client feedback to improve service quality.

9. Manage Finances & Business Growth Effectively

A well-run business balances cost control with service expansion. Labs should:
• Keep operational costs in check without compromising quality.
• Diversify service offerings to attract a broader client base.
• Implement marketing strategies to boost the lab’s reputation and reach.

10. Maintain Regulatory Compliance & Accreditation

Regulatory compliance ensures credibility and market access. To stay compliant:
• Keep up with industry requirements, standards, and regulatory updates.
• Gain recognition from relevant authorities such as the FDA, EPA, or FCC.
• Obtain and maintain ISO/IEC 17025 accreditation from reputable accreditation bodies, such as PJLA.

Running a successful testing laboratory is a multifaceted endeavor requiring technical precision, strategic planning, and continuous improvement. By implementing these best practices, laboratories can ensure compliance, build trust, and maintain a competitive edge in the industry.

By: George Anastasopoulos, Technical & International Business Development Manager, PJLA

In addition to technical competence and professional approach, at the heart of PJLA’s operations lies a staunch commitment to ethics. This commitment ensures impartiality, integrity, and transparency in all PJLA’s activities. Our approach is rooted in principles such as accountability, objectivity, and adherence to international norms, fostering confidence among stakeholders.
PJLA’s principles of operation can be summarized as below:

Impartiality: PJLA operates free from any commercial, financial, or other pressures that could compromise the accreditation process. Our decisions are based solely on objective evidence, ensuring fairness to all CABs.

Integrity: Ethical conduct is paramount for PJLA. This includes avoiding conflicts of interest, maintaining confidentiality, and upholding honesty in all interactions. Our Assessors and our staff are trained to act with the highest standards to foster trust and credibility in the accreditation process.

Transparency: Clear, open communication about criteria, processes, and decisions is essential for PJLA. Stakeholders are provided with accessible information about accreditation standards, ensuring that the process is clear, understandable and subject to scrutiny.

Confidentiality: Sensitive information of accredited bodies is protected with strict confidentiality PJLA policies.

Competence: PJLA’s accreditation decisions are based on rigorous, evidence-based assessments conducted by qualified professionals, that remain updated to the latest technological and standardization developments.

Accountability: PJLA upholds responsibility for its actions and continuously improves its practices to maintain its credibility, safeguarding not only its own brand but also the integrity of the global conformity assessment industry.

Continuous Improvement: PJLA not only adheres to current standards but also actively seeks to improve its practices. This includes regular internal audits and stakeholder feedback analysis, to achieve continuous improvement and to maintain adherence to international norms like ISO/IEC 17011.

By embedding these principles into its core operations, PJLA not only enhances the value of its accreditation but also contributes to the broader goal of improving quality, safety, and trust in products and services worldwide.

In today’s dynamic marketplace, ensuring consumer confidence and product credibility is more critical than ever. Businesses worldwide are under pressure to demonstrate their commitment to delivering safe, reliable, and high-quality products and services. For those in the certification industry, ISO/IEC 17065 is a vital standard—a globally recognized benchmark for organizations that certify products, processes, and services.

At PJLA, we are proud to support certification bodies seeking to achieve or maintain ISO/IEC 17065 accreditation. Our program is designed to help organizations meet this rigorous standard and thrive in an increasingly competitive market.

What Is ISO/IEC 17065?

ISO/IEC 17065, formally titled “Conformity Assessment—Requirements for Bodies Certifying Products, Processes, and Services,” sets out the criteria certification bodies must meet to operate competently and consistently. Published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), this standard ensures that certification bodies operate impartially and follow reliable, transparent procedures.

Accreditation to ISO/IEC 17065 is crucial for organizations that want to:

• Demonstrate credibility and integrity in their certification activities.
• Enhance trust in their certifications among clients and stakeholders.
• Operate in accordance with globally recognized best practices.

Key Benefits of ISO/IEC 17065 Accreditation

Achieving ISO/IEC 17065 accreditation delivers numerous advantages for certification bodies and the clients they serve:

1. Enhanced Reputation: Accreditation signals to the marketplace that your certification processes meet internationally accepted criteria for impartiality, competence, and consistency.
2. Global Recognition: Certification bodies accredited to ISO/IEC 17065 are often more competitive in international markets, as this accreditation is widely respected across borders.
3. Client Confidence: Businesses and consumers are more likely to trust certifications issued by an accredited body, enhancing your organization’s credibility.
4. Regulatory Compliance: Many industries and governments require ISO/IEC 17065-accredited certification bodies to ensure compliance with regulations and standards.
5. Operational Improvement: The accreditation process helps certification bodies refine their procedures, ensuring ongoing efficiency and effectiveness.

Who Needs ISO/IEC 17065 Accreditation?

ISO/IEC 17065 accreditation is essential for certification bodies that certify:

• Products (e.g., electrical appliances, food items, medical devices, etc.)
• Processes (e.g., manufacturing processes, environmental management practices, etc.)
• Services (e.g., professional services, utility services, etc.)

Whether you operate in agriculture, energy, construction, or any other sector, ISO/IEC 17065 accreditation can set you apart from competitors and reinforce your position as a trusted choice.

How PJLA Can Help

At PJLA, we understand the challenges certification bodies face in meeting the rigorous requirements of ISO/IEC 17065. Our expert team offers comprehensive accreditation services to guide you through every step of the process. From initial assessments to surveillance and re-accreditation, we’re here to ensure you achieve and maintain compliance with confidence.

ISO/IEC 17065 accreditation is more than a certification—it’s a commitment to excellence, integrity, and continuous improvement. By achieving this prestigious accreditation, you not only strengthen your organization’s credibility but also contribute to the trust and safety of the industries you serve.

Ready to begin your ISO/IEC 17065 accreditation journey? Visit our program page here to learn more about how PJLA can support your goals. Let us help you achieve the highest standard of certification excellence!

When companies consider pursuing accreditation, cost is often one of the first concerns. While the financial commitment is an important factor, it’s crucial to shift the perspective from “cost” to “value.” At Perry Johnson Laboratory Accreditation, Inc. (PJLA), we’ve seen how accreditation not only elevates performance but also secures its long-term success.

Accreditation by a globally recognized body like PJLA demonstrates that your company meets the highest standards of quality and technical competence. This credibility reassures your clients, stakeholders, and regulatory bodies that your results are reliable and accurate—a reputation that money simply can’t buy.

In today’s competitive marketplace, accreditation is often the differentiator that sets your organization apart. Many industries require or prefer working with accredited organizations, giving your business a significant edge over non-accredited competitors. It opens doors to new clients, larger contracts, and international opportunities.

Moreover, accreditation isn’t just about compliance—it’s about improvement. The entire process encourages companies to optimize their procedures, eliminate inefficiencies, and standardize operations. This can lead to cost savings, improved turnaround times, and better resource allocation in the long run.

In the long term, clients who trust the quality and accuracy of your results are more likely to remain loyal. Accreditation provides the assurance they need, fostering long-term partnerships and opportunities for growth. Accreditation fosters a culture of quality and continuous improvement, which benefits your team as much as your clients. Employees take pride in working for a company that upholds world-class standards, contributing to higher morale and retention rates.

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Addressing the Cost Concern

While accreditation does require an upfront investment, it’s important to view it as a strategic decision rather than a simple expense. The cost of not being accredited—missed opportunities, inefficiencies, and potential compliance failures—can far outweigh the investment in accreditation.

• Engage the Right Partner: Work with an experienced accrediting body like PJLA, which provides comprehensive support and guidance throughout the process.
• Focus on Continuous Improvement: View accreditation as an ongoing journey, using it as a foundation for future enhancements.
• Leverage Accreditation in Marketing: Highlight your accredited status in promotional materials to attract clients and build trust.

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At PJLA, we believe that accreditation is a pathway to long-term success. By investing in accreditation, you’re not just meeting industry standards; you’re raising the bar for quality, efficiency, and trust in your company.

Are you ready to make the leap? Let PJLA guide you through the process and help your organization unlock its full potential. Request a free, no-obligation quote by submitting our easy online form or calling us at 877-369-5227.

Laboratory assessors play a pivotal role in ensuring organizations meet the highest standards of quality and compliance. At Perry Johnson Laboratory Accreditation, Inc. (PJLA), our assessors are the backbone of our commitment to excellence, guiding laboratories through the accreditation process with precision and expertise. But what exactly makes an assessor? Here, we highlight the top skills and qualities that contribute to effective accreditation assessments.

1. Technical Expertise: Assessors must have a strong technical background in their respective fields. Whether it’s calibration, testing, inspection, etc., assessors need to be well-versed in industry-specific standards and methodologies. This expertise enables them to evaluate processes and equipment with a keen eye for detail.
2. In-Depth Knowledge of ISO/IEC Standards: A deep understanding of standards such as ISO/IEC 17025, ISO/IEC 17020, and ISO/IEC 17043 is essential. Assessors must not only understand the requirements but also interpret and apply them in real-world settings. Staying updated on revisions and changes to these standards is also a critical part of the role.
3. Analytical Thinking: Effective assessors are natural problem solvers. They must be able to analyze complex systems, identify potential issues, and offer constructive feedback. This requires critical thinking and the ability to assess both technical and organizational aspects of an organization’s operations.
4. Attention to Detail: Accreditation assessments require meticulous attention to detail. Assessors must carefully review documentation, observe procedures, and evaluate compliance with standards. Even minor oversights can have significant consequences, making this skill indispensable.
5. Strong Communication Skills: From conducting interviews to preparing assessment reports, clear and effective communication is key. Assessors must convey their findings in a way that is both professional and constructive, ensuring laboratories understand what is needed to achieve and maintain accreditation.
6. Interpersonal Skills: Building rapport with staff is an important part of the job. Assessors must be approachable and professional, fostering a collaborative environment that encourages open dialogue and continuous improvement.
7. Time Management: Assessments often involve tight schedules and multiple tasks. Assessors must prioritize effectively, ensuring all aspects of the evaluation are completed within the allotted time while maintaining a high standard of quality.
8. Adaptability: Every client is unique, and no two assessments are the same. Assessors must be adaptable, capable of navigating different environments, processes, and challenges with ease.
9. Commitment to Continuous Learning: The world of laboratory accreditation is constantly evolving. Assessors need to stay informed about industry advancements, new technologies, and changes to accreditation standards. A commitment to professional development is crucial for long-term success.
10. Ethical Integrity: Above all, assessors must uphold the highest standards of integrity and impartiality. They are entrusted with the responsibility of ensuring companies meet critical quality benchmarks, which requires unwavering honesty and professionalism.

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Ready to Make a Difference?

Do you have what it takes to be an exceptional assessor? Want to join a network of professionals dedicated to providing the best accreditation experience possible? Perry Johnson Laboratory Accreditation, Inc. (PJLA) is always looking for skilled individuals to join our team.

Apply today and become part of a global leader in laboratory accreditation!
Visit our website to learn more.

Perry Johnson Laboratory Accreditation, Inc. (PJLA) is excited to announce its comprehensive schedule of free virtual training workshops for 2025, now open for registration. These workshops are designed to support laboratory professionals, quality assurance personnel, and technical staff in achieving excellence through ISO/IEC 17025 compliance and best practices.

The workshops, led by PJLA’s Technical Program Manager, Matthew Sica, will provide practical, discussion-based learning experiences covering a range of critical topics, from calibration and method validation to data integrity and quality control. Each session is tailored to equip participants with actionable insights that can immediately enhance laboratory performance and compliance.

Highlights of the 2025 Educational Series:

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1. Determining Calibration Intervals for Laboratory Equipment – REGISTER NOW!
Date: Tuesday, January 21, 2025 | Time: 1:00 PM EST
Description: Learn to set optimal calibration intervals to ensure accuracy, reliability, and compliance with ISO/IEC 17025 standards.

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2. Quality Control and Monitoring for Consistent Laboratory Performance (Clause 7.7) – REGISTER NOW!
Date: Tuesday, March 18, 2025 | Time: 1:00 PM EDT
Description: Explore QC tools and techniques to sustain high-quality results and improve processes.

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3. Method Validation and Verification for Reliable Results (Clauses 7.2.1.1 to 7.2.2) – REGISTER NOW!
Date: Tuesday, April 15, 2025 | Time: 1:00 PM EDT
Description: Master the essentials of validating and verifying laboratory methods for accuracy and reliability.

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4. Managing Proficiency Testing for Continual Improvement (Clause 7.7) – REGISTER NOW!
Date: Tuesday, June 24, 2025 | Time: 1:00 PM EDT
Description: Discover how to leverage proficiency testing outcomes to drive ongoing laboratory improvements.

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5. Data Integrity and Records Management in Laboratory Practice (Clause 7.11) – REGISTER NOW!
Date: Tuesday, July 15, 2025 | Time: 1:00 PM EDT
Description: Gain strategies to safeguard data integrity and maintain robust records in compliance with ISO/IEC 17025.

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Each workshop offers a blend of expert-led discussions, real-world examples, and interactive engagement, empowering participants to confidently implement best practices in their laboratories.

“At PJLA, we are committed to advancing the knowledge and capabilities of the laboratory community,” said Matthew Sica, Technical Program Manager. “Our free training workshops are designed to deliver practical, hands-on insights that help laboratories enhance their processes, ensure compliance, and achieve sustained success.”

Don’t Miss Out!

Seats are limited, so register early to secure your spot. Whether you are a seasoned professional or new to laboratory operations, these workshops provide a unique opportunity to stay ahead in the evolving field of laboratory accreditation and quality management.

For additional details, visit PJLA’s Training Page or contact us at [email protected].