By Dr. George Anastasopoulos

Read the full article: https://www.linkedin.com/pulse/accredited-adaptive-unlocking-power-flexible-scope-anastasopoulos-w1xmc/

In today’s fast-paced testing, inspection, and certification industries, agility is essential. Dr. George Anastasopoulos of Perry Johnson Laboratory Accreditation, Inc. (PJLA) offers an insightful and practical guide to Flexible Scopes of Accreditation — game-changing approach that allows accredited organizations to quickly adapt their services without waiting for lengthy reassessments.

This comprehensive article explores:

• What a flexible scope is and how it differs from a fixed scope
• How it empowers Conformity Assessment Bodies (CABs) to act swiftly within validated boundaries
• CAB responsibilities, including internal controls, validation, and risk management
• Examples across ISO/IEC 17025, ISO 15189, ISO/IEC 17020, 17024, and 17065 contexts
• The role of Flex Codes (F0–F5) in defining permissible flexibility
• Accreditation Body (AB) assessment priorities and common risks

Key Takeaway:

Flexible scopes are not about loosening standards—they’re about enabling qualified organizations to move faster without sacrificing integrity. Properly implemented, they boost responsiveness, foster innovation, and uphold trust in accreditation.

For questions or deeper insights, contact Dr. Anastasopoulos at: [email protected]

We are proud to share that Dr. George Anastasopoulos is in the June 2025 edition of Quality Magazine. He is the Technical and International Business Development Manager at Perry Johnson Laboratory Accreditation, Inc. (PJLA). He titled his article “The Modified FINK Risk Analyzing Method for Conformity Assessment Bodies.” Dr. Anastasopoulos is a well-known leader in conformity assessment. He has decades of experience in laboratory accreditation, risk assessing, and quality management. His article presents a new way to evaluate risk for Conformity Assessment Bodies (CABs). It builds on the FINK model and changes it to fit the needs of accredited organizations better.

About the Article

In “The Modified FINK Risk Analyzing Method for Conformity Assessment Bodies,” Dr. Anastasopoulos shares a useful method. This method helps CABs find, study, and handle operational risks. The modified model emphasizes:

• Improved objectivity in risk identification
• Alignment with ISO/IEC standards for accreditation bodies
• Custom applicability for organizations seeking continual improvement
• Integration with existing quality management systems

The article explains the theory behind the method. It also gives real case examples to show how to use it and its benefits. This makes it a valuable read for quality professionals, auditors, and decision-makers in testing, inspection, and certification sectors.

Why It Matters

Risk-based thinking is a key part of modern quality management systems. Organizations that want or need ISO/IEC 17025 and similar accreditations are extremely important. Dr. Anastasopoulos’s new method gives CABs a strong way to manage risks. This improves both compliance and credibility.

A Legacy of Expertise

Dr. Anastasopoulos has been instrumental in expanding PJLA’s global reach and strengthening its technical foundations. His thought leadership continues to shape best practices in laboratory accreditation and quality assurance worldwide.

We invite professionals in quality and conformity assessment to read the full article on Quality Magazine’s website. Read the article here.

About Perry Johnson Laboratory Accreditation, Inc.

PJLA is a global leader in accreditation services, offering ISO/IEC 17025, 17020, 17065, and other internationally recognized standards. With a commitment to excellence, integrity, and continual improvement, PJLA supports laboratories and organizations across industries in achieving globally recognized conformity.

PJLA Joins the Global Celebration

World Accreditation Day (WAD), an annual global initiative led by ILAC and IAF, returns on June 9, 2025, to spotlight the essential role of accreditation in supporting quality, safety, and global market access. This year’s theme centers on “Accreditation: Empowering Small and Medium-Sized Enterprises (SMEs)”, acknowledging the vital contributions these businesses make to innovation, employment, and local economies.

Despite their importance, SMEs often encounter significant hurdles, such as limited resources and tough market competition. Accreditation can play a transformative role in helping them overcome these challenges. Through accredited conformity assessment, SMEs can demonstrate compliance with recognized standards, boost their reputation, access new markets, and gain the confidence of customers, regulators, and investors alike.

For SMEs aiming to enhance product quality, streamline operations, or qualify for funding and incentives, accreditation provides a reliable foundation for growth. By partnering with accredited conformity assessment bodies, these businesses signal their commitment to excellence and reduce perceived risk for stakeholders.

Internationally, the IAF Multilateral Recognition Arrangement (MLA) and ILAC Mutual Recognition Arrangement (MRA) enable accredited results to be accepted across borders—eliminating duplicate testing and inspections, and promoting seamless global trade.

As part of this celebration, ILAC and IAF will host a virtual event on June 9, with more details to be shared on social media (@ILAC_Official on X and ILAC on LinkedIn).

Perry Johnson Laboratory Accreditation, Inc. (PJLA) is proud to join in the celebration of World Accreditation Day 2025, reaffirming our commitment to advancing the benefits of accreditation for SMEs and organizations of all sizes. Together, we continue to promote trust, quality, and global cooperation.

Learn more and join the celebration: World Accreditation Day 2025 Event Info

Perry Johnson Laboratory Accreditation, Inc. (PJLA) would like to extend a heartfelt thank you to everyone who stopped by our booth at the World Conference on Quality & Improvement (WCQI), held May 4–7, 2025, in Denver, CO. It was a pleasure connecting with so many professionals across the quality industry and engaging in insightful conversations about laboratory accreditation and quality assurance.

As one of the leading events in the quality field, WCQI is a premier global forum that brings together experts dedicated to advancing quality management, continuous improvement, and organizational excellence. This dynamic conference fosters collaboration, innovation, and the exchange of best practices—empowering attendees to make impactful changes within their organizations and beyond. You can learn more about WCQI HERE.

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“It was great to meet our colleagues in the quality industry and attend several invaluable training sessions.”

– Tracy Szerszen, PJLA President

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Whether you’re just learning about accreditation or looking to take the next step with PJLA, we’re here to help. If you’d like to continue the conversation or learn more about Our Services, please don’t hesitate to reach out.

Phone: (248) 519-2603
Email: [email protected]

We look forward to staying connected and working together to elevate quality across the industry. Thank you again for being part of an incredible event!

PJLA Hosts Free Assessor Training in Mumbai, India

Perry Johnson Laboratory Accreditation, Inc. (PJLA) recently held a free assessor training in Mumbai, India. The two-day session took place April 21–22, 2025, at the Holiday Inn Mumbai International Airport.

Participants joined from four different countries and ten regions across India. The diverse group created a collaborative and engaging learning environment. The training was specially designed to provide in-depth knowledge and hands-on experience necessary for PJLA assessors in the conformity assessment industry.

This two-day session provided more than just technical knowledge. It also offered networking opportunities with experienced professionals and PJLA leadership. Commitment to quality and competence was on full display during the event, leaving attendees with the tools and confidence required to pursue assessor qualification with PJLA.

Stay tuned for more international training events from PJLA! Our mission is to support assessors globally with access to world-class learning experiences.

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Want more information on career opportunities at Perry Johnson Laboratory Accreditation, Inc. (PJLA)? Submit your information on our website and someone will be in touch!

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COMING SOON!

In a recent LinkedIn post, George Anastasopoulos, Technical & International Business Development Manager at PJLA, highlighted why ISO/IEC 17024 accreditation is a strategic move for organizations certifying individuals. Whether you’re a Certification Body, Professional Association, Training Organization, or Government/Regulatory entity, accreditation through PJLA can significantly enhance the credibility, consistency, and global recognition of your certification programs.

What is ISO/IEC 17024?

ISO/IEC 17024 is the international standard that outlines requirements for organizations that certify individuals against specific requirements. Accreditation to this standard demonstrates that your certification body operates with competence, impartiality, and consistency.

Who Should Consider Accreditation?

PJLA’s ISO/IEC 17024 accreditation is ideal for:

• Certification Bodies certifying individuals across industries.
• Professional Associations offering certification programs to members.
• Training Organizations with independent certification programs.
• Government and Public Sector bodies overseeing or operating certification schemes.
• Cybersecurity and IT certifiers providing credentials recognized in the tech sector.

Why Choose PJLA for Your ISO/IEC 17024 Accreditation?

✅ International Recognition
Accreditation by PJLA ensures your certification processes align with globally recognized standards, adding international credibility to your programs.

✅ Confidence and Trust
Your stakeholders—including employers, regulators, and the public—will have greater trust in your certification process, knowing it’s backed by a recognized accreditor.

✅ Improved Quality and Consistency
ISO/IEC 17024 outlines requirements for fairness, consistency, and validity in certification. PJLA’s assessment ensures your processes are high quality and impartial.

✅ A Competitive Edge
Stand out from non-accredited competitors. Accreditation can unlock access to new markets and contracts where recognized credentials are a prerequisite.

✅ Regulatory Compliance
In many sectors, accredited certification is not just preferred—it’s required. PJLA helps ensure your programs meet those legal and regulatory expectations.

✅ Enhanced Internal Processes
The accreditation journey strengthens internal controls, improves risk management, and streamlines certification program operations.

✅ Stakeholder Assurance
Being PJLA-accredited demonstrates to employers, industry bodies, and government entities that the individuals you certify meet well-established competence standards.

Take the Next Step

Accreditation to ISO/IEC 17024 is more than a credential—it’s a commitment to excellence and integrity in certification. Don’t wait to raise the bar.

Contact PJLA at [email protected] to learn more about how PJLA can support your journey toward ISO/IEC 17024 accreditation.

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.