CE Marking is one of the most recognized symbols in global trade. Yet few manufacturers and conformity assessment bodies understand the legal framework behind it. Based on insights from a recent webinar by Perry Johnson Laboratory Accreditation (PJLA), this article breaks down the EU notification process, explains why accreditation alone is not enough, and outlines how products legally gain access to the European market.

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The Compliance System Most Companies Never See

When a product carries the CE Mark, many assume it simply means it passed a test. That mark represents:

• European legislation
• Government oversight
• Technical conformity assessment
• Legal authorization
• Continuous market surveillance

In PJLA’s recent webinar, George Anastasopoulos explained how the system truly functions.

“This presentation explains the real mechanism behind EU notification and conformity assessment; not just the symbol you see on the product.”

Without proper notification, no laboratory or certification body can legally approve CE-marked products, even if fully accredited.

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Why EU Notification Is the Gateway to the European Market

The European Union is one of the world’s largest regulated markets, importing products from North America, Asia, and beyond.

Understanding notification provides both regulatory compliance and business advantage.

Benefits of EU Notification

Advantage	Business Impact
Legal authority	Certify CE-marked products
Market access	Sell across 30+ EU countries
Reduced risk	Avoid regulatory violations
Faster approvals	Streamlined conformity
Increased trust	Government-recognized competence

As George emphasized:

“Notification is the passport that opens the commercial door of the European Union.”

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Accreditation vs Notification: The Most Common Compliance Mistake

Many organizations mistakenly believe accreditation equals legal approval.

Accreditation Provides:

• Technical competence
• ISO standard compliance

Notification Provides:

• Legal authority to issue CE-related conformity assessments
• Recognition by EU regulators
• Listing in the official NANDO database

“Accreditation is required, but it does not mean notification. Without notification, CE-related activities have no legal standing.”

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What CE Marking Really Means

CE Marking is not a quality seal or voluntary label.

It is a legal declaration that a product complies with European safety, health, and environmental regulations.

CE Marking Confirms

Area	Purpose
Consumer safety	Prevents hazardous products
Harmonized rules	Same standards across Europe
Legal accountability	Manufacturer responsibility
Market freedom	EU-wide product movement

George explained:

“CE Marking is not a certification level; it is a legal commitment that a product complies with EU requirements.”

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When Notified Bodies Are Required

While a few low-risk products allow self-declaration, most regulated products must be assessed by a notified body.

Common Product Categories Requiring Third-Party Assessment

Industry	Examples
Medical devices	Surgical tools, diagnostics
Machinery	Industrial equipment
Electrical products	Chargers, radios
Consumer products	Toys, electronics
Emerging technologies	AI & cybersecurity
Environmental	Packaging & waste

Many products fall under multiple EU regulations, increasing the need for careful classification.

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Who Issues EU Notification?

EU notification is granted by national authorities within EU Member States, not by accreditation bodies.

The Three-Level Structure

Level	Role
Accreditation bodies	Technical evaluations
National authorities	Legal designation
European Commission	Central registry

Once notified in one EU country, recognition applies across all EU Member States.

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Europe’s Unique Accreditation Framework

Under EU Regulation 765/2008:

• Each country has one national accreditation body
• No competition between states
• Government-backed authority

These bodies support notification technically but do not grant legal approval.

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Can Non-EU Organizations Become Notified?

Yes, through Mutual Recognition Agreements (MRAs).

Countries with EU MRAs

Eligible Countries:

United States, Canada, Australia, Japan, New Zealand, Switzerland, Turkey

Organizations outside these countries must establish an EU-based entity to pursue notification.

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CE Compliance Does not End at Certification

European market surveillance authorities routinely:

• Inspect products in stores
• Perform independent testing
• Review technical documentation
• Enforce recalls and penalties

“You cannot certify one compliant product and later downgrade quality; surveillance systems will catch it.”

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The Most Common Regulatory Errors

Mistake	Result
Confusing accreditation with notification	Illegal approvals
Wrong directive selection	Delays and redesign
Missing multiple regulations	Non-compliance
Outdated standards	Invalid certification
Poor documentation	Rejection
Ignoring surveillance	Fines & bans

George warned:

“Approval in one non-EU country does not transfer to Europe, and compliance must be continuous.”

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Why Understanding EU Notification Matters Today

With expanding EU regulations in:

• Medical technology
• Artificial intelligence
• Cybersecurity
• Environmental compliance

Conformity is becoming more complex, and more strictly enforced.

Organizations that understand notification early:

• Enter markets faster
• Avoid costly redesigns
• Protect legal standing
• Strengthen credibility

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Watch the Full Webinar

Explore the complete explanation of EU notification and CE Marking here: https://youtu.be/uz4qX0plB7k?si=uXvSS7KRH2Jpord3

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About PJLA

Perry Johnson Laboratory Accreditation (PJLA) is a globally recognized accreditation body established in 1999 and headquartered in Troy, Michigan. PJLA has performed more than 2,200 accreditations in over 30 countries, supporting laboratories, inspection bodies, and certification organizations in achieving internationally recognized competence.

PJLA is recognized internationally through major cooperation frameworks including International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Accreditation Cooperation (APAC).

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PJLA Contact Information

Website: www.pjlabs.com
Email: [email protected]
Phone: +1 (248) 519-2603

ISO/IEC 17025 applies to laboratories performing testing and calibration activities. Clauses 7.6 and 7.7 work together to ensure that laboratory results are both technically valid and consistently reliable.

Clause 7.6 focuses on measurement uncertainty, requiring laboratories to understand and evaluate factors that influence measurement results. Clause 7.7 addresses ensuring the validity of results, requiring laboratories to monitor performance over time using both internal and external checks.

Together, these clauses support confidence—in laboratory data, laboratory processes, and laboratory competence.

Clause 7.6: Measurement Uncertainty

What Is Measurement Uncertainty?

Measurement uncertainty is an expression of the doubt that exists in any measurement result. No measurement is exact, and ISO/IEC 17025 requires laboratories to understand what affects their results and how significant those effects are.

Clause 7.6 requires laboratories to:

• Identify significant contributors to measurement uncertainty
• Evaluate uncertainty using appropriate methods
• Apply uncertainty evaluation consistently with laboratory activities

The intent is not perfection but understanding.

Identifying Contributors to Uncertainty

Uncertainty contributors can arise from many sources, including:

• Reference standards
• Equipment resolution
• Repeatability of measurements
• Environmental conditions such as temperature or humidity
• Equipment drift over time
• Sampling, when applicable

Not every possible contributor must be included—only those that significantly affect the measurement result. The evaluation should be appropriate to the measurement being carried out.

Type A and Type B Uncertainty

Uncertainty contributors are commonly categorized as Type A or Type B.

• Type A uncertainty is evaluated using statistical methods, such as repeated measurements and calculation of standard deviation.
• Type B uncertainty is evaluated using non-statistical information, including calibration certificates, manufacturer specifications, reference materials, published data, or professional judgment.

Most uncertainty budgets include a combination of both. The key is not the classification, but whether the contributor is technically justified and properly quantified.

Uncertainty Distributions

To estimate uncertainty, laboratories apply probability distributions to contributors.

Common distributions include:

• Normal distribution, often used for statistically derived (Type A) uncertainty
• Rectangular (uniform) distribution, commonly used for specifications or resolution limits
• Triangular or U-shaped distributions, used less frequently in specific cases

When uncertainty exists about which distribution applies, a rectangular distribution is often a conservative and acceptable choice when justified.

Calibration vs. Testing Laboratories

Clause 7.6 applies differently depending on laboratory activities.

• Calibration laboratories must evaluate measurement uncertainty for all calibrations, including in-house calibrations supporting testing.
• Testing laboratories must evaluate uncertainty when the test method allows. If a rigorous evaluation is not possible, a reasonable estimation based on theory or experience is required.

When recognized test methods specify how uncertainty is addressed or how results are reported, following the method correctly may satisfy the requirement.

Clause 7.7: Ensuring the Validity of Results

Clause 7.7 focuses on monitoring laboratory performance to ensure results remain valid over time. This monitoring must be planned, implemented, recorded, and reviewed.

Internal Monitoring Activities

Laboratories must use internal controls to detect trends or issues before incorrect results are reported.

Examples include:

• Use of reference materials
• Functional and intermediate equipment checks
• Replicate testing
• Control charts
• Review of results prior to release

Where practical, statistical techniques should be used, and records must demonstrate that monitoring activities are performed and reviewed.

External Monitoring and Proficiency Testing

In addition to internal monitoring, laboratories must participate in external comparisons where available and appropriate.

This includes:

• Proficiency testing programs
• Interlaboratory comparisons

These activities provide objective evidence of laboratory competence by comparing results with peer laboratories.

When proficiency testing is not available or appropriate, alternative approaches—such as intralaboratory comparison may be used, but they must be justified and documented.

Reviewing Results and Taking Action

Results from internal and external monitoring activities must be analyzed. If results fall outside acceptable criteria, laboratories are required to:

• Investigate the issue
• Implement corrective actions
• Prevent incorrect results from being reported

Monitoring activities are not simply a compliance exercise, they are a critical tool for continual improvement and confidence in laboratory performance.

Why Clauses 7.6 and 7.7 Matter

Measurement uncertainty and result validity are essential to demonstrating technical competence under ISO/IEC 17025. These clauses ensure that laboratories:

• Understand the limitations of their measurements
• Apply consistent and defensible evaluation methods
• Detect issues before they impact customers
• Build trust with accreditation bodies and clients

When applied effectively, Clauses 7.6 and 7.7 strengthen not only compliance, but the overall quality and reliability of laboratory operations.

Contact PJLA

If you have questions about ISO/IEC 17025 accreditation, measurement uncertainty, or how to implement effective systems in your laboratory, Perry Johnson Laboratory Accreditation, Inc. (PJLA) is here to help.

Phone: 1-877-369-5227 (1-877-369-LABS) or (248) 519-2603
Email: [email protected]
Website: https://www.pjlabs.com
Address: Perry Johnson Laboratory Accreditation, Inc., 755 W. Big Beaver Rd., Suite 1325, Troy, Michigan, 48084, USA pjlabs.com

PJLA provides expert accreditation services and support for laboratories seeking compliance with international standards such as ISO/IEC 17025.

At PJLA (PJLA), we specialize in accreditation of labs and testing services, ensuring food, beverage, and consumer product safety and compliance. This Halloween, our focus turns to the treat bowl: how testing, allergen verification, and robust control help manufacturers, retailers and families enjoy the fun with confidence.

Why Food Testing Matters for Halloween Treats

Each year, candy and snack makers release special seasonal products like “fun sizes”, themed packaging, and limited editions. These variants may have different formulations or manufacturing lines, raising risks of unexpected allergens or cross-contact. In 2025, experts are echoing this concern. New York Family

For manufacturers and retailers, quality control and batch testing matter more than ever. For parents and families, label-reading and awareness are key.

Key Food Testing and Allergen Control Tips

 
For Manufacturers/Retailers:

• Validate that fun-size or holiday variants meet the same allergen control and labeling standards as regular products.
• Conduct allergen swab testing and verify certifications when using private label treats.
• Clearly label all packages, including mini sizes, with full ingredient panels and allergen disclaimers.

For Families:

• Don’t assume a mini size is identical to the regular bar. Check the label every time! FoodAllergy.org
• Avoid unlabeled items or homemade treats if you are managing a food allergy.
• Consider non-food treats to bypass allergen risk altogether, a point increasingly emphasized in 2025. Children’s Wisconsin

Manufacturers create the safely tested product; retailers distribute it; families consume or swap it. When all stakeholders play their part, Halloween becomes safer and smoother.

2025 Trends to Watch

• The expansion of the Teal Pumpkin Project (non-food treats) is driving stronger demand for “allergen-free” treat options. https://www.whsv.com
• More social-media and retail signage alerting trick-or-treaters to safe-house zones or non-food treat houses.
• Increased consumer expectation: limited-edition candies must have the same allergen rigor, or they will be rejected by allergy-sensitive households.
• Use of dedicated allergen-free manufacturing lines or certified nut-free facilities is no longer niche. It’s becoming mainstream in treat production.

Tips for Families Built on a Food-Testing Mindset

• Approach your candy haul like a quality sample: inspect, sort, verify.
• Retire any item with missing labels or ambiguous ingredient lists.
• Use your safe treats as “control samples” you trust.
• Consider hosting or attending a Halloween event where the hosts openly advertise allergen-safe or non-food treats.

At PJLA, we know that rigorous testing brings peace of mind and on Halloween night, that peace of mind means children can trick-or-treat, families can celebrate, and manufacturers and retailers can meet the promise of safe fun. Whether you’re producing the treats, lining the shelves, or testing the products, let’s make Halloween 2025 one where food safety, testing, and celebration all come together.

Have a Fun, Safe, and Allergen-Smart Halloween!

In the world of accreditation, impartiality is everything. Without it, the credibility of any conformity assessment body (CAB), whether a testing or calibration laboratory, inspection agency, or certification body, quickly unravels. Yet, as PJLA’s Technical & International Business Development Manager Dr. George Anastasopoulos has observed through years of accreditation assessments, many CABs still treat impartiality as a simple compliance box to check rather than a living, breathing part of their management system.

In his recent article, “Impartiality Under the Microscope: Understanding and Managing Risks in Conformity Assessment Bodies Accreditation,” Dr. Anastasopoulos explores why impartiality is often misunderstood and highlights the real-world risks that can quietly erode objectivity and trust.

Recognizing the Risks

Impartiality risks come in many forms, some obvious, others subtle. Among the most common are financial dependence on key clients, pressures to retain business, and conflicts of interest when the same personnel also act as consultants or trainers. CABs may also face governance risks, where owners or board members have ties to clients or industry groups that could influence outcomes.

Other threats are more personal. Over time, long-term relationships between auditors and clients can lead to “familiarity risk,” where friendliness replaces healthy scrutiny. Even marketing practices, like promising “guaranteed certification” or prioritizing customer satisfaction, can undermine public confidence in a CAB’s independence.

Dr. Anastasopoulos also points out that external pressures from regulators, industry associations, or political bodies can distort impartiality, especially when national prestige or commercial interests are at stake. Meanwhile, competence and resource limitations can create risks of their own, encouraging shortcuts and overreliance on client-provided information.

Managing Impartiality as a Living System

The good news is that accreditation standards, including those in the ISO/IEC 17000 series, do not expect CABs to eliminate every impartiality risk. Instead, they require organizations to identify, analyze, and control those risks systematically and to demonstrate that these controls are active and effective.

Effective CABs manage impartiality through:

• Structured risk assessments
• Independent impartiality committees/li>
• Conflict-of-interest declarations/li>
• Auditor rotation and governance oversight/li>
• Ongoing evaluation and improvement of controls/li>

What accreditation assessors look for is not a static statement of compliance, but a culture of impartiality, where risks are recognized, addressed, and continually monitored.

The Bottom Line

Impartiality is not about perfection; it is about awareness and management. As Dr. Anastasopoulos emphasizes, the true measure of a CAB’s impartiality framework lies not in the absence of risk, but in its ability to recognize, manage, and justify how those risks are controlled.

By treating impartiality as a dynamic part of everyday operations, CABs can strengthen both their credibility and the confidence of the clients and communities they serve.

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For more insights, read Dr. George Anastasopoulos’s full article on LinkedIn here or contact him directly at [email protected].

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In his recent LinkedIn article, PJLA’s Technical & International Business Development Manager, Dr. George Anastasopoulos, reflects on why process-based auditing, though introduced with ISO 9001:2000, continues to challenge auditors/assessors more than two decades later.

Drawing from years of experience as an auditor, assessor, and auditee, Dr. Anastasopoulos notes that many audits/assessments remain focused on paperwork, checklists, and documented procedures instead of exploring whether processes truly deliver value. He suggests that this often stems from two main causes:

• Gaps in competence, auditors/assessors who are less confident in evaluating processes beyond documentation.
• Comfort zones, auditors/assessors who rely on familiar tools rather than engaging directly with people and activities where processes happen.

This trend risks reducing the credibility of audits/assessments and leaves organizations viewing them as routine box-ticking exercises.

Yet, the outlook is far from bleak. Dr. Anastasopoulos emphasizes that process-based auditing is not only possible but transformative, if auditors embrace a shift in perspective. By stepping out of the meeting room, following the flow from inputs to outputs, and assessing whether processes achieve their intended results, audits/assessments can once again serve their purpose: building trust, driving improvement, and delivering assurance.

👉 Read the full article here: Management Systems Process-Based Auditing: Mission Impossible!

Article from Dr. George Anastasopoulos

🔗 Read the full article

Intermediate checks—quick, periodic performance verifications conducted between full calibrations—are a critical but often overlooked requirement in ISO/IEC 17025. Unlike full calibrations, these checks provide ongoing assurance that equipment remains accurate, reliable, and fit for use.

Dr. Anastasopoulos explains that ISO/IEC 17025:2017 explicitly requires labs to establish procedures for intermediate checks (clauses 6.4.10 and 7.7.1). The frequency must be determined through a risk-based approach, considering factors such as equipment stability, usage, environmental conditions, and potential consequences of inaccurate results.

Key takeaways:

• Intermediate checks ≠ internal calibrations — they are faster verifications, not full recalibrations.
• They cannot be replaced by proficiency testing (PT) or interlaboratory comparisons (ILCs)—they serve a distinct, complementary role.
• Proper planning, documentation, and recordkeeping are essential to demonstrate compliance during audits.
• Benefits include early detection of drift, reduced risk of invalid results, stronger audit evidence, and greater client confidence.

Ultimately, neglecting intermediate checks risks nonconformities, reputational damage, and compromised measurement integrity. When performed and documented correctly, they are a powerful tool for ensuring continuous confidence in laboratory results.

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]

At PJLA, we take great pride in fostering strong client relationships and delivering top-tier assessment experiences. We were honored to receive a heartfelt note of appreciation from Kareem Farouk Ismail, Quality Assurance Manager and Head of the Microbiology Laboratory at NAWAH Scientific, following a recent successful accreditation assessment.

In his message to PJLA President, Tracy Szerszen, Kareem shared sincere gratitude for the dedication and professionalism shown throughout the process, stating:

“I’d like to extend my sincere thanks for the tremendous efforts you dedicated during our recent assessment. Your support, especially in resolving scheduling challenges, was instrumental to its success—without it, the process would not have been possible.”

Kareem went on to praise PJLA team members Alessandro and Matt for their outstanding contributions during the on-site visit.

“Alessandro’s performance—as always—was outstanding. He was incredibly helpful throughout, and I must say, PJLA is truly fortunate to have him on your team. As for Matt, words fall short in expressing my appreciation for his support and understanding during the visit. His contribution made a significant difference.”

The collaboration between PJLA and NAWAH Scientific extends beyond this recent visit. Kareem and Alessandro have worked together on four assessments across multiple laboratories since 2020, reflecting a strong and enduring professional rapport.

We thank Kareem and the entire team at NAWAH Scientific for their trust and continued partnership—and we look forward to many more successful assessments in the future.

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.

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.