Proficiency Testing Providers

ISO/IEC 17043 Standard Is Primarily Utilized For Proficiency Testing. ISO/IEC 17043 Is Utilized For Inter-laboratory Comparison Of Deciding The Presentation Of Individual Laboratories For Specific Tests. The Essential Goal Of Proficiency Testing Is To Give The Laboratories With A Data And Support To Exhibit And Work On The Quality Of Their Insightful Estimation.

SDAB Confirmation Expects That The Proficiency Testing Suppliers To The Most Recent Version Of The Following Standards:

• ISO/IEC 17043:latest – Rules For The Necessities For The Skill Of Suppliers Of Proficiency Testing Plans.
• Shown Specialized Ability Well Defined For The Field Where Testing Is Performed.
• The SDAB Certification Scheme Manual.

Comprehensive Guide to Proficiency Testing Providers and SDAB Certification Under ISO/IEC 17043

1. Introduction to Proficiency Testing (PT)

Proficiency Testing (PT) is a cornerstone of quality assurance in analytical, clinical, calibration, and testing laboratories worldwide. It is a critical tool for evaluating the performance of laboratories by comparing their results against predefined criteria, reference values, or the results of other laboratories. The primary objective is to provide laboratories with objective evidence of their competence, identify potential areas for improvement, and ultimately, enhance the reliability and accuracy of their test and measurement results.

In regulated industries—from healthcare and pharmaceuticals to environmental monitoring, food safety, and forensic science—participation in recognized PT schemes is often mandatory. It forms an integral part of accreditation standards like ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) and ISO 15189 (Medical laboratories). For laboratories seeking or maintaining accreditation, demonstrating consistent, satisfactory performance in relevant PT schemes is non-negotiable.

At the heart of a reliable PT system is the Proficiency Testing Provider (PTP). A PTP designs, coordinates, distributes, and evaluates PT schemes. The credibility of the entire process hinges on the technical competence, impartiality, and consistent operation of the PTP. This is where the international standard ISO/IEC 17043:2023 (Conformity assessment — General requirements for the competence of proficiency testing providers) comes into play. It sets the global benchmark for PTPs, ensuring they operate with the highest level of integrity and technical rigor.

Furthermore, specific accreditation bodies, such as the Saudi Accreditation Board (SDAB), have established stringent certification schemes based on ISO/IEC 17043. SDAB certification is a mark of excellence and a mandatory requirement for PTPs wishing to operate or supply services within the Kingdom of Saudi Arabia and other regions recognizing its authority.

This comprehensive guide delves into the world of Proficiency Testing Providers, exploring the requirements of ISO/IEC 17043, the specifics of SDAB’s certification scheme, and the broader impact on laboratory quality and global trade.

2. Deep Dive into ISO/IEC 17043:2023

ISO/IEC 17043 is the principal international standard that specifies general requirements for the competence of PTPs and the consistent operation of PT schemes. Its latest edition, ISO/IEC 17043:2023, supersedes the 2010 version, incorporating clarifications and enhancements to address evolving practices in conformity assessment.

2.1. Core Principles and Scope

The standard is built on several core principles:

Impartiality and Independence: The PTP must ensure its activities are free from commercial, financial, and other pressures that could compromise its integrity.
Confidentiality: The PTP must legally protect all confidential information obtained during its operations.
Technical Competence: The PTP must demonstrate it possesses the personnel, facilities, equipment, and technical knowledge to design and operate PT schemes fit for their intended purpose.
Risk-Based Thinking: The PTP must identify and address risks to the impartiality and quality of its PT schemes.

The scope of ISO/IEC 17043 covers all types of PT schemes, including:

Quantitative Schemes: Where numerical results are assigned (e.g., concentration of an analyte in water).
Qualitative Schemes: Where identification or classification is required (e.g., detection of a pathogen, fiber identification).
Sequential Schemes: Where samples are distributed consecutively.
Simultaneous Schemes: Where samples are distributed at the same time.
Single-event vs. Continuous Schemes.

2.2. Key Clauses and Requirements for PTPs

A PTP’s management system must address all clauses of the standard systematically.

Clause 4: General Requirements

Impartiality: The PTP must identify risks to impartiality on an ongoing basis. This includes preventing conflicts of interest, ensuring staff act objectively, and not allowing commercial considerations to override quality.
Confidentiality: The PTP must have enforceable agreements to protect participant data, proprietary information, and the details of the PT scheme design.

Clause 5: Structural Requirements

The PTP must be a legal entity (or part of one) that can be held accountable. It must define its organizational structure, reporting lines, and the responsibilities of key personnel.

Clause 6: Resource Requirements

Personnel: The PTP must employ a sufficient number of competent personnel. This includes defining qualification criteria, providing training, and maintaining records of competence. Key roles include the Technical Manager, Statistician, and Scheme Coordinators.
Facilities and Environmental Conditions: Laboratories and storage areas must be suitable to prevent contamination, deterioration, or damage to PT items. Environmental conditions (temperature, humidity) must be monitored and controlled where they influence the homogeneity and stability of samples.
Equipment: All equipment used for assigning reference values, checking homogeneity/ stability, and sample handling must be calibrated, maintained, and operated by competent staff.

Clause 7: Process Requirements (The Heart of PT Operations)
This is the most extensive and technically demanding section.

7.2 Review of Requests, Tenders, and Contracts: Requirements for each PT scheme must be agreed upon with the customer.
7.3 Selection, Purchase, and Preparation of PT Items: Items must be appropriate, sufficiently homogeneous, and stable for the intended use. The PTP must verify this through rigorous testing.
7.4 Homogeneity and Stability Testing: This is a critical technical requirement. The PTP must conduct statistically sound studies to prove that between-unit variation is negligible compared to the expected inter-laboratory variation. Stability must be tested over the entire distribution and return period.
7.5 Assignment of Reference Values and Their Uncertainties: The “true value” for the PT item must be established reliably. Methods include:
- Formulation: Known values from preparation.
- Certified Reference Materials (CRMs).
- Reference Methods: Using a definitive method in an expert laboratory.
- Consensus from Expert Laboratories: Using a group of competent labs.
- Consensus from Participants: (Less common for scoring, but used for educational purposes). The PTP must also calculate a realistic uncertainty for the assigned value.
7.6 Packaging, Storage, and Dispatch: Procedures must ensure PT items are not compromised during transit.
7.7 Instructions for Participants: Clear, comprehensive instructions must be provided.
7.8 Data Analysis and Performance Evaluation: The PTP must use appropriate statistical techniques to evaluate participant results. Common approaches include:
- z-scores: (Result – Assigned Value) / Target Standard Deviation. |z| ≤ 2 is satisfactory, 2 < |z| < 3 is questionable, |z| ≥ 3 is unsatisfactory.
- En-numbers: For comparing a result with an expanded measurement uncertainty.
- Percent difference, pass/fail criteria.
7.9 PT Reports: Reports must be clear, accurate, and comprehensive, including descriptions of the scheme, statistical methods, individual participant results (coded), performance evaluations, and interpretive comments.
7.10 Management of Nonconforming Work: Procedures for handling issues like late results, non-participation, or protocol deviations.
7.11 Complaints and Appeals: A documented process must be in place.

Clause 8: Management System Requirements
The PTP can choose to operate a management system per ISO/IEC 17043 alone or align it with ISO 9001. Requirements include:

Document and record control.
- Management reviews and internal audits.
Corrective action procedures.
Dealing with changes that could affect the quality of PT schemes.

3. The Role and Importance of Proficiency Testing Providers

A competent PTP acts as more than just a sample distributor; it is a partner in the laboratory’s quality journey.

3.1. Functions of a Competent PTP

Scheme Design: Developing a PT plan that is relevant, technically sound, and fit-for-purpose for the intended participant community.
Material Sourcing & Preparation: Sourcing or creating materials that are representative of routine test samples, ensuring they are homogeneous and stable.
Homogeneity & Stability Studies: Conducting the rigorous statistical testing required by clause 7.4 of ISO/IEC 17043.
Reference Value Assignment: Applying robust, defensible methods to establish the “true value” of the PT item.
Logistics & Distribution: Managing a global supply chain to ensure timely, intact delivery of samples.
Data Analysis & Evaluation: Applying correct statistical models to evaluate laboratory performance fairly and consistently.
Reporting & Feedback: Providing detailed, constructive reports that allow labs to benchmark themselves and identify root causes of deviations.
Expert Support & Consultation: Offering technical guidance to participants on interpreting results and improving performance.

3.2. Impact on Laboratory Quality and Accreditation

Objective Performance Evidence: Provides external, unbiased proof of a lab’s capability to accreditation bodies (like SDAB, SASO, EMA, FDA) and clients.
Benchmarking: Allows labs to compare their performance against peers nationally and internationally.
Identification of Systematic Errors: Helps detect issues with methods, equipment calibration, training, or reference materials.
Validation & Verification of Methods: PT results can support claims that a laboratory’s methods are fit for purpose.
Staff Training & Competence Assessment: A practical tool for training new analysts and assessing the ongoing competence of staff.
Continuous Improvement: Drives the corrective and preventive action cycle within a laboratory’s quality management system.

3.3. Consequences of Using Non-Accredited PT Providers

Engaging with a PTP not accredited to ISO/IEC 17043 carries significant risks:

Questionable Results: The homogeneity, stability, or assigned value of the PT item may not be reliable, leading to misleading performance assessments.
Accreditation Rejection: Accreditation bodies typically require participation in PT from “recognized providers,” with accreditation to ISO/IEC 17043 being the primary recognition.
Wasted Resources: Time and money are spent on an exercise that does not provide credible quality assurance.
Legal & Regulatory Risk: In regulated sectors, use of non-accredited PT may not fulfill regulatory requirements, leading to compliance failures.

4. SDAB Certification Scheme for Proficiency Testing Providers

The Saudi Accreditation Board (SDAB) is the national accreditation body of the Kingdom of Saudi Arabia. Established to align with global best practices and Vision 2030’s goals of quality and economic diversification, SDAB provides accreditation services across conformity assessment bodies (CABs), including testing labs, calibration labs, inspection bodies, certification bodies, and Proficiency Testing Providers.

4.1. Introduction to SDAB

SDAB operates under the umbrella of the Saudi Standards, Metrology and Quality Organization (SASO). Its mandate is to:

Enhance confidence in the quality of Saudi goods and services.
Support regulatory authorities.
Facilitate international trade by signing mutual recognition arrangements (MRAs) with other accreditation bodies (like Global Laboratory Accreditation and International Body).
Ensure that conformity assessment bodies within the Kingdom operate to the highest international standards.

4.2. SDAB’s Requirements for PTP Certification

SDAB explicitly mandates that PTPs seeking certification must comply with the following triad of documents:

ISO/IEC 17043:latest: Compliance with the most current version of the standard (presently ISO/IEC 17043:2023) is non-negotiable. This forms the technical foundation of the certification.
Shown Specialized Ability Well Defined For The Field Where Testing Is Performed: This requirement emphasizes that generic competence is insufficient. The PTP must demonstrate domain-specific expertise. For example:
- A PTP for clinical chemistry must have experts in medical laboratory science, access to clinical sample matrices, and understand regulations like those from SFDA.
- A PTP for construction materials testing must have civil engineers and understand relevant ASTM or SASO standards.
- A PTP for petroleum testing must have chemists specializing in hydrocarbons and access to relevant CRM producers.
  This is demonstrated through the CVs of key personnel, validation data for methods used in reference value assignment, and the design of the PT schemes themselves.
The SDAB Certification Scheme Manual: This is SDAB’s own governing document. It details:
- The application process and required documentation.
- Fee structures.
- The specific policies and procedures for assessments (document review, on-site/remote assessments, witness activities).
- The rules for using the SDAB accreditation symbol.
- The surveillance and re-assessment cycle (typically annual surveillance and a full re-assessment every 2-4 years).
- The process for handling complaints and appeals against SDAB decisions.

4.3. The SDAB Certification Process for a PTP

The journey to SDAB certification is rigorous and involves several stages:

Stage 1: Application & Document Review

The PTP submits a formal application along with its quality manual, procedures, records for at least one fully completed PT scheme, and evidence of technical competence.
SDAB reviews the documentation for completeness and compliance with ISO/IEC 17043 and its manual. Any gaps must be addressed before proceeding.

Stage 2: On-Site Assessment

A team of SDAB-assigned assessors (lead assessor and technical expert(s) in the relevant field) conducts a detailed on-site evaluation.
The assessment includes:
- Opening meeting.
- Tour of facilities (labs, storage, dispatch).
- In-depth interviews with management and technical staff.
- Witnessing critical activities (e.g., sample preparation, homogeneity testing, data analysis).
- Review of records (training, calibration, internal audits, corrective actions, scheme files).
- Evaluation of impartiality and confidentiality safeguards.
- Closing meeting to present findings.

Stage 3: Corrective Action & Decision

The PTP receives an assessment report detailing any nonconformities (major or minor).
The PTP must root-cause and correct these nonconformities within a specified timeframe, providing evidence to SDAB.
The SDAB certification committee reviews the entire file and makes the final certification decision.

Stage 4: Surveillance & Re-assessment

Certification is not a one-time event. SDAB conducts annual surveillance visits (which may be partial) to ensure ongoing compliance.
A full re-assessment is conducted before the certificate expires to renew certification.

4.4. Benefits of SDAB Certification for a PTP

Formal Recognition: Official proof of competence that is recognized by Saudi regulatory authorities (SFDA, MoEWA, etc.).
Market Access: A prerequisite for providing PT services to labs in Saudi Arabia that are themselves seeking or holding SDAB accreditation.
Competitive Advantage: Distinguishes the PTP from non-accredited competitors in the regional market.
Enhanced Credibility: Builds trust with participants and stakeholders globally, especially in regions that have MRAs with SDAB.
Continuous Improvement: The assessment process itself drives the PTP to refine its systems and technical processes.

5. Technical Competence in Specific Fields

The SDAB requirement for “shown specialized ability” cannot be overstated. Here are expanded examples of what this entails in various sectors:

5.1. Clinical & Medical Laboratory Testing

Expertise: Staff with advanced degrees in medical biochemistry, hematology, microbiology, etc., and often with practical laboratory experience.
Matrix Expertise: Ability to work with human-derived matrices (serum, plasma, whole blood, urine, tissue) while adhering to strict ethical and biosafety standards (often requiring Institutional Review Board approval).
Methodology: Understanding of diagnostic techniques (ELISA, PCR, mass spectrometry, flow cytometry).
Regulatory Landscape: Knowledge of SFDA requirements, CLSI guidelines, and ISO 15189.
Sample Preparation: May involve collaborating with hospitals, using artificial matrices, or innovative techniques to create commutable samples.

5.2. Food & Water Testing

Expertise: Food chemists, microbiologists, toxicologists.
Matrices: Proficiency in a vast range of matrices (meat, dairy, grains, oils, beverages, tap water, wastewater).
Parameters: Testing for nutrients, additives, pesticide residues, heavy metals, allergens, pathogens (Salmonella, E. coli, Listeria).
Standards: Knowledge of SASO food standards, GCC regulations, Codex Alimentarius, and methods from ISO, FDA BAM, or USP.
Homogeneity Challenges: Creating homogeneous samples for microbiology PT is particularly challenging and requires specialized techniques like cryo-milling and irradiation.

5.3. Petroleum, Petrochemicals & Fuels

Expertise: Chemists and engineers specialized in hydrocarbon analysis.
Parameters: Octane/cetane number, distillation profile, sulfur content, viscosity, flash point, elemental analysis.
Safety: Handling flammable and hazardous materials requires specific safety protocols and facilities.
Reference Materials: Strong relationships with CRM producers for fuels and lubricants.
Standards: ASTM, IP, and SASO standards are paramount.

5.4. Construction Materials & Civil Engineering

Expertise: Civil engineers, materials scientists.
Testing Types: Compressive strength of concrete, soil geotechnical properties, asphalt penetration, steel tensile strength, chemical analysis of cement.
Sample Preparation: Creating stable, homogeneous samples for concrete or soil is highly technical and often involves large, specialized equipment.

5.5. Microbiology (Environmental & Industrial)

Expertise: Microbiologists with specialization in environmental, pharmaceutical, or cosmetic microbiology.
Parameters: Bioburden, sterility testing, enumeration of specific organisms, identification.
Viability & Stability: Maintaining microbial viability during shipping is a critical technical hurdle.
Matrix: Preparation of samples in relevant media or on carriers.

6. Case Studies and Applications

Case Study 1: An SDAB-Accredited PTP for Water Testing in the Gulf Region

Challenge: Gulf countries have unique water challenges (desalination, high salinity, specific industrial pollutants). Labs needed relevant PT.
PTP Solution: A regional PTP sought SDAB accreditation. It demonstrated specialized ability by:
- Employing hydrologists and chemists familiar with Gulf water matrices.
- Developing PT schemes for parameters critical to the region (e.g., boron, total dissolved solids, specific petroleum hydrocarbons).
- Using artificial seawater matrices that were commutable for common analytical methods.
- Assigning reference values through a consortium of expert labs in the region.
Outcome: The SDAB accreditation gave the scheme immediate credibility. Saudi environmental labs used it to meet SDAB (SASO) accreditation requirements, leading to improved data quality for water resource management.

Case Study 2: A Global Pharmaceutical PTP Expanding into Saudi Arabia

Challenge: A multinational PTP offering PT for pharmaceutical raw material and finished product testing wanted to access the growing Saudi market.
Solution: The PTP, already accredited to ISO/IEC 17043 by its home body, applied for SDAB certification. The process involved:
- Translating key documents into Arabic as per SDAB requirements.
- Hosting SDAB assessors who focused on how the PTP’s global schemes met SFDA expectations and local needs.
- Demonstrating that its statisticians and pharmaceutical scientists understood the relevant SASO and USP monographs.
Outcome: SDAB certification via a mutual recognition arrangement streamlined the process. The PTP could now market its services directly to Saudi pharmaceutical manufacturers, who required SFDA compliance.

7. Challenges and Future Trends for PTPs

7.1. Ongoing Challenges

Creating Commutable Samples: Ensuring PT samples behave identically to real-world samples across all measurement methods remains a significant technical hurdle, especially in clinical chemistry.
Cost and Complexity: Running accredited PT schemes, particularly for esoteric tests or unstable analytes, is expensive and technically demanding.
Data Security & Confidentiality: With increasing cyber threats, protecting sensitive participant data is paramount.
Logistics for Perishable Items: Maintaining the cold chain for biological or live microbiological samples across international borders.

7.2. Future Trends

Digital PT (dPT) and Virtual Samples: The use of data sets, simulated results, or digital images (e.g., for histopathology, radiology) is growing, reducing shipping constraints.
Increased Regulatory Reliance: Globally, regulators are moving towards mandating ISO/IEC 17043 accredited PT for more and more fields.
Focus on Measurement Uncertainty (MU): PT schemes are increasingly requiring participants to report their MU, and evaluation methods (like En-numbers) that incorporate MU are becoming more common.
Personalized Medicine and Genomics: PT for next-generation sequencing, pharmacogenomics, and molecular diagnostics is a rapidly evolving frontier requiring new PTP competencies.
Sustainability: Pressure to reduce the environmental footprint of PT through smarter packaging, digital reporting, and optimized logistics.

8. Conclusion

Proficiency Testing is an indispensable component of the global quality infrastructure. The reliability of PT, in turn, is wholly dependent on the competence and integrity of the Proficiency Testing Provider. The international standard ISO/IEC 17043:2023 provides the comprehensive framework that defines this competence, covering everything from management principles to the deepest technical details of homogeneity testing and reference value assignment.

For PTPs operating in or supplying to the Saudi market, achieving SDAB certification is the definitive mark of trust. It goes beyond mere compliance with ISO/IEC 17043; it requires demonstrable, field-specific technical expertise and adherence to SDAB’s rigorous operational scheme. This certification is not a bureaucratic hurdle but a strategic asset, opening doors, building credibility, and ultimately contributing to the elevation of laboratory standards across industries.

As technology advances and regulatory demands grow, the role of the accredited PTP will only become more critical. Laboratories must be discerning in their choice of PT provider, prioritizing those with recognized accreditation like SDAB’s. By doing so, they invest not just in a compliance check-box, but in a powerful partnership for continuous improvement, ensuring their data stands up to the strictest scrutiny in an increasingly interconnected and quality-conscious world.

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