ISO 13528

ISO 13528:2022 is an international standard that provides statistical methods for use in proficiency testing by interlaboratory comparison. It ensures the reliability and consistency of test and calibration results across laboratories. Quality Asia Certification offers ISO 13528:2022 certification to help laboratories demonstrate their technical competence, data accuracy, and compliance with global testing norms.

This certification is vital for laboratories aiming to enhance their credibility, support accreditation efforts (such as ISO/IEC 17025), and ensure the quality of their measurement processes.

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What is ISO 13528?

ISO 13528:2022 – Statistical Methods for Use in Proficiency Testing by Interlaboratory Comparison – outlines robust statistical approaches for analyzing proficiency testing (PT) results. It provides practical tools and models to evaluate and compare test data across different labs participating in PT schemes.

This standard is essential for PT providers, laboratories, and quality managers to ensure that test results are statistically valid, traceable, and comparable, fostering transparency and trust in laboratory performance assessments.

Why is ISO 13528 important?

Laboratories face increasing pressure to produce accurate and reproducible results. ISO 13528:2022 certification validates that your lab’s participation in proficiency testing is based on internationally accepted statistical methods. This enhances stakeholder confidence, improves the quality of internal processes, and supports regulatory and accreditation requirements.

Moreover, clients and regulators prefer working with ISO 13528 certified laboratories, as it guarantees the use of globally recognized techniques for evaluating laboratory performance.

What are the benefits of ISO 13528?

  1. Enhanced Statistical Rigor: Ensures use of globally accepted statistical methods in proficiency testing.
  2. Supports Accreditation: Strengthens your ISO/IEC 17025 or ISO 17043 accreditation process.
  3. Reliable Data Analysis: Helps identify biases, outliers, and performance trends for corrective actions.
  4. Improved Quality Control: Boosts the overall quality and precision of laboratory testing procedures.
  5. Reputation and Credibility: Positions your laboratory as a competent and compliant testing provider.
  6. Standardization Across Labs: Encourages consistency in evaluation across multiple testing bodies.

What kind of businesses can benefit from ISO 13528?

Getting ISO 13528:2022 certified offers strategic advantages for laboratories and testing organizations:

Win more contracts by proving your lab's proficiency and quality.

Increase stakeholder confidence with consistent, validated testing processes.

Reduce risk of errors and retesting, saving time and operational costs.

Gain a competitive edge in tenders and partnerships by demonstrating international compliance.

Enhance internal decision-making through reliable data-driven insights.

Align with global best practices for statistical data evaluation and laboratory improvement.


Top Tips on making ISO 9001 effective for you.

#1

Top management commitment while practicing and accomplishing the standard is the key to success.

#2

Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.

#3

Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.

#4

Review systems, policies, processes, and procedures for a smooth working of QMS.

#5

Speaking to customers & suppliers while getting feedback & working on improvements.

#6

Training staff carrying out the internal audits with the opportunity for improvement.

#7

Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.

#8

Ensure continuous improvement by regularly reviewing and updating your quality management practices.

#9

Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.

Why QualityAsia?

QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:

Initial Certification – Stage 1 (Preparatory Phase)
  • Thorough documented information review.
  • Exchange of information with staff through online or onsite presence.
  • Identification of key performances, processes & objectives as per the standard requisites.
  • Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.

Initial Certification – Stage 2 (On-site Audit)
  • Measurement, reporting & reviewing the performances against key performances objectives.
  • Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
  • Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
  • Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.


    Surveillance & Certification Renewal

    Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.

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