American Association for Laboratory Accreditation (A2LA)

Proficiency Testing: ISO/IEC 17043/13528 and Accreditation

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This course is a comprehensive look at Proficiency Testing (PT), including the design and operation of PT schemes, statistical methods, reporting, and interpretation. The course covers the requirements of the International Standards for PT, namely ISO/IEC 17043 Conformity assessment- General requirements for proficiency testing and ISO 13528 Statistical methods for proficiency testing by interlaboratory comparisons.

These International Standards will be demonstrated with real examples from different types of PT in different areas of application. Statistical methods for PT will be examined, including the basic considerations for statistical design and data analysis. Techniques reviewed will cover PT for testing (quantitative and qualitative) and calibration. The course also includes an overview of the A2LA accreditation process, including how accreditation for proficiency testing providers may be accomplished along with related accreditations to ISO/IEC 17025 (for testing/calibration laboratories) and ISO Guide 34 (for reference material producers). The course covers the management system requirements of ISO/IEC 17043 only to the extent that they differ from the management system requirements of ISO/IEC 17025. These differences, as needed for consistency with ISO 9000:2008, relate to considerations for PT rather than testing or calibration.

COURSE CONTENT:

Introduction to Proficiency Testing

  • Definitions from ISO/IEC 17043.
  • Types of proficiency testing.
  • Various standards and guides for PT.
  • National and international practices.

Requirements of ISO/IEC 17043

  • Management system requirements (differences from ISO/IEC 17025).
  • Design of PT schemes.
  • Subcontracting.
  • Personnel and equipment.
  • Preparation of PT items.
  • Handling and shipment.
  • Data analysis.
  • Reports.
  • Communication with participants.

Statistical Methods for PT: ISO 13528 and Other Methods

  • Statistical design of PT.
  • Homogeneity and stability assessment.
  • Determining the assigned value.
  • Evaluation of performance.
  • Use of uncertainty.

Interpretation and Use of Scheme Results

  • For participants in PT schemes.
  • For accreditation bodies and other interested parties.

A2LA Accreditation Process and Benefits

  • Similarities with and differences from other accreditations.

PREREQUISITE:

Understanding of:

  • Interlaboratory comparison studies; and
  • Basic management system requirements of ISO/IEC 17025:2005.v

TARGET ATTENDEES:

Proficiency testing providers considering accreditation to ISO requirements, or seeking a better understanding of the basic requirements for PT and process improvement.

EXAMS:

A 1-hour exam is administered at the conclusion of the course.

LEARNING OUTCOMES:

After successful completion of the course, the trainee will be able to:

  • Apply the requirements of ISO/IEC 17043 to their own PT scheme;
  • Prepare an optimal statistical design for the objectives of their scheme;
  • Apply basic statistical techniques for analysis (if needed); and
  • Understand accreditation requirements.

CEUs AWARDED:

1.2 CEUs Awarded*

PRESENTATION STYLE:

Lecture, discussion, and group exercises.

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