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Obtaining laboratory accreditation - required activities.

Vítor Vasata Macchi Silva1, José Luis Duarte Ribeiro1

  • 1Graduate Program of Industrial Engineering, Universidade Federal do Rio Grande do Sul , Porto Alegre, Brazil.

International Journal of Health Care Quality Assurance
|March 13, 2019
PubMed
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This study outlines essential activities for laboratory staff to achieve ISO/IEC 17025 accreditation. It details criteria for selecting, developing, and validating analytical methods to ensure reliable testing and calibration results.

Keywords:
ISO/IEC 17025Technical requirements

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Area of Science:

  • Laboratory Science
  • Quality Management Systems

Background:

  • ISO/IEC 17025 accreditation is crucial for laboratory competence.
  • Laboratories require standardized procedures for testing and calibration.

Purpose of the Study:

  • To describe activities for laboratory staff to meet ISO/IEC 17025 accreditation requirements.
  • To assist in obtaining accreditation for testing and calibration services.

Main Methods:

  • Literature review on activities supporting ISO/IEC 17025 accreditation.
  • Interviews with electro-medical equipment quality control researchers on analytical steps.

Main Results:

  • Identified key criteria for selecting, developing, and validating analytical methods.
  • Demonstrated the quantitative nature of essential analytical method criteria.

Conclusions:

  • Presents a model for improving analytical step selection, development, and validation.
  • Enhances the reliability of test and calibration results to meet client needs and accreditation standards.