Obtaining laboratory accreditation - required activities

Int J Health Care Qual Assur. 2019 Feb 11;32(1):71-83. doi: 10.1108/IJHCQA-10-2017-0191.

Abstract

Purpose: The purpose of this paper is to describe the activities needed to meet specified requirements to assist laboratory staff running tests and calibrations and to obtain ISO/IEC 17025 accreditation.

Design/methodology/approach: The relevant literature that contributes to establishing activities that help laboratory staff to obtain ISO/IEC 17025 accreditation was studied. Laboratory researchers specializing in electro-medical equipment quality control were questioned about the criteria to be observed when selecting, developing and validating analytical steps.

Findings: Results revealed the analytical method criteria to be observed, which demonstrated their essentially quantitative nature.

Originality/value: This study presents a model that improves selecting, developing and validating analytical steps and contributes to producing reliable test and calibration results. These improvements can help laboratory testing and calibration to meet clients' needs, satisfy specified requirements and provide reliable results.

Keywords: ISO/IEC 17025; Technical requirements.

Publication types

  • Review

MeSH terms

  • Accreditation / organization & administration*
  • Brazil
  • Evaluation Studies as Topic
  • Female
  • Humans
  • Job Satisfaction*
  • Laboratories / organization & administration*
  • Male
  • Organizational Innovation
  • Personal Satisfaction
  • Quality Control
  • Total Quality Management*