BS EN ISO 15189:2022
Medical laboratories. Requirements for quality and competence
- Standard No.
- BS EN ISO 15189:2022
- Release Date
- 2022
- Published By
- British Standards Institution (BSI)
- Status
- Replace By
- BS EN ISO 15189:2022+A11:2023
- Latest
- BS EN ISO 15189:2022+A11:2023
- Scope
- Download BS EN ISO 15189:2022 Executive Briefing here . What is BS EN ISO 15189 - Quality and competence in medical laboratories about? This established international standard focuses on quality and competence requirements in medical laboratories. BS EN ISO 15189:2022 can be used by medical laboratories to develop their quality management systems and assess their competence. Who is BS EN ISO 15189 - Quality and competence in medical laboratories for? Medical laboratories Healthcare facilities Regulating authorities Accreditation bodies What does BS EN ISO 15189 - Quality and competence in medical laboratories cover? BS EN ISO 15189 specifies requirements for quality and competence in medical laboratories and includes requirements for Point of Care Testing (POCT). As the primary considerations are the welfare of patients and the satisfaction of users, BS EN ISO 15189 contains requirements for the medical laboratory to plan and implement actions to address risks and opportunities. NOTE: International, national, or regional regulations or requirements may also apply to specific topics covered in BS EN ISO 15189:2022 . Why should you use BS EN ISO 15189 - Quality and competence in medical laboratories? Medical laboratories can use BS EN ISO 15189 to increase the effectiveness of their management system, thereby improving results and preventing negative effects that could result in harm to patients, laboratory personnel, the public and the environment. Laboratory users, regulatory authorities and accreditation bodies...
BS EN ISO 15189:2022 Referenced Document
- ISO/IEC 17000:2020 Conformity assessment — Vocabulary and general principles
- ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
- ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
BS EN ISO 15189:2022 history
- 2023 BS EN ISO 15189:2022+A11:2023 Medical laboratories. Requirements for quality and competence
- 2022 BS EN ISO 15189:2022 Medical laboratories. Requirements for quality and competence
- 2012 BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
- 0000 BS EN ISO 15189:2007
