BS EN ISO 15195:2019
$102.76
Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 18 |
This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 4 | European foreword |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions |
| 10 | 4 General requirements |
| 11 | 5 Structural requirements 6 Resource requirements 6.1 General 6.2 Personnel 6.3 Laboratory facilities and environmental conditions 6.4 Equipment |
| 12 | 6.5 Metrological traceability 6.6 Reference materials 6.7 Externally provided products and services |
| 13 | 7 Process requirements 7.1 Review of requests, tender and contracts 7.2 Reference measurement procedures 7.3 Handling of samples 7.4 Measurement records 7.5 Evaluation of measurement uncertainty |
| 14 | 7.6 Ensuring the validity of measurement results 7.7 Reporting measurement results 8 Management requirements 8.1 General 8.2 Internal audits |
| 15 | Annex A (informative) Relationship to ISO/IEC 17025:2017 |
| 16 | Bibliography |
