What’s new in ISO15189:2022
DECODED
After ten years, ISO 15189 has been updated with technical revisions. We all know that ISO 15189 specifies requirements for quality and competence in medical laboratories. The main objective of ISO 15189:2022, is
6.8.3 Review and approval of externally provided products and services
7.7.1 Process
7.7.2 Receipt of complaint
7.7.3 Resolution of complaint
8.7.1 Actions when nonconformity occurs
8.7.2 Corrective action effectiveness
8.7.3 Records of non-conformitiess under
Personnel introduction to the organizational environment (5.1.4) is reflected in Continuing education and professional development. (6.2.4)
Training (5.1.5) is merged with personnel records under (6.2.5)
5.7.2 Storage, retention, and disposal of clinical samples changed to 7.4.2 post-examination handling of samples in new version
7.4.1.3 Critical result reports are included
5.8.3 Report content is now 7.4.1.6 Requirements for reports and NEW Claus 7.4.1.7 Additional information for reports is added
5.9.2 Automated selection and reporting of results earlier is now 7.4.1.5 Automated selection, review, release and reporting of results
5.9.3 Revised reports earlier is now 7.4.1.8 Amendments to results reported
Author:
Chetana S Nayak
Co-Founder
MedigrowHealthcare Consulting LLP
DECODED
After ten years, ISO 15189 has been updated with technical revisions. We all know that ISO 15189 specifies requirements for quality and competence in medical laboratories. The main objective of ISO 15189:2022, is
- To promote the welfare of patients and satisfaction of laboratory users through confidence in the quality and competence of medical laboratories
- To guide medical laboratories to plan and implement actions to address risks and opportunities for improvement.
- The “standard” is now referred to as “Document” and largely classified as
- Section 4-General requirements
- Section 5: Structural & Governance requirements
- Section 6: Resource Requirements
- Section 7: Process Requirements
- Section 8: Management Systems requirements
- Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document
- Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated
- Increased emphasis on risk management
- The format of this document is based on the mother document ISO/IEC 17025:2017
- In section 3, the Number of definitions is reduced to 32 instead of 37
- Section 4 -Management requirements-Claus remains same however management requirement is now general requirements under ISO 15189:2022
- 4.2 Quality management system (QMS) is now 8 Management system requirements
- 4.1.2.7 Quality manager is reflected as 5.4.2 Quality management
- 4.2.2 Documentation requirements is now 8.2 Management system documentation
- 4.2.2.2 Quality manual is optional, no longer a requirement
NOTE: The management system documents can, but are not required to, be contained in a quality manual - 4.4 service agreements is under 6.7(Resource requirements)
- Earlier 4.5 is now under 6.8.2 Referral laboratories and consultant
- Earlier 4.6 External services and supplies Is now under Resource Requirements
6.8.3 Review and approval of externally provided products and services
- 4.7 Advisory services is now under structure and authority of 5 Structural and governance requirements
- 5.3.3 Advisory activities under 5.3 Laboratory activities
- Earlier 4.8 Resolution of complaints Is now under 7 Process requirements
7.7.1 Process
7.7.2 Receipt of complaint
7.7.3 Resolution of complaint
- Earlier 4.9 Identification and control of nonconformities Is now 7 Process requirements under 7.5 Nonconforming work
- 4.10 Corrective action is now under 8 Management system requirements
8.7.1 Actions when nonconformity occurs
8.7.2 Corrective action effectiveness
8.7.3 Records of non-conformitiess under
- Under 4.15, 4.15 Management review is now 8.9 In this section 4.15.3 Review activities is not specified
- In this new version, 5 Technical requirements is now 6 Resource requirements
- Earlier 5.1 has become 6.2
Personnel introduction to the organizational environment (5.1.4) is reflected in Continuing education and professional development. (6.2.4)
Training (5.1.5) is merged with personnel records under (6.2.5)
- 5.3 is now 6.2 under resources
- 5.2 Accommodation and environmental conditions is now 6.3 Facilities and environmental conditions
- 5.3 Laboratory equipment, reagents, and consumables is now 6.4 Equipment and 6.6 Reagents and consumables
- Earlier 5.4 is now 7.2
- 5.4 Pre-examination processes had 7 sub-Claus earlier. Now in new version is 18
- Earlier 5.5 is now 7.3
- Terminology 5.5.1.3 validation of examination processes is changed to Under 7.3.3 Validation of examination methods
- 5.6 is now 7.3.3 under process
- examination procedures is redefined as examination methods
- Term Quality Control (5.6.2) is replaced by Internal Quality Control in new version (7.3.7.2)
- 5.6.3 Inter-laboratory comparisons is changed to 7.3.7.3 External quality assessment (EQA)
- 5.7.1 Review of results is now under 7.4.1.2 Result review and release 7.4.1.3 Critical result reports (NEW)
- Changes in earlier post examination processes (5.7) is now -
5.7.2 Storage, retention, and disposal of clinical samples changed to 7.4.2 post-examination handling of samples in new version
7.4.1.3 Critical result reports are included
- 5.8 Minor changes
5.8.3 Report content is now 7.4.1.6 Requirements for reports and NEW Claus 7.4.1.7 Additional information for reports is added
- 5.9 is now 7.4.1.2
5.9.2 Automated selection and reporting of results earlier is now 7.4.1.5 Automated selection, review, release and reporting of results
5.9.3 Revised reports earlier is now 7.4.1.8 Amendments to results reported
- 5.10 Laboratory information management is now 7.6 Control of data and information management
Author:
Chetana S Nayak
Co-Founder
MedigrowHealthcare Consulting LLP
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