SADCAS F 134 (c)

ASSESSMENT CYCLE MATRIX FOR MEDICAL LABORATORIES – ISO 15189:2022

Organization Name:
SADCAS Accreditation No:
Team Leader

Dates
Types of assessment
(Initial, Periodic on-site
assessment, Re-assessment, Total No
NCs/
Extension, Re-instatement, …)
Cycle
Extent of assessment: Exte
F: Full assessment of the clause nt: Extent: Extent: Extent: Extent:
Major Minor Major Minor Major Minor Major Minor Major Minor
P: Partial assessment of clause F/P/ F/P/N F/P/N F/P/N F/P/N
N: Not assessed N
SADCAS Publications
Previous Corrective Action(s)
cleared
4.1 Impartiality
4.2 Confidentiality
4.3 Requirements regarding
patients
5.1 Legal Entity
5.2 Laboratory Director
5.3 Laboratory Activities
5.4 Structure and Authority
5.5 Objectives and Policies
5.6 Risk Management
6.1 Resource Requirements
6.2 Personnel
6.3 Facilities and environmental
conditions
6.4 Equipment
Issue No: 1 1 Date: 2023-12-08
 SADCAS F 134 (c)

Dates
Types of assessment
(Initial, Periodic on-site
assessment, Re-assessment, Total No
NCs/
Extension, Re-instatement, …)
Cycle
Extent of assessment: Exte
F: Full assessment of the clause nt: Extent: Extent: Extent: Extent:
Major Minor Major Minor Major Minor Major Minor Major Minor
P: Partial assessment of clause F/P/ F/P/N F/P/N F/P/N F/P/N
N: Not assessed N
6.5 Equipment calibration and
metrological Traceability
6.6 Reagents and Consumables
6.7 Service Agreements
6.8 Externally provided products
and services
7.1 Process Requirements
7.2 Pre-examination Processes
7.3 Examination Process
7.4 Post Examination process
7.5 Nonconforming work
7.6 Control of data and
information Management
7.7 Complaints
7.8 Continuity and emergency
preparedness planning
8.1 General Management system
Requirements
8.2 Management System
Documentation
8.3 Control of Management
System Documents
8.4 Control of Records
8.5 Actions to address Risks and
opportunities for Improvement
8.6 Improvement

Issue No: 1 2 Date: 2023-12-08

 SADCAS F 134 (c)

Dates
Types of assessment
(Initial, Periodic on-site
assessment, Re-assessment, Total No
NCs/
Extension, Re-instatement, …)
Cycle
Extent of assessment: Exte
F: Full assessment of the clause nt: Extent: Extent: Extent: Extent:
Major Minor Major Minor Major Minor Major Minor Major Minor
P: Partial assessment of clause F/P/ F/P/N F/P/N F/P/N F/P/N
N: Not assessed N
8.7 Nonconformities and
Corrective Actions
8.8 Evaluations
8.9 Management Reviews

Issue No: 1 3 Date: 2023-12-08

 SADCAS F 134 (c)

SCOPE COVERAGE OF TESTS OVER THE ASSESSMENT CYCLE

Please note: The coverage of tests over the accreditation cycle must include tests on the scope of accreditation

INITIAL ASSESSMENT : Date and Type of Assessment: Technical Assessor:

TESTS: VERTICAL ASSESSMENTS TESTS WITNESSED PERSONNEL WITNESSED COMMENTS/NEW TESTS ADDED/ ISSUES
FOR FOLLOW-UP

ASSESSMENT 1: Date and Type of Assessment: Technical Assessor:

TESTS: VERTICAL ASSESSMENTS TESTS WITNESSED PERSONNEL WITNESSED COMMENTS/NEW TESTS ADDED/ ISSUES
FOR FOLLOW-UP

Issue No: 1 4 Date: 2023-12-08

 SADCAS F 134 (c)

SCOPE COVERAGE OF TESTS OVER THE ASSESSMENT CYCLE

Please note: The coverage of tests over the accreditation cycle must include tests on the scope of accreditation

ASSESSMENT 2: Date and Type of Assessment: Technical Assessor:

TESTS: VERTICAL ASSESSMENTS TESTS WITNESSED PERSONNEL WITNESSED COMMENTS/NEW TESTS ADDED/
ISSUES FOR FOLLOW-UP

ASSESSMENT 3: Date and Type of Assessment: Technical Assessor:

TESTS: VERTICAL ASSESSMENTS TESTS WITNESSED PERSONNEL WITNESSED COMMENTS/NEW TESTS ADDED/
ISSUES FOR FOLLOW-UP

Issue No: 1 5 Date: 2023-12-08

 SADCAS F 134 (c)

ASSESSMENT 5: Date and Type of Assessment:

TESTS: VERTICAL ASSESSMENTS TESTS WITNESSED PERSONNEL WITNESSED COMMENTS/NEW TESTS ADDED/
ISSUES FOR FOLLOW-UP

Issue No: 1 6 Date: 2023-12-08

 SADCAS F 134 (c)

TREND ANALYSIS: Based on the number of findings raised over the Accreditation Cycle
Total Findings Per Clause

4.1 4.2 4.3 5.1 5.2 5.3 5.4 5.5 5.6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8
ISO 15189:2022 Clause Numbers

Issue No: 1 7 Date: 2023-12-08

 SADCAS F 134 (c)

TREND ANALYSIS: Based on the number of findings raised over the Accreditation Cycle
Total Findings Per Clause

8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9

RECOMMENDATIONS/COMMENTS:

Signed by: __________________________ Name: ______________________________________ Date: _____________________

Issue No: 1 8 Date: 2023-12-08