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QMS ISO13485
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ORGANISATION
Quality Manual V35
QUALITY POLICY V11
ENVIRONMENTAL SUSTAINABILTY POLICY V6
Pandemic or Occupational Biological Hazards POLICY V6
CYBERSECURITY Policy V5
POPI Policy V7
System Procedures V5
Change Control V17
Competence, Awareness and Communication (Training) V40
Documentation V23
MD File
Internal & External Communication V11
Management Review V17
Improvement Actions V5
Regulatory Control V19
Adverse Incident, Advisory Notices & Recall V16
Clinical Evidence V10
Post Market Surveillance V16
Promotional and Training Material Approval
Operational Procedures V5
Customer Focus, Feedback and Complaints V17
External Providers (Purchasing & Supplier Management) V31
Infrastructure & Environment V8
Service Provision Operation V15
FACILITY (CLEANLINESS & PERSONAL HYGIENE, WASTE & PEST CONTROL), HEALTH & S
Sales, Customer Related Processes & Returns V20
Warehousing, Preservation, Identification & Traceability V25
VEHICLE MANAGEMENT V25
STOCK MANAGEMENT V26
PRODUCT DECONTAMINATION V17
Continual Improvement
Data Analysis V16
Non Conformance Corrective Action V29
Preventative Action Risk Assessment V32
QMS Auditing V25
Audit Schedule
Audit Reports
FORMS POLICIES & OTHER PROCESSES
HR POLICIES
HR FORMS
Logistics / Warehouse Forms
Logistics / Trauma
Training Documents
QUALITY RECORDS
SALES FORMS
OPS FORMS
QMS ISO13485
QUALITY RECORDS
Classification of Medical Devices and IVDs
SAHPRA
Werkomed QUALITY POLICY
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