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SA Health ISO 13485
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ORGANISATION
Quality Manual V21
QUALITY POLICY V11
POPI POLICY V2
Pandemic or Occupational Biological Hazards POLICY V1
CYBERSECURITY V1
OH&S POLICY V1
System Procedures
Change Control V8
Competence, Awareness and Communication (Training) V15
Documentation V10
MD File
Internal & External Communication V10
Management Review V16
Improvement Actions V14
Regulatory Control V12
Adverse Incident, Advisory Notices & Recall V15
Post Market Surveillance V3
Promotional and Training Material Approval V4
Operational Procedures
Customer Focus, Feedback and Complaints V17
External Providers (Purchasing & Supplier Management) V27
Infrastructure & Environment V12
Service Provision Operation V9
Cleanliness , Waste , Health & Safety V22
Manufacture V1
MASK MANUFACTURE SPECIFICATION
MASK MANUFACTURE PROCESS
Sales, Customer Related Processes & Returns V20
Validation V16
Warehousing, Preservation, Identification & Traceability V27
Pharmacy Wholesale V4
Continual Improvement
Monitoring & Measurement of Products and Processes V3
Data Analysis V9
Non Conformance Corrective Action V17
Preventative Action Risk Assessment V15
QMS Auditing V10
Audit Schedule
POLICIES
SA Health ISO 13485
SYSTEM PROCEDURES
Revision 1; new 19.01.2021
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