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ISO 13485 QMS
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ORGANISATION
Quality Manual V14
QUALITY POLICY V5
Environmental Sustainability Policy V4
POPI POLICY V5
Cybersecurity Policy V4
System Procedures
Change Control Management V10
Competence, Awareness and Communication (Training) V19
Documentation V12
MD File
Internal & External Communication V12
Management Review V13
Improvement Actions V8
Regulatory Control V16
Adverse Incident, Advisory Notices & Recall V13
Clinical Evidence V7
Post Market Surveillance V8
Promotional and Training Material Approval V8
Operational Procedures V3
Customer Focus, Feedback and Complaints V14
External Providers (Purchasing & Supplier Management) V21
Infrastructure & Environment V13
Service Provision Operation V10
Cleanliness & Personal Hygiene, Waste & Pest Control, Health & Safety V14
Sales, Customer Related Processes & Returns V10
Validation V7
Warehousing, Preservation, Identification & Traceability V13
Stock Management V15
Vehicle Management V7
Product decontamination V16
Continual Improvement
Monitoring & Measurement of Products and Processes V5
Data Analysis V13
Non Conformance Corrective Action V20
Preventative Action Risk Assessment V23
QMS Auditing V15
Audit Schedule
Audit Reports
FORMS & RECORDS
HR POLICIES
HR FORMS
Logistics /Warehouse Forms
Logistics / Arthroplasty
Training Documents
QUALITY RECORDS
SALES FORMS
OPS FORMS
ISO 13485 QMS
Audit Reports
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