Standard Focus Areas
• Customer Focus to meet their needs and expectations
• Consistently producing products or services according to specifications
• Ensuring regulatory compliance
• Increased productivity and efficiency
• Access to new markets and higher market share
How to implement ISO 13485 with Documentation Kit
Establish, implement & get certified for ISO 13485 with pre-built documentation kit developed by highly competent and experienced professionals with hands-on experience of the quality management system in multiple industries sectors. The documentation kit includes:
1. Scope statement established in i-Scope in iCompliance
2. MDMS procedures, work instructions and guidelines established in i-Governance in iCompliance
3. MDMS policy and MDMS objectives established in iCompliance
4. MDMS forms and templates uploaded and readily available in iCompliance
5. MDMS folders established to record evidences in iCompliance
6. MDMS audit checklists established in iCompliance
7. MDMS non-conformities, customer complaints and other discripancies managed for iCompliance
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