ISO 13485:2016
Medical Devices Quality Management System
الجودة والسلامة في تصنيع وتوريد الأجهزة الطبية
Get Free ConsultationWhat is ISO 13485:2016?
ISO 13485 is the international standard for quality management systems in the medical device industry, focusing on safety, effectiveness, and regulatory compliance.
Who Needs ISO 13485:2016?
Medical Device Manufacturers
Medical Supply Distributors
Medical Maintenance Companies
Medical Research Labs
Why is ISO 13485:2016 Important?
✓ Compliance with Saudi Food and Drug Authority (SFDA)
✓ Facilitating global market entry and CE marking
✓ Ensuring safety and quality for patients
✓ Improving process efficiency and waste reduction
✓ Enhancing trust with healthcare providers
Key Requirements
1 Defining regulatory context and legal requirements
2 Risk management (aligned with ISO 14971)
3 Strict control of medical documents and records
4 Providing suitable infrastructure for medical manufacturing
5 Control of medical procurement and suppliers
6 Robust traceability and recall systems
7 Monitoring and measuring products and processes
Implementation Steps (Wadi Methodology)
1
Gap Analysis: Assessing current status against SFDA and standard requirements
2
Risk Management: Identifying product and patient safety risks
3
Documentation: Preparing quality manuals and technical files
4
Training: Qualifying staff on Good Manufacturing Practices (GMP)
5
Implementation: Applying policies in production, storage, and distribution
6
Internal Audit: Verifying system effectiveness and compliance
7
Certification: Obtaining certification and initiating SFDA registration
Required Documents & Records
Medical Quality Manual
Product Technical File
Risk Management Plan
Design and Development Verification procedures
Sterilization records (if applicable)
Equipment maintenance logs
Post-Market Surveillance reports
Common Mistakes to Avoid
Neglecting technical file documentation
Weak link between risk management and design
Inadequate traceability and recall systems
Overlooking local regulatory requirements (SFDA)
Lack of control over suppliers and subcontractors
Frequently Asked Questions
Is ISO 13485 required by SFDA?
Yes, it is the fundamental requirement for MDQMS certification in Saudi Arabia.
vs ISO 9001?
13485 focuses on regulatory compliance and product safety over general customer satisfaction.
Covers maintenance companies?
Yes, entities providing medical device services like installation and maintenance are covered.
ISO 14971?
ISO 14971 is the specific risk management standard for medical devices, integrated within 13485.
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