What This Service Covers
- Design and implementation of ISO 13485:2016-compliant quality management systems
- Documentation hierarchy: quality manual, procedures, work instructions, forms
- Process mapping and validation across design, production, and post-market activities
- CAPA, nonconformance, and corrective action system design
- Document and record control infrastructure
- Supplier and contract manufacturer quality agreements
- Internal audit program structure and audit trail systems
- Management review frameworks and quality metrics
- Training and competency management systems
- Traceability architecture for product and component identification
When This Service Is Typically Required
- Pre-market: establishing QMS before first regulatory submission
- Pre-certification: preparing for ISO 13485 certification audit
- Remediation: addressing nonconformities identified during regulatory inspections
- Acquisition integration: harmonizing quality systems post-merger
- Market expansion: adapting QMS for new jurisdictions (EU, US, Canada, Japan)
- Notified Body transition: aligning QMS with new conformity assessment body requirements
Applicable Regulations & Standards
- ISO 13485:2016 Medical devices — Quality management systems
- 21 CFR Part 820 Quality System Regulation (US)
- EU MDR 2017/745 Annex IX (Quality Management System requirements)
- MDSAP AU/BR/CA/JP/US regulatory requirements
- ISO 9001:2015 (where applicable for dual certification)
How This Fits Within the Quality System
The ISO 13485 QMS serves as the structural foundation for all regulatory and operational activities. It governs:
System Integration Points:
- Design controls and development lifecycle documentation
- Production and process validation
- Risk management integration per ISO 14971
- Post-market surveillance and vigilance reporting
- Clinical evaluation and performance data collection
- Regulatory submission content and technical file organization
- Supplier qualification and ongoing monitoring
- Corrective and preventive action linkage to all quality events
All other services—regulatory documentation, clinical evaluation, post-market compliance—operate within and reference the QMS as the system of record.