About ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It applies across the device life cycle, including design and development, production, storage and distribution, installation, servicing and final decommissioning.
Innovative Quality Consultancy helps medical device manufacturers, component suppliers, distributors and service providers implement a QMS that satisfies ISO 13485:2016 and supports regulatory submissions and customer audits.
Key implementation areas
- Quality manual, medical device files and documentation control appropriate to device classification and regulatory requirements.
- Management responsibility, regulatory role identification and quality objectives.
- Design and development controls: planning, inputs, outputs, review, verification, validation, transfer and design changes.
- Risk management applied throughout product realization.
- Purchasing controls, supplier evaluation and control of externally provided product.
- Production and service provision: process validation, cleanliness and contamination control, installation and servicing, identification and traceability.
- Monitoring and measurement, feedback, complaint handling, reporting to regulatory authorities, control of nonconforming product and corrective and preventive action (CAPA).
Suitable organizations
- Manufacturers of medical devices, surgical instruments, consumables and in-vitro diagnostic products.
- Contract manufacturers, component and packaging suppliers to the medical device industry.
- Importers, distributors and organizations providing installation, servicing or sterilization services.
Business benefits
- A QMS aligned with medical device regulatory expectations in many markets.
- Controlled design, production and traceability that supports product safety and performance.
- Stronger supplier, complaint and CAPA processes with documented evidence.
- Readiness for customer audits and regulatory inspections.
- A credible foundation for market access and customer qualification.
How Innovative Quality Consultancy supports you
Innovative Quality Consultancy supports your organization through every stage of implementation:
- Gap analysis against ISO 13485:2016 and applicable regulatory requirements for your devices.
- QMS documentation including quality manual, procedures, device master records and forms.
- Design control, risk management and validation documentation structure.
- Awareness training, internal auditor training and internal audits.
- CAPA, management review and certification readiness support.
Certification to ISO 13485:2016 is assessed and issued by an independent certification body. Regulatory approvals and device registrations are granted by the relevant regulatory authorities and are separate from management system certification.
Discuss ISO 13485:2016 for your organization
Tell us about your products, processes and timeline and we will outline a practical implementation plan.
Enquire about ISO 13485:2016