ISO 13485:2016 - Medical Devices Quality Management Systems
Introduction
Establish, implement, maintain and continually improve a management system aligned to ISO-13485.
Risk-based thinking, process approach, and performance evaluation.
Consistent, effective, and evidence-based results.
ISO 13485:2016 specifies QMS requirements for organizations involved in medical device design, production, installation, and servicing, emphasizing risk management and regulatory compliance.
It covers the full device lifecycle, including post-market surveillance.
Major Requirements Mapped to Clauses:
- Clause 4: General – QMS scope.
- Clause 5: Management responsibility – Policy, reviews.
- Clause 6: Resource management – Infrastructure, work environment.
- Clause 7: Product realization – Design, purchasing, production, validation.
- Clause 8: Measurement – Monitoring, audits, improvement.
Major Requirements (mapped to clauses)
- Clause 4 — Context of the organization
- Clause 6 — Planning (risks & opportunities, objectives)
- Clause 8 — Operation (operational planning & control, change, outsourced processes)
- Clause 10 — Improvement (nonconformity, corrective action, continual improvement)
- Clause 5 — Leadership
- Clause 7 — Support (resources, competence, communication, documented information)
- Clause 9 — Performance evaluation (monitoring, internal audit, management review)
Certification Expectations (for auditees)
- Design history files (DHF); risk management per ISO 14971; validation records for processes.
- Supplier controls and traceability; post-market vigilance reports; CAPA for complaints.
- Cleanroom/sterility controls; regulatory submission evidence.
How ACSGP conducts the audit
Aligned to ISO/IEC 17021-1 (requirements for bodies providing audit and certification) and ISO 19011 (guidelines for auditing management systems).
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Per ISO/IEC 17021-1 and ISO 19011, with MDD/MDR alignment.
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Stage 1: Technical file review; Stage 2: Cleanroom audits; surveillance on complaints.
Value Addition Auditing: We assess both efficiency and effectiveness, ensuring your management system becomes an asset, not a liability—while maintaining impartiality, competence, and evidence-based principles.
Benefits of conformity with the standard
- Accelerates regulatory approvals (FDA, EU MDR), enabling faster market entry.
- Ensures device safety, reducing liability and recalls.
- Enhances supply chain reliability for medtech globals.
Benefits of ACSGP Certification
- IASCB for Notified Body equivalence.
- Bundled with ISO 14971 risk training.