ISO 13485 — Quality Management System
Plain-language guides to ISO 13485:2016 — the global QMS standard for medical device manufacturers and their supply chains.
ISO 13485:2016 — ISO ↗Self-assess your QMS against all key clauses — free, no registration required.
What is ISO 13485 and who needs it?
Scope, applicability, and why ISO 13485 is the global baseline for medical device QMS.
How does ISO 13485 differ from ISO 9001?
Key divergences: regulatory focus, risk-based approach, and medical device-specific clauses.
What documents does ISO 13485 require?
Mandatory procedures, records, and the medical device file under ISO 13485:2016.
Design and development under ISO 13485
Clause 7.3 requirements: planning, inputs, outputs, review, verification, validation, and transfer.
How to manage suppliers under ISO 13485
Clause 7.4 purchasing controls, supplier evaluation, and supplier agreements.
CAPA and nonconformance under ISO 13485
Clauses 8.3, 8.5.2, 8.5.3: handling nonconforming product, corrective and preventive actions.
How to prepare for an ISO 13485 audit
Audit types (stage 1, stage 2, surveillance), common findings, and preparation checklists.
ISO 13485:2016 — what changed from 2003?
Key updates in the 2016 revision: risk management, supply chain, and regulatory requirements.