ISO and Compliance Blog: Guides and Checklists

Risk management runs through all of ISO 13485, and ISO 14971 is the framework for doing it. Learn the risk management process, the risk file, and why auditors focus on it.

The FDA QMSR now incorporates ISO 13485:2016 by reference, replacing the old Quality System Regulation. Here is what changed, what it means, and what still differs.

ISO 13485 is built on ISO 9001 but serves a different purpose. Here is how the two QMS standards differ — structure, risk, documentation, and regulatory focus.

ISO 13485 certification step by step — from gap analysis and design controls through the Stage 1 and Stage 2 audits, plus timeline, MDSAP, and how to prepare.

The complete list of documents, procedures, and records required by ISO 13485:2016 — including the quality manual, medical device file, design controls, and CAPA.

ISO 13485:2016 is the international standard for medical device quality management systems. Learn what it is, why it matters, how it is structured, and how to get certified.

ISO 45001 replaced OHSAS 18001, which is now withdrawn. Here is what changed — structure, leadership, worker participation, context — and what migration involved.

Worker participation and consultation is the requirement that sets ISO 45001 apart. Learn what it means, what to consult on, and how to evidence it for audit.

How to identify hazards and assess risk under ISO 45001 — the difference between hazard and risk, the step-by-step process, and the hierarchy of controls.

ISO 45001 certification step by step — from gap analysis and risk assessment through worker consultation and the Stage 1 and Stage 2 audits, plus timeline and prep tips.

The complete list of documents and records required by ISO 45001:2018 — policy, hazard and risk assessment methodology, legal register, objectives, and more.

ISO 45001:2018 is the international standard for occupational health and safety management. Learn what it is, why it matters, how it is structured, and how to get certified.

ISO 42001 is a voluntary standard; the EU AI Act is law. Here is how they differ, how they complement each other, and why certification is not legal compliance.

ISO 42001 certification step by step — from gap analysis and AI impact assessment through the Stage 1 and Stage 2 audits, plus how long it takes and how to prepare.

ISO 42001 Annex A provides reference AI controls across nine areas (A.2–A.10). Here is how they are organized, what each area covers, and how you select them.