Free download • PowerPoint • 64 slides
ISO 13485:2016 Master Presentation
A clause-by-clause slide deck covering documentation, design controls, suppliers, production, CAPA, audit findings and a certification roadmap. Built for trainers, QA teams and anyone preparing for a certification audit.
- 16:9 widescreen — projects cleanly in any classroom or meeting room.
- Editable .pptx — add your logo, product examples and internal references.
- No sign-up — free for personal and internal training use.
What's inside
64 slides across 10 sections
Every ISO 13485 clause is broken into short slides with clause references, practical checks and the audit findings each one usually attracts.
| Slides | Section | Covers | Count |
|---|---|---|---|
| 2–6 | Foundations | Purpose and scope, ISO 13485 vs ISO 9001, global regulatory mapping, clause structure, process approach and risk-based thinking. | 5 |
| 7–15 | Clause 4 — QMS & Documentation | General requirements, documentation hierarchy, quality manual, Medical Device File, control of documents and records, electronic records and QMS software. | 9 |
| 16–22 | Clause 5 — Management Responsibility | Leadership commitment, customer focus, quality policy and objectives, responsibility and authority, management review inputs and outputs, common findings. | 7 |
| 23–28 | Clause 6 — Resource Management | Resources and human competence, training programme lifecycle, infrastructure, work environment and cleanrooms, contamination control. | 6 |
| 29–39 | Clause 7.1–7.3 — Planning & Design Controls | Realisation planning, customer-related processes, design planning, inputs, outputs, reviews, verification vs validation, transfer, change control, design files, IEC 62304. | 11 |
| 40–44 | Clause 7.4 — Purchasing & Supplier Control | Purchasing process, supplier categorisation, purchasing information, supplier verification, oversight of outsourced critical services. | 5 |
| 45–52 | Clause 7.5–7.6 — Production & Service | Controlled production, cleanliness, installation and servicing, process validation, sterile devices, identification and traceability, customer property, preservation, measuring equipment. | 8 |
| 53–59 | Clause 8 — Measurement & Improvement | Feedback and post-market surveillance, complaint handling and reporting, internal audits, monitoring and nonconforming product, data analysis KPIs, CAPA. | 7 |
| 60–63 | Certification & Roadmap | Stage 1 and Stage 2 audit process, top 10 audit nonconformities, and a step-by-step implementation roadmap. | 4 |
| 64 | Key Takeaways | Closing summary of the habits that keep a medical device QMS audit-ready. | 1 |
| 1–64 | Total | 64 |
Use it for
- Onboarding new QA, RA and production staff
- Pre-audit briefings before Stage 1 or Stage 2
- Internal auditor refresher sessions
- Gap-analysis workshops with your team
- Supplier and contract-manufacturer training
Keep in mind
- It summarises ISO 13485:2016 — it is not a substitute for buying the standard.
- Add your own product, process and site examples before delivering it.
- Keep attendance records if you use it for evidence of training.
- Free to use internally; please don't resell or rebrand it as your own paid course.
- Questions or a branded version for your site? Email info@skillmed.in.
Turn the slides into a certificate
Reading the deck is a good start. Completing modules and passing the exam gets you a verifiable certificate you can share.
Something out of date in the deck? Email info@skillmed.in and we'll fix the download. More free material lives on the resources page.