Six foundational documents that give your quality management system the structure auditors expect — Quality Manual, Document Control, Management Review, Internal Audit, Training SOP, and KPI Dashboard.
For QA managers and RA leads at medical device companies.
ISO 13485 auditors and FDA investigators do not audit your intentions. They audit your documents. A Quality Manual with vague scope, a document control procedure no one follows, management reviews with no documented outputs — these are the gaps that generate Major nonconformances and 483 observations before you even get to product-specific requirements.
Most device companies cobble together QMS documents from multiple sources with inconsistent structure, missing required elements, and no clear link between documents. This toolkit gives you six consistent, cross-referenced documents that build a coherent QMS foundation from day one.
From quality policy through objectives, audit, and training — every foundational layer covered.
Top-level QMS document defining your quality management system scope, exclusions, and policy. Structured to satisfy ISO 13485 §4.2.2 and FDA 21 CFR 820 quality system requirements. Includes documented scope statement, process interaction maps, and quality policy. Auditor-ready format.
Procedure governing document approval, review, distribution, and version control under 21 CFR 820.40 and ISO 13485 §4.2.4. Covers creation, approval workflow, change control, obsolete document handling, and master document register format. The #1 procedure every QMS needs first.
Standard operating procedure for management review meetings per ISO 13485 §5.6 and 21 CFR 820.20(c). Includes required input/output checklist, meeting agenda template, action item tracking, and minutes format that satisfies both FDA and notified body expectations.
Procedure and audit checklist for conducting ISO 13485 internal audits per §8.2.4 and 21 CFR 820.22. Covers audit planning, scheduling, auditor independence, finding classification (Major/Minor/Observation), and CAPA linkage. Checklist covers all 8 ISO 13485 clauses.
SOP for establishing, documenting, and verifying employee training and competency per ISO 13485 §6.2 and 21 CFR 820.25. Includes training matrix template, competency assessment criteria, OJT documentation, and training record retention requirements. Covers contractor and temp worker scenarios.
Structured template for setting measurable quality objectives per ISO 13485 §5.4.1 and 21 CFR 820.20(b). Includes 12 standard QMS KPIs (complaint rate, CAPA cycle time, audit findings, training compliance, etc.), target-setting methodology, and management review reporting format.
Every document maps to specific ISO 13485 clauses and FDA 21 CFR Part 820 requirements. One set of documents satisfies your FDA QSR and ISO certification audit simultaneously.
These six documents are the foundational layer every QMS needs. Customization-ready templates with placeholder fields — drop in your company name, scope, and processes and you are 80% done.
Written to answer the exact questions FDA investigators and ISO notified body auditors ask. Document structure, required fields, and process language are designed for audit evidence, not just compliance checkbox.
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“We were preparing for our ISO 13485 initial certification audit and realized our Quality Manual was a mess — copied from an old template with wrong scope statements. This kit gave us a clean foundation. Our auditor commented that our document structure was one of the best organized they had seen.”
“Our document control procedure was causing so many NCRs — people were using outdated forms constantly. The procedure from this kit had a clear version control workflow that we implemented in two weeks. Zero document control NCRs at our surveillance audit six months later.”
“The internal audit checklist alone was worth the purchase. I had been writing audit questions from scratch every year. This maps to every ISO 13485 clause with specific questions tied to real regulatory requirements. Cut my audit prep time from two days to two hours.”
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