Document Control, Records & Training

Document Control, Records & Training Toolkits

Document control, records control, and training are foundational to every functioning ISO 13485 system. If these areas are weak, the rest of the QMS becomes inconsistent, difficult to maintain, and hard to defend during audit. This collection brings together the tools you need to structure controlled documentation, protect record integrity, manage staff competence, and support training with real evidence.

These products are designed for teams that need more than a basic SOP template library. They help you build the supporting mechanisms that keep a quality system usable over time: revision control, controlled distribution, master document visibility, training assignment, competence records, and proof that people were trained appropriately for the work they perform.

What This Collection Includes

  • Document control systems and bundles
  • Master document list and controlled document architecture tools
  • Training kits for core ISO 13485 processes
  • Competence and training systems aligned to clause 6.2
  • Record control support documents and training evidence structure
  • Bundled products supporting broader QMS architecture

Who This Collection Is For

  • QA teams building controlled documentation systems
  • Businesses replacing informal file-sharing and training methods
  • Startups preparing for certification and needing stronger QMS discipline
  • Consultants implementing document architecture for clients
  • Organizations scaling from founder-led control to team-based control

Why These Controls Matter

Many quality systems fail not because the company lacks procedures, but because the company cannot prove which version was approved, who had access, what changed, who was trained, and whether records are complete and retrievable. These toolkits help you fix that. They create the structure that makes the rest of the QMS maintainable, consistent, and auditable.

Strengthen the Core Infrastructure of Your QMS

If your system needs more control over documents, records, competence, and training delivery, this collection gives you the practical tools to build that backbone properly.

Three ways to buy ISO 13485 templates

Start with the gap assessment, build the core system with the Starter Kit, or get every kit at once. Upgrade credits mean you never pay twice for the same kit.

Gap Assessment Workbook See where you stand before you commit $49View Gap Assessment WorkbookStarter Kit Core system: 6 kits for clauses 4 to 6 and 8 $249 $504View Starter KitBest valueComplete QMS Kit All 15 kits, including design, risk and production $449 $1,375View Complete QMS Kit
Gap assessment, 71 requirement areas with action plan
Quality manual and management review kit
Document control and records kit
CAPA and nonconformance kit
Internal audit kit
Training and competence kit (8 modules)
Design controls and DHF kit, ISO 14971 risk management file kit
Supplier control, production and traceability, equipment and calibration kits
Software validation, medical device file and labelling kits
Complaint handling, PMS and vigilance kit, plus the process validation IQ/OQ/PQ pack
Start-here roadmap to certification
Optional 60-minute onboarding call with the author
30-day money-back guarantee, instant download, one-organization licence, free updates for this edition

Prices in USD. Crossed-out prices are the combined price of the included items bought separately. Own a smaller kit already? Upgrade credits are listed on each product page. Still unsure? Which kit is right for me?

Instant downloadFiles by email within minutes
Fully editableWord, Excel, PowerPoint. No macros
30-day money-back guaranteeDoesn't fit your system? Full refund, no fuss
Free updatesRevised files sent free when the standard changes

Not sure which ISO 13485 kit you need?

Run the free ISO 13485 gap assessment to see where you stand, then compare the Starter Kit, the Complete Kit and the individual kits side by side.

Get the free gap assessmentCompare ISO 13485 kits