ISO 13485 Starter Kit

The six kits most organizations need first to build a certifiable ISO 13485 quality management system: the quality manual and management review, document control, CAPA, internal audit, training with eight ready modules, and a gap assessment to plan the work.

Bought separately these kits cost $504. The bundle is $249.

Kits included

• ISO 13485 Gap Assessment Workbook: Score your QMS against 71 ISO 13485 requirement areas with an automatic dashboard.
• ISO 13485 Quality Manual & Management System Kit: Quality manual, policy, objectives, management review and data analysis templates in one kit.
• ISO 13485 Document Control & Records Kit: Document and records control SOPs, master document list, retention schedule and two training modules.
• ISO 13485 CAPA & Nonconformance Kit: NC and CAPA procedure, registers, root cause toolkit and a CAPA training module.
• ISO 13485 Internal Audit Kit: 71-row ISO 13485 audit checklist, audit SOP, programme, plan, report and auditor training.
• ISO 13485 Training & Competence Kit (8 Training Modules): Training SOP, matrix and records plus 8 ready-to-run ISO 13485 training modules.

How it's organized

Each kit sits in its own numbered folder, in a practical implementation order, with its own Start Here guide. A bundle Start Here guide gives you the roadmap and a realistic timeline to certification. Training modules are kept once, in the Training & Competence Kit folder.

Need design controls, risk management, production or post-market too? The Complete QMS Kit adds the other nine kits.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Includes a Start Here guide with the contents and how to use them.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.