ISO 13485 Document Control & Records Kit

Document control is the first thing an auditor samples. This kit gives you the procedures, the master list and the registers to prove every document in use is current and approved, and every record is retrievable for as long as you need it.

What's inside (18 files)

• Procedures: Document Control SOP; Records Control SOP.
• Registers and Logs: Archived Document Review Log; Backup Verification Log; Document Control Register; External Document Register; Master Document List; Records Destruction Log; Records Retention Schedule.
• Training: Document Control training module (slides, trainer guide, workbook, assessment); Records Management training module (slides, trainer guide, workbook, assessment).

How to use it

1. Adapt the Document Control SOP: numbering scheme, approval levels and how obsolete documents are handled.
2. Load every controlled document into the Master Document List with owner, revision and review date.
3. Record standards and regulations in the External Document Register.
4. Set retention periods in the Records Retention Schedule (at least device lifetime and not less than two years from release).
5. Run the two training modules with everyone who writes, approves or uses controlled documents.

Who it's for

Any medical device organization setting up document control, or fixing document control findings.

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.
• Also in the ISO 13485 Starter Kit and the Complete QMS Kit, which cost less than buying kits separately.