ISO 13485: every control, and what you already have

24 controls 219 frameworks share controls with it International held in the corpus

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

ISO 13485 Evidence & Implementation Kit

24 controls is the documentation set somebody has to write. This is that set, already written: an adopt-ready artifact for every control in policy and procedure text you edit rather than draft, and the evidence checklist an auditor asks for against each.

See what is in it, $249

The same set every buyer of this kit receives. Nothing here is produced on request.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you run	Shared controls
ISO 27799:2025	12	measure it →
MARS-E	12	measure it →
MDS2 (Medical Device)	12	measure it →
NIST SP 800-66	12	measure it →
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)	11	measure it →
NIST Privacy Framework	11	measure it →
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0	10	measure it →
FTC GLBA Safeguards Rule (16 CFR Part 314)	10	measure it →
Oman National Cybersecurity Framework	10	measure it →
TISAX	10	measure it →
Bahrain PDPL	9	measure it →
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)	9	measure it →

Every control

Code	Control	Also in
`ISO13485-01`	ePHI access controls and authorization	122
`ISO13485-02`	ePHI encryption at rest and in transit	112
`ISO13485-03`	Minimum necessary standard enforcement	89
`ISO13485-04`	Patient data de-identification procedures	89
`ISO13485-05`	Audit trail for ePHI access	121
`ISO13485-06`	Security management process and risk analysis	123
`ISO13485-07`	Workforce security and clearance procedures	12
`ISO13485-08`	Information access management	98
`ISO13485-09`	Security awareness and training program	23
`ISO13485-10`	Contingency planning for ePHI	0
`ISO13485-11`	Business associate management	0
`ISO13485-12`	Unique user identification and authentication	69
`ISO13485-13`	Automatic logoff and session management	0
`ISO13485-14`	Audit controls and monitoring	0
`ISO13485-15`	Integrity controls for ePHI	0
`ISO13485-16`	Transmission security and encryption	112
`ISO13485-17`	Facility access controls	98
`ISO13485-18`	Workstation security and use policies	0
`ISO13485-19`	Device and media controls	0
`ISO13485-20`	Disposal and re-use procedures	0
`ISO13485-21`	Security and privacy policies	0
`ISO13485-22`	Documentation and record retention	0
`ISO13485-23`	Compliance evaluation and review	0
`ISO13485-24`	Incident reporting procedures	0

Tell me when ISO 13485 files something new

One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.

What an auditor will ask you to produce

The artefacts named on the failure modes this framework speaks to.

Control testing plan
Test results
Effectiveness metrics
Remediation plan
internal audit plan and schedule
internal audit reports of the ISMS
Threat catalogue
Threat actor profiles
Intel sources list
Update log

How programmes fail on this

Failure modes named by this framework and others. Each opens the full record.

findings not remediated named by 14 frameworks
No insider threats named by 8 frameworks
Catalogue not refreshed named by 8 frameworks
Tactical only named by 8 frameworks
Design-only testing named by 6 frameworks
Exclusions unjustified named by 5 frameworks

What this page is

A control-level reference for ISO 13485, drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

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