ISO 13485:2016: every control, and what you already have

73 controls 101 frameworks share controls with it International verified against its source document

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

73 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 10005:2005	25	measure it →
ISO 19011:2018	20	measure it →
ISO 9001:2015	15	measure it →
ISO 9001	15	measure it →
ISO/IEC 38500:2024	13	measure it →
ISO 50001:2018	12	measure it →
ISO 31000:2018	11	measure it →
ISO/IEC 23894:2023	11	measure it →
ASIS SPC.1-2009	11	measure it →
ISO 22000:2018	10	measure it →
AS9100D	8	measure it →
ISO 27701:2019	6	measure it →

Every control

Code	Control	Also in
`4.1`	General requirements	30
`4.2`	Documentation requirements	4
`4.2.2`	Quality manual	0
`4.2.3`	Medical device file	0
`4.2.4`	Control of documents	3
`4.2.5`	Control of records	7
`5.1`	Management commitment	4
`5.2`	Customer focus	3
`5.3`	Quality policy	7
`5.4`	Planning	8
`5.4.1`	Quality objectives	6
`5.4.2`	Quality management system planning	1
`5.5`	Responsibility, authority and communication	0
`5.5.1`	Responsibility and authority	1
`5.5.2`	Management representative	0
`5.5.3`	Internal communication	4
`5.6`	Management review	33
`5.6.2`	Review input	3
`5.6.3`	Review output	2
`6.1`	Provision of resources	1
`6.2`	Human resources	1
`6.3`	Infrastructure	4
`6.4`	Work environment and contamination control	1
`6.4.1`	Work environment	1
`6.4.2`	Contamination control	0
`7.1`	Planning of product realization	3
`7.2`	Customer-related processes	1
`7.2.1`	Determination of requirements related to product	0
`7.2.2`	Review of requirements related to product	0
`7.2.3`	Communication	32
`7.3`	Design and development	13
`7.3.10`	Design and development files	6
`7.3.2`	Design and development planning	7
`7.3.3`	Design and development inputs	7
`7.3.4`	Design and development outputs	6
`7.3.5`	Design and development review	5
`7.3.6`	Design and development verification	5
`7.3.7`	Design and development validation	5
`7.3.8`	Design and development transfer	5
`7.3.9`	Control of design and development changes	1
`7.4`	Purchasing	2
`7.4.1`	Purchasing process	1
`7.4.2`	Purchasing information	2
`7.4.3`	Verification of purchased product	3
`7.5`	Production and service provision	12
`7.5.1`	Control of production and service provision	4
`7.5.10`	Customer property	2
`7.5.11`	Preservation of product	2
`7.5.2`	Cleanliness of product	0
`7.5.3`	Installation activities	1
`7.5.4`	Servicing activities	1
`7.5.5`	Particular requirements for sterile medical devices	0
`7.5.6`	Validation of processes for production and service provision	0
`7.5.7`	Particular requirements for validation of processes for sterilization and sterile barrier systems	0
`7.5.8`	Identification	15
`7.5.9`	Traceability	6
`7.5.9.2`	Particular requirements for implantable medical devices	0
`7.6`	Control of monitoring and measuring equipment	2
`8.2`	Monitoring and measurement	8
`8.2.1`	Feedback	1
`8.2.2`	Complaint handling	5
`8.2.3`	Reporting to regulatory authorities	4
`8.2.4`	Internal audit	31
`8.2.5`	Monitoring and measurement of processes	5
`8.2.6`	Monitoring and measurement of product	5
`8.3`	Control of nonconforming product	2
`8.3.2`	Actions in response to nonconforming product detected before delivery	0
`8.3.3`	Actions in response to nonconforming product detected after delivery	0
`8.3.4`	Rework	2
`8.4`	Analysis of data	1
`8.5`	Improvement	2
`8.5.2`	Corrective action	3
`8.5.3`	Preventive action	3

Tell me when ISO 13485:2016 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 this page is

A control-level reference for ISO 13485:2016, 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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