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Standards and regulations

ISO standards management software for every framework you need

Quality, environment, health and safety, information security, privacy, AI and medical devices: docxpert covers the most important ISO standards and regulations in one management software. For each standard you'll find what it requires and how docxpert supports implementation.

All standards at a glance

One system for several standards

Most ISO management system standards follow the shared Harmonized Structure with clauses 4 to 10. Context, policy, roles, control of documented information, internal audit, management review and improvement are therefore structured similarly everywhere. In docxpert you use shared documents for them: templates contain sections that only appear when the respective standard applies to you.

AreaStandards and regulations
QualityISO 9001, IATF 16949, ISO 17025
Medical devicesISO 13485, ISO 14971, EU MDR
Environment and health & safetyISO 14001, ISO 45001
Information security and resilienceISO 27001, NIS2, ISO 22301
Privacy and AIISO 27701, ISO 42001

For ISO 9001, ISO 13485, ISO 14001, ISO 27001, ISO 27701, ISO 42001, NIS2, the EU AI Act, the Cyber Resilience Act and EASA Part-IS, a requirement catalogue for the gap analysis is also built in.

Frequently asked questions

Does docxpert certify my management system?

No. Certification and accreditation are carried out by independent bodies. docxpert is the tool you use to build and run your system and to provide the evidence for the audit.

Can I cover several standards at once?

Yes. You select the standards that apply to you, and templates show the matching sections. Shared documents such as the policy, roles or internal audit are maintained only once.

Is a standard I need missing?

The template library covers 20 standards and regulations, including AS9100D, FDA 21 CFR 820, 21 CFR Part 11, EU GMP Annex 11 and the Cyber Resilience Act. You can create your own templates for further frameworks at any time.

Try docxpert free for 14 days

Document control, approvals, training and evidence in one platform – with English and German templates for more than ten standards.