> ISO standards management software: ISO 9001, 13485, 14001, 45001, 27001, 27701, 42001, 22301, 17025, 14971, IATF 16949, EU MDR and NIS2 at a glance.

Source: [https://docxpert.io/en/standards](https://docxpert.io/en/standards)

# ISO Standards Management Software | docxpert

## All standards at a glance

[ISO 9001Quality management: document control, competence, audits and improvement in one platform.Learn more](https://docxpert.io/en/standards/iso-9001) [ISO 13485Medical device QMS with document control, training records, CAPA and risk links.Learn more](https://docxpert.io/en/standards/iso-13485) [ISO 14001Environmental management: aspects, compliance obligations and evidence in order.Learn more](https://docxpert.io/en/standards/iso-14001) [ISO 45001Occupational health and safety with briefings, risk assessments and incidents.Learn more](https://docxpert.io/en/standards/iso-45001) [ISO 27001ISMS documentation, policies, Statement of Applicability and awareness training under control.Learn more](https://docxpert.io/en/standards/iso-27001) [ISO 27701Privacy management as an extension of your ISMS – roles, policies and evidence.Learn more](https://docxpert.io/en/standards/iso-27701) [ISO 42001AI management system with AI register, impact assessment, policies and competence records.Learn more](https://docxpert.io/en/standards/iso-42001) [ISO 22301Business continuity: document impact analysis, continuity plans and exercises.Learn more](https://docxpert.io/en/standards/iso-22301) [ISO/IEC 17025Laboratory quality with controlled methods, competence records and nonconforming work.Learn more](https://docxpert.io/en/standards/iso-17025) [ISO 14971Medical device risk management – a controlled, traceable risk management file.Learn more](https://docxpert.io/en/standards/iso-14971) [IATF 16949Automotive QMS with customer-specific requirements, core tools and contingency plans.Learn more](https://docxpert.io/en/standards/iatf-16949) [EU MDRKeep technical documentation, post-market surveillance and clinical evaluation under control.Learn more](https://docxpert.io/en/standards/eu-mdr) [NIS2Implement risk management measures, management training duties and reporting deadlines.Learn more](https://docxpert.io/en/standards/nis2)

## 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.

| Area | Standards and regulations |
| --- | --- |
| Quality | [ISO 9001](https://docxpert.io/en/standards/iso-9001), [IATF 16949](https://docxpert.io/en/standards/iatf-16949), [ISO 17025](https://docxpert.io/en/standards/iso-17025) |
| Medical devices | [ISO 13485](https://docxpert.io/en/standards/iso-13485), [ISO 14971](https://docxpert.io/en/standards/iso-14971), [EU MDR](https://docxpert.io/en/standards/eu-mdr) |
| Environment and health & safety | [ISO 14001](https://docxpert.io/en/standards/iso-14001), [ISO 45001](https://docxpert.io/en/standards/iso-45001) |
| Information security and resilience | [ISO 27001](https://docxpert.io/en/standards/iso-27001), [NIS2](https://docxpert.io/en/standards/nis2), [ISO 22301](https://docxpert.io/en/standards/iso-22301) |
| Privacy and AI | [ISO 27701](https://docxpert.io/en/standards/iso-27701), [ISO 42001](https://docxpert.io/en/standards/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](https://docxpert.io/en/features/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.

## Read next

[Template library65 templates for 20 standards and regulations – tailored to your company, in English and German.Learn more](https://docxpert.io/en/features/template-library) [Gap analysisCheck existing documents against standard requirements and work off gaps as tasks.Learn more](https://docxpert.io/en/features/gap-analysis) [GuidesPractical guides for quality, information security and compliance teams.Learn more](https://docxpert.io/en/guides) [ChecklistsFree checklists for audits, certification, NIS2 and the EU AI Act – online and as PDF.Learn more](https://docxpert.io/en/checklists)

## 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.

[Start free trial](https://docxpert.io/en/trial)[See pricing](https://docxpert.io/en/pricing)