ISO 9001

CIBORIUS is certified to ISO 9001.

ISO 9001 is the most important international standard for quality management systems. It sets cross-sector minimum requirements that organisations have to meet in order to deliver products and services consistently – products and services that meet customer expectations as well as statutory and regulatory requirements.

The standard is published by the International Organization for Standardization (ISO) and is recognised worldwide. In principle it applies to any organisation – regardless of size, sector or location.

Current state of the standard (2026)

• ISO 9001:2015 – the version currently in force (German version: DIN EN ISO 9001:2015)
• ISO/DIS 9001:2025 – draft of the coming revision (publication planned for autumn 2026)
• ISO 9001:2015/Amd 1:2024 – additions on climate-related action

The coming 2026 revision will place greater emphasis on digitalisation, sustainability, quality culture and ethical conduct.

Purpose and significance

ISO 9001 aims to strengthen an organisation’s ability to deliver products and services that consistently meet customer requirements. At the same time, the quality management system itself is to be subject to continuous improvement. The standard builds confidence in the quality and reliability of the organisation and raises customer satisfaction.
Worldwide, more than 1.2 million organisations in over 189 countries are certified to ISO 9001. In Germany, around 51,000 organisations hold such a certification.

Core areas of requirement

The current standard is based on the High Level Structure with ten clauses and requires:

• Context of the organisation (analysis of external and internal issues, interested parties)
• Leadership and commitment on the part of top management
• Planning with a risk-based approach
• Support (resources, competences, documentation)
• Operation (process planning, product development, service delivery)
• Performance evaluation (monitoring, measurement, analysis, internal audits)
• Improvement (corrective action, continuous improvement)

Process approach and principles

ISO 9001 follows a process-oriented approach based on the PDCA cycle (plan-do-check-act). The standard requires the interactions between processes to be set out, and risk-based thinking to be built into all activities.
The seven quality management principles of ISO 9000 form the conceptual basis:

• Customer focus
• Leadership
• Engagement of people
• Process approach
• Improvement
• Evidence-based decision making
• Relationship management

How it differs from industry-specific standards

ISO 9001 is a generic system standard that serves as the basis for industry-specific quality standards:

• IATF 16949 – for the automotive industry (stricter requirements than ISO 9001)
• ISO 13485 – for manufacturers of medical devices
• EN 15224 – for healthcare
• DIN 77200 – for security services (goes beyond ISO 9001 with industry-specific requirements)

While ISO 9001 defines general quality requirements, industry-specific standards add further, specialised ones.

The certification procedure

Certification is carried out by accredited, independent certification bodies (for example TÜV, DEKRA, DQS, VdS).
The procedure comprises:

• Stage 1 audit – review of documentation and readiness assessment
• Stage 2 audit – the main audit, examining effectiveness in practice (one to two days depending on company size)
• Issue of the certificate once the audit is passed

Certificates are valid for three years, with annual surveillance audits. After three years a recertification audit is required.

Cost and time required

The cost of ISO 9001 certification varies with company size, headcount and process complexity:

• Small companies: 3,000 to 8,000 euros (for three years including surveillance audits)
• Medium-sized companies: 8,000 to 25,000 euros
• Large companies: from 25,000 euros

Implementing a quality management system normally takes two to six months. The internal effort for preparation averages around 80 hours.

Benefits of certification

For organisations: improved business processes, higher customer satisfaction, reduced risk, process optimisation, lower costs, access to tenders, greater market confidence, improved competitiveness.
For customers and partners: verifiable quality, reliability in service delivery, and assurance regarding statutory compliance.

Integration with other management systems

Thanks to the common High Level Structure, ISO 9001 is compatible with other management system standards such as:

• ISO 14001 (environmental management)
• ISO 45001 (occupational health and safety management)
• ISO 27001 (information security)

This makes it easier to integrate several management systems within one company.

Related standards

• ISO 9000 – fundamentals and vocabulary for quality management systems
• ISO 9004 – guidance for sustained success and self-assessment
• ISO 19011 – guidelines for auditing management systems