The ISO 9001 is an internationally recognized standard for quality management systems (QMS). It serves as a guideline for companies to make their processes more efficient, reduce risks, and sustainably strengthen customer trust. The standard is intended to ensure that processes are planned, controlled, and systematically improved. A central principle of the standard is continuous improvement: not today’s perfect solution is the focus, but the continuous optimization with a view to the future.
Historical development of the standard
The origins of quality standards can be traced back to the military quality requirements of the 1950s, for example, to ensure traceability and documentation – a precursor to later standard systems.
- 1987: Publication of the first official version.
- 1994: Revision with stronger requirements for preventive measures and clarification of existing provisions.
- 2000: Introduction of the process-oriented approach using the PDCA cycle (Plan–Do–Check–Act).
- 2008: Clarifications and adjustments of existing requirements.
- 2015: Stronger focus on risk and opportunity management, analysis of the organizational context, and performance evaluation.
- 2024: With Amendment 1:2024 to ISO 9001:2015 (“Climate action changes”), climate change aspects were added to the standard. Specifically, Sections 4.1 (Context of the Organization) and 4.2 (Interested Parties) were supplemented to require organizations to verify whether climate change is a relevant issue for their quality management system and consider the corresponding requirements of relevant stakeholders.
- 2026 (planned): The next revision is expected to be published in the second half of 2026, currently scheduled for September, as ISO 9001:2026, adapted to the Harmonized Structure (HS). The current draft standard (DIS) indicates that, in particular, topics such as digitalization, sustainability, climate change, supply chain management, and resilience management, as well as quality culture, are to be addressed more strongly. The final content will, as usual, only be determined upon publication of the final version of the standard.
The seven basic principles
The standard is based on seven basic principles that are considered guidelines for successful business management:
- Customer orientation: Customer needs are the focus.
- Leadership responsibility: Company management exemplifies quality awareness.
- Involvement of people: Employees are actively involved and strengthened in their competencies.
- Process-oriented approach: Companies are viewed as a total system of interconnected processes.
- Continuous improvement: Continuous optimization is mandatory.
- Fact-based decision making: Decisions are based on data and facts.
- Relationship management: Cooperation with partners and suppliers is promoted.
Structure of the standard
The current version, ISO 9001:2015, is structured according to the High-Level Structure (HLS), which has since been further developed into the Harmonized Structure (HS), and comprises ten sections. In particular, sections 4 to 10 contain the binding requirements:
- Context of the organization: Understanding internal and external influencing factors.
- Leadership: Commitment of company management to the introduction of the QMS.
- Planning: Definition of objectives, evaluation of risks and opportunities, planning of changes.
- Support: Provision of resources, knowledge, and technologies.
- Operation: Control of operational processes, including development, production, and service, if applicable.
- Performance evaluation: Review through audits and management evaluations.
- Improvement: Correction of deviations and continuous further development.
The HLS facilitates integration with other standards, such as the ISO 14001 for environmental management.
Areas of application
The ISO 9001 can be applied across various industries and adapted to suit the size and structure of a company.
In the pharmaceutical industry, it complements Good Manufacturing Practice (GMP) systems by supporting overarching quality management principles and process control.
Additionally, the automotive industry utilizes ISO 9001. It forms the basis for standards such as IATF 16949, which is based on ISO 9001 and includes additional, automotive-specific requirements, including error prevention, risk management, and reduction of variation and waste.
Another major field of application is the service sector, as the standard creates standardized processes to strengthen customer trust.
Advantages and challenges
The ISO 9001 is fundamentally aimed at improving customer satisfaction and brings greater customer trust through a structured quality management system. It leads to increased efficiency and error reduction through clearly defined processes. Communication and employee engagement are also improved. In addition, it enables access to new markets through the international recognition of certification.
In addition to the advantages, the standard also brings challenges. Certification requires documentation effort, which is more flexible than before, however. There is a risk of over-bureaucratization. The introduction, certification, and regular audits entail high costs, which, however, are offset by the advantages.
The ISO 9001 certification
Independent bodies carry out the certification. The process involves analyzing existing processes, implementing the requirements of ISO 9001, and conducting internal audits.
Ultimately, an external audit by the certification body is conducted, following which, if conformity is demonstrated, certification is issued.
An ISO 9001 certificate is usually valid for three years. In the first two years of the cycle, surveillance audits are conducted (usually annually). In the third year, a recertification audit is performed, marking the initiation of the next three-year period.
Process descriptions, records, and documented information are central evidence for certification. A QM manual is optional; although a classic QM manual has not been mandatory since ISO 9001:2015, it can still be used voluntarily.