ISO 9001:2015 is an international standard for quality management systems that can be applied across all industries. It defines responsibilities and processes in order to continuously improve the company organization.
Modern companies must be innovative, adaptable and quality-oriented. Systematic quality management with clear processes and responsibilities helps them to meet the highest standards and remain competitive.
In summer 2023, the ISO/TC 176 SC2 technical committee decided to revise ISO 9001:2015. Publication of the revised standard was originally planned for the end of 2025. However, according to current information, completion is likely to be delayed until autumn 2026.
The revision aims to adapt the standard to current developments. Planned focal points include
These adjustments are intended to ensure that ISO 9001 fulfils current requirements and supports companies in continuously improving their processes.
TÜV Saarland Certification GmbH recommends that companies follow the developments closely and start planning the implementation of the new requirements at an early stage. Our experts are available to provide you with advice and assistance to inform you about the effects of the revision for certified customers.
The international standard ISO 9001 defines the requirements for a quality management system (QMS) that companies must implement in order to fulfil the expectations of internal and external stakeholders. ISO 9001 is based on seven principles of quality management (source: DIN EN ISO 9000):
The current DIN EN ISO 9001:2015 has a superordinate structure called “High Level Structure” (HLS) and is therefore compatible with other ISO standards for management systems (such as ISO/IEC 27001, ISO 50001, ISO 45001, ISO 14001). In addition, DIN EN ISO 9001 is characterised by economical, market-oriented, sustainable and user-friendly operating procedures.
One of the key features of ISO 9001 is the risk-based approach, which identifies opportunities and potential hazards, derives suitable measures and evaluates their effectiveness. This ensures that the quality management system and the accompanying processes in your company achieve the desired results.
The current, German-language version of DIN EN ISO 9001:2015 is available from DIN Media Verlag.
When companies obtain ISO 9001 certification, they go through a multi-stage certification process. If a certified management system is already in place, the process can be shortened.
A quality management system (QMS) is a structured framework of defined processes, specifications and tasks that supports companies in providing their products and services to a consistently high level of quality. It helps to minimise risks, increase efficiency and ensure the continuous improvement of business processes.
ISO 9001 is an internationally recognised standard for quality management systems that was first published by the International Organisation for Standardisation (ISO) in 1987. It specifies the requirements for companies to establish an effective quality management system that fulfils both internal and external requirements.
A quality management system in accordance with ISO 9001 serves to sustainably improve products, services and processes. The systematic integration of quality management in all areas of the company increases customer satisfaction, operational processes become more efficient and company goals are achieved in a more targeted manner. The new ISO 9001 also enables the economic, market-orientated and sustainable design of operational processes.
The certification of a quality management system according to ISO 9001 offers numerous advantages - regardless of company size, industry or orientation:
Competitive advantage: You receive a recognised proof of quality that strengthens your company in the eyes of customers and business partners.
Greater efficiency: Optimising your processes leads to improved productivity and lower error rates.
Cost reduction: Unnecessary costs can be avoided through targeted process control.
Risk minimisation: Proactive risk management helps you to identify and solve potential problems at an early stage.
Increase customer satisfaction: Standardised processes and a consistent customer focus improve the quality of your products and services.
The High Level Structure (HLS) is a standardised basic structure for all new and revised ISO management standards. It facilitates the integration of multiple systems in a company through standardised terms, content and chapter layouts.
The ten main chapters of the HLS are:
Area of application
Normative references
Terms
Context of the organisation
Guidance
Planning for the quality management system
Support for
Operation
Evaluation of performance
Improvement
HLS consistently implements the Plan-Do-Check-Act (PDCA) cycle in all processes and supports continuous improvement (CIP).
The risk-based approach is a central component of ISO 9001, which requires the systematic identification and assessment of risks and opportunities that could influence business success.
Relevant chapters on risk assessment:
6.1 - Risks and opportunities
4.1 - Context of the organisation
4.2 - Interested parties
4.4 - Processes
9.3 - Management review
The aim is not only to minimise risks, but also to identify and exploit opportunities in order to further develop the company strategically.