Quality Management Systems title – Requirements (ISO 9001:2015)
Requirements for a quality management system (QM system)
Last edition 2008-12 ISO 9001 EN ISO 9001 specifies the minimum requirements for a quality management system (QM system) that an organization must meet in order to be able to provide products and services that meet customer expectations and any regulatory requirements. At the same time, the management system should be subject to a continuous improvement process.
The introduction of a quality management system is a strategic decision for an organization. If an organization wants to become more customer-oriented to gain competitive advantage, it has to co-operate with this standard. The standard only provides a specific framework, which is much broader than the previous standards.
The process-oriented approach is based on the four main processes of an organization, which convert an input into an output. The standard looks at these processes (operations) and compares the target specifications (plans) with the actual values. In the event of deviations, improvements and changes are defined and planned. This closes the circle of Plan – Do – Check – Act, also known as the PDCA cycle.
(Chapters 1-3 contains general information)
4.1 General requirements
4.2 Dokumentationsanforderungen (dokumentierte Anforderungen, QM-Handbuch, Lenkung von Dokumenten, Lenkung von Aufzeichnungen) => 4.2 Documentation requirements (documented requirements, QM manual, control of documents, control of records)
5.1 Managment´s commitment
5.2 Customer orientation
5.3 Quality policy
5.4 Planning
5.5 Responsibility, Authority and Communication
5.6 Management review
6.1 Provision of Resources
6.2 Human resources
6.3 Infrastructure
6.4 Work Environment
7.1 Planning product implementation
7.2 Customer-related processes
7.3 Development (this point can be excluded during certification)
7.4 Procurement
7.5 Production and service provisioning
7.6 Control of monitoring and measuring equipment
8.1 General
8.2 Monitoring and measurement
8.3 Control of defective products
8.4 Data analysis
8.5 Improvement
The current EN ISO 9001 was last revised in 2008 (EN ISO 9001:2008). Dubbed an “amendment”, this is not a major change, but mostly clarifications (e.g. through the choice of words “legal and official requirements”, definition of “outsourced process”, choice of words “competence” instead of “training”, introduction of the term “risk ” in the introduction)
At vero eos et accusamus et iusto odio dignissimos ducimus qui blanditiis praesentium voluptatum deleniti atque corrupti quos dolores et quas molestias excepturi sint occaecati cupiditate non provident, similique sunt in culpa qui officia deserunt mollitia animi, id est laborum et dolorum fuga.
Nam libero tempore, cum soluta nobis est eligendi optio cumque nihil impedit quo minus id quod maxime placeat facere.
Nam libero tempore, cum soluta nobis est eligendi optio cumque nihil impedit quo minus id quod maxime placeat facere.
Et harum quidem rerum facilis est et expedita distinctio.
Nam libero tempore, cum soluta nobis est eligendi optio cumque nihil impedit quo minus id quod maxime placeat facere possimus, omnis voluptas assumenda est, omnis dolor repellendus.
Et harum quidem rerum facilis est et expedita distinctio.
Nam libero tempore, cum soluta nobis est eligendi optio cumque nihil impedit quo minus id quod maxime placeat facere possimus, omnis voluptas assumenda est, omnis dolor repellendus.
We work dedicatedly and with full commitment for our customers. We enjoy our work. You can see this in the way we treat each other and in the quality of our work.