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)
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