ISO 9001:2015 is the fourth edition of ISO 9001 quality management system. It does not contain any new requirements and simply elaborates the existing system by fine tuning the clauses of ISO 9001: 2015
ISO 9001:2008 specifies requirements for a quality management system where an organization
- Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
- Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
An organization in order to operate efficiently must focus and manage many activities connected to each- other.
An activity that employs resources and that is managed to allow the transformation of incoming elements into out coming elements can be considered a process.
Sometimes an out coming element is the incoming element on the next process.
The model PDCA (Plan, Do, Check, Act,) can be applied to all the processes.
The standard is divided into 5 paragraphs
- Paragraph 4: "quality system management" concerning the general requirements and the system documentation
- Paragraph 5: "management responsibility" that defines the management roles and responsibilities
- Paragraph 6: "management resources" concerning human resources and materials
- Paragraph 7: "production" that is the core of the organization's activity
- Paragraph 8: "measurements, analysis and amelioration" concerning the activities of measurement and analysis with the aim of a continuous improvement that is the base of the standards itself.