- Introduction (0)
- Object and field of application (1)
- Normative references (2)
- Terms and definitions (3)
- Context of the organization(4)
- Leadership (5)
- Planning (6)
- Support (7)
- Operation (8)
- Performance evaluation (9)
- Improvement (10)
General historical development of the norm
- 1979: BS 5750 First quality assurance standard, published by British Standards Institute (BSI).
- 1987: ISO 9000 family, based on BSI 5750 and published by ISO.
- 1994: The ISO 9000 family is modified.
- 2000: New version of the ISO 9000 family.
- 2008: Update of the 2000 version.
- 2015: Last update of the standard.
Explanation of the rule
The following is a general description of the standard’s numerals, the complete information and the support material you can download for free from the links published in the downloads section.
First we must reflect on the meaning of QUALITY. Watch the following videos that can help in this purpose.
What is certification?
It is the voluntary process by means of which a third party (Certifying Body), different from the producer and consumer, validates and assures in writing that a product and / or service complies with previously specified requirements.
Certification MUST BE Seen as an Acknowledgment NEVER as an End
The guarantee that the product that has a seal of quality meets all the requirements of an ISO standard.
Principles of quality management
PHVA cycle vs numerals of the norm
4. Context of the Organization
- Understanding of the organization and its context
- Understanding the needs and expectations of interested parties
- Determination of the scope of the Quality Management System
- The Quality Management System and its Processes (Strategic, mission and support)
Includes the following items:
- Leadership and commitment
- Focus on the client
- Establishment of the quality policy
- Communication of the quality policy
- Roles, authorities and responsibilities in the organization
Includes the following items:
- Actions to address risks and opportunities
- Quality objectives and planning to achieve them
- Planning changes
Analysis and treatment of risks
- Environment for the operation of processes
- Monitoring and measurement resources
- Traceability of measurements
- Knowledge of the organization
- Documented information
- Creation and update
- Control of documented information
- Planning and operational control
- Requirements for products and services
- Communication with the customer
- Determination of requirements for products and services
- Review of requirements for products and services
- Changes in the requirements of products and services
- Design and development of products and services
- Control of processes, products and services supplied externally
- Type and scope of control
- Information for external providers
- Production and provision of the service
- Release of products and services
- Control of non-conforming outputs
9. Performance evaluation
- Monitoring, measurement, analysis and evaluation
- Internal audit
- Review by the Directorate
- Non-compliance and corrective action
- Continuous improvement
More reference material in the Downloads section
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