ISO 9001

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Conformed by the following numerals:

  1.  Introduction (0)
  2. Object and field of application (1)
  3. Normative references (2)
  4. Terms and definitions (3)
  5. Context of the organization(4)
  6. Leadership (5)
  7. Planning (6)
  8. Support (7)
  9. Operation (8)
  10. Performance evaluation (9)
  11. 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

Certification is

The guarantee that the product that has a seal of quality meets all the requirements of an ISO standard.

Access resources on Quality Management Systems

Principles of quality management

PHVA cycle vs numerals of the norm

4. Context of the Organization

Includes the following items:

  • 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)

5. Leadership

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

6. Planning

Includes the following items:

  • Actions to address risks and opportunities
  • Quality objectives and planning to achieve them
  • Planning changes

Analysis and treatment of risks

7. Support

Includes the following items:

  1. Resources
    1. People
    2. Infraestructure
    3. Environment for the operation of processes
    4. Monitoring and measurement resources
    5. Traceability of measurements
    6. Knowledge of the organization
  2. Competition
  3. Awareness
  4. Comunication
    1. Documented information
    2. Creation and update
    3. Control of documented information

Obtenga la herramienta para efectuar Diagnóstico Inicial

8. Operation

Includes the following items:

  1. Planning and operational control
  2. Requirements for products and services
    1. Communication with the customer
    2. Determination of requirements for products and services
    3. Review of requirements for products and services
    4. Changes in the requirements of products and services
  3. Design and development of products and services
  4. Control of processes, products and services supplied externally
    1. Type and scope of control
    2. Information for external providers
  5. Production and provision of the service
  6. Release of products and services
  7. Control of non-conforming outputs

9. Performance evaluation

Includes the following items:

  1. Monitoring, measurement, analysis and evaluation
  2. Internal audit
  3. Review by the Directorate

10. Improvement

Includes the following items:

  1. Non-compliance and corrective action
  2. Continuous improvement


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More reference material in the Downloads section

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