ISO 9001

Conformed by the following numerals

0. Introduction

1. Object and field of application

2. Normative references

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

General historical development of ISO 9001

  • 1979: BS 5750 First quality assurance standard, published by the British Standards Institute (BSI)
  • 1987: ISO 9000 family, based on BS 5750 and published by ISO
  • 1994: The ISO 9000 family is modified
  • 2000: New version of the ISO 9000 family
  • 2008: Upgrading version 2000
  • 2015: Last update of the standard


General historical development of ISO 9001

Below is a general description of the numerals of the standard, the complete information and the support material can be downloaded free of the links published in the section of downloads.

First we must reflect on the meaning of QUALITY. Watch the following videos that can help you in this regard.


What is certification according to ISO 9001?

It is the voluntary process through which a third party (Certification Body), other than the producer and consumer, validates and assures in writing that a product and / or service meets certain pre-specified requirements.

Certification with a standard should be seen as an acknowledgment

Never as an end

The certification is

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

Download Workshop 1 on the Quality Management System


Principles of Quality Management

PHVA cycle vs. norm numerals

4. Context of the organization

Includes the following items:

  1. Understanding the organization and its context

  2. Understanding stakeholder needs and expectations

  3. Determination of the scope of the Quality Management System – SGC

  4. The Quality Management System and its processes. (Strategic, missionary and support)


5. Leadership

Includes the following items:

  1. Leadership and commitment

  2. Customer focus

  3. Establishment of quality policy

  4. Communication of the quality policy

  5. Roles, authorities and responsibilities in the organization

6. Planning

Includes the following items:

1. Actions to address risks and opportunities

2. Quality objectives and planning to achieve them

3. Planning changes

Analysis and treatment of risks

7. Support

Includes the following items:

  1. Resources
    1. People

    2. Infrastructure

    3. Environment for the operation of the processes

    4. Monitoring and measurement resources

    5. Traceability of measurements

    6. Knowledge of the organization

  2. Competition

  3. Awareness raising

  4. Communication

    1. Documented information

    2. Creation and update

    3. Control of documented information

Download the tool to perform the initial diagnosis

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 requirements for products and services

    4. Changes in product and service requirements

  3. Design and development of products and services

  4. Control of externally supplied processes, products and services

    1. Type and scope of control

    2. Information for external suppliers

  5. Production and service provision

  6. Release of products and services

  7. Control of nonconforming outputs

9. Performance evaluation

Includes the following items:

  1. Monitoring, measurement, analysis and evaluation

  2. Internal audit

  3. Management Review


10. Improvement

Includes the following items:

  1. Nonconformity and corrective action

  2. Continuous improvement

Download the complete presentation for ISO 9001 courses

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