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Student: Julio Noguera

E2016590
ORIGIN

ISO, the International Standard Organization, is an independent,

non-governmental organization that currently gathers 162

members from different countries around the world. This

organization began after World War II (February 1947) where

delegates from 25 countries met in England to coordinate and

unify global standards


ORIGIN
ISO 9001 reviews.
- ISO 9001: 1987: Original Version.
- ISO 9001: 1994: First revision of original model.
- ISO 9001: 2000: Second revision of the original
model.
- ISO 9001: 2008: Third revision of the original
model.
- ISO 9001: 2015: Fourth revision of the original
model
EVOLUTION
Importance

Quality management system is the set of interrelated norms of a


company or organization by which the quality of the company is managed
in an orderly way, in the search for the satisfaction of its customers.
The program provides all the basic foundations underlying quality
management and considers that the success of an organization should be
the result of implementing and maintaining a customer-oriented
management system, based on the definition of systems and processes
that Are clearly understandable, manageable and improveable.
Objetives
Leadership

Quality politics

Quality objectives

Awareness raising

Competition

Address Review
New Structure
Changes in
ISO
9001:2015
Risk-based approach
It is based on the process approach, leadership and planning, as they are the places where
certain risks can happen.
Process Focus
The processes have to be defined in an orderly and clear way.
Documented information
The term refers to what is known as documents, records and processes documented in the
Quality Management System.
Goods and services
In the old rule they were called products, but it has changed since this way is a much clearer
term when establishing or making communications with suppliers.
Requirements of the standard 9001 : 2015

The organization shall establish, document, implement and maintain a Quality


Management System, and continuously improve efficiency in accordance with the
requirements of the standard:

Identify the processes required for the Quality Management System


Determine the sequence and interactions of such processes.
Determine the criteria and methods of operation and control of such processes.
Ensure the availability of resources the necessary information for the operation
and monitoring of such processes.
Monitor, measure and analyze such processes. Implement necessary actions to
obtain the expected results and the constant improvement of such processes.
Stages of implementation

Information

Planning

Development

Training

Internal audits

Registry audits
Step for the implementation

Step 1: Understand the organization context both internally and externally,


and understand the basic elements of ISO 9001: 2015

Step 2: Plan the quality management system, Identify your risks and
identify your stakeholders

Step 3: Create the ISO Driver Team

Step 4: Analyze the situation (Gap Analysis) in your reality and assess your
RISKS (Threats and opportunities)
Step for implementation
Step 5: Create the Task Teams.

Step 6: Train all staff on ISO 9001 fundamentals in their work and responsibility
reality

Step 7: Train Internal Auditors

Step 8: Perform Internal Audits

Step 9: Use the quality system (QMS), record its use, measure its performance
and improve for several months.

Step 10: Apply for Certified Audit.


Advantage
1- Administration participation
2- Benefits in productivity and efficiency
3- Customers satisfied
4- Economic benefits, which are the reward for the hard work and
investment in the quality management system.
5 - Consistent improvement of the service and constant development
of its products.
6- Improves the community's concept of the company.
7- Greater profitability.
Disadvantage

1. Concentration in an area, the perspective of the interdependence


that exists between all the members of the company is lost.

2. Requires a change throughout the organization

3. Continuous improvement is a very long process.

4. Major investments have to be made


Aguije Rehe Ijepysaka
Thank you for you attention

Obrigado pela ateno

Gracias por tu atencin