BASIC INTRODUCTION TO ISO 9001-

2015 STANDARD AND OUR COF IT QMS

COF IT (QMS)
 The implementation of a
quality management It is a strategic decision for the organization, which helps to
system and certification in improve its overall performance and provides a solid
foundation for sustainable development and continuous
ISO 9001-2015 improvement initiatives.
 1. Are standards important?

ISO 9001-2015 2. What is ISO?

Standard

3. What is a Quality
Management System?
Are Standards Important?
ARE STANDARD'S IMPORTANT?
Provide guidance and tools for companies and organizations that
want to ensure that their products and services consistently meet
customer requirements, and that quality is constantly being
improved.
What is ISO?

International Organization for Standarization (ISO)

It is the world entity that works for the establishment of

arrangements designed for common and repeated use, which allows
reaching a certain order that helps to solve a potential or real
problem.

It oversees promoting and supervising the development of

international standards. Its purpose is to develop standards to
facilitate the universal exchange of goods and services.
 1. The ISO quality norms constitute a standard that
certifies the qualities of a product or service, with this
What is ISO? the user is guaranteed that he will receive a high-quality
product or service, with which the organization ensures
user satisfaction.
 Which are?
THE POTENTIAL
BENEFITS TO AN
ORGANIZATION OF
IMPLEMENTING A
QUALITY MANAGEMENT
SYSTEM:
 1. The ability to consistently provide products and
services that meet customer and applicable
statutory and regulatory requirements.
2. Facilitating opportunities to enhance customer
satisfaction.

Which Are? 3. Addressing risks and opportunities associated with

its context and objectives.
4. The ability to demonstrate conformity to specified
quality management system requirements.
5. Allow companies to become much more
competitive in the market by meeting these
standards.
WHAT IS QUALITY?
 Relationship
Customer focus.
management.

Evidence-based
Leadership.

Quality decision making.

management
principles (7)
Continuous Engagement of
improvement. people.

Process approach.
ISO 9001-2015
STANDARD
FOCUSING.!
 1. Is a set of rules and principles related to each other
in an orderly way.

What is a Quality
Management 2. It establishes the way in which the strategy, processes
and resources are organized.
System? (QMS)

3. Guides the strategy, policies, objectives, processes and

resources towards the Client (user) and their
satisfaction.
 WHAT IS A
QUALITY
MANAGEMENT
SYSTEM FOR?
(QMS)
What is a quality management system for? ...

1. It helps the organization increase the customer

satisfaction

2. Promotes the analysis of customer

requirements and how to meet them

3. Promotes the definition of processes,

procedures and keeps them under control

4. Provides the framework for continual

improvement → increase customer and another
stakeholder satisfaction

5. Provides confidence to the organization and

its customers
PROCESS-
BASED
APPROACH
(QMS)
 Establish the objectives and
Take actions to processes necessary to obtain
continually improve results according to the client's
process performance. requirements and the
organization's policies.

Continuous
Improvement

PDCA Cycle

PHVA Ciclo Measure and monitor

processes according to the Implement the
established objectives, processes.
policies and requirements
of the client, and the
organization.
 Continuous
Improvement

PDCA Cycle

PHVA Ciclo
 USER’S

1 2 3
STRATEGIC Planning
10 9 6 5 4
Policies Improvement Objective's

OPERACIONAL User’s Satisfaction QMS Model

8
ISO 9001-2015 Productive Process Doc
Standard
Chapters BACKING
7
HR Infrastructure

Satisfied User’s  Quality of Service

 PLAN, CHECK and
Focusing on
ACT
◦ 1. Establish a vision, policies, strategic objectives and scope

USER’S ◦ 2. Communicate

STRATEGIC Planning
◦ 3. Feedback
Policies Improvement Objective's

◦ 4. Monitor the performance

OPERACIONAL User’s Satisfaction
Productive Process Doc
◦ 5. Provide

BACKING
◦ 6. Promote
HR Infrastructure

◦ 7. Participate
Strategic Process
 Focusing on DO
USER’S
◦ 1. The effective and efficient operation
STRATEGIC Planning

Policies Improvement Objective's

◦ 2. The interrelation.

OPERACIONAL User’s Satisfaction

◦ 3. Continuous improvement.
Productive Process Doc

◦ 4. The processes must be documented

BACKING

HR Infrastructure

(Operational Process)
 Focusing on DO

USER’S

STRATEGIC Planning

Policies Improvement Objective's

◦ 1. The organization must determine and provide the necessary resources to
implement, maintain and improve the management system, as well as to
OPERACIONAL User’s Satisfaction increase user's satisfaction by ensuring the fulfillment of their expectations.
Productive Process Doc

BACKING

HR Infrastructure

(Backing Process)
 Review of the
normative
requirements of
ISO 9001-2015
 4. Context of the organization
4.1 Understanding the organization and its 4.2 Understanding the needs and 4.3 Determining the scope of the quality 4.4 Quality management system and its
context expectations of interested parties management system processes
 5. Leadership
5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and
authorities

Customer focus Establishment Assignment

Compliance with quality objectives Communication Communication

Promoting Understanding and application Understanding

Collaborating Stakeholder availability

 6. Planning
6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes

Determine risks Establishment of objectives Purpose

Action plans Communication Resources

Legal requirements Measurement(KPIS) Follow up

Regulatory Requirements Follow up Responsibilities and authorities

 7. Support or Backing
7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information

People Education Quality politics Internal Creating and Updating

Infrastructure Training Quality objectives External Review and control

Environment for operation Experience Contribution Follow up Approval

Knowledge of the Training plan Implications of non- Availability

organization compliance
Job profile Protection

Staff competency record Distribution

Access

Recovery

Storage

Conservation
 8. Operation
8.1 Operational planning and 8.2 Requirements for products 8.4 Control of externally 8.5 Production and service 8.7 Control of nonconforming
control and services provided processes, products provision outputs
and services

Plan, implement and Customer Type and extent of control Control of production and Correction;
control the processes communication service provision Segregation, containment,
Information for external return or suspension of
Determining the Determining the providers Identification and
provision of products and
requirements for services requirements for services traceability
Performance monitoring services
The acceptance of services Review of the Property belonging to
Informing the customer;
requirements Verification of: customers or external
Determining the resources Obtaining authorization
•Competence providers
needed Changes to requirements for acceptance under
• Processes Preservation (Materials, concession.
•Equipment tools and equipment)
• Methods Describes the
•Identification
nonconformity
•Handling
•Packaging the actions taken
•Storage
Protection
Control of changes
 9. Performance Evaluation
9.1 Monitoring, measurement, analysis and 9.2 Internal audit 9.3 Management review
evaluation

KPI’s of: Auditor training Schedule:

Customer satisfaction Audit program Status of actions from previous reviews

Effectiveness of the QMS Execution of audits Changes in the QMS

Planned vs Executed Audit report Performance, effectiveness and trends of

the QMS, processes, suppliers, audits,
Effectiveness of actions to face risks and Follow-up of findings customer satisfaction, objectives and
opportunities programs.
Corrective actions
Supplier performance Effectiveness of actions to face risks and
Closure of findings opportunities
Resources needed for the QMS

Improvements in quality performance

 10. Improvement
10.1 Service improvement 10.2 Nonconformity and corrective action 10.3 Continual improvement

Determine, select and implement Actions for control and correction Analysis and evaluation for the continuous
improvement opportunities to increase improvement of the QMS
customer satisfaction Root cause analysis

Actions to avoid recurrence

Evaluate effectiveness of actions

WHAT IS CONTINUOUS
IMPROVEMENT FOR?
 CONTINUOUS
PROCESS
IMPROVEMENT,
HOW TO CARRY
OUT.
Implementation
based on key COF
IT needs
THANK YOU.!