Class #11 June 13th, 2022

Selected Topics
International Organization for Standardization
(ISO)
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology

Chapter 9:
ISO 9001:2015 and
Definitions
Performance
evaluation
Structure
Grouped according to Chapter 4:
the Plan-Do-Check-Act Company
context
Chapter 8: (PDCA)
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning
Plan-Do-Check-Act Plan:
(PDCA) 1. To establish the system
and processes
objectives.
2. To establish the needed
Plan resources in order to
generate and provide
results according to the
client’s requirements,
Act PDCA Do and the organization’s
policies.
3. To identify and establish
actions to approach risks
Check and opportunities.

ISO 9001:2015
Plan-Do-Check-Act
(PDCA)

Plan

Do:
Act PDCA Do To implement what was
planned.

Check

ISO 9001:2015
Plan-Do-Check-Act
(PDCA)
Plan

Check:
1. To follow up and
measure the processes,
Act PDCA Do

products, and services

that result from the
previous steps (Plan and Check
Do).
2. To comunicate the
results.
ISO 9001:2015
Plan-Do-Check-Act
(PDCA)
Plan

Act:
To take actions to improve
the performance
Act PDCA Do

indicators.

Check

ISO 9001:2015
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology
and
Chapter 9:
Performance ISO 9001:2015 Definitions

evaluation
¿How to group the
Chapter 4:
chapters according to the Company
Plan-Do-Check-Act context
Chapter 8:
Operation (PDCA)?
Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning

ISO 9001:2015
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology
and
Chapter 9:
Performance ISO 9001:2015 Definitions

evaluation
Grouped according to the
Chapter 4:
Plan-Do-Check-Act (PDCA) Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning

ISO 9001:2015
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology
and
Chapter 9:
Performance ISO 9001:2015 Definitions

evaluation
Grouped according to the
Chapter 4:
Plan-Do-Check-Act (PDCA) Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning

ISO 9001:2015
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology
and
Chapter 9:
Performance ISO 9001:2015 Definitions

evaluation
CHECKGrouped according to the Chapter 4:
Plan-Do-Check-Act (PDCA) Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning

ISO 9001:2015
ACT Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology
and
Chapter 9:
Performance ISO 9001:2015 Definitions

evaluation
Grouped according to the
Chapter 4:
Plan-Do-Check-Act (PDCA) Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning

ISO 9001:2015
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology

Process focused
and
Chapter 9: Definitions
Performance
evaluation

Chapter 4:
Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning

ISO 9001:2015
Process Starting Ending

elements
point point

Input Output
source Inputs Activities Outputs receivers

Interested Such as: Such as: Interested

parties such as materials, product, parties such as
internal and energy and service or a internal and
external information decision external clients
suppliers, and
clients
Possible control
points for measuring
and monitoring
performance
Chapter 1: Objective and
application
Objectives:
ISO 9001:2015 demostrates the company’s
capacity to meet client requirements, as well
as, statutory and regulatory requirements.
“legales y reglamentarios”

ISO 9001:2015 inspires to increase the client

satisfaction.
Chapter 1: Objective and
application
Application:
ISO 9001:2015 applies to any type of
organization

ISO 9001:2015 applies to any size of

organization
 Chapter 2: References
ISO 9000:2015 NMX-CC-9000-IMNC-2015
Quality management Sistemas de gestión de
systems- fundamentals calidad-Fundamentos y
and vocabulary vocabulario

It provides the fundamental concepts, principles

and terminology of quality management systems.
Chapter 3: Terminology and
Definitions Refers to ISO 9000:2015
Related to: Data
People Information
Organization Documents
Activity Client
Process Characteristics
System Determination
Requirements Actions
Results Audits
Example:

Taken from NMX-CC-9000-IMNC-2015

Chapter 4: Company context
4.1 To comprehend the organization and its
context
 The organization must determine the external and internal issues
that are applicable to its purpose and strategic direction; and that
affect its capacity to reach the anticipated results of its quality
management system.

 The organization must do a follow up and revision of the

information related to the external and internal issues.
Chapter 4: Company context
4.2 Comprehesion of the interested parties needs
and expectations
 The organization must determine the interested parties
that are relevant to the quality management system.
 The organization must determine the relevant needs of its
interested parties.
 The organization must do a follow up and revision of the
information related to its interested parties and their
relevant needs.
Chapter 4: Company context
4.3 Determination of the quality management
system scope
 The organization must consider the external and
internat issues of section 4.1
 The organization must consider the needs of the
interested parties of section 4.2
 The organization must consider its products and
services.
Activity No. 12A
(individual work, 30 minutes)
Chapter 3 of ISO 9001:2015 refers to the terminology and definitions used
in the rest of the 9000 family group of standards. Some of such definitions
are found on the following slides. Refer to those definitions and write the
ones that correspond to the red words on the list below. Write each
definition with your own words and in English.

Chapter 4: Company context

4.1 To comprehend the organization a its context
4.2 Comprehension of the interested parties needs and expectations
4.3 Determination of the quality management system scope
4.4 Quality mangement system and it processes
Taken from NMX-CC-9000-IMNC-2015
Taken from NMX-CC-9000-IMNC-2015
Taken from NMX-CC-9000-
IMNC-2015
Taken from NMX-
CC-9000-IMNC-
2015
Taken from NMX-CC-9000-IMNC-2015