Class #11 June 13th, 2022

Part II

Selected Topics
ISO 9001:2015
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 Process focused
Chapter 4:
Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning
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
performance
measurement and
monitoring
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology
and
Chapter 9: Definitions

ISO 9001:2015
Performance
evaluation

structure
Chapter 4:
Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning
Chapter 4: Company context
4.1 To comprehend the organization and its
context
4.2 Comprehension of the interested parties
needs and expectations
4.3 Determination of the quality management
system scope
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.
Strategic direction

Strategic direction
Strategic direction

Strategic direction
 Strategic direction

Internal issue: available resources

Internal issue:
internal policies

Strategic direction
Strategic direction

External issue:
stockholders interests

External
issue:
government
regulations

Strategic direction
Strategic direction

Strategic direction
Strategic direction

Strategic direction
Chapter 4: Company context
4.3 Determination of the quality management
system scope
 The organization must apply all of the ISO 9001:2015
requirements (NMX-CC.9001-IMNC-2015).
 If necessary, the organization can provide with a
justification about why a requirement is not being met.
As long as, such requirement does not affect the
organization’s capacity, or responsibility, of ensuring the
compliance of its products and services, and the
increasing satisfaction of the client.
Chapter 4: Company context
4.4 Quality management system and its processes

4.4.1 The organization must establish, implement

and continually improve a quality management
system, including the necessary processes and
their interactions.
ISO 9001:2015 b) Determine the
a) Determine the processes’ c) Determine and apply the
expected sequence and necessary criteria and
processes’ inputs interaction methods to ensure that the
and outputs operation is effective and
under control.
h) To improve
d) Determine the
the processes Section 4.4.1 processes
and the quality
management The organization must necessary
resources, as well
system meet the following. as their
availability

g) To evaluate the
processes and e) Assign the corresponding
implement any f) Approach the responsibilities and
needed change in risks and authorities over the
order to reach the opportunities processes
planned results as determined
in section 6.1
Chapter 4: Company context
4.4 Quality management system and its processes

4.4.2 As needed, the organization must do:

b) Keep the information

a) Maintain information
documented in order to
documented in order to
have confidence that the
support the operation of
processes are performed
its processes.
as planned.
 Chapter 1:
Objective
Chapter 10: and
application Chapter 2:
Improvement References
Chapter 3:
Terminology
and
Chapter 9: Definitions

ISO 9001:2015
Performance
evaluation

structure
Chapter 4:
Company
context
Chapter 8:
Operation

Chapter 5:
Chapter 7: Chapter 6: Leadership
Support Planning
Chapter 5: Leadership
5.1 Leadership and Commitment
5.1.1 General aspects
The top management must demonstrate
leadership and commitment with respect to the
quality management system.
ISO 9001:2015 b) Assures that the
quality policy and c) Assures the
a) Assumes quality objectives integration of the
responsibility and are established quality management
obligation system requirements

d) Promotes the
use of a process
j) Supports
focused
other directive
approach, as well
roles
as a risk-based
Section 5.1.1 thinking

i) Promotes e) Assures the

the availability of
improvement all needed
resources
h) Engaged, f) Communicates
supported and g) Assures that
the planned the importance of
directing the an effective quality
people results are met
management
Chapter 5: Leadership
5.1 Leadership and Commitment
5.1.2 Client focused
The top management must demostrate
leadership and commitment with respect to the
client.
b) Determines the
a) Determines, risks and c) Maintain
understands and opportunities that focused on
meets the client affect the increasing the
and legal compliance with the client
requirements requirements satisfaction
Chapter 5: Leadership
5.2 Policy
5.2.1 Establishment of the quality policy
The top management must establish, implement
and maintain a quality policy that:

a) is
b) provides a
appropriate c) Commits to d) Commits
framework for
to the meet the to continuous
the quality
organization requirements improvement
objectives
purpose
Chapter 5: Leadership
5.2 Policy
5.2.2 Communication of the quality policy
The quality policy must:

b) be
a) be available as c) be available to
comminicated,
documented the interested
understood and
information parties
applied
Chapter 5: Leadership
5.3 Roles, responsibilities and authorities in the
organization
The top management must assure that the
responsibilities and authorities are assigned,
communicated and understood.

The top management must assign responsibilities

and authority for:
Chapter 5: Leadership
a) to assure that the b) to assure that c) To inform, in
quality management the processes particular, to top
system complies with provide the management about
the requirements planned results the quality
management system
performance and
d) to assure that improvement
e) to assure that the
the client-focused opportunities
integrity of the
approach is being (related to 10.1)
quality management
promoted system maintains
throughout the when changes are
organization implemented
Activity No. 12B
(you can work with a partner, due time: 1:45pm)
Section 5.2.2 of ISO 9001:2015 indicates that the
quality policy of an organization must be available
to the interested parties. Do a WEB search, select
one organization and answer to the following:
a) What information is posted on WEB that can be
related to their quality policy?
b) What product or service they provide?
c) What WEB site did you use?