Module II: QMS Requirements

Clause 4:
Context of the Organization
Clause 4: Context of the Organization

4 Context of the
Organization 4.1 Understanding the
Organization and
its context
4.2 Understanding the
needs and
expectations of
interested parties
4.3 Determining the
scope of the QMS
4.4 QMS and its
processes
 REQUIREMENT

Clause 4: Context of the Organization

4.1 Understanding the organization and its context

 The organization SHALL determine

external and internal issues
relevant to the organization’s
purpose and strategic direction
affecting its ability to achieve the
QMS’ intended results
 REQUIREMENT

Clause 4: Context of the Organization

4.1 Understanding the organization and its context

Organization and its Context

Organization’s context often

referred to by other terms such
as:
• Organizational environment
• Business environment
• Ecosystem of an
Organization
…relative to its products,
services, investments, and
behavior towards its relevant
interested parties.
 REQUIREMENT

Clause 4: Context of the Organization

4.1 Understanding the organization and its context

Note Issues can include positive and negative factors or

conditions for consideration
1
Understanding the external context can be facilitated
Note by considering issues arising from legal, technological,
competitive, market, cultural, social and economic
2 environments, whether international, national, regional
or local

Note Understanding the internal context can be facilitated

by considering issues related to values, culture,
3 knowledge and performance of the organization.
Clause 4: Context of the Organization
4.1 Understanding the organization and its context

University Mandate
CvSU is mandated "to provide excellent, equitable and relevant
educational opportunities in the arts, sciences and technology through
quality instruction, and responsive research and development activities.
It shall produce professional, skilled and morally upright individuals for
global competitiveness."

University Vision
The Premier University in historic Cavite recognized for excellence in the
development of globally and morally upright individuals.
University Mission
Cavite State University shall provide excellent, equitable, and relevant
educational opportunities in the arts, sciences and technology through
quality instruction and responsive research and development activities.

It shall produce professional, skilled and morally upright individuals for

global competitiveness.
 HOW TO
ADDRESS

Clause 4: Context of the Organization

4.1 Understanding the organization and its context

The organization
SHALL monitor and SWOT ANALYSIS
review information on
external and internal
issues through PESTLE
various tools and ANALYSIS
techniques
 HOW TO
ADDRESS
Clause 4: Context of the Organization
4.1 Understanding the organization and its context

Sample Tools
and
Techniques
 GLISTEN
International Academy

SWOT ANALYSIS
Internal issues that affects the organization
STRENGTHS WEAKNESSES
Advantages • Gaps in capabilities
• Accreditations Financials
• Qualifications • Cash flow, start-up cash drain
• Certifications • High cost structure
• Location and geography Our vulnerabilities
INTERNAL

• Innovative aspects • Timescales, deadlines and, pressures

Resources, Assets, People
• Processes, systems, IT,
communications
• Culture, attitudes, behaviors
• Experience, knowledge, data
• Patents
• Reliability of data
• Plan predictability
Processes and systems
• Succession, morale, commitment,

OPPORTUNITIES THREATS
• Partnerships
• Unfulfilled customer needs • Seasonal, weather effects
EXTERNAL

• New technologies • Political effects

• Loosening of regulations • Legislative effects
• New technologies, IT developments
• Changing customer needs
• New regulations
 HOW TO
ADDRESS
Clause 4: Context of the Organization
4.1 Understanding the organization and its context
 GLISTEN
International Academy

PESTLE ANALYSIS
External issue that affect the organization
Political Economic Social Technological Legal Environmental
• Schools • Central or local • Local • Changes to • New • New highway
owned by government population standards/equi legislation layout may pose
government funding changes pment may create danger to
being decisions may • Closure of required risk of students
privatized. affect school local firms • Risks of noncomplianc • Waste disposal
• A government finances providing selecting the e with the • Reduction of
initiative • Closure of employment wrong law/create green space
creates the risk financial • Social technology at administrative available for
that the school institution networking times of burden activities
may fail to may affect • Integration change • Changes to • Changes to local
deliver the funding plans of students • New computer child transportation
policy or be • Cost of with special viruses may protection routes
diverted away providing needs affect legislation • Using significant
from priorities resources • Parental operations • Changes in amount of toner
• Changes to (staff/technolo preference • Move from age in starting and paper to
curriculum gy paper-based school produce printed
with short lead support/basic) books to e- • Change in information
times • Customers books reader school • Organization
• Stability of confidence in • Computer opening hours structure
government fees payment hardware/ • Health and situated in low
policies. • Inflation rates software being safety plane area
• Global in goods and outdated legislation making it prone
influence on services to flood.
educational •
standards.
Gia/mgt/018.
 REQUIREMENT

Clause 4: Context of the Organization

4.2 Understanding the needs and expectations of interested parties

The organization SHALL:

1. Determine the:
a. Interested parties that are
relevant to the QMS
b. Requirements of these
interested parties that are
relevant to the QMS
2. Monitor and review
information on these interested
parties and their requirements
 REQUIREMENT

Clause 4: Context of the Organization

4.2 Understanding the needs and expectations of
interested parties

STAKEHOLDER
• Interested party refers - A person or an
to stakeholders* organization
• Relevant interested that can affect,
be affected by,
parties (RIPs) provide
or perceive itself
significant risk to to be affected
organizational by a decision or
sustainability if their activity.
needs and expectations
are not met.
 HOW TO
ADDRESS

Clause 4: Context of the Organization

4.2 Understanding the needs and expectations of
interested parties

Identify, monitor BUSINESS

and review PROCESS MODEL
information on
relevant
interested parties
and relevant their RIPs MATRIX
requirements
SAMPLE
Interested Parties
Citizens The Organization Competitors

Customers Media
Top Management
Shareholders Commentators

Distributors Those accountable for QMS policy

Trade Groups
and its implementation
Investors Neighbors

Owners Those who implement and Pressure Groups

maintain the QMS
Insurers Emergency
Services
Those who maintain QMS and
Government risk procedures Other Response
Agencies

Regulators Transport
Other staff Contractors
Recovery Service Dependents of
Suppliers Staff
SAMPLE OF RELEVANT INTERESTED
PARTIES
Relevant Requirements
Interested Type
Party Needs Expectations
Staff Internal • Training and support • Timely and fair provision
• Safe working conditions
Contractors External • Agreements • Adherence to agreements
• Payment terms • Timey processing of
payments
 REQUIREMENT

Clause 4: Context of the Organization

4.3 Determining the scope of the QMS

The QMS defines the

boundaries and applicability of the
QMS taking into consideration:
 internal and external issues (the
context of the organization),
 requirements of relevant
interested parties, and,
 products and services.
 REQUIREMENT

Clause 4: Context of the Organization

4.3 Determining the scope of the QMS

Consider issues, requirements of interested

1 parties, and products and services

2 Be maintained as documented information

State the type of products and

3 services covered
Provide justification for any ISO 9001:2015
4 requirement that is claimed to be “not
applicable” to the organization
 HOW TO
ADDRESS

Clause 4: Context of the Organization

4.3 Determining the scope of the QMS ons of

 Determine the QMS Based on :

scope and provide a. Mandate
justification (if any) if a
specific requirement of b. Products and
the ISO 9001 standard Services
is not applicable.
 Maintain and ensure
availability of c. Sites
documented
information on these. d. ISO 9001:2015
standard
 REQUIREMENT

Clause 4: Context of the Organization

4.3 Determining the scope of the QMS

 The organization SHALL apply all

the requirements within the
determined scope of its QMS.
 Conformity to the standard may
only be claimed IF the requirements
determined as not being applicable
do not affect
(a) the organization’s ability or
responsibility to ensure conformity of
its products and services and the
(b) enhancement of customer
satisfaction.
 HOW TO
ADDRESS

Clause 4: Context of the Organization

4.3 Determining the scope of the QMS ons of
Who are we? Identify the nature of the
ISO 9000:2015 defines “organization”
as a “person or group or people that
organization and what parts of the
has its own functions with organization are included in the
responsibilities, authorities and management system being
relationships to achieve its objectives”.
developed.

What do we do?
ISO 9000:2015 defines “output” as Identify the type of QMS that needs
the
“result of a process”. to be implemented

Who are our customers?

ISO 9000:2015 defines “customer” as
the “organization or person that
Complete the description of the
could or does receive a product or a
service that is intended for or
interrelationship between the
required by this person/org”. The “organization” and the “customer”.
customer may be internal or external.
 REQUIREMENT

Clause 4: Context of the Organization

4.4 QMS and its processes

4.4.1 The organization SHALL

CONTINUALLY
ESTABLISH IMPLEMENT MAINTAIN IMPROVE

…a quality management system, including the PROCESSES

needed and their interactions
 REQUIREMENT

Clause 4: Context of the Organization

4.4 QMS and its processes

Determine the processes Determine the sequence

needed for the QMS and and interaction of these
their application processes

1 2 3 4

Determine the inputs Determine and apply criteria and

required and the outputs
expected from these
processes
methods, including monitoring,
measurement, and related
performance indicators to ensure
effective operation and control of
these processes
 REQUIREMENT

Clause 4: Context of the Organization

4.4 QMS and its processes

Determine the resources

Address the determined
needed for these
risks and opportunities
processes and ensure
their availability

5 6 7

Assign the responsibilities

and authorities for these
processes
 REQUIREMENT

Clause 4: Context of the Organization

4.4 QMS and its processes

Evaluate these processes and

implement any changes needed to
ensure that these processes
achieve their intended results

8 9

Improve the processes

and the QMS
 REQUIREMENT

Clause 4: Context of the Organization

4.4 QMS and its processes
4.4.2 To the extent necessary, the
organization SHALL:

a. Maintain documented Example

information to support Maintain: • Instructions
• Manuals • Internal
the operation of its issuances
• Process
processes flowcharts • Blank forms
b. Retain documented
information to have Example
confidence that the Retain:
• Files • Filled-out
processes are being • Reports checklists
carried out as planned. and forms
 HOW TO
ADDRESS

Clause 4: Context of the Organization

4.4 QMS and its processes ons of

QMS PDCA
Determine the MODEL
processes (input-
process-outputs- PROCESS MAP
controls) Document
the processes, as PROCESS
necessary MATRIX
QMS Processes
Organization QMS (4)
and its context
(4)
Support
(7)
Operations
(8)
Customer
Satisfaction
Plan Do

Results of
Customer Planning Leadership Performance the QMS
Requirements (6) (5) Evaluation (9)

Act Products and

Check Services

Needs and
Improvement
Expectations (10)
of Relevant
Interested
Parties (4)
QMS
PDC
A
Cycl
e
Process Map

A process map shows

process-related activities,
including input/output, and
cross-functional interfaces.
The main goal of the map is
to provide an overview of
the relevant business
processes
QMS Processes
Categories of Processes:
Management
Processes A process needed for oversight and
governance of the agency to comply
with the applicable legislation,
policies, and Standards (e.g.
Corporate Planning, Management
Reviews, Internal Audits, etc.)

Core Processes
A process needed to achieve the
overall mission and objectives of the
agency
QMS Processes
Categories of Processes:
Operational
Processes The operational part of the core
process that allows the agency to
provide goods and services that meet
the needs and expectations of
citizens.

Support
Processes A process needed to ensure the
satisfactory performance of the core
processes (e.g. human resource
management, financial, material
procurement, IT management, etc.)
 - END -
Module II: QMS Requirements
Clause 4:
Context of the Organization