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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
1 conditions for consideration

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

Understanding the internal context can be facilitated
Note
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
SAMPLE OF SWOT ANALYSIS
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 • Reliability of data
• Processes, systems, IT, • Plan predictability
communications Processes and systems
• Culture, attitudes, behaviours • Succession, morale, commitment,
• Experience, knowledge, data leadership
• Patents
OPPORTUNITIES THREATS
• Partnerships
• Unfulfilled customer needs • Seasonal, weather effects
EXTERNAL

• New technologies • Political effects
• Loosening of regulations • Legislative effects
• Industry • 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
SAMPLE OF PESTLE ANALYSIS
Political Economic Social Technological Legal Environmental
• Schools being • Central or local • Local • Changes to • New • New highway
privatised government population standards/equi legislation layout may pose
• A government funding changes pment may create danger to
initiative decisions may • Closure of required risk of students
creates the risk affect school local firms • Risks of noncomplianc • Waste disposal
that the school finances providing selecting the e with the • Reduction of
may fail to • Closure of employment wrong law/create green space
deliver the local industry • Social technology at administrative available for
policy or be may affect networking times of burden activities
diverted away funding plans • Integration of change • Changes to • Changes to local
from priorities • Cost of students with • New computer child transportation
• Changes to providing special needs viruses may protection routes
curriculum resources • Parental affect legislation • Using significant
with short lead (staff/technolo preference operations • Changes in amount of toner
times gy • Move from age in starting and paper to
support/basic) paper-based school produce printed
books to e- • Change in information
books reader school
• Computer opening hours
hardware/ • Health and
software being safety
Source, PESTLE analysis for schools and education, RAPIDbi outdated legislation
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,
parties (RIPs) provide be affected by,
or perceive
significant risk to
itself to be
organizational affected by a
sustainability if their decision or
needs and expectations activity.
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
Trade Groups
policy and its implementation
Investors Neighbors
Owners Those who implement and Pressure Groups
maintain the QMS
Insurers Emergency
Those who maintain QMS and Services

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
Clause 4:
4: Context
Context of
of the
the Organization
Organization
4.3
4.2 Determining
Understandingthethe
scope of and
needs the QMS
expectations of
interested parties
 Determine the QMS
Based on :
scope and provide a. Mandate
justification (if any) if a
specific requirement b. Products and
of the ISO 9001 Services
standard is not
applicable.
c. Sites
 Maintain and ensure
availability of
documented d. ISO 9001:2015
information on these. 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
Clause 4:
4: Context
Context of
of the
the Organization
Organization
4.3
4.2 Determining
Understandingthethe
scope of and
needs the QMS
expectations of
interested parties
Who are we? Identify the nature of the
ISO 9000:2015 defines “organization” as organization and what parts of the
a “person or group or people that has
its own functions with responsibilities, organization are included in the
authorities and relationships to achieve management system being
its objectives”.
developed.

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

Who are our customers?
ISO 9000:2015 defines “customer” as
the “organization or person that could
Complete the description of the
or does receive a product or a service interrelationship between the
that is intended for or required by this
person/org”. The customer may be “organization” and the “customer”.
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 Determine the
processes needed sequence and
for the QMS and their interaction of these
application processes

1 2 3 4

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

Clause 4: Context of the Organization
4.4 QMS and its processes

Determine the
resources needed for Address the
these processes and determined risks and
ensure their opportunities
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 • Process issuances
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
Clause 4:
4: Context
Context of
of the
the Organization
Organization
4.4
4.2 QMS and its processes
Understanding the needs and expectations of
interested parties
QMS PDCA
MODEL
Determine the
processes (input-
process-outputs- PROCESS MAP
controls)
Document the PROCESS
processes, as MATRIX
necessary
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 PDCA Cycle
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