Training Course on ISO 9001:2015 QMS

Requirements and Documentation

May 27-29, 2019

Clause 4: Context of the Organization

Module II: QMS Requirements

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

REQUIREMENT REQUIREMENT

Clause 4: Context of the Organization 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
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.

Development of a QMS Certifiable to ISO 9001:2015 Standard

for the Mariano Marcos State University 1
 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019
REQUIREMENT HOW TO
ADDRESS

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

4.1 Understanding the organization and its context 4.1 Understanding the organization and its context

Note Issues can include positive and negative factors or

1 conditions for consideration SWOT ANALYSIS
The organization
Understanding the external context can be facilitated SHALL monitor and PESTLE
Note by considering issues arising from legal, technological, review information ANALYSIS*
competitive, market, cultural, social and economic
2 environments, whether international, national, regional on external and
or local internal issues ENVIRONMENTAL
through various SCANNING
Understanding the internal context can be facilitated tools and
Note
by considering issues related to values, culture,
3 knowledge and performance of the organization. techniques
* Use of PESTLE Analysis is Recommended; use SWOT if available

HOW TO
ADDRESS

Clause 4: Context of the Organization

SAMPLE OF PESTLE ANALYSIS
4.1 Understanding the organization and its context Political Economic Social Technological Legal Environmental
• Schools being • Central or local • Local • Changes to • New • New highway
Sample Tools and Techniques privatised
• A government
government
funding
population
changes
standards/equi
pment
legislation
may create
layout may pose
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
outdated legislation
Source, PESTLE analysis for schools and education, RAPIDbi

Development of a QMS Certifiable to ISO 9001:2015 Standard

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 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019

SAMPLE OF SWOT ANALYSIS

The MMSU and Its Context
STRENGTHS WEAKNESSES
Advantages • Gaps in capabilities
• Accreditations Financials MMSU’s Mandate
•
•
Qualifications
Certifications
•
•
Cash flow, start-up cash drain
High cost structure The Mariano Marcos State University (MMSU) is a comprehensive
• Location and geography Our vulnerabilities
Timescales, deadlines and, pressures
institution of higher learning in the Ilocos region, which was
INTERNAL • Innovative aspects •
Resources, Assets, People
• Processes, systems, IT,
•
•
Reliability of data
Plan predictability
establish in 06 January 1978 by Presidential Decree (PD) 1279.
communications Processes and systems The University shall provide advance instruction in the arts,
• Culture, attitudes, behaviours • Succession, morale, commitment,
• Experience, knowledge, data leadership agricultural and natural sciences as well as in technological and
• Patents
professionals fields.
OPPORTUNITIES THREATS
Vision
• Seasonal, weather effects
A premiere Philippine university by 2028.
• Partnerships
• Unfulfilled customer needs
• Political effects Mission
EXTERNAL

• Legislative effects
•
•
New technologies
Loosening of regulations
• New technologies, IT developments To develop virtuous human capital and sustainable innovations in
• Changing customer needs
• Industry
• New regulations a knowledge-driven global economy.
Core Values
• Knowledge • Inclusiveness • Professionalism
• Spirituality and Social Responsibility

REQUIREMENT REQUIREMENT

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

4.2 Understanding the needs and expectations of 4.2 Understanding the needs and expectations of
interested parties interested parties

The organization SHALL:

1. Determine the: STAKEHOLDER
• Interested party refers - A person or an
a. Interested parties that are organization
to stakeholders*
relevant to the QMS • Relevant interested that can affect,
b. Requirements of these parties provide significant be affected by,
interested parties that are or perceive
risk to organizational
itself to be
relevant to the QMS sustainability if their affected by a
2. Monitor and review needs and expectations decision or
information on these interested are not met. activity.
parties and their requirements

Development of a QMS Certifiable to ISO 9001:2015 Standard

for the Mariano Marcos State University 3
 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019
HOW TO
ADDRESS
SAMPLE OF RIP
Clause 4: Context of the Organization
Interested Parties
4.2 Understanding the needs and expectations of
Citizens
interested parties The Organization Competitors

Customers Media
Top Management
Shareholders Commentators
Identify, monitor Distributors Those accountable for QMS
BUSINESS policy and its implementation
Trade Groups
and review Investors
PROCESS MODEL Neighbors

information on Owners Those who implement and

maintain the QMS
Pressure Groups

relevant Insurers
Those who maintain QMS and
Emergency
Services

interested parties RIPs MATRIX Government risk procedures Other Response

Agencies

Regulators
and relevant their Other staff Contractors
Transport
Recovery Service
requirements
Dependents of
Suppliers Staff

SAMPLE OF RIP REQUIREMENT

(Cavite State University, 2018) 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.

Development of a QMS Certifiable to ISO 9001:2015 Standard

for the Mariano Marcos State University 4
 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019
REQUIREMENT HOW TO
ADDRESS

Clause 4: Context of the Organization Clause

Clause 4:
4: Context
Context of
of the
the Organization
Organization
4.3 Determining the scope of the QMS 4.3
4.2 Determining
Understandingthethe
scope of the
needs andQMS
expectations of
interested parties
 Determine the QMS
Based on :
scope and provide a. Mandate
Consider issues, requirements of interested
1 parties, and products and services justification (if any) if a
specific requirement b. Products and
of the ISO 9001 Services
2 Be maintained as documented information standard is not
applicable.
State the type of products and c. Sites
3 services covered
 Maintain and ensure
availability of
Provide justification for any ISO 9001:2015 documented d. ISO 9001:2015
4 requirement that is claimed to be “not information on these. standard
applicable” to the organization

REQUIREMENT HOW TO
ADDRESS

Clause 4: Context of the Organization Clause

Clause 4:
4: Context
Context of
of the
the Organization
Organization
4.3 Determining the scope of the QMS 4.3
4.2 Determining
Understandingthethe
scope of the
needs andQMS
expectations of
 The organization SHALL apply all the interested parties
Who are we? Identify the nature of the
requirements within the determined ISO 9000:2015 defines “organization” as
a “person or group or people that has
organization and what parts of the
its own functions with responsibilities, organization are included in the
scope of its QMS. authorities and relationships to achieve
its objectives”.
management system being
 Conformity to the standard may developed.

only be claimed IF the requirements

What do we do?
determined as not being applicable ISO 9000:2015 defines “output” as the
Identify the type of QMS that needs
“result of a process”. to be implemented
do not affect
(a) the organization’s ability or
Who are our customers?
responsibility to ensure conformity of ISO 9000:2015 defines “customer” as Complete the description of the
the “organization or person that could
its products and services and the or does receive a product or a service
that is intended for or required by this
interrelationship between the
(b) enhancement of customer person/org”. The customer may be “organization” and the “customer”.
internal or external.
satisfaction.

Development of a QMS Certifiable to ISO 9001:2015 Standard

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 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019
REQUIREMENT

SAMPLE QMS SCOPE Clause 4: Context of the Organization

4.4 QMS and its processes
Provision of management of learning, research, and extension
services including support and outsourced processes in CvSU. 4.4.1 The organization SHALL

- Cavite State University

Provision of Higher and Advanced Educational Services CONTINUALLY

ESTABLISH IMPLEMENT MAINTAIN IMPROVE

- Bataan Peninsula State University

Provision of Tertiary Education Services in the College of

Teacher Education covering Admission and Enrollment …a quality management system, including the PROCESSES
Process to Promotion and Conferment of Degrees needed and their interactions

- University of Northern Philippines

REQUIREMENT REQUIREMENT

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

4.4 QMS and its processes 4.4 QMS and its processes

Determine the
Determine the Determine the
resources needed for Address the
processes needed sequence and
these processes and determined risks and
for the QMS and their interaction of these
ensure their opportunities
application processes
availability
1 2 3 4 5 6 7

Determine and apply criteria

Determine the inputs
required and the
outputs expected
from these processes
and methods, including Assign the
monitoring, measurement,
responsibilities and
and related performance
indicators to ensure effective authorities for these
operation and control of processes
these processes

Development of a QMS Certifiable to ISO 9001:2015 Standard

for the Mariano Marcos State University 6
 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019
REQUIREMENT REQUIREMENT

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

4.4 QMS and its processes 4.4 QMS and its processes
4.4.2 To the extent necessary, the
Evaluate these processes
organization SHALL:
and implement any changes
needed to ensure that these a. Maintain documented Example
processes achieve their information to support Maintain: • Instructions
intended results • Manuals • Internal
the operation of its • Process issuances
8 9 processes flowcharts • Blank forms
b. Retain documented
information to have Example
Improve the
processes and the
confidence that the Retain:
• Files • Filled-out
QMS processes are being • Reports checklists
carried out as planned. and forms

HOW TO
ADDRESS QMS Processes
Clause Organization QMS (4)
Clause 4:
4: Context
Context of
of the
the Organization
Organization and its context
4.4
4.2 QMS and its processes
Understanding the needs and expectations of (4)
Support
interested parties (7)
Operations
QMS PDCA (8)
Customer
MODEL Plan
Satisfaction
Determine the Do

processes (input- Customer Planning Leadership Performance

Results of
the QMS
process-outputs- PROCESS MAP Requirements (6) (5) Evaluation (9)

controls) Act Products and

Check Services
Document the PROCESS
processes, as MATRIX Needs and Improvement
Expectations
necessary
(10)
of Relevant
Interested
Parties (4)

QMS PDCA Cycle

Development of a QMS Certifiable to ISO 9001:2015 Standard

for the Mariano Marcos State University 7
 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019
QMS Processes
Process Map
Categories of Processes:
Management A process needed for oversight and
Processes governance of the agency to
A process map shows comply with the applicable
process-related activities, legislation, policies, and Standards
including input/output, and (e.g. Corporate Planning,
cross-functional interfaces. Management Reviews, Internal
Audits, etc.)
The main goal of the map
Core/Operational A process needed to achieve the
is to provide an overview Processes overall mission and objectives of
of the relevant business the agency; allows the agency to
processes provide goods and services that
meet the needs and expectations of
citizens.

QMS Processes
Categories of Processes:
Process Approach
Starting
Externally-provided A process needed for the operations Point
End Point

Processes and QMS that are carried out by an

Sources of Receivers of
external provider outside the Inputs
Inputs Activities Outputs
Outputs
managerial control of your facility
and may not be subject to the same Predecessor Matter, Energy Matter, Energy
Processes Information Information Subsequent
QMS as your organization e.g. e.g. e.g. Processes e.g.
customers, materials,
Support Processes other relevant resources,
product, customers, other
A process needed to ensure the interested requirements
service, relevant interested
Decision parties
satisfactory performance of the parties
core processes (e.g. human
resource management, financial, Possible Controls and
material procurement, IT check points to monitor
and measure performance
management, etc.)
02

Development of a QMS Certifiable to ISO 9001:2015 Standard

for the Mariano Marcos State University 8
 Training Course on ISO 9001:2015 QMS
Requirements and Documentation
May 27-29, 2019
Sample of Process Map

- END -
Module II: QMS Requirements
Clause 4:
Context of the Organization

(Cavite State University)

Development of a QMS Certifiable to ISO 9001:2015 Standard

for the Mariano Marcos State University 9