ISO 9001 : 2015

AWARENESS TRAINING
12th December 2017

Presented by:

Myra C. Cabales
 ISO 9001 : 2015

Introduction
International Management System Marketing
0
Course Objectives :
To provide participants with
the following knowledge:

An interpretation of the ISO

9001:2015 requirements.

An understanding of the
rationale and the foundation of
the Standard.
 Time Table :
0900 ~ 1200

Presenter may adjust timing to maximize learning

 ISO 9001 : 2015

The ISO 9001 Evolution

International Management System Marketing
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The ISO 9001 Evolution

• Evolution of the ISO 9001 Standard

• ISO 9000 Series
• Rationale for the revision
• Main changes from previous version
Evolution of ISO 9001 Standard

Fifth Edition

2015 Risk-Based Thinking

2008
2000
1994
Quality Management System
1987 – process approach
Quality System
– 20 elements
Rationale for the Revision

• Periodic Review
• Adapt to maintain relevance to changing
needs
• Standardization of Management Systems
structure – high level structure of
ANNEX SL
Three Pillars of Sustainable Development
E-business
Emerging
Trade Facilitation
Economies
Good Business Practices
Alleviating
Dissemination of Poverty
New technologies
Consumer
Environmental Economic
Protection
Management Growth
Life Cycle Analysis Worker
& Green Labeling Protection
Social
Environmental Responsibility
Health Services
GHG emissions & Integrity
climate change
Security

Energy efficiency & Fair Trading

renewable resources
Ethics
Water, soil & air quality
Waste Management
Main Changes from previous version

• The adoption of the High Level Structure in Annex SL

• Explicit requirement for risk-based thinking to support and I
improve the understanding and application of the process
approach
• Fewer prescribed requirements (more freedom)
• Less emphasis on documents
• Improved applicability for services
• A requirement to define the boundaries of the QMS
• Increased emphasis on organizational context
• Increased leadership requirements
• Greater emphasis on achieving desired outcomes to improve
customer satisfaction
 ISO 9001 : 2015

Understanding the High Level

Structure, Terminology and Concepts
International Management System Marketing
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High Level Structure
ISO 9001:2015
ISO 9001:2015
ISO 9001:2015
Explanations of Verbs
 ISO 9001 : 2015

The Foundation of the Standard

International Management System Marketing
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The Foundation of the Standard

• The quality management principles

• Process approach
• Plan, Do, Check, Act cycle
• The QMS Model
• Risk-based thinking
The 7 Quality Management Principles

• Customer Focus
• Leadership
• Engagement of People
• Process Approach
• Improvement
• Evidence-based Decision Making
• Relationship Management
Process Approach

• Understanding and managing interrelated processes

as a system contributes to the organization’s
effectiveness and efficiency in achieving its intended
results.
Process Approach

Application of process approach enables :

a) Understanding & consistency in meeting
requirements;
b) The consideration of processes in terms of added
value;
c) The achievement of effective process
performance;
d) Improvement of processes based on evaluation of
data and information.
Plan, Do, Check and Act Approach
Establish the objectives of the system and its processes; resources
needed to deliver results in accordance with customer’ requirements
P and the organization’s policies; identify and address risks and
opportunities.

D Implement what was planned.

Monitor and (where applicable) measure processes and

C products/services against the policies, objectives, requirements and
planned activities, and report the results.

A Take actions to improve performance, as necessary.

The QMS Model

Quality Management System (4)

Organization and
Its context (4) Support
(7)
Operation
(8)

Customer
PLAN DO Satisfaction

Performance Results of the

Customer Planning Leadership Evaluation
(6) (5) (9) QMS
requirements

ACT CHECK Customer

Satisfaction

Improvement
(10)

Needs and expectations

of relevant interested
parties (4)
Risk-based Thinking

An organization needs to plan and implement actions to

address risks and opportunities – a basis for increasing
effectiveness of the QMS, achieving improved results and
preventing negative effects :

• Risk – effect of uncertainty; it is often expressed in terms of a

combination of the consequences of an event and the
associated likelihood of occurrence.
• An effect can be positive or negative.
• A positive deviation arising from a risk can provide an
opportunity, but not all positive effects of risk results in
opportunity.
 ISO 9001 : 2015

Summary and END of Course

International Management System Marketing
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Summary
1. Organization needs to understand its organizational context;
determining the external and internal issues, needs and
expectation of interested parties for business strategic
planning in achieving the intended results of the QMS.
2. Determine and manage its risks and opportunities; removal
of “Preventive Action”.
3. Emphasis on “Organizational Knowledge” and “Prevention of
Human Error”.
4. Enhanced top management leadership role in taking
accountability for the effectiveness of the QMS.
END OF COURSE
Thank you!