Quality Management System

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 ISO 9001 General Concepts
 The Seven (7) Quality Management Principles
 Process Approach
◦ PDCA Cycle
◦ Risk-Based Thinking
 QMS Structure

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 An organization focused on quality promotes
a culture that results in the behavior, attitude,
activities and processes that deliver value
through fulfilling the needs and expectations
of customer and other interested parties.

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 Determined by the ability to satisfy customers
and intended and unintended impact on
relevant interested parties.
 Include not only the intended function and
performance but also their perceived value
and benefit to the customer.

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If :
QUALITY = Conforming Characteristics
= Fulfilled Requirements

Therefore:
QUALITY MANAGEMENT SYSTEM (QMS)

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 Comprises activities by which the
organization identifies its objectives and
determines the processes and resources
required to achieved desired results.

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 Enables top management to optimize the use of
resources considering the long and short term
consequences of their decision.

 Provides the means to identify actions to address

identified and unintended consequences in providing
products and services

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 An independent, non-governmental
international organization
 From the greek word “ISOS” meaning equal
 With membership of 161 national standards
bodies
 Formed on 23 of February 1947

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 NOT an acronym
 NOT a product/ service quality label
 DOES NOT assess management systems to
confirm that they conform to international
standard

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 ISO DOES NOT issue ISO certificates
 ISO DOES NOT approve ISO certificates

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 It provides a model for setting up a Quality
Management System.
 A model not certainly perfect, but one that,
since 1987 has proven to be valuable and
applicable to all types of organization.

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 QMS aims to increase an organization’s
awareness of its duties and commitment in
fulfilling the needs and expectations of its
customers and interested parties and in
achieving satisfaction with its products and
services

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 ISO 9001 has been aligned with ISO 14001 for the
benefit of the user community.
 ISO 9001 does not include requirements specific to
other management systems.

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 However, ISO 9001 enables an organization
to align or integrate its own QMS with
related management system requirements.

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 ABILITY to consistently provide products and
services that meet customer and applicable
statutory and regulatory requirements

 FACILITATES opportunities to enhance

customer satisfaction

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 ADDRESSES risks and opportunities
associated with its context and objectives

 ABILITY to demonstrate conformity to

specified QMS requirements

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 Improves their ability to fully understand and
meet customer requirements consistently

 Brings greater clarity to the goals and

objectives of the organization

 Standardizes the ways things are done, reducing

variability, and making it easier to solve problem

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 Makes it easier to manage using facts and
data rather than opinions

 Enhances communication throughout the

organization

 Foster continual improvement as an

institutionalized core values

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 Aim to
facilitate a
successful
management
culture.

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 The primary focus of quality management is
to meet customer requirements and strive to
exceed customer expectations.

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 Leaders at all levels establish unity of
purpose and direction of the organization
and create conditions in which people are
engaged in achieving the organization’s
quality objectives.

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 Competent, empowered and engaged people
at all levels throughout the organization are
essential to enhance the organization’s
capability to create and deliver value.

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 Consistent and predictable results are
achieved more effectively and efficiently
when activities are understood and managed
as interrelated processes that function as a
coherent system.

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 Successful organizations have an ongoing
focus on improvement
 Responding to changes in the external and
internal environment is necessary if you want
to continue to deliver value to your
customers.

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 Decisions based on the analysis and
evaluation of data and information are more
likely to produce desired results.

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 For sustained success, organizations
managed their relationships with relevant
interested parties, such as providers.

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 Involves systematic definition and
management of processes and their
interactions
 Enables control of the interrelationships and
interdependencies among processes in the
system

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 Understanding and consistency in meeting
requirements
 Consideration of processes in terms of added
value
 Achievement of effective process
performance
 Improvement of process

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 RBT is “something we all do automatically
and is already part of the process approach”.

 It has always part of the ISO 9001. This new

version of the standard makes risk more
explicit and builds it into the whole
management system.

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 RBT ensures that risk is considered in full
cycle of the process approach. It brings
preventive action as an inherent part of the
strategic and operational planning.

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 Essential for achieving an effective QMS
 Plan and implement actions to address risk
and opportunities

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 Addressing risks and opportunities
establishes a basis for increasing the
effectiveness of the QMS, achieving improved
results and preventing negative effects.

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 Risk is the effect of  Prevent the
uncertainty and any negative effects of
such uncertainty risk.
can have positive or
negative effects.

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 Opportunities can arise as a result of a situation
favorable to achieving the intended results:

◦ Attract new customer/ clients

◦ Develop new products and services
◦ Reduce waste
◦ Improve productivity

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 ISO 9001 specifies requirements for a QMS where an
organization:

◦ Needs to demonstrate its ability to consistently provide product

that meets customer and applicable regulatory requirements

◦ Aims to enhance customer satisfaction through the

effective application of the system

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 YEAR EDITION

After WWII NATO- AQAPs and DEFSTAN

1979 BS 5750 QMS
1987 ISO 9001 1ST Edition
1S1994 ISO 9001 2nd Edition
2000 ISO 9001 3rd Edition
2008 ISO 9001 4th Edition
2015 ISO 9001 5th Edition
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 Current trends:
◦ Keeping up with recent developments in
management system practices.

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 Quality- degree to which a set if inherent
characteristics of an object fulfills requirements
 Requirement- need or expectation that is
stated , generally implied or obligatory
 Nonconformity- non-fulfillment of a requirement
 Risk- effect of uncertainty

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 Process- set of interrelated or interacting activities
that use inputs to deliver an intended result
 Product- output of an organization that can
be produced without any transaction taking
place between the organization and the
customer

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 Service- output of an organization with at
least one activity necessarily performed
between the organization and the customer
 Customer- person or organization that could or
does receive a product or a service that is intended
for or required by this person or organization.

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 Customer Satisfaction- Customer’s
perception of the degree to which
expectation have been fulfilled
 Top Management- person or group of people
who directs and control of an organization at
the highest level.

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 SHALL- requirements
 SHOULD- recommendation
 MAY- permission
 CAN- possibility or capability
 NOTE- for guidance and clarification

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 Introduction
1. General

2. QM Principle

3. Process Approach

 PDCA Cycle And Risk-based thinking

4. Relationship with other Management Standard

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1. Scope
2. Normative Reference
3. Terms and Definition
4. CONTEXT OF THE ORGANIZATION
5. LEADERSHIP
6. PLANNING
7. SUPPORT
8. OPERATION
9. PERFORMANCE EVALUATION
10. IMPROVEMENT
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 Understanding the organization and its
 Understanding the needs and expectations of
interested parties
 Determining the scope of the QMS
 QMS and its processes

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 Leadership and Commitment
 Policy
 Organizational Roles, Responsibilities and
Authorities

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 Actions to Address Risk and Opportunities
 Quality Objectives and Planning to Achieve
Them
 Planning of Changes

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 Resources
 Competence
 Awareness
 Communication
 Documented Information

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1. Operational Planning and Control
2. Requirements for products and Services
3. Design and Development of products and Services
4. Control of Externally Provided Processes and Services
5. Production and Service Provision
6. Release of Products and Services
7. Control of Non-Conforming Outputs

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 Monitoring Measurement Analysis and
Evaluation
 Internal Audit
 Management Review

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 General
 Non-Conformity and Corrective Action

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 ISO 9001:2015
QUALITY MANAGEMENT SYSTEM
Reporters: Mr. Bernardo Siarot and Mr. Enrique Biton
Professor: Dr. Victor D. Villaganas

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