An

Overview of
ISO 9001 Ivy Mar J. Ramos, PIE, ASEAN ENG.
LEARNING OBJECTIVES
When the students completed this lesson, they should be able
to:

Define ISO 9001:2015

Discuss the Evolution and History

Know the Importance of ISO 9001

WHAT IS ISO 9001– QUALITY MANAGEMENT SYSTEMS?

ISO 9001 is defined as the international standard that specifies

requirements for a quality management system (QMS). Organizations use
the standard to demonstrate the ability to consistently provide products
and services that meet customer and regulatory requirements. It is the
most popular standard in the ISO 9000 series and the only standard in the
series to which organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for
Standardization (ISO), an international agency composed of the national
standards bodies of more than 160 countries. The current version of ISO
9001 was released in September 2015.
WHAT IS ISO 9001– QUALITY MANAGEMENT SYSTEMS?

A Quality Management System based on ISO 9001:

• Defines how an organization can meet the
requirements of its customers and other
stakeholders.
• Promotes the idea of continual improvement.
• Requires organizations to define objectives and
continually improve their processes to reach them.
WHAT IS ISO 9001– QUALITY MANAGEMENT SYSTEMS?

There are over one million

ISO 9001 defines the criteria for a companies and organizations in
Quality Management System and over 170 countries certified to ISO
is the only standard in the family 9001. All the requirements of ISO
that can be audited against the 9001 are generic and are intended
goal of voluntary compliance or to to apply to any organization,
become 3rd party registered. regardless of its type or size, or the
products and services it provides.
 Customer
Focus

Relationship
Management Leadership

WHAT IS ISO
Quality
9001– QUALITY Management
Evidence- Principles
MANAGEMENT based
Decision
Engagement
of People

SYSTEMS? Making

Continual Process
Improvement Approach
 Customer Focus : Focus on your customer and their needs

Leadership: Develop a strong management team

Engagement of People: Getting your team involved in

the management system.
Quality
Management Process Approach: Create a process culture
Principles
Continual Improvement: Embrace continual
improvement
Evidence-based Decision Making: Base your decisions on
facts
Relationship Management: Develop mutually beneficial
relationships with suppliers
 HISTORY OF ISO 9001
1987 1994 2000 2008 2015

• Publication • Revision • Major • Minor • Major

of ISO 9000 • 20 Clauses, Revision Revision for Revision
series of 20 required • 8 Clauses, 6 word • 10 Clauses,
standards procedures required clarification no required
• 3 auditable procedures procedures
standards: • Process per se
9001, 9002 Approach • Risk
and 9003 introduced Assessment
• 1 auditable introduced
standard: • Top
9001 Management
emphasized
 The ISO 9001 standard is based on a series of ISO 9000 standards:
• ISO 9001 – defines the requirements of a quality management
system.
• ISO 9000 – contains detailed explanations of the seven-quality
management principles with tips on how to ensure these are
reflected in the way you work. It also contains many of the terms
HISTORY OF and definitions used in ISO 9001.
• ISO 9004 – focuses on how to make a quality management
ISO 9001 system more
• efficient and effective.
• ISO 19011 – gives guidance for performing both internal and
external audits to
• ISO 9001. This will help ensure your quality management system
delivers on the promise and will prepare you for an external
audit, should you decide to seek third-party certification.
 Why Implement ISO 9001?
ISO 9001 specifies requirements for a quality management system when an
organization wants to:
• Demonstrate its ability to consistently provide products and services that
meet customer and applicable statutory and regulatory requirements.
• Enhance customer satisfaction through the effective application of the
system.
• Implement processes for improvement of the system.
• Integrate multiple management systems where the ISO 9001 structure is
the same, such as ISO 14001 (Environmental), ISO 45001 (Occupational
Health and Safety), etc.
• Define its overall context and who is affected as well as what is
expected.
• Clearly state its objectives and identify new business opportunities.
Why Implement ISO 9001?
ISO 9001 specifies requirements for a quality management system
when an organization wants to:
• Put customers first, making sure that their needs are consistently
met and enhance their satisfaction.
• Have repeat customers, increase customer loyalty, add new clients
and increase business.
• Expand into new markets, as some sectors and clients require ISO
9001 before doing business.
• Identify and address the risks within the organization.
• Work in a more efficient way to increase productivity and efficiency,
bringing internal costs down.
How to Implement ISO 9001?
Organizations should commit to:
• Recognize direct and indirect customers as those who receive value from the
organization
• Understand customers’ current and future needs and expectations
• Link the organization’s objectives to customer needs and expectations
• Communicate customer needs and expectations throughout the
organization
• Plan, design, develop, produce, deliver and support goods and services to
meet customer needs and expectations
• Measure and monitor customer satisfaction and take appropriate actions
• Determine and take actions on interested parties’ needs and expectations
that can affect customer satisfaction
• Actively manage relationships with customers to achieve sustained success
The PDCA cycle can briefly described as
follows:
• Plan: establish the objectives of the
system and its processes, and the
resources needed to deliver results in
accordance with customers’ requirements
and the organization’s policies, and identify
and address risks and opportunities.
• Do: implement what was planned
• Check: monitor and (where applicable)
measure process and the resulting
products and services against policies,
objectives, requirements and planned
activities, and report the results.
• Act: take actions to improve performance,
as necessary.
 1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization

Quality 4.1. Understanding the organization and its context

4.2. Understanding the needs and expectations of interested

Management
parties
4.3. Determining the scope of the quality management system
4.4. Quality management system and its processes

Systems- 5. Leadership
5.1. Leadership and commitment

Requirements 5.1.1 General

5.1.2 Customer Focus
5.2. Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3. organizational roles, responsibilities and authorities
 6. Planning
6.1. Actions to address risk and opportunities
6.2. Quality objectives and planning to achieve them
6.3. Planning of changes
7. Support

Quality 7.1. Resources

7.1.1. General

Management
7.1.2. People
7.1.3. Infrastructure
7.1.4. Environment for operation of processes

Systems- 7.1.5 Monitoring and measuring resources

7.1.6. Organizational knowledge

Requirements 7.2. Competence

7.3. Awareness
7.4. Communication
7.5. Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
 8. Operation
8.1. Operational planning and control
8.2. Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements for
Quality products and services
8.2.3 Review the requirements for products

Management and services

8.2.4 Changes to requirements for product
and services
Systems- 8.3. Design and development of products and
services

Requirements 8.3.1 General

8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
 8.4. Control of externally provided processes,
products and services
8.4.1 General
8.4.2 Type and extent of control

Quality 8.4.3 Information for external providers

8.5. Production and service provision

Management 8.5.1 Control of production and service

provision

Systems- 8.5.2 Identification and traceability

8.5.3 Property belonging to customers or

Requirements
external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6. Release of products and services
8.7 Control of nonconforming outputs
 9. Performance evaluation
9.1 Monitoring, measurement, analysis and
evaluation
9.1.1 General

Quality 9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation

Management 9.2 Internal Audit

9.3 Management review

Systems- 9.3.1 General

9.3.2 Management review inputs

Requirements 9.3.3 Management review outputs

10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Quality-
One’s Seven
Phase Executive and Gap
Approach Overview/Planning
Management Assessment and
Planning
Documentation

Internal
Sustain and 3rd Party
Assessment and Implementation
Continual Registration Management
Improvement Assessment and Training
Review
ISO 9001 is defined as
Summary A proven Quality
Management System
development and
implementation
the international
approach should be
standard that specifies
Implementing an used based on project
requirements for a
effective and robust management
quality management methodologies. ISO
ISO 9001 Quality
system (QMS).
Management System 9001 Compliance can
Organizations use the
(QMS) will help you to be achieved through
standard to
focus on the important Seven Phases:
demonstrate the ability Executive and
areas of your business
to consistently provide Management
and improve efficiency.
products and services
Increase in efficiency, Overview/Planning,
that meet customer
productivity, and profit. Gap Assessment and
and regulatory
Improved customer Planning,
requirements. It is the Documentation,
retention and
most popular standard Implementation and
acquisition. Consistent
in the ISO 9000 series
outcomes, measured, Training, Internal
and the only standard
and monitored. Assessment and
in the series to which
Management Review,
organizations can 3rd Party Registration
certify.
Assessment, Sustain,
and Continual
References
ISO 9001 (2015) How to use it, ISBN 978-92-67-10640-3,
issued by iso.org
The Process Approach in ISO 9001 (2015) ISO/TC 176/SC
2/N 1289, issued by iso.org
https://quality-one.com/iso-9001/
https://asq.org/quality-resources/iso-9001
Philippine National Standard