Lead Auditor Training Program

ISO 9001:2015

Rev. 0 – [15-Jan-18]
(c) 2018 Aegis Services L.L.C All Rights Reserved.
What is Quality?

The common element of the business

definitions is that the quality of a product or
service refers to the perception of the degree
to which the product or service meets the
customer's expectations.

The totality of features and characteristics of a

product or service that bears on its ability to satisfy
given needs. — QUALITY IS NOT ACHIEVED BY
DOING DIFFERENT THINGS. IT IS ACHIEVED BY
DOING THINGS DIFFERENTLY.
Other Definitions
Grade of Quality

CATEGORY OR RANK GIVEN TO DIFFERENT QUALITY

REQUIREMENTS FOR PRODUCTS, PROCESSES OR
SYSTEMS HAVING THE SAME FUNCTIONAL USE

Customer Satisfaction

CUSTOMER’S PERCEPTION OF THE DEGREE TO WHICH

THE CUSTOMER’S REQUIREMENTS HAVE BEEN FULFILLED

Quality Policy

OVERALL INTENTIONS AND DIRECTION OF AN

ORGANIZATION RELATED TO QUALITY, AS FORMALLY
EXPRESSED BY TOP MANAGEMENT
Other Definitions
Quality Objectives

SOMETHING SOUGHT OR AIMED FOR, RELATED TO

QUALITY

Top Management

PERSON OR GROUP OF PEOPLE WHO DIRECTS AND

CONTROLS AN ORGANIZATION, AT THE HIGHEST LEVEL

Quality Control

PART OF QUALITY MANAGEMENT FOCUSED ON

FULFILLING QUALITY REQUIREMENTS
Other Definitions
Quality Assurance

PART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING

CONFIDENCE THAT QUALITY REQUIREMENTS WILL BE FULFILLED

Quality Planning

PART OF QUALITY MANAGEMENT, FOCUSED ON SETTING QUALITY

OBJECTIVES AND SPECIFYING NECESSARY OPERATIONAL
PROCESS AND RELATED RESOURCES TO FULFILL THE QUALITY
OBJECTIVES

Quality Improvement

PART OF QUALITY MANAGEMENT, FOCUSED ON INCREASING THE

ABILITY TO FULFIL QUALITY REQUIREMENTS
What is ISO & QMS?

ISO 9001 is a standard that sets out the requirements for a

quality management system. It helps businesses and
organizations to be more efficient and improve customer
satisfaction.

A new version of the standard is ISO 9001:2015 replacing the

previous version (ISO 9001:2008).

A quality management system (QMS) is a formalized system

that documents processes, procedures, and responsibilities for
achieving quality policies and objectives.
What is ISO 9001: 2015
Standard Purpose Remarks

ISO 9000:2005 Establishes the starting point to understand the Only for reference
standards and defines the fundamental terms and
definitions used in the ISO 9000 family

ISO 9001:2015 This is the requirement standard used to assess Against which is
the ability to meet customer and applicable the third party
regulatory requirements and there by address certification
customer satisfaction

ISO 9004:2009 This provides guidelines for continual Only for reference
improvement of QMS to all benefit all parties
through sustained customer satisfaction
How is an ISO standard revised?

• International organization for standardization (ISO) is a federation of

national standards bodies

• ISO works through technical committees. (TC–176 has the responsibility to

issue and update ISO 9000 standards )

• TC – 176 is supported by Sub Committees and Working Groups (WG)

• The standard progresses from Preliminary Working Draft (PWD) Î

Committee Draft (CD) Î Draft International Standard (DIS) Î Finalized Draft
International Standard (FDIS) Î Published International Standard

• The standard is published only after positive votes from members

What is importance of QMS?

Effective QMS' are rigorous processes, which are

able to continually increase the economic and
quality value of products and services. They work to
enhance the experience of your customers, which,
for a small business, is essential when it comes to
ensuring customer retention.
Some of the elements of QMS

Some of the elements of QMS are:

 A sustained management commitment to quality

 Focusing on customer requirements and
expectations
 Preventing defects rather than detecting them
 A continual improvement approach
 Quality is everyone’s responsibility
 Team work produces quality
 Root cause corrective / preventive action
Why QMS is prominent in any organization

The effect of QMS in any organization is directly

proportional to the profit and customer satisfaction.

A good QMS will reduce deficiencies, which will bring

down the cost (which will increase the profit) and
increase customer satisfaction.

Other reasons are:

• Competition;
• Changing customer;
• Product complexity;
• Higher Level of customer expectations;
What is TQM?

Total Quality Management is a management framework based on

the belief that an organization can build long-term success by
having all its members, from low-level workers to its highest
ranking executives, focus on quality improvement and, thus,
delivering customer satisfaction.

TQM focuses on continuous improvement of organizational

processes resulting in high quality products and services.
The ideal goal of TQM is do things right the first time and
every time. The customer is the ultimate judge of quality.
What is ZERO defect in Quality?

Zero defects means “doing it right the first

time” to avoid costly and time-consuming fixes
later in the project management process. Zero
defects theory is based on four elements for
implementation in real projects. Quality is a
state of assurance to requirements
Purpose of Quality Standards?

Quality management standards are details

of requirements, specifications, guidelines and
characteristics that products, services and
processes should consistently meet in order to
ensure: their quality matches expectations.
they are fit for purpose. they meet the needs of
their users.
Purpose of QMS
Benefits of QMS

 Customer Confidence

 Consistency in Quality

 Reduction in waste and re work

 Employee Participation

 Reduction in Liabilities

 Improvement in Profits

 Continual Improvement
PDCA (Plan-Do-Check-Act)
QMS Principles

ISO 9001:2015 is based on 7 quality management principles that

senior management can apply for organization improvement:

 Customer focus
 Leadership
 Engagement of people
 Process approach
 Improvement
 Evidence-based decision-making
 Relationship management
Customer Focus
The primary focus of quality management is to meet customer
requirements and to strive to exceed customer expectations.

Sustained success is achieved when an organization attracts and

retains the confidence of customers and other interested parties.
Understanding current and future needs of customers and other
interested parties contributes to sustained success of the
organization.

Key benefits
 Increased customer satisfaction and customer loyalty
 Enhanced repeat business and reputation of the organization
 Increased revenue and market share
Customer Focus - Actions
• 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.
• Actively manage relationships with customers to achieve
sustained success
Leadership
Leaders at all levels establish unity of purpose and direction and create
conditions in which people are engaged in achieving the organization’s
quality objectives.

Creation of unity of purpose and direction and engagement of people

enable an organization to align its strategies, policies, processes and
resources to achieve its objectives.

Key benefits
• Increased effectiveness and efficiency in meeting the organization’s
quality objectives
• Better coordination of the organization’s processes
• Improved communication between levels and functions of the
organization
• Development and improvement of the capability of the organization
and its people to deliver desired results
Leadership - Action
Communicate the organization’s mission, vision, strategy, policies and
processes throughout the organization.

• Create and sustain shared values, fairness and ethical models for
behavior at all levels of the organization.

• Establish a culture of trust and integrity.

• Encourage an organization-wide commitment to quality.

• Provide people with the required resources, training and authority to

act with accountability.

• Inspire, encourage and recognize people’s contribution

 Engagement of people
Competent, empowered and engaged people at all levels throughout the
organization are essential to enhance its capability to create and deliver value.

To manage an organization effectively and efficiently, it is important to involve all

people at all levels and to respect them as individuals. Recognition, empowerment
and enhancement of competence facilitate the engagement of people in achieving
the organization’s quality objectives.

Key benefits
Improved understanding of the organization’s quality objectives by people in the
organization and increased motivation to achieve them
• Enhanced involvement of people in improvement activities
• Enhanced personal development, initiatives and creativity
• Enhanced people satisfaction
• Enhanced trust and collaboration throughout the organization
• Increased attention to shared values and culture throughout the
organization
Engagement of people - Action
Communicate with people to promote understanding of the importance of their
individual contribution.

• Promote collaboration throughout the organization.

• Facilitate open discussion and sharing of knowledge and experience.

• Empower people to determine constraints to performance and to take initiatives

without fear.

• Recognize and acknowledge people’s contribution, learning and improvement.

• Enable self-evaluation of performance against personal objectives.

• Conduct surveys to assess people’s satisfaction, communicate the results, and take
appropriate actions.
Process

SET OF INTERRELATED OR INTERACTING ACTIVITIES WHICH TRANSFORM INPUTS INTO

OUTPUTS

OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTS INTO OTHER PROCESSES

PROCESSES MAY BE INTERRELATED OR INDEPENDENT

OVERALL AIM IS TO ADD VALUE BY PLANNING AND CONTROLLING PROCESSES

Process Approach

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.

The quality management system consists of interrelated processes. Understanding

how results are produced by this system enables an organization to optimize the
system and its performance

Key benefits

• Enhanced ability to focus effort on key processes and opportunities for improvement
• Consistent and predictable outcomes through a system of aligned processes
• Optimized performance through effective process management, efficient use of
resources, and reduced cross-functional barriers
• Enabling the organization to provide confidence to interested parties as to its
consistency, effectiveness and efficiency
Process Approach - Action
• Define objectives of the system and processes necessary to achieve them.

• Establish authority, responsibility and accountability for managing processes.

• Understand the organization’s capabilities and determine resource constraints

prior to action.

• Determine process interdependencies and analyze the effect of modifications to

individual processes on the system as a whole.

• Manage processes and their interrelations as a system to achieve the

organization’s quality objectives effectively and efficiently.

• Ensure the necessary information is available to operate and improve the

processes and to monitor, analyze and evaluate the performance of the overall
system.

• Manage risks that can affect outputs of the processes and overall outcomes of the
quality management system.
Improvement
Successful organizations have an ongoing focus on improvement

Improvement is essential for an organization to maintain current levels of performance,

to react to changes in its internal and external conditions and to create new
opportunities.

Key Benefits

 Improved process performance, organizational capabilities and customer satisfaction

 Enhanced focus on root-cause investigation and determination, followed by
prevention and corrective actions
 Enhanced ability to anticipate and react to internal and external risks and
opportunities
 Enhanced consideration of both incremental and breakthrough improvement
 Improved use of learning for improvement • Enhanced drive for innovation
Improvement - Action
Promote establishment of improvement objectives at all levels of the organization.

• Educate and train people at all levels on how to apply basic tools and
methodologies to achieve improvement objectives.

• Ensure people are competent to successfully promote and complete improvement

projects.

• Develop and deploy processes to implement improvement projects throughout the

organization.

• Track, review and audit the planning, implementation, completion and results of
improvement projects.

• Integrate improvement considerations into the development of new or modified

goods, services and processes.

• Recognize and acknowledge improvement.

Evidence – based decision making
Decisions based on the analysis and evaluation of data and information are more likely
to produce desired results.

Decision making can be a complex process, and it always involves some uncertainty
Facts, evidence and data analysis lead to greater objectivity and confidence in decision
making.

Key benefits

• Improved decision-making processes

• Improved assessment of process performance and ability to achieve objectives

• Improved operational effectiveness and efficiency

• Increased ability to review, challenge and change opinions and decisions

• Increased ability to demonstrate the effectiveness of past decisions

Action

Determine, measure and monitor key indicators to demonstrate the organization’s

performance.

• Make all data needed available to the relevant people.

• Ensure that data and information are sufficiently accurate, reliable and secure.

• Analyze and evaluate data and information using suitable methods.

• Ensure people are competent to analyze and evaluate data as needed.

• Make decisions and take actions based on evidence, balanced with experience and
intuition.
Relationship Management
For sustained success, an organization manages its relationships with interested
parties, such as suppliers.

Interested parties influence the performance of an organization. Sustained success is

more likely to be achieved when the organization manages relationships with all of its
interested parties to optimize their impact on its performance. Relationship
management with its supplier and partner networks is of particular importance.

Key Benefits:

Enhanced performance of the organization and its interested parties through

responding to the opportunities and constraints related to each interested party
• Common understanding of goals and values among interested parties
• Increased capability to create value for interested parties by sharing resources and
competence and managing quality-related risks
• A well-managed supply chain that provides a stable flow of goods and services
Relationship Management - Action
Determine relevant interested parties (such as suppliers, partners, customers, investors,
employees, and society as a whole) and their relationship with the organization.

• Determine and prioritize interested party relationships that need to be managed.

• Establish relationships that balance short-term gains with long-term considerations.

• Pool and share information, expertise and resources with relevant interested parties.

• Measure performance and provide performance feedback to interested parties, as

appropriate, to enhance improvement initiatives.

• Establish collaborative development and improvement activities with suppliers,

partners and other interested parties

. • Encourage and recognize improvements and achievements by suppliers and partners.

Important Clauses of ISO 9001:2015
PDCA – ISO Requirements (Deming Cycle)
Management Responsibilities
 Establishing policy and objectives (SMART)

(S - specific, significant, stretching. M - measurable, meaningful, motivational. A -

agreed upon, attainable, achievable, acceptable, action-oriented)

 Communicate the importance of meeting

 Customer and regulatory requirements

 Conducting Management Reviews

 Ensuring the availability of resources

 Planning

 Customer Focus

 Responsibility, Authority and Communication

Resource Management

 Provision of Resources (In a timely manner)

 Human Resource

 Competence
 Awareness
 Training

 Infrastructure

 Work Environment
Production Realization

 Customer Related Processes

 Determination of requirements
 Review of requirements
 Customer communication

 Design and Development

 Control of Monitoring and Measuring Devices

 Purchasing
 Vendor Selection
 Purchasing information
 Verification of purchased product
Production & Service Provision

 Control of Production and Service Provision

 Validation of Processes for production and service provision

 Identification and traceability

 Customer Property

 Preservation of Product
Measurement, Analysis & Improvement
 Control of Monitoring and Measuring Devices (Calibration of equipment)

 Monitoring and Measurement

Customer Satisfaction
Internal Audit

 Analysis of Data
Customer Satisfaction
Conformity to product requirements

 Suppliers
Supplier qualification
Supplier performance evaluation

 Improvements and Management Reviews

 Continual improvement through policy, objectives, audit results, CAPA

Monitoring and Measurement
 Customer Focus

 Internal Audit

 Monitoring and Measurement of Processes

 Monitoring and Measurement of Products

Context of the Organization

From ISO 9001:2015:

Context of an organization

 “Understanding the context of the organization is a process.

This process determines factors which influence the
organization’s purpose, objectives and sustainability.”

 “combination of internal and external issues that can have an

effect on an organization’s approach to developing and
achieving its objectives.”
Example of internal issues…

One process, that is underused but powerful in identifying

internal issues, it is self assessment through:

 Internal Audit results

 Analysis of quality cost data
 Analysis of technology trend information
 Competitive analysis
 Results of customer reviews, audits, complaints and feedback
 Actual versus intended internal values and culture
 Organizational performance
 Best practices of the organization and comparisons with
industry benchmarks
 Employee satisfaction data analysis
Example of external issues…

External Issues can be found through several Techniques such as

analysis of:

 Economic environment and trends

 International Trade conditions
 Competitive products and services
 Opportunities and conditions related to outsourcing
 Technology trends
 Raw material availability and prices
 Potential changes in statutes and regulations
 Benchmarking best in class performers in and outside the
current market place
Understanding “Interested Parties”
When determining the scope of the organization, we shall consider the expectations of
“relevant interested parties.”

All of the following can be "interested parties”:

Person having an
Organization that
interest in the Person that can affect
perceives itself to be
success of an an activity
affected by a decision
organization

Person having an
interest in the Providers’ regulators
Stakeholder
performance of an
organization

Opposing pressure
Competitors There are more!
group
Understanding “Risk”
The term “risk” has been added to ISO 9001:2015 and is noted in many places
throughout the standard.

From ISO 9000:2015, clause 3.7.9:

Risk is …..

effect of uncertainty…positive or negative….

Often characterized by reference to potential events….
Often expressed in terms of the consequences of an event …
and the associated likelihood of occurrence

This may apply, for example, to a product, service,

process, provider, customer, consumer, environment,
employee, and the competition.
Documentation requirements
ISO 9001:2015 require

 Documented statements of quality policy and quality

objectives

 Organizational chart with all the current positions

 A quality manual

 Documented procedures & records required by the standard

 Documents needed by the organization to ensure effective

planning, operation and control of its processes.
A typical Quality Manual
A quality manual is a document that states the company's intentions for
operating the processes within the quality management system and meet
your customers' and ISO's requirements

1. Title and scope

2. Table of contents

3. Review, approval and revision

4. Quality policy and objectives

5. Organization, responsibility and authority

6. References

7. Quality management system description

8. Appendices
Structure of Documented Procedure

1. Title and scope

2. Table of contents

3. Introduction, Purpose and Scope

4. Definitions and Abbreviations

5. Roles and Responsibilities

6. Detailed Procedure

7. Flowchart/Process Maps

8. Review, approval and revision, Identification of changes

9. Appendices
Work Instructions

The structure, format and level of detail used

in the work instructions should be tailored to
the needs of the organization’s personnel and
depends on the complexity of the work
Value of Documentation

 Enables communication of intent and consistency of action

 Definition of roles for members
 Enhancement of understanding
 Control and measurement
 System becomes auditable
 Evaluation of the effectiveness and continuing suitability of
QMS
 Information useful for training and competence building
 Provides confidence in the QMS
 Helps in continual improvement
 Provides repeatability and traceability
Customer Complaints & Review
Customer Complaints
7 Quality Control tools…
7 Quality Control tools

 Cause-and-effect diagram (also known as the "fishbone" or

Ishikawa diagram)

 Check sheet

 Control chart

 Histogram

 Pareto chart

 Scatter diagram

 Stratification (alternately, flow chart or run chart)

Roles and Responsibilities
Top Management
Management Representative
Function Head
QMS Co-Ordinator
Certification and Registration
Accreditation
ISO does not certify
Achieving ISO is the only beginning…
Questions Please…