Walk with me…

Kuwait Chapter

Introduction to
Quality Management System
ISO 9001
Ujwal Ritwik
CRSP, QEP, REM, LA ISO 45001/14001/9001/22000/50001
Course Objectives

Participants will become aware of -

 ISO organization and background
 Background and foundational knowledge of ISO MS
Standards
 Principles of quality management
 ISO 9001 structure
 Overview of requirements of ISO 9001:2015
 ISO audit approach
 Overview of ISO certification process
 Understand usefulness of ISO 9001 to your professional
career
Agenda

 Introduction
 Background to ISO and ISO 9001
 Foundation
 ISO 9001 structure & requirements
 Approach to internal audit
 Certification
 Advantage to professionals
 Conclusion
Preparation

 Pre-read ?

 Pre-questionnaire completed?

 This is a training course, you would be required to take notes

 Keep blank paper and pen ready

 Note down all text written in blue color or on a blue strip

Introduction
Why I am interested
– Was interested in Management Systems as a student, as an engineer and when doing
Management Course
– Was influenced by authors like Peter Drucker, Edward Deming, Joseph Juran, Philip
Crosby, and Kaoru Ishikawa etc.
– Was a certified tutor for Quality Circles/TQM, a program popular in 1980s
– Came to actually participate implement ISO 9000 in 1996
– Got on road to ISO 14001 in 2000
– First hand implementation and auditing experience ISO 9001, ISO 14001, OHSAS
18001, and ISO 45001
– Administrator of IMS program in KNPC, the leader in ISO certifications in Kuwait
– I remain deeply interested in spreading what I learned
Introduction to QMS ISO 9001 : Ujwal Ritwik
The ISO 9001 Recipe

Introduction to QMS ISO 9001 : Ujwal Ritwik

Background
Opening question

Would you like to improve your company’s performance on a

sustained basis?

It requires adopting a structured Management System

Quality Management System ISO 9001 is a good choice
By focusing on quality of products and services it helps improve
customer satisfaction, performance and profitability

Introduction to QMS ISO 9001 : Ujwal Ritwik

New approach: Deliver perfect quality to customer, by everyone's
participation
Old approach: Inspect bad quality out and build good quality in
Introduction to QMS ISO 9001 : Ujwal Ritwik
What is a Management System?

A Framework
• Consisting of policies & procedures,
• To ensure that organization can execute and manage their business,
• To achieve the organizational objectives.
Without Management System Different functions work
independently as per their intended
objectives without taking into
account of organization goal/target
and system may collapse or perform
ineffective.

With Management System

Management system helps to

synchronise all functions in the
organization to achieve company’s
goal/target and improve overall
performance.
Quality Management Systems (QMS)

• According to the American Society for Quality, a quality management

system (QMS), is a
“formalized system that documents processes, procedures, and
responsibilities for achieving quality policies and objectives.”
• A QMS will allow a company to meet customer needs and continually
improve its effectiveness and efficiency.
• A quality management system should help an organization recognize
and then address their needs, and customers’ needs.

Introduction to QMS ISO 9001 : Ujwal Ritwik

Introduction to QMS ISO 9001 : Ujwal Ritwik
Background of ISO

• ISO is an independent, non-governmental international organization

with a membership of 161 national standards bodies
• On 23 February 1947, ISO began operations
• ISO from Greek means equal (IOS in English, OIN in French for
Organisation internationale de normalisation)

Introduction to QMS ISO 9001 : Ujwal Ritwik

Based in Geneva, Switzerland

Introduction to QMS ISO 9001 : Ujwal Ritwik

Introduction to QMS ISO 9001 : Ujwal Ritwik
Some relevant ISO Standards
• ISO 9001 – “Consistent, conforming products”
• ISO 14001 – “Prevention of pollution”
• ISO 45001 – “Safe working conditions”
• ISO 22000 – “Safe food”
• ISO 50001 – “Efficient energy usage”
• etc.

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Introduction to QMS ISO 9001 : Ujwal Ritwik
ISO 9001
• ISO 9001 is the international standard for quality management for
small, mid-size businesses and large corporations
• World’s most popular MS for quality and performance improvement
• Being certified by ISO 9001 means that you are serious about your
company, that its purposes are legitimate, and that you are a
trustworthy business owner and partner
• ISO 9001 provides you, the business owner, with a platform to ensure
that your company is thriving with quality and efficiency

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Who developed the standard?
• The work of preparing International Standards on QMS is carried out
through ISO technical committees ISO/TC 176
• The procedures used to develop this document and those intended
for its further maintenance are described in the ISO/IEC Directives,
Part 1.
• This fifth edition cancels and replaces the fourth edition (ISO
9001:2008), which has been technically revised,

Introduction to QMS ISO 9001 : Ujwal Ritwik

 Based on Annex L
Introduction to QMS ISO 9001 : Ujwal Ritwik
The Annex L (called Annex SL before 2019)
• A section of the ISO/IEC Directives part 1 that prescribes how ISO Management System
Standard (MSS) standards should be written.
• The aim of Annex L is to enhance the consistency and alignment of MSS by providing a
unifying and agreed-upon high level structure, identical core text and common terms and
core definitions.
• The aim being that all ISO Type A MSS (and B where appropriate) are aligned and the
compatibility of these standards is enhanced.
• Before 2012, various standards for management systems were written in different ways.
Several attempts have been made since the late 90s to harmonize the way to write these
• The first group that succeeded to reach an agreement was the Joint Technical
Coordination Group (JTCG) set up by ISO/Technical Management Board.
• Various of Technical Committees within ISO are currently working on revising all MSS
published before Annex L was adopted. Many standards are already following Annex L
such as ISO 9001, and ISO 14001

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Introduction to QMS ISO 9001 : Ujwal Ritwik
Goals of ISO 9001, ISO 14001 and ISO 45001
standards
Quality Management System
1. Helps the company consistently provide products and services as per
customer and applicable statutory /regulatory requirements.
2. Provide Opportunities for Customer Satisfaction
3. Addressing risk and opportunities associated with its context and
objectives
4. Improves overall performance of the organization.

Environment Management System

1. Protecting environment by mitigating adverse environment impacts
2. Mitigating the potential adverse effect of environment conditions
3. Assisting in fulfilment of compliance obligations
4. Enhancing environmental performance
Goal of ISO 9001, ISO 14001 and ISO 45001
standards
Occupational Health and Safety Management System (OHSMS)
1. Provide framework for managing OH&S risks
2. Provide safe and healthy work places
3. Prevent injuries and ill-health
4. Eliminate hazards and minimize OH&S risks
5. Improve Organization OH&S Performance
6. Fulfil legal and other requirements
Key Terms
QUALITY
Meeting the customer requirements
Performance improvement of Product / Service

OCCUPATIONAL HEALTH & SAFETY

Maintaining good health and safety of people at the
workplace

ENVIRONMENT
Maintaining good surroundings such as Air, Water and Land
Quality Control Vs Quality Management
System

Introduction to QMS ISO 9001 : Ujwal Ritwik

Quiz 1
1. QMS means Quantitative Management Service
a) true b) false

2. ISO 9001 is for use by all size and all types of businesses
a) true b) false

Introduction to QMS ISO 9001 : Ujwal Ritwik

Foundation
Seven Quality Principles

Introduction to QMS ISO 9001 : Ujwal Ritwik

The Seven Quality Management Principles
1. Customer Focus – Understanding customer needs and striving to meet those needs and exceed
expectations.
2. Leadership – Organizational leaders that create a goal-driven environment and embrace the
principles outlined in a quality management system.
3. Engagement of People – Equipping employees with the tools they need to learn more about
improving systems to perform at their best.
4. Process Approach – Creating and maintaining processes that will enhance efficiency.
5. Improvement – Making improvement a continual objective and using audits to keep moving in the
right direction.
6. Evidence-Based Decision Making – Using data to improve performance and processes.
7. Relationship Management – Selecting businesses that prioritize quality and improvement to
collaborate with.

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Foundation
• The quality management system requirements specified in this
International Standard are complementary to requirements for
products and services.
• This International Standard employs the process approach, which
incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based
thinking.

Introduction to QMS ISO 9001 : Ujwal Ritwik

Process Approach
The process approach enables an organization to plan its processes and
their interactions.
The application of the process approach in a quality management
system enables:
a) understanding and 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.

Introduction to QMS ISO 9001 : Ujwal Ritwik

Schematic representation of any process

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What is a Process (Business)?
SOPs, Operations &
Maint. manual, Controls Objectives
Procedures

Inputs Outputs

Feed to the process

Process Result of a process

Supports to transform input

Resources into output

Monitoring & Performance Measures (KPI)

PDCA Deming Cycle

• What to do? Goals

• How to do it?
Procedure

• Did things happen as • Do what was

per plan? planned
W. Edward Deming
1900 - 1993

Introduction to QMS ISO 9001 : Ujwal Ritwik

PDCA Cycle
• The PDCA cycle enables an organization to ensure that its processes are adequately
resourced and managed, and that opportunities for improvement are determined
and acted on.
• Organization might find it necessary to adopt various forms of improvement in
addition to correction and continual improvement, such as breakthrough change,
innovation and re-organization.
• The PDCA cycle can be 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 processes 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.

Introduction to QMS ISO 9001 : Ujwal Ritwik

Introduction to QMS ISO 9001 : Ujwal Ritwik
Risk-based thinking
• Risk-based thinking (Clause A.4) is essential for achieving an effective
quality management system.
• To conform to the requirements of this International Standard, an
organization needs to plan and implement actions to address risks
and opportunities.
• Addressing both risks and opportunities establishes a basis for
increasing the effectiveness of the quality management system,
achieving improved results and preventing negative effects.

Introduction to QMS ISO 9001 : Ujwal Ritwik

What is Risks & Opportunities?
RISK

What is Risk?
Risk is effect of uncertainty in achieving result.
OPPORTUNITY

What is Opportunity?
Opportunity is circumstance or set of circumstances that can lead to improvement of
performance.

The outcome of the risk can be negative or positive.

• When effect is negative, it is a Threat.
Need to control by eliminate / mitigate / transfer by appropriate control measures.
• When effect is positive, it is an Opportunity. Need to maximize to get benefited.
Introduction to QMS ISO 9001 : Ujwal Ritwik
Language
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or
clarifying the associated requirement.

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Quiz 2
1. ISO 9001 is based on ten princilpes
a) true b) false

2. P-D-C-A cycle means Plan, Direct, Control and Act

a) true b) false

Introduction to QMS ISO 9001 : Ujwal Ritwik

ISO 9001 Structure
Annex L High Level Structure
1. Scope 7. Support
2. Normative references • Resources
• Competence
3. Terms and definitions • Awareness
4. Context of the organization • Communication
• Understanding the organization and its • Documented information
context 8. Operation
• Needs and expectations interested parties
• Determining the scope Management System
• Operational planning and control
5. Leadership 9. Performance evaluation
• Leadership and commitment • Monitoring, measurement, analysis &
evaluation
• Policy • Internal audit
• Roles, responsibility and authority • Management review
6. Planning 10. Improvement
• Actions to address risks & opportunities
• Non conformity and corrective action
• Objectives and plans to achieve them
• Continual Improvement
Introduction to QMS ISO 9001 : Ujwal Ritwik
1 Scope
This International Standard specifies requirements for a quality
management system when an organization:
a) needs to demonstrate its ability to consistently provide products and
services that meet customer and applicable statutory and regulatory
requirements, and
b) aims to enhance customer satisfaction through the effective
application of the system,
All the requirements of this International Standard are generic and are
intended to be applicable to any organization, regardless of its type or
size, or the products and services it provides.
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ISO 9001 Clauses

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3 Terms & definitions

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Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Clause 4: Context of the Organization

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4 Context of the organization
• Understanding the organization and its context - The organization
shall determine external and internal issues, monitor and review
information about them
• Understanding the needs and expectations of interested parties –
determine the relevant interested parties and their requirements
• Determining the scope of the quality management system -
determine scope of the quality management system considering the
above two and products and services of the organization

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What is Interested Parties?
Person or organization that can affect, be affected by, or perceive itself to be affected by a
decision or activity. These interested parties can be internal or external to the company.
They are also known as ‘stakeholder’

Who are the Internal Who are the External

Interested Parties? Interested Parties?
• Employees, • Parent company
• Departments within company • Regulatory bodies
• Contractors’ personnel • Suppliers and vendors
• Customers
• Financial institutes
• Civil society/community
• Media
What are Internal and External Issues?
Internal Issues are factors that exist within the company itself that can
affect its ability to achieve sustained success, e.g.
1. Absenteeism
2. Equipment and infrastructure downtime
3. Customer complaints not attended as per schedule

External Issues are factors that exist outside the company that can affect
the its ability to achieve sustained success, few examples are
1. Legal and regulatory constraints 2. Market challenges
3. Customer concerns 4. External providers issues
5. Cultural diversity 6. Technology changes
7. Social, economic and environment challenges
Context of the organization”
External context includes
• cultural, social, political, legal, regulatory, financial, technological, economic,
natural and competitive environment, whether international, national, regional
or local;
• relationships with, and perceptions/values of external stakeholders
Internal context includes
• corporate culture;
• governance, organizational structure, roles and accountabilities;
• policies, objectives, and strategies
• resources (capital, time, people, processes, systems technologies);
• information systems, information flows and decision-making processes (both
formal and informal)

Introduction to QMS ISO 9001 : Ujwal Ritwik

4.4 Quality management system and its
processes
Establish, implement, maintain and continually improve the QMS,
including the processes needed and their interactions, in accordance
with the requirements of this International Standard.
(This is key to maintaining the “process approach”, which will now be
embedded in ALL ISO management system standards)

Introduction to QMS ISO 9001 : Ujwal Ritwik

Organizations shall determine:

• inputs required and outputs expected from the QMS processes;

• criteria, methods, including measurements and related performance
indicators needed to ensure the effective operation and control;
• assignment of the responsibilities and authorities these processes; for
• risks and opportunities and plan and appropriate actions to address
them;

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Clause 5: Leadership

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5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment with
respect to the quality management system by
• taking accountability of the effectiveness of the QMS;
• ensuring policy and objectives are compatible with strategic direction
• ensuring the quality policy is communicated, understood and applied
• ensuring integration of the QMS requirements into business processes
• Promoting awareness of the process approach;
• communicating importance of effective quality management and of conforming to NEWtheQMS
requirements;
• ensuring that the system achieves its intended results
• engaging, directing and supporting persons to contribute to the effectiveness of the QMS;
• promoting continual improvement
• supporting other relevant management roles to demonstrate their leadership as it applies to their
areas of responsibility.
Introduction to QMS ISO 9001 : Ujwal Ritwik
5.1 Leadership and commitment
Top management is also required to ensure that:
• customer requirements and applicable statutory / regulatory requirements are
determined and met;
• the risks and opportunities that can affect conformity of products and services
and the ability to enhance customer satisfaction are determined and addressed;
• the focus on consistently providing products and services that meet customer
and applicable statutory and regulatory requirements is maintained;
• the focus on enhancing customer satisfaction is maintained.

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5.2 Quality Policy
Top management shall establish a quality policy that:
Is appropriate to the purpose of the organization,
Provides a framework for setting quality objectives;
Includes a commitment to satisfy applicable requirements, and includes a
commitment to continual improvement of the management system quality

The quality policy shall

• be available as documented information
• be communicated within the organization
• be available to interested parties, as appropriate.”

Introduction to QMS ISO 9001 : Ujwal Ritwik

Why we require QHSSE Policy ?

• Management’s commitment
• To achieve the Mission, Vision and Values
• To set the framework for the management system
• Framework for setting QHSE objectives and action plan
• A mandatory requirement in all Management System
Standards
(QHSSE Policy – Quality, Health, Safety, Security & Environment Policy)
What is employees’ role in QHSSE policy?
1. Understand and implement the Policy requirements
2. Identify, assess and manage the Business Risk, OHS risk and
Environmental aspects and impacts of existing and planned
operations
3. Implement procedures and control measures
4. Report all incidents and near-misses
5. Attend required trainings and meetings
5.3 Organizational roles, responsibilities and
authorities
Top management shall assign authority for-
Ensuring that the processes outputs; the responsibility and are
delivering their intended
Reporting on the performance of the quality management system, on
opportunities for improvement and on the need for change or
innovation, and especially for reporting to top management;

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Clause 6: Planning

Introduction to QMS ISO 9001 : Ujwal Ritwik

6.1 Actions to address risks & opportunities
“determine the risks and opportunities that need to be addressed
give assurance that the QMS can achieve its intended result(s)
prevent or reduce undesired effects achieve continual improvement.
Plan:
a) actions to address these risks and opportunities, and
b) b) how to
integrate and implement these actions into the QMS processes
evaluate the effectiveness of these actions.”
Actions taken to address risks and opportunities shall be proportionate potential impact on
the conformity of products and services.
NOTE Options can include: avoiding risk, taking risk in order to pursue an opportunity,
eliminating the risk source, changing the likelihood or consequences, sharing the risk, or
retaining risk by informed decision.

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6.2 Quality objectives and planning to achieve
them
• “The organization shall establish quality objectives at relevant
functions, levels and processes.
• The quality objectives shall
• be consistent with the quality policy
• be measurable
• take into account applicable requirements
• be relevant to conformity of products and services and the
enhancement of customer satisfaction
• be monitored communicated, and updated as appropriate.

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6.2 Quality objectives and planning to achieve
them
• “When planning how to achieve its quality objectives, the
organization shall
• what will be done
• what resources will be required
• who will be responsible
• when it will be completed determine
• how the results will be evaluated.”

Introduction to QMS ISO 9001 : Ujwal Ritwik

6.3 Planning of changes
• Where there is a need for change to the QMS this must be done in a
planned and systematic manner, considering:
• the purpose of the change and any potential consequences;
• the integrity of the QMS
• the availability of resources;
• allocation or reallocation of responsibilities and authorities.

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Clause 7: Support

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7.1 Resources
• The organization shall determine and provide the resources needed
for the establishment, implementation, maintenance and continual
improvement of the QMS.
• ISO 9001:2015 will include additional requirements:
• People
• Infrastructure
• Process environment
• Monitoring & measuring resources
• Organizational knowledge

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7.1.6 Organizational Knowledge
• When addressing changing needs and trends, organization shall
consider its current knowledge and determine how to acquire or
access the necessary additional knowledge:
• Can include information such as intellectual property, lessons learned
• Can consider:
• internal sources (e.g. learning from failures and successful projects, capturing
undocumented knowledge and experience of topical experts within the
organization);
• external sources (e.g. standards, academia, conferences, gathering knowledge
with customers or providers).

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7.2 Competence
“The organization shall
• determine the necessary competence of person(s) doing work under its
control that affects its quality performance,
• ensure that these persons are competent on the basis of appropriate
education, training, or experience;
• where applicable, take actions to acquire the necessary competence, and
evaluate the effectiveness of the actions taken
• retain appropriate documented information as evidence of competence.
• NOTE: Applicable actions may include, for example: the provision of
training to, the mentoring of, or the re-assignment of currently employed
persons; or the hiring or contracting of competent persons.”

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7.3 Awareness
“Persons doing work under the organization’s control shall be aware of:
• the quality policy and relevant objectives
• their contribution to the effectiveness of the QMS, including the
benefits of improved quality performance
• the implications requirements.” of not conforming with the QMS

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7.4 Communication
• “The organization shall determine the internal and external
communications relevant to the QMS including
• on what it will communicate
• when to communicate
• with whom to communicate
• How to communicate”

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Clause 7.5: Documented Information

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7.5 Documented information
• “Documents” need to be “maintained as documented information”
• “Records” need to be “retained as documented information”

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Clause 8: Operation

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8.1 Operational planning and control
• “Plan, implement and control the processes needed to meet requirements
for the provision of products and services, and to implement the actions
determined in 6.1 by:
• determining requirements for the products and services
• establishing criteria for the processes and acceptance criteria
• determining the resources needed
• implementing the control of processes
• retaining documented information”
• “Control planned changes and review the consequences of unintended
changes, taking action to mitigate any adverse effects, as necessary”
• “Ensure that outsourced processes are controlled.”
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8.2 Determination of requirements for
products and services
8.2.1 Customer communication
Establish the processes for communicating with customers in relation to:
• information relating to products and services;
• enquiries, contracts or order handling, including changes;
• obtaining customer views and perceptions, including customer complaints;
• handling or treatment of customer property, if applicable;
• specific requirements for contingency actions, when relevant
8.2.2 Determination of requirements. Process to determine the
requirements for the products and services to be offered to potential
customers.
Ensure the organization has the ability to meet the defined requirements
and substantiate the claims for the products and services it offers.
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8.3 Design and development of products and
services
• “Where the detailed requirements of the organization’s products and
services are not already established or not defined by the customer or by
other interested parties, such that they are adequate for subsequent
production or service provision, the organization shall establish, implement
and maintain a design and development process.
• The organization can also apply the requirements given in 8.5 (Prod &
Service provision) to the development of processes for production and
services provision
• For services, design and development planning can address the whole
service delivery process. The organization can therefore choose to consider
the requirements of clauses 8.3 and 8.5 together.
Introduction to QMS ISO 9001 : Ujwal Ritwik
8.4 Control of externally provided products
and services
Ensure that externally provided processes, products, and services conform to
specified requirements.
Apply the specified requirements for the control of externally provided products
and services when:
• products and services are provided by external providers for incorporation into
the organization’s own products and services;
• products and services are provided directly to the customer(s) by external
providers on behalf of the organization;
• a process or part of a process is provided by an external provider as a result of a
decision by the organization to outsource a process or function.
• Type and extent of controls to be applied depends on:
• potential impact of the externally provided processes, products and services
• perceived effectiveness of controls applied by external provider.

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8.5 Control of Production and service
provision
Implement controlled conditions for production and service provision,
including delivery and post-delivery activities. This can include:
• definition of the product and service characteristics (documented);
• activities to be performed and results to be achieved (documented);
• monitoring and measurement activities
• use and control of suitable infrastructure and process environment;
• availability and use of suitable monitoring and measuring resources;
• competence and, where applicable, required qualification of persons;
• validation, and periodic revalidation, of “special processes”;
• formal release of products and services, delivery and post-delivery
activities.

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8.5 Production and service provision
• Identification and traceability
• Property belonging to customers or external providers
• Preservation
• Post-delivery activities – Consider:
• risks associated with the products and services;
• nature, use and intended lifetime
• customer feedback;
• statutory and regulatory requirements.
• Control of changes
• review and control unplanned changes essential for production or service provision
to ensure continuing conformity

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8.6 Release of products and services

8.7 Control of nonconforming process outputs,

products and services
• Now requires actions taken to be documented
• includes any concessions obtained
• details of person or authority that made the decision regarding
dealing with the nonconformity.

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Clause 9: Performance Evaluation

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9.1 Monitoring, measurement, analysis and
evaluation
• Determine:
• what needs to be monitored and measured
• methods for monitoring, measurement, analysis evaluation, as applicable, to
ensure valid results
• when the monitoring and measuring shall be performed and
• when the results from monitoring and measurement shall be analysed and
evaluated.
• Retain appropriate documented information.
• Evaluate the quality performance and the effectiveness of the QMS

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9.3 Management review
Includes requirements to consider:
• changes in external and internal issues that are relevant to the QMS
and strategic direction;
• information on the quality performance, including trends and
indicators for:
• monitoring and measurement results;
• issues concerning external providers and other relevant interested parties;
• adequacy of resources
• effectiveness of actions taken to address risks and opportunities

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Clause 10: Improvement

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10 Improvement
• General
• Nonconformity and corrective action
• Continual improvement

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10.1 General
Implement actions to meet customer requirements and enhance
customer satisfaction, by:
• improving processes to prevent nonconformities;
• improving products and services to meet known and predicted requirements;
• improving quality management system results.
• NOTE: “Improvement” includes more than continual improvement
(“Kaizen”)
• May also include breakthrough improvements, innovation,
transformation etc.

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10.2 Nonconformity and corrective action
“When a nonconformity occurs, the organization shall:
a) react to the nonconformity, and as applicable
• take action to control and correct it, and
• deal with the consequences;
b) evaluate the need for action to eliminate the causes of the nonconformity,
in order that it does not recur or occur elsewhere, by
• reviewing the nonconformity
• determining the causes of the nonconformity, and
• determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken; and
e) make changes to the quality management system, if necessary.”

Introduction to QMS ISO 9001 : Ujwal Ritwik

10.3 Continual improvement
• Consider outputs of analysis and evaluation, and outputs from
management review, to identify areas of underperformance or
opportunities for improvement.
• Select and utilise applicable tools and methodologies for investigation
of the causes of underperformance and for supporting continual
improvement.

Introduction to QMS ISO 9001 : Ujwal Ritwik

Quiz 3
1. ISO 9001 requirements are found in Clause 4 – 10
a) true b) false

2. Clause 8 contains the main requirements

a) true b) false

Introduction to QMS ISO 9001 : Ujwal Ritwik

Approach to Internal Audit
Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Certification
Benefits of ISO 9001 Certification

1. Improve Customer Satisfaction

2. Increase Revenue
3. Improve Your Company and Products
4. Understand Your Company Processes
5. Improve Operations
6. Improve Morale and Job Satisfaction
7. Focus on Quality
8. Save Money
9. Earn Recognition

Introduction to QMS ISO 9001 : Ujwal Ritwik

Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
What are the ISO 9001 certification
requirements?
There are five requirements to achieve ISO 9001 certification:
1.Comprehensive quality management system
2.Management responsibility
3.Resource management
4.Product realization
5.Measurement, analysis, and improvement

Introduction to QMS ISO 9001 : Ujwal Ritwik

How to get started with ISO 9001

• Choose your approach to ISO 9001 certification

• In-house implementation
• Consultant Hands-On
• Consultant Hands-Off
• Be sure that you have someone on your team, or that you find someone
who is an expert at ISO 9001
• Obtain training resources and conduct training for management,
employees, and the certification leader
• Plan implementation of your new quality management platform
• you can expect to obtain your certification in 3 to 6 months. There are
numerous steps you and your team must complete
• Complete certification

Introduction to QMS ISO 9001 : Ujwal Ritwik

Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
ISO 9001 Advantage to
Professionals
The Professional Value of ISO 9001 to a
Person's Career
• Increasing competence regarding ISO 9001 can help in enhancing
career but also in creating new career opportunities
• Knowledge of ISO 9001 and other standards, concepts and
requirements, helps a professional whatever he / she pursuing
• ISO 9001 competence may also be pursued as a career in consulting
and auditing

Introduction to QMS ISO 9001 : Ujwal Ritwik

Benefits of ISO 9001 for the career
• Risk based thinking is continuous and ensures greater knowledge and
preparedness
• Learn valuable management strategies
• Increase your earning potential
• Seamless transition between diverse industries, or positions
• Start your own consulting or audit business
• Getting away from office kind of job

Introduction to QMS ISO 9001 : Ujwal Ritwik

Career choices regarding ISO 9001
• Quality Manager
• Independent consultant
• Lead Auditor

Introduction to QMS ISO 9001 : Ujwal Ritwik

How to Achieve Competence
• What is the position you are aspiring
• What to expect from the courses?
• What makes a good course?
Challenges –
• Where to start?
• How to ensure success?
• Is this career right for me?
• Examine the context of your business and choose the best

Introduction to QMS ISO 9001 : Ujwal Ritwik

Quiz 4
1. Internal audit can be replaced with external audit
a) true b) false

2. Professionals from other fields need not have a knowledge of ISO

9001
a) true b) false

Introduction to QMS ISO 9001 : Ujwal Ritwik

Further Help
Introduction to QMS ISO 9001 : Ujwal Ritwik
Conclusion
Introduction to QMS ISO 9001 : Ujwal Ritwik
What did we do?
• ISO organization and background
• Background and foundational knowledge of ISO MS Standards
• Principles of quality management
• ISO 9001 structure
• Overview of requirements of ISO 9001:2015
• ISO audit approach
• Overview of ISO certification process
• Understand usefulness of ISO 9001 to your professional career

Introduction to QMS ISO 9001 : Ujwal Ritwik

Home Work
• The detailed class presentation mailed to you contains more slides,
including explanation of all the clauses
• Study the full presentation and ISO 9001 Certification Guide sent to
you earlier
• Prepare a plan for implementing ISO 9001 standard at a company M/s
Excellent 2100

Introduction to QMS ISO 9001 : Ujwal Ritwik

Develop Your Action Plan
1. Plan
2. Identify your role
3. Future
4. Improve your competence

Introduction to QMS ISO 9001 : Ujwal Ritwik

Introduction to QMS ISO 9001 : Ujwal Ritwik
Introduction to QMS ISO 9001 : Ujwal Ritwik
Thank you for being with us

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