Why implement a QMS?

ISO 9001 is a standard that sets out the

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

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History of ISO 9001 revisions

ISO 9001:1987

Pubn

1st

ISO 9001:1994

7
years

ISO 9001:2000

6
years
8
years

ISO 9001:2008

9
years

ISO 9001:2015

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How is the standard structured?

Clause1
Clause2
Clause 3
Clause 4
Clause 5
Clause 6

Normative references
Terms and Definitions
Context of the organization
Leadership
Planning

Clause 7

Support

Clause 8

Operation

Clause 9

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Scope

Clause 10

Performance evaluation
Improvement

Facts
ISO 9001 provides a framework for implementing an QMS which
meets an organizations stakeholder interests and can help to:

1.
2.
3.
4.
5.
6.
7.
8.

Reduce liability and risk

Facilitate better business processes
Minimize waste and energy bills
Enhance company reputation
Improve Compliance
Meet concerns of interested parties
Gain International recognition
Improve marketing potential

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What is quality management all about?

Seven Quality Management Principles behind ISO 9001:2015
1.
2.
3.
4.
5.
6.
7.

Customer Focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management

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Customer Focus
Meeting and exceeding customer needs is the primary focus of quality
management and will contribute to the long-term success of your
enterprise.
Some potential key benefits are:
1.
2.
3.
4.
5.
6.
7.

Increased customer value

Increased customer satisfaction
Improved customer loyalty
Enhanced repeat business
Enhanced reputation of the organization
Expanded customer base
Increased revenue and market share

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Leadership
Leaders establish unity of purpose and direction of the organization.
They should create and maintain the internal environment in which people
can become fully involved in achieving the organizations objectives
Potential key benefits are:
1. Co-ordination of the organizations processes
2. Communication between levels and functions of the organization
3. Deliver desired results

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ISO 9001:2015 QMS Structure

PLAN
Context of
the org.

Understan
ding of the
org.in the
context

Understanding
the needs and
expectations of
interested
parties

Determining
the scope of
the QMS

Leadership

Leadership
and
commitment

Policy

Org. roles,
responsibiliti
es and
authorities

Planning

Support

Actions to
address risks
and
opportunities

Quality
objectives
and planning
to achieve
them

Planning
objectives

DO

CHECK

Operation

Performance
Evaluation

Resources

Competence

Operational
planning
and control
Req.for
products and
services
Design and
dev.pf
products and
services

Awareness

Control of
externally provided
processes ,
products and

services

QMS and
its process

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Communication

Documented
information

Production
and service
provision

Release of
products and
services
Control of
nonconforming
outputs

ACT
Improvement

Monitoring,
measurement
,analysis and
evaluation

Internal
Audit

Management
Review

General

Nonconfor
mity and
corrective
action

Continual
Improvement

Scope
Fundamental concepts and principles of quality management:
1. Organizational seeking sustained success through
implementation of QMS
2. Customers seeking confidence in an organization's ability
3. Consistently provide products and services
4. Improve communication with interested parties
5. Providers of training, assessment or advice in QMS
6. Developers of related standards

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Clause : 3
Terms and Definitions

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Clause 3:Terms and Definitions

3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12

Terms related to person and people

Terms related to organization
Terms related to activity
Terms related to process
Terms related to system
Terms related to requirement
Terms related to result
Terms related to data, information and document
Terms related to customer
Terms related to characteristic
Terms related to determination
Terms related to audit

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Clause: 4
Context of the Organization

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Clause:4.1, Understanding the org. and its context

An organizations context involves its operating environment. The context must

be determined both within the organization (internal and external) to the
organization.
It is important to understand the unique context of an organization before starting
the strategic planning
To establish the context means to define the external and internal factors that the
organizations must consider when they manage risks
How it should respond in the form of a defined quality management system

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Clause:4.1, Understanding the org. and its context

The context of the organization relates to

Requires the organization to consider a wide spectrum of potential factors
which can impact on the management system , in terms of its structure ,
scope , implementation and operation.
a) Environmental conditions related to climate, air quality, water quality,
land use, existing contamination, natural resource availability and
biodiversity, that can either affect the organizations purpose, or be
affected by its outcome.

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Clause:4.1, Understanding the org. and its context

The context of the organization relates to

b) The external cultural, social, political, legal, regulatory, financial,
technological, economic, natural and competitive circumstances,
whether international, national and regional or local.
c) The internal characteristics or conditions of the organization, such as
its activities , products and services , strategic direction, culture and
capabilities (i.e. people, knowledge, processes, systems)

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Clause:4.2 Understanding the needs and expectations

of interested parties
Organization to determine the needs and expectations of interested
parties, both internal and external. Interested parties could include.

Past, present and future employees and their representatives

Customers and consumers
Suppliers, contractors, wholesalers and distributors
Competitors
Shareholders
Banks and financial/investment community
Insurance companies
Rating Agencies
Public authorities

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Clause:4.2 Understanding the needs and expectations

of interested parties
Legislators
Regulators
Politicians and opinion leaders
Neighbors and local community
Communities associated with supply chain organizations
Schools, academics and researchers
Professionals involved in environmental issues
Media Organizations
Non-governmental organizations

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Clause:4.3, Determining the scope of the quality

management system

Organization shall determine the boundaries and applicability of

the quality management system
Organization shall consider:
1.
2.
3.
4.
5.

External and internal issues

Relevant interested parties
Maintained as documented information
Ensure the conformity of its products and services
Enhancement of customer satisfaction

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Clause 5:
Leadership

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Clause:5.1, Leadership and commitment

Clause:5.1.2, General
Top management shall demonstrate leadership and commitment . By:
Ensuring (i.e. someone else can do it)
The quality policy and objectives are established for the quality management
system and are compatible with the strategic direction and context of the
organization.
The quality policy is communicated ,understood and applies within the
organization.
Integration of the quality management system requirements into the
organizations business processes
The resources needed and achieves its intended results for the QMS

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Clause:5.2, Quality Policy

Clause:5.2.1, Establishing Quality Policy

Set of principles stated as commitments in which top management

outlines the intentions of the organization to support and enhance its
quality performance.

Top management must be responsible for formulating the quality policy,

and must implement, document, communicate, and expect personnel to
comply with that policy.

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Clause:5.2, Quality Policy

Clause:5.2.2, Communicating Quality Policy
Seven basic commitments for the quality policy from the top
management :
a)
b)
c)
d)

Supports organization quality strategic decision

Framework of setting quality objectives
Fulfill the organizations compliance obligations
Continually improve the quality management system to
enhance environmental performance
e) Maintain a documented information
f) Communication within organization
g) Available to interested parties

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Clause:5.3, Organizational roles , responsibilities and

authorities
1. Top management must ensure that key responsibilities and
authorities are clearly defined and that everybody involved
understand their roles.
2. Defining roles is a function of planning, ensuring awareness
can then be achieved through communication and training
3. Organizations to use job descriptions or procedures to define
responsibilities and authorities
4. There is a clear expectation for consistent and appropriate
process ownership from top-to-bottom approach within an
organization.

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Clause 6: Planning

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Clause:6.1.1, General

Consideration needs to be specified to its identified internal and

external issues and the needs and expectations of its interested
parties and determine the risk and opportunities during planning.
1.
2.
3.
4.

Achieve its intended result(s)

Enhance desirable effects
Prevent, or reduce, undesired effects
Achieve improvement

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What is Risk based Thinking?

Risk-based thinking is something we all do automatically and

often sub-consciously.
The concept of risk has been implicit in ISO 9001:2015 and
more explicit and builds it into the whole quality management
system
Risk-based thinking is already part of the process approach

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What is Risk?

Risk is the possibility of events or activities obstruction of

achievement of an organizations strategic & operational
objectives.

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What is Risk based Thinking?

Risk-based thinking makes preventive action part of the routine

Risk is often thought of only in the negative sense
Risk-based thinking can also help to identify opportunities
This can be considered to be the positive side of risk

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Why should we adopt Risk-based thinking?

1.Improve customer confidence and satisfaction

2.Assure consistency of quality of goods and services
3. Establish a proactive culture of prevention and improvement
4. Successful companies intuitively take a risk based approach

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Why should we do ISO 9001:2015?

Analyze and prioritize the risks and opportunities in the organization

1. What is acceptable?
2. What is unacceptable?
3. Plan actions to address the risks
4. How can we avoid or eliminate the risk?
5. How can we mitigate the risks?
6. Implement the plan- take actions
7. Check the effectiveness of the actions- does it work?
8. Learn from experience continual improvement

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Clause:6.2 (6.2.1/6.2.2) Quality objectives and planning

to achieve them
Organization shall establish and ensure quality objectives
The quality objectives shall:
1.
2.
3.
4.
5.
6.
7.
8.
9.

Be consistent with the quality policy

Measurable
Applicable requirements
Enhancement of customer satisfaction
Monitored
Communicated
Updated as appropriate
Maintain documented information
Use 5 W 1 H principle while planning objectives

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Clause:7 Support

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Clause:7.1 Resources
Clause:7.1.2 People

Organization shall consider:

1. Persons necessary for the effective implementation of QMS
2. Operations and control of its processes

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Clause:7.1 Resources
Clause:7.1.3 Infrastructure

The organization shall determine:

Provide and maintain the infrastructure towards
conformity of products and services.
Infrastructure can include:
Buildings and associated utilities
Equipment ,including hardware and software
Transportation resources
Information and communication technology

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Clause:7.1 Resources
Clause:7.1.4 Environment for the operation of processes
The organization shall determine:
Provide and maintain the infrastructure towards conformity of
products and services.
Environment can be a combination of human and
physical factors, such as;
1. Social (e.g. non discriminatory , calm, non
confrontational)
2. Psychological (e.g. stress-reducing , burnout
prevention, emotionally protective)
3.Physical (e.g. temperature, heat, humidity, light,
airflow, hygiene, noise)

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Clause:7.1 Resources
Clause:7.1.5 Monitoring and measuring resources & (7.5.5.2)
Measurement traceability

Measuring equipment shall be:

1.
2.
3.
4.

Calibrated protocol
Calibration status
Validity of previous measurement results
Safeguard from adjustments, damage or deterioration

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Clause:7.1 Resources
Clause:7.1.6 Organizational Knowledge
This knowledge shall be
1.
2.
3.
4.
5.
6.

Maintained
Made available to the extent of necessary
Changing needs and trends
Consideration of current knowledge
Necessary additional knowledge
Updates

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Clause:7.1 Resources
Clause:7.1.6 Organizational Knowledge

Organizational knowledge can be based on:

1.External sources
2.Standards
3.Academic
4.Conferences
5.Gathering knowledge from customers or external
providers

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Clause:7.2 Competence

The organization shall:

1.Necessary competence of person(s)
2.Evaluate the effectiveness of the actions taken
3.Retain appropriate documented information as
evidence of competence

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Clause:7.2 Communication

The organizations shall determine the internal and

external communications
1. What it will communicate
2. When to communicate
3. With whom to communicate
4. How to communicate
5. Who communicates

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Clause:7.5 Documented Information

Clause:7.5.3 Control of Documented Information (7.5.3.1)

Standard shall be controlled to ensure:

1.Availaiblity and suitability for use
2.Adequately protected (e.g. from of confidentiality, improper
use, or loss of integrity)

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Clause:7.5 Documented Information

Clause:7.5.3 Control of Documented Information (7.5.3.2)

Organization shall address the following activities, as

applicable:
1.distribution, access, retrieval and use
2.Storage and preservation, including preservation of
legibility
3.Control of changes (e.g. version control)
4.Retention and Disposition
5.External origin identified and controlled
6. Documented information retained-protected from
unintended alterations

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Clause:8 Operations

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Clause:8.1 Operational planning and control

The organization shall plan, implement and control the
processes by:

1.Requirements for products and services

2.Establishing criteria
3.Processes
4.Accepance of products and services
5.Resource conformity w.r.t product &service
6.Control planned changes
7.Review the consequences of unintended changes
8.Outsouced processes

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Clause:8.2 Operational planning and control

Clause:8.2.1 Customer Communication
Communication with customers shall include:
1.Information relating to products and services
2.Handling enquiries
3.Contracts or orders
4.Including changes
5.Obtaining customer feedback
6.Customer Complaints
7.Handling or controlling customer property
8.Specific requirements for contingency actions, when relevant

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Clause:8.2 Operational planning and control

Clause:8.2.3/8.2.3.2 Review of the requirements for products and
services

Organization shall retain documented information

1.Results of the review
2.Any new requirements for the products and services

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Clause:8.3 Design and development of products and services

Clause:8.3.1 General

Organization shall consider

1.Implement
2.Maintain a design and development process
3.Appropriate to provision of products and services

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Clause:8.3 Design and development of products and services

Clause:8.3.2 Design and development planning
Organization shall consider
1.nature,duration and complexity
2.Process stages
3.Verification and validation
4.Responsibilities and authorities
5.Internal and external sources
6.Control interfaces between persons
7.Involvement of customers and users
8.Subsequent provision
9.Level of control expected by customers and other relevant interested parties
10.Documented information

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Clause:8.3 Design and development of products and services

Organization shall consider
1.nature,duration and complexity
2.Process stages
3.Verification and validation
4.Responsibilities and authorities
5.Internal and external sources
6.Control interfaces between persons
7.Involvement of customers and users
8.Subsequent provision
9.Level of control expected by customers and other relevant
interested parties
10.Documented information

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Clause:8.4 Control of externally provided processes, products and

services
Clause:8.4.1 General
Organization shall consider:
1.Products and services from external providers
2.Product and services are provided directly to the customers(s)
by external providers
3.Process or part of a process, is a provided by an external
provider
Organization shall determine:
1.Criteria for the evaluation
2.selection,monitoring of performance
3.re-evaluation of external providers
4.Documented information

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Clause:8.5 Production and service provision

Clause:8.5.1 Control of production and service provision
Organization shall implement:
1.Availibilty of documented information
2.Availibilty and use of suitable monitoring and measuring
resources
3.Monitoring and measurement activities-acceptance criteria
4.Infrastructure and environment operation of processes
5.Competent persons
6.Validation and periodic revalidation(resulting output cannot be
verified)
7.Actions to prevent human error
8.Release delivery and post-delivery activities

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Clause:8.6 Release of products and services

Organization shall consider & ensure:
1.Planned arrangements , at appropriate stages
2.Verify product and service requirements have been
met
3.Customer shall not proceed until the planned
arrangements have been satisfactorily completed
4.Documented information
5.Accepted criteria
6.Traceability to the person(s) authorizing the release

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Clause:9 Performance
Evaluation

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Clause:9.1 Monitoring, Measurement, Analysis and Evaluation

Organization shall determine:

1.Methods for monitoring
2.Measurement
3.Analysis
4.Evaluation
5.Ensure valid results
6.Effectiveness of QMS
7.Documented information

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Clause:9.1 Monitoring, Measurement, Analysis and Evaluation

Clause:9.1.2 Customer Satisfaction

1. Organization shall monitor customers perceptions

2. Methods for obtaining, monitoring and reviewing

NOTE: Monitoring customer perceptions

Customer surveys
Customer feedback on delivered products
and services
Meetings with customers
Market-share analysis
Compliments
Warranty
Claims
Dealer reports

Clause:9.1 Monitoring, Measurement, Analysis and Evaluation

Clause:9.1.3 Analysis and Evaluation

Organization shall analyze &retain:

1.Conformity
2.Customer satisfaction
3.Performance and effectiveness
4.Planning
5.Risks and opportunities
6.Performance of external providers
7.Improvement related QMS

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Clause:9.2/9.2.1 Internal Audit

Organization conforms:
1.Conduct internal audits at planned intervals
2.Audit criteria
3.Auditor selection
4.Correction and corrective actions
5.Effectively implemented and maintained
6.Documented information

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Clause:9.3 Management review

Clause:9.3.2 Management review inputs

Organization shall consider:

1.
2.
3.
4.
5.
6.
7.

Actions status
Changes in external and internal issues
QMS performance and effectiveness
Customer satisfaction
Feedback objectives
Quality objectives
Conformity of products and services

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Clause:9.3 Management review

Clause:9.3.2 Management review inputs
Organizations shall consider:
8. Nonconformities and corrective actions
9. Results of monitoring and measurement
10.Audit results
11.Performance of external providers
12.Adequacy of resources
13.Effectiveness of risks and opportunities
14.Opportunities for improvement

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Clause: 10 Improvement

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Clause:10 Improvement
Clause:10.1 General

Organization shall determine improvement protocol in:

1.Products and services
2.Address future needs and expectations
3.Correcting , preventing or reducing undesired effects
4.Performance and effectiveness of QMS
NOTE: Improvement can
include Correction
Corrective action
Continual improvement
Breakthrough change
Innovation
Re-organization

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Clause:10 Improvement
Clause:10.2 (10.2.1 & 10.2.2) Nonconformity and corrective action

When a nonconformity occurs, including complaints, the organization

shall:
1.
2.
3.
4.
5.
6.
7.

React to the nonconformity

Action to control and correct
Deal with the consequences
Action to eliminate the cause(s) of the nonconformity
Review the nonconformity
Analyzing the nonconformity
Causes of the nonconformity

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Clause:10 Improvement
Clause:10.2 (10.2.1 & 10.2.2) Nonconformity and corrective action

When a nonconformity occurs, including complaints, the organization

shall:
8. Where similar nonconformities exist
9.Implement any action needed
10. Review the effectiveness of any corrective action taken;
11.Update risks and opportunities determined during planning
12.Changes to QMS
13.Results of any corrective action
14.Documented information as evidence

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Clause
4.1

Maintain
(procedure)
X

Retain (records)
X

4.2

4.3

4.4.1

4.4.2

5.1.1

5.1.2

5.2.1

5.2.2

5.3

6.1.1

6.1.2

6.2.1

6.2.2

6.3

Clause

Maintain(proce
dure)

Retain(records
)

7.1.1-4

7.1.5.1

7.1.5.2

7.1.6

7.2

7.3

7.4

7.5.1

7.5.2

7.5.3.1

7.5.3.2

X
X
X
X
X
X
X
X
X
X
X

X
X
X

X
X
X
X
X

Clause

Maintain(procedu Retain(records)
re)

8.1

8.2.1/2.2

8.2.3.1

8.2.3.2

8.2.4

8.3.1

8.3.2

8.3.3

8.3.4-6

8.4.1

8.4.2

8.4.3