Topic 1 QMS 9001-2015

Background of ISO 9000
What is standards and Standardization

 ISO is an international standard for quality management
system.
 Standard can be defined as:
 Something established by authority, custom, or general
consent as a model and example.
 Something set up and established by authority as a rule for
the measurement of quantity, weight, extent. Value, or
quality……..
 Standardize can be defined as:
 To compare with the standard
 To bring into conformity with the standard.
 Standard and standardization is used to achieve the
purpose of “common language” in community .
 Standard is applied in all areas such as education,
manufacturing, and others.
 Quality management system(QMS) is the system that
applied standard ISO 9000 series to the process on how
thing are done or performed.
 ISO 9000 series is about standardizing the approach
organizations everywhere take to managing and
improving the processes that result in their products and
services.
International Organization For Standardization
 ISO is not International Standardization Organization.
 ISO is International Organization for Standardization.
 ISO was established in 1947 and based in Geneva,
Switzerland. It is one of nongovernmental organization.
 It has a membership of 158* national standards institutes
from countries large and small, industrialized and
developing, in all regions of the world.
 ISO develops voluntary technical standards which add
value to all types of business operations.
 ISO membership fall into 3 categories:
1. Full member-is a national body designated by respective
country as the ”most representative of standardization”.
2. Correspondent member-A nation does not have a
standardization body.
3. Subscriber member-A small nation with a very small
economy.
 Only full member may participate in the development of
standards.
ISO 9000 Family
ISO
ISO
Quality management 10012
Measurement 10012
systems - ISO ISO
Fundamentals & Audits 19011
9000
vocabulary
Guidelines
Quality
management
systems -
ISO ISO Quality management
Guidelines for 9004 9001 systems -
performance Requirements
improvement
Technical
Reports
 ISO 9001 is the standard that gives the requirements for a
quality management system.
 ISO 9001:2015 is the latest, improved version.
 It is the only standard in the ISO 9000 family that can be
used for certification.
 There are 16 other standards in the family that can help
an organization on specific aspects such as performance
improvement, auditing, training…
Evolution of ISO
STILL APPLY
ACTIVELY
Why was ISO 9001 revised?
• All ISO standards are reviewed and revised regularly to make sure they
remain relevant to the marketplace.
• ISO 9001 has been updated to take into account the different challenges
that businesses now face.
• For example, increased globalization has changed the way we do business

and organizations often operate more complex supply chains, and there
are increased expectations from customers.
• ISO 9001 needs to reflect these changes in order to remain relevant.

Eight Quality Management Principles 9001-2008
Principle 1: Customer focus
Principle 2: Leadership
Principle 3: Involvement of people
Principle 4: Process approach
Principle 5: System approach to management
Principle 6: Continual improvement
Principle 7: Factual approach to decision making
Principle 8: Mutually beneficial supplier relationships

Seven Quality Management Principles 9001-2015
Seven Quality Management Principles 9001-2015
1. 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. It is important to not only attract but also retain the
confidence of your customers, so adapting to their future needs is key.
2. Leadership. Having a unified direction or mission that comes from strong
leadership is essential to ensure that everyone in the organization
understands what you are trying to achieve.
3. Engagement of people. Creating value for your customers will be easier if
you have competent, empowered and engaged people at all levels of your
business or organization.
4. Process approach. Understanding activities as processes that link together
and function as a system helps achieve more consistent and predictable
results. People, teams and processes do not exist in a vacuum and ensuring
everyone is familiar with the organization’s activities and how they fit
together will ultimately improve efficiency.
5. Improvement. Successful organizations have an ongoing focus on
improvement. Reacting to changes in the internal and external environment is
necessary if you want to continue to deliver value for your customers. This is
of paramount importance today when conditions evolve so quickly.
6. Evidence-based decision making. Making decisions is never easy and
naturally involves a degree of uncertainty, but ensuring your decisions are
based on the analysis and evaluation of data is more likely to produce the
desired result.
7. Relationship management. Today’s businesses and organizations do not
work in a vacuum. Identifying the important relationships you have with
interested parties such as your suppliers – and setting out a plan to manage
them – will drive sustained success.
Comparison of 9001-2008 Vs 9001-2015
8 Quality Management Principles 7 QMPs
Principle 1: Customer focus QMP 1: Customer Focus
Principle 2: Leadership QMP 2: Leadership
Principle 3: Involvement of people QMP 3: Engagement and Competence of

People
Principle 4: Process approach QMP 4: Process Approach
Principle 5: System approach to

management
Principle 6: Continual improvement QMP 5: Improvement
Principle 7: Factual approach to decision QMP 6: Informed Decision Making

making
Principle 8: Mutually beneficial supplier QMP 7: Relationship Management
relationships
Model of 9001-2008
1. Customer focus
2. Continual improvement
Model of 9001-2015
Contents ISO 9001:2015
The new standard has 10 clauses .
1. Scope-When/why should an organization adopt this standard?
2. Normative references- Blank clause introduced to match with other management
system standards.
3. Terms and definitions- Definitions of various terms referred in the standard.
4. Context of the organization- Determine the purpose and the direction of the
organization.
5. Leadership- Commitment of the top management, quality policy, roles and
responsibilities.
6. Planning- Planning to address risks and opportunities and achieving quality
objectives.
7. Support -People, infrastructure, knowledge , communication, documented
information
8. Operation -Finding out customer requirements, designing, delivering, post
delivery support.
9. Performance- evaluation Customer satisfaction, analysis, internal audits and
management review.
10. Improvement- Nonconformity, corrective actions and continual improvement.
Objective of ISO 9001
 Ultimate objective:
1. Consistently deliver products and services that meet
the requirements of its customer
2. Continually improve the processes that affect its
product or services quality.
Scope of ISO 9001
 ISO describe the scope of ISO as:
Specific requirement for a quality management system where
an organization
a)need to demonstrate its ability to consistently provide
product that meets customer and applicable regulatory
requirements
b)Aims to enhance customer satisfaction through the effective
application of system, including processes for continual
improvement of system and the assurance of conformity to
customer and applicable regulatory requirements.
 All department in an organization shall practice and follow the
set standards.
 The standard requires the certified organization to structure its
quality management system conform to all of the ISO 9001
clause from clause 1 to clause 10.
 ISO 9001 is used successfully all over the world. In 2013 alone,
over one million certificates to the standard were issued across
187 countries, and many other companies and organizations
have used the standard without seeking certification.
Applicability of ISO 9001
 ISO 9001 applies to any organization that is certified or
seeks certification to the standard regardless type and
size from any sector such as manufacturing, service,
wholesale trade, transportation, construction or
others.
What benefits will it bring to business or organization ?
1. Assess the overall context of your organization to define who is affected

by your work and what they expect from you. This will enable you to
clearly state your objectives and identify new business opportunities.
2. Put your customers first, making sure you consistently meet their needs
and exceed their expectations. This can lead to repeat custom, new
clients and increased business for your organization.
3. Work in a more efficient way as all your processes will be aligned and
understood by everyone in the business or organization. This increases
productivity and efficiency, bringing internal costs down.
4. Meet the necessary statutory and regulatory requirements.
5. Expand into new markets, as some sectors and clients require ISO 9001
before doing business.
6. Identify and address the risks associated with your organization.
Rationale of ISO 9001 certification
• International practices for quality management.
• Common language for dealing with customers and suppliers
worldwide in B2B (Business to Business).
• Increase efficiency and effectiveness by early recognising
problems.
• Model for continual improvement.
• Model for satisfying customers and other stakeholders.
• Build quality into products and services from design onwards.
• Address environmental concerns of customers and public, and
comply with government regulations.
• Integrate with global economy.
• Optimizing processes for production and information.
How do I get started with ISO 9001:2015?
Key tips
Tip 1 – Define your objectives. Why do you want to implement the standard?
Tip 2 – Ensure senior management is on board. It is crucial that everyone is

supportive of the initiative and its objectives.
Tip 3 – Identify your organization’s key processes for meeting your objectives
and customers’ needs. Within each of these processes, ensure you understand
your customers’ requirements and can guarantee that these are met. This will
form the basis of your quality management system.
Examples of success with ISO 9001
Success with ISO 9001 can take many forms. For some
enterprises, it is all about attracting new clients, while others
see it as the blueprint for internal efficiency.
Sénégalaise Des Eaux
One step ahead of customer needs
“We have been using ISO 9001 since 2002 and it helps us anticipate and meet the needs of our
customers. At the beginning, the most important thing was providing sufficient water for the
client. Then, when this was satisfied, the focus turned to the quality of the water and services.
“Now, we meet with consumer associations every six months to ensure we can adapt to our
customers’ needs. At the moment, for example, it is all about the diversification of payment
methods, using mobile phones or other services to make money transfers.”
Mamadou Dia
CEO of Sénégalaise Des Eaux
Sénégalaise Des Eaux supplies drinking water to approximately five million citizens in some
of the largest towns in Senegal.
Baltika Breweries
Optimizing operations
“ Using production systems based on ISO 9001, ISO 14001 and ISO 22000 allows
us to optimize operations between factories and better integrate many of the
companies we have acquired.
“In addition, by asking suppliers to implement robust quality management

systems, we ensure the ingredients we use are of consistently high quality.”
Dr. Isaac Sheps

CEO of Baltika Breweries from 2011 to 2014
Baltika Breweries is a leader in the Russian beer market and part of the Carlsberg
Group.
END

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Background of ISO 9000

What is standards and Standardization

• For example, increased globalization has changed the way we do business

• ISO 9001 needs to reflect these changes in order to remain relevant.

Principle 3: Involvement of people

Principle 4: Process approach

Principle 5: System approach to management

Principle 6: Continual improvement

Principle 7: Factual approach to decision making

Principle 8: Mutually beneficial supplier relationships

Principle 2: Leadership QMP 2: Leadership

Principle 3: Involvement of people QMP 3: Engagement and Competence of

Principle 5: System approach to

Principle 7: Factual approach to decision QMP 6: Informed Decision Making

1. Assess the overall context of your organization to define who is affected

Tip 2 – Ensure senior management is on board. It is crucial that everyone is

“In addition, by asking suppliers to implement robust quality management

Dr. Isaac Sheps

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