ISO 9001 PRESENTATION

STANCIAS BRANDON MANYANGA

MICHAEL NGWENYA
ONISMO RUGARA

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WHAT IS A QUALITY MANAGEMENT SYSTEM?

A quality management system is a way of defining how an organization can meet the
requirements of its customers and other stakeholders affected by its work.

ISO 9001 is based on the idea of continual improvement.

It doesn’t specify what the objectives relating to “quality” or “meeting customer needs” should
be, but requires organizations to define these objectives themselves and continually improve their
processes in order to reach them.

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Approaches to Quality

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3 Approaches to Quality Management

Consultancy Quality award

approach approach

Consultants help
• ISO 9001 • Demin Prize
organizations to apply
• Baldride Award
principles, methods and • Total Quality Management
• European Quality Award
techical tools proposed by (TQM)
quality experts • Six Sigma
• Kaizen
• Juran

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 Establishing and Implementing QMS

Control & Review &

Design & Build Deploy
Measure Improve

• Set up steering • Breaking each • Monitoring & • Maintenance of the

committee process down evaluation system
• Evaluate current into • Internal audit • Continual
quality system subprocesses External audit improvement
• Set up documentation • Training all staff (Certification audit) • Surveillance audits
system on documentation
• Implement the
QMS

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Guideline
ISO 9000

ISO 9001 ISO 9002 ISO 9003

• Design • Production • Inspection

• Development • Installation • Testing
• Production
• Installation
• servicing 6
The ISO 9000 Family
There are many other standards in the ISO 9000 series that can help you reap the full benefits of a quality
management system and put customer satisfaction at the heart of your business.

ISO 9000 contains detailed explanations of the seven quality management principles with tips on how to ensure
these are reflected in the way you work. It also contains many of the terms and definitions used in ISO 9001.

ISO 9004 provides guidance on how to achieve sustained success with your quality management system.

ISO 19011 gives guidance for performing both internal and external audits to ISO 9001. This will help ensure
your quality management system delivers on promise and will prepare you for an external audit, should you
decide to seek third-party certification.

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The ISO 9000 Family cont.

The International Organization for Standardization started working on these guidelines in the late 1980s

To facilitate international trade by providing a single internationally-accepted set of standards for

everybody's reference

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 Motive behind ISO 9000
ISO based the foundation of ISO 9001 in the content of a British set of standards, BS5750, an older document
for military applications.

BS5750 aimed at tightly controlling the quality of munitions assembly in factories that built bombs in United
Kingdom during World War II.

With the encouragement of the British government, ISO drafted the first version of these standards in 1987

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 Motive behind ISO 9000 cont.
As opposed to ISO 9000 which was introduced in 1987, ISO 9001,ISO 9002, and ISO 9003
were all combined in year 2000 and called ISO 9001:2000.

ISO 9001 was last updated in 2015 and is known as ISO 9001:2015.

Companies that seek ISO 9001:2015 certification will be evaluated by the process of examining
a sample of their product(s) , processes and functions to see if they are compliant

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ISO 9001:2015
Latest version

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 What is ISO 9001?

ISO 9001 is a standard that set s out the requirement s for a qualit y management
system. It helps businesses and organizations to be more efficient and improve
customer satisfaction.

A new version of the standard, ISO 9001:2015, has just been launched, replacing the previous
version (ISO 9001:2008).

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 Who is ISO 9001 for?

ISO 9001 is suitable for organizations of all types, sizes and sectors.

In fact, one of the key improvements of the newly revised ISO 9001:2015 was to make it
more applicable and accessible to all types of enterprises.

Smaller companies that do not have staff dedicated to quality can still enjoy the benefits of
implementing the standard – ISO has many resources to assist them.

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 What benefits will it bring to my
business or organization?

Implementing a quality management system will help you:

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.

Put your customers first, making sure you consistently meet their needs and
enhance their satisfaction. This can lead to repeat custom, new clients and
increased business for your organization.

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 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.

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 Why was ISO 9001 revised? cont.

The new version of the standard brings the user a number of benefits.

ISO 9001:2015:

ü Puts greater emphasis on leadership engagement

ü Helps address organizational risks and opportunities in a structured manner

ü Uses simplified language and a common structure and terms, particularly helpful to organizations using
multiple management systems

ü Addresses supply chain management more effectively

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ü Is more user-friendly for service and knowledge-based organizations
 Steps of Implementation of the ISO 9000

Step 1: Top Management Commitment - Requires total management commitment, particularly the Chief
executive officer (CEO).

Step 2: Establish Implementation Teams - Management representative (MR) who has genuine commitment to
quality methods of ISO 9000. Quality Steering Committee (QSC), includes the CEO, MR, top managers, functional
managers, and a trade union representative.
Their responsibility is policy formulation, objective setting, approval of plans,evaluation of reports and prescription
of required changes. Quality Action Teams (QATs), can be departmental under functional manager who should sit
on the QSC. There should be a clear and elaborate reporting and communication structure between QATs, MR and
QSC.

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 Steps of Implementation of the ISO 9000 cont.
Step 3: Assess Current Quality System Status - To identify and compare existing quality programme/system with
the requirements of ISO 9000. This can done internally if the expertise exists in the organisation.

Step 4: Create a Documented Implementation Plan - Address all deficiences of the existing system. The
documentedplan should include procedures to be developed, pertinent ISO 9000 section required training and
resources,implementation time table, approval required and by whom. A Gantt chart should be prepared and
reviewed by the QSC.

Step 5: Provide Training -Training needs shall be included in the implementation plan and will depend n level of
non-conformance.

Step 6: Generate Documentation - All work that affects quality must be planned, controlled and documented.

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 Steps of Implementation of the ISO 9000 cont.

Step 7: Control Documentation - Employees should have access to the documentation and records needed to fulfil
their tasks.

Step 8: Monitor Progress - This is the most critical phase during which management should put emphasis on
results to ensure the elements of the system are logical and effective.

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 Quality Audits
Quality Audit is a systematic and independent examination to determine whether quality activities are suitable to
achieve objectives. Types of Audits:

• 1st Party Audit (Internal Audit) – Its objective is to ensure that the system is operating normally. Should be
done at least once every 6 months by trained and independent internal assessors from each department.

• 2nd Party Audit (Vendor Quality Audit) – firm audits its suppliers who may or may not be ISO registered.
Usually not required for registered supplier firm. Prior notice is given before audit.

• 3rd Party Audit (Adequacy, Compliance or Surveillance Audit) – carried out by a certified agency, usually
registered with a national certification body. In Zimbabwe it is the Standard Association. A mock (Adequacy)
audit can be carried out prior to the actual (Compliance) audit. After firm has been certified a surveillance audit
is done at least annually. Registration certificate renewed every year.

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 Shortcomings of ISO 9000 and Solutions
1. Costly Implementation: The process of obtaining ISO 9000 certification can be expensive. To overcome this,
organizations can focus on long-term benefits such as improved efficiency and customer satisfaction, which can
offset the initial costs.

2. Bureaucratic Nature: ISO 9000 can be seen as overly bureaucratic. Organizations can address this by ensuring
that the quality management system is tailored to their specific needs, avoiding unnecessary complexity.

3. Lack of Flexibility: Some critics argue that ISO 9000 is too rigid. Organizations can overcome this by using the
standard as a flexible framework that allows for adaptation and continuous improvement.

4. Focus on Documentation: There is a perception that ISO 9000 places too much emphasis on documentation
rather than actual quality improvement. To counter this, organizations should emphasize the importance of process
effectiveness and customer satisfaction.

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 ISO 9001: Benefits
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.

Meet the necessary statutory and regulatory requirements.

Expand into new markets, as some sectors and clients require ISO 9001 before doing
business.

Identify and address the risks associated with your organization

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 ISO Standards

ISO 31000 IATG 16949 ISO 13485

Risk management Automotive Quality ISO 20000
IT service management. Medical Device
Management

ISO/TS 29001:2010
Petroleum, petrochemical and natural gas industries AS 9100D
Aviation, Space, and Defense Organizations

ISO 9000: Quality Management

ISO15378 and PS9000 ISO 14000

ISO 22000 ISO 50001
Pharmaceutical Packaging Environmental management
Food safety management Energy management
Materials
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 ISO 9001 Principles
Customer Focus is to meet customer Leaders at all levels establish unity of purpose
requirements and to strive to exceed and direction and create conditions in which
customer expectations. people are engaged in achieving the
organization’s quality objectives.

Competent, empowered and engaged

An organization manages its people at all levels throughout the
relationships with interested parties, organization are essential to enhance its
such as suppliers. capability to create and deliver value.

Decisions based on the analysis and Consistent and predictable results are
achieved more effectively and efficiently
evaluation of data and information are when activities are understood and
more likely to produce desired results. managed as interrelated processes that
function as a coherent system.

Successful organizations have an ongoing focus on

improvement. 24
ISO 9001 Approach Based on PDCA Cycle

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Comparing between ISO9000 and TQM
Characteristics ISO 9000 TQM
Customer focus  
Obsession with quality 
Scientific approach to problem solving  
Long term commitment Partial 
Teamwork 
Continual process and product improvement  
Education and training intensive  
Freedom through control 
Unity of purpose  
Employee involvement and empowerment Partial 

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 Success with ISO 9001

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.

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.

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THE END
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