ISO (International Organization for Standardization) • An independent, non-governmental organization.

• ISO develops and publishes International Standards.

• ISO creates documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

• founded in 1946 in Geneva, Switzerland,

• Because 'International Organization for Standardization' would have different acronyms in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), the founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal.

1 Source: https://www.iso.org

ISO (International Organization for Standardization)

• ISO is coordinated by a Central Secretariat in Geneva, Switzerland.

• not for profit: selling the standards allows ISO to finance their development in a neutral environment, to maintain them and to make new ones.

What are standards?

• International Standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade.

• ISO has published 22528 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare. ISO International Standards impact everyone, everywhere.

What are the benefits of ISO International Standards?

• ISO International Standards ensure that

products and services are safe, reliable and of good quality.

• For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity.

• They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade.

How does ISO decide what standards to develop?

• Working through the ISO community, it is the people

who need the standards that decide. A particular industry or business sector can communicate its need for a standard to their national ISO member; the idea is then proposed to ISO as a whole.

• If accepted, the project is assigned to an existing technical committee. Proposals may also be made to establish technical committees to cover new scopes of technological activity. In order to use resources most efficiently, ISO only launches the development of new standards for which there a clear market requirement.

Source: https://www.iso.org

How does ISO develop standards?

• The standards are developed by the people that need them, through a consensus process.

• Experts from all over the world develop the standards that are required by their sector.

• The experts form a technical committee that is responsible for a specific subject area. They begin the process with the development of a draft that meets a specific market need. This is then shared for commenting and further discussion.

• The voting process is the key to consensus. If that’s achieved then the draft is on its way to becoming an ISO standard. If agreement isn’t reached then the draft will be modified further, and voted on again.

• From first proposal to final publication, developing a standard usually takes about 3 years.

Source: https://www.iso.org

Key principles in standard development 1. ISO standards respond to a need in the market

ISO does not decide when to develop a new standard, but responds to a request from industry or other stakeholders such as consumer groups. Typically, an industry sector or group communicates the need for a standard to its national member who then contacts ISO.

2. ISO standards are based on global expert opinion

ISO standards are developed by groups of experts from all over the world, that are part of larger groups called technical committees. These experts negotiate all aspects of the standard, including its scope, key definitions and content. Details can be found in the list of technical committees.

3. ISO standards are developed through a multi-stakeholder process

The technical committees are made up of experts from the relevant industry, but also from consumer associations, academia, NGOs and government.

4. ISO standards are based on a consensus

Developing ISO standards is a consensus-based approach and comments from all stakeholders are taken into account.

ISO members • Individuals or companies cannot become ISO members. • Companies that apply or certify ISO standards are not ISO members. • ISO members are the foremost standards organizations in their countries and

there is only one member per country. Each member represents ISO in its country.

• There are three member categories. Each enjoys a different level of access and influence over the ISO system. This helps us to be inclusive while also recognizing the different needs and capacity of each national standards body. – Full members (or member bodies) influence ISO standards development

and strategy by participating and voting in ISO technical and policy meetings. Full members sell and adopt ISO International Standards nationally.

– Correspondent members observe the development of ISO standards and strategy by attending ISO technical and policy meetings as observers. Correspondent members can sell and adopt ISO International Standards nationally.

– Subscriber members keep up to date on ISO’s work but cannot participate in it. They do not sell or adopt ISO International Standards nationally.

How to get involved?

• Whether you’re a consumer or in business you can be part of the next generation of standards.

• Standards are developed by groups of experts called technical committees. These experts are put forward by ISO’s national members. If you are interested in getting involved, contact your national member.

Certification • Certification can be a useful tool to add credibility, by demonstrating

that your product or service meets the expectations of your

customers. For some industries, certification is a legal or contractual

requirement.

• ISO does not perform certification

• "At ISO, we develop International Standards, such as ISO 9001 and ISO

14001, but we are not involved in their certification, and do not issue

certificates. This is performed by external certification bodies, thus a

company or organization cannot be certified by ISO."

• However ISO's Committee on Conformity Assessment (CASCO) has

produced a number of standards related to the certification process,

which are used by certification bodies. Read more about CASCO

Standards.

Certification • To become certified under the ISO standard, a company must select a

registrar and prepare for a certification audit by this registrar.

• Preparing for a certification audit involves many activities, including an initial or phase I audit that checks the present quality management system against the standard.

• This is usually followed by

– Establishing teams

– Training personnel

– Developing applicable documentation

– Developing and installing all new components of the quality system

• Then the certification audit takes place.

• If the company is certified, then periodic surveillance audits by the registrar continue, usually on an annual basis.

13

Choosing a certification body

• When choosing a certification body, you should:

• Evaluate several certification bodies.

• Check if the certification body uses the relevant CASCO standard

• Check if it is accredited. Accreditation is not compulsory, and non-accreditation does not necessarily mean it is not reputable, but it does provide independent confirmation of competence. To find an accredited certification body, contact the national accreditation body in your country or visit the International Accreditation Forum.

ISO 9000 family - Quality management

• The ISO 9000 family is the world's most best known quality management standard for companies and organizations of any size.

• The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards.

• The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.

ISO 9001:2015

• Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

• ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).

• There are over one million companies and organizations in over 170 countries certified to ISO 9001.

ISO 9001:2015 Quality Management Systems - Requirements

• ISO 9001:2015 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, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

• All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

17

ISO 9001:2015 Quality Management Systems - Requirements

The potential benefits to an organization of implementing a quality management system based on this International Standard are:

a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements,

b) facilitating opportunities to enhance customer satisfaction,

c) addressing risks and opportunities associated with its context and objectives,

d) the ability to demonstrate conformity to specified quality management system requirements.

18

ISO 9001:2015

• This standard is based on the following quality management principles:

– customer focus;

– leadership (motivation and implication of top management);

– engagement of people;

– process approach;

– continual improvement;

– evidence-based decision making;

– relationship management

ISO 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.

ISO 9001:2015

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.

Should I be certified to ISO 9001?

• Certification - when an independent certification body audits your

practices against the requirements of the standard – is not a

requirement of ISO 9001, but is a way of showing stakeholders that

you have implemented the standard properly.

• For some companies, third- party certification may be a

requirement. For example, some governments or public bodies may

only contract suppliers that have been certified to ISO 9001.

• ISO does not perform certification. For more information about the

certification process, see www.iso.org and the publication ISO

9001:2015 – How to use it.

Sector-specific applications of ISO 9001

• ISO has a range of standards for quality management

systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:

ISO 13485 – Medical devices ISO 17582 – Electoral organizations at all levels of government ISO 18091 – Local government ISO/TS 22163 – Business management system requirements for rail organizations ISO/TS 29001 – Petroleum, petrochemical and natural gas industries ISO/IEC 90003 – Software engineering

ISO 14000 family - Environmental management

• The ISO 14000 family of standards provides practical tools for companies and organizations of all kinds looking to manage their environmental responsibilities.

ISO 14001:2015

• ISO 14001:2015 sets out the criteria for an environmental management system and can be certified to. It maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization regardless of its activity or sector.

• Using ISO 14001:2015 can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.

The Malcolm Baldrige National Quality Award (MBNQA)

• It was created by the U.S. Congress in 1987. • It is given annually to recognize U.S. organizations for

performance excellence. • Awards are given to organizations in five categories:

manufacturing, service, small business, health care, and education. Three awards may be given each year in each category.

• Many organizations compete for the awards, and many companies use the performance excellence criteria for self-assessment.

• The award is administered by NIST (the National Bureau of Standards and Technology).

27

The Malcolm Baldrige National Quality Award (MBNQA)

28

Six Sigma

Motorola developed the six-sigma program in the late 1980s as a response to the demand for their products.

The six sigma program helped the company win the Malcolm Baldridge National Quality Award in 1988.

The focus of six sigma is reducing variability in key product characteristics to the level at which failure or defects are extremely unlikely.

29

Six Sigma

Six-sigma is a process-focused approach to business improvement: a process is the basic unit for improvement.

The process can be a production system, a customer billing system, or a product itself.

Six sigma concept is to reduce the variability in the process so that the specification limits are six standard deviations from the mean.

30

31

32

Six Sigma

Companies involved in a six-sigma effort utilize specially trained individuals, called Green Belts (GBs), Black Belts (BBs), and Master Black Belts (MBBs)

The “belts” have specialized training and education on statistical methods and the quality and process improvement tools that equips them to function as team leaders, facilitators, and problem solvers.

Typical six-sigma projects are four to six months in duration are selected for their potential impact in the business.

Six-sigma uses a specific five-step problem-solving approach: Define, Measure, Analyze, Improve, and Control (DMAIC).

33

What Makes it Work?

• Successful implementations characterized by: – Committed leadership

– Use of top talent

– Supporting infrastructure • Formal project selection process

• Formal project review process

• Dedicated resources

• Financial system integration

• Project-by-project improvement strategy (borrowed from Juran)

34

Normal Distribution

35

Example 2:

A certain type of light bulb has an output known to be normally

distributed with mean of 2500 end footcandels and a standard deviation

of 75 end footcandles. Determine a lower specification limit such that

only 5% of the manufactured bulbs will be defective.

Example 1: