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What is ISO?

ISO, founded in 1947, is a worldwide federation of national standards bodies from some 100 countries,
with one standards body representing each member country. The American National Standards Institute
(ANSI), for example, represents the United States. Member organizations collaborate in the development and
promotion of international standards. Among the standards the ISO fosters is Open Systems Interconnection
(OSI), a universal reference model for communication protocols.

According to ISO, "ISO" is not an abbreviation. It is a word, derived from the Greekisos, meaning
"equal", which is the root for the prefix "iso-" that occurs in a host of terms, such as "isometric" (of equal
measure or dimensions) and "isonomy" (equality of laws, or of people before the law). The name ISO is used
around the world to denote the organization, thus avoiding the assortment of abbreviations that would result
from the translation of "International Organization for Standardization" into the different national languages of
members. Whatever the country, the short form of the organization's name is always ISO.



What is ISO 9001?

ISO 9001 is the international standard that specifies requirements for a quality management system
(QMS). Organizations use the standard to demonstrate the ability to consistently provide products and
services that meet customer and regulatory requirements. It is the most popular standard in theISO 9000
seriesand the only standard in the series to which organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an
international agency composed of the national standards bodies of more than 160 countries. The current
version of ISO 9001 was released in September 2015.



Moving from ISO9001:2008 to ISO9001:2015

ISO9001 is a standard that sets out the requirements for a quality management system. It helps
businesses and organizations to be more efficient and improve customer satisfaction. A new version of the
standard, ISO9001:2015, has just been launched, replacing the previous version (ISO9001:2008).

Why has the standard been revised?

ISOstandards are reviewed every five years and revised if needed. This helps ensure they remain
useful tools for the marketplace. The challenges faced by business and organizations today are very different
from a few decades ago and ISO9001 has been updated to take this new environment into account. For
example, increased globalization has changed the way we do business and organizations often operate more
complex supply chains than they did in the past. In addition, there are increased expectations from customers
and other interested parties and, with more access to information; todays wider society has a stronger voice
than ever before. ISO9001 needs to reflect these changes in order to remain relevant.

What are the major differences?

The most noticeable change to the standard is its new structure. ISO9001:2015 now follows the same
overall structure as other ISOmanagement system standards (known as the High-Level Structure), making it
easier for anyone using multiple management systems. More information can be found in AnnexSL of ISO/IEC
Directives Part 1 (the rules for developing ISOstandards). Another major difference is the focus on risk-based
thinking. While this has always been part of the standard, the new version gives it increased prominence. More
information on how to adapt to this risk-based thinking can be found on the Website run by ISO/TC 176/SC 2,
the group of experts behind the standard (www.iso.org/tc176/sc2/public).

What benefits does the new version bring?

The new version of the standard brings the user a number of benefits. For example, ISO9001:2015:

Puts greater emphasis on leadership engagement

Helps address organizational risks and opportunities in a structured manner

Uses simplified language and a common structure and terms, which are particularly helpful to organizations
using multiple management systems, such as those for the environment, health & safety, or business

Addresses supply chain management more effectively

Is more user-friendly for service and knowledge-based organizations

I am currently using ISO9001:2008. What should I do?

The 2015 edition has now replaced the 2008 version. Since it has been revised to meet the needs of
todays business world, we recommend that you update your quality management system to fit the new
version. Every organization is different, so the steps needed to adjust your management system are likely to be
unique to your situation. However, here are some tips that will help you get started on the journey.

Tip 1 Familiarize yourself with the new document. While some things have indeed changed, many remain the
same. A correlation matrix, available from ISO/TC176/SC 2, will help you identify if parts of the standard have
been moved to other sections.

Tip 2 Identify any organizational gaps which need to be addressed to meet the new requirements.

Tip 3 Develop an implementation plan.

Tip 4 Provide appropriate training and awareness for all parties that have an impact on the effectiveness of
the organization.

Tip 5 Update your existing quality management system to meet the revised requirements.

Tip 6 If you are certified to the standard, talk to your certification body about transitioning to the new

I am certified to ISO9001:2008. What should I do?

If you wish to maintain your certification to ISO9001, you will need to upgrade your quality
management system to the new edition of the standard and seek certification to it. You have a three-year
transition period from the date of publication (September 2015) to move to the 2015 version. This means that,
after the end of September 2018, a certificate to ISO9001:2008 will no longer be valid.



What is ISO 9001:2015?

Who should use the ISO 9001:2015 quality management systems revision?

ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million
organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality
management systems.

Organizations of all types and sizes find that using the ISO 9001 standard helps them:

Organize processes
Improve the efficiency of processes
Continually improve

All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible.
This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in
training or certifying others.

What topics does ISO 9001:2015 cover?

ISO 9001 is based on the plan-do-check-act methodology and provides aprocess-oriented approachto
documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality
management in an organization. Specific sections of the standard contain information on topics such as:

Requirements for a quality management system, including documented information, planning and
determining process interactions
Responsibilities of management
Management of resources, including human resources and an organizations work environment
Product realization, including the steps from design to delivery
Measurement, analysis, and improvement of the QMS through activities like internal audits and
corrective and preventive action

Changes introduced in the 2015 revision are intended to ensure that ISO 9001 continues to adapt to the
changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include the
introduction of new terminology, restructuring some of the information, an emphasis on risk-based thinking to
enhance the application of the process approach, improved applicability for services, and increased
leadership requirements.

How do I get started with ISO 9001:2015?

Organizations and individuals that use ISO 9001 are encouraged to transition to the 2015 revision as
soon as possible. However, the International Accreditation Forum (IAF) and the ISO Committee on Conformity
Assessment (CASCO) have agreed to a three-year transition period from the publication date of ISO

What are the benefits of ISO 9001?

ISO 9001 helps organizations ensure their customers consistently receive high quality products and
services, which in turn bring many benefits, including satisfied customers, management, and employees.

Because ISO 9001 specifies the requirements for an effective quality management system, organizations
find that using the standard helps them:

Organize a QMS
Create satisfied customers, management, and employees
Continually improve

"It has been my experience, with several companies, that the culture change associated with ISO
implementation is multilayered. The first and most obvious benefit is quality awareness," ASQ senior member
Bud Salsbury writes onASQs Ask the Experts blog. "This quality awareness does not fade away easily. Even
those who offer strong resistance to change learns to respect and very much appreciate all the practical value
in a good quality management system."

ISO 9001 also provides financial benefits, such as cost savings.

In Nevada, theClark County School District used ISO 9001to save $174 million over 10 years in actual
expenditures and cost avoidance. More than 3,000 employees were trained to the standard, enabling three
critical components of the systems success: training, communication and respect, and efficiency.

ISO 9001:2015 as a business management tool

In an article for ASQsQPmagazine, Oscar Combs summarizes results of a Harvard Business School
study comparing 916 organizations that have adopted ISO 9001 and 17,849 non-adopters. As Combs explains,
the business benefits enjoyed by the ISO 9001 organizations included higher rates of survival and growth,
increased wages, reduced waste, enhanced productivity, and improved health and safety performance.

ISO 9001 offers more than quality benefits. The standard should be thought of as a business
management tool an organization can use to drive value, improve its operations and reduce its risks.

- Oscar Combs,Standard Wise

Achieving ISO 9001 certification

ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving
certification means that an organization has demonstrated the following:

Follows the guidelines of the ISO 9001 standard

Fulfills its own requirements
Meets customer requirements and statutory and regulatory requirements
Maintains documentation

Certification to the ISO 9001 standard can enhance an organizations credibility by showing customers
that its products and services meet expectations. In some instances or in some industries, certification is
required or legally mandated.

The certification process includes implementing the requirements of ISO 9001:2015 and then completing a
successful registrars audit confirming the organization meets those requirements.

As Bill Aston explains in an Expert Answers column for ASQsQPmagazine, organizations should consider
the following as they begin preparing for an ISO 9001 quality management system certification:

Registrars costs for ISO 9001 registration, surveillance and recertification audits
Current level of conformance with ISO 9001 requirements
Amount of resources that the company will dedicate to this project for development and
Amount of support that will be required from a consultant and the associated costs

ASQ does not issue ISO 9001 certification.

"For many organizations, once certification is achieved, there is an attitude that no more effort is needed to
improve the QMS. Such an attitude is contrary to both the explicit requirements of ISO 9001 and its intent."

- Charles A. Cianfrani and John E. "Jack" West,ISO 9001:2008 Explained & Expanded

Training in the ISO 9001 standard

Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality
management principles in a practice environment.

Professionals responsible for developing, implementing, auditing, and managing an ISO quality
management system or quality professionals interested in updating their documented ISO 9001-based QMS
can takeISO 9000 training courses, which include courses focused on ISO 9001 and quality management
systems. Additionally, organizations looking to improve employee performance and employees looking to
continually improve will also find ISO 9000 training relevant.

Previous versions of ISO 9001

Originally published in 1987, ISO 9001 underwent revisions in 1994, 2000 and again in 2008. The latest
revision was published in September 2015.

As John E. "Jack" West, Lorri Hunt, Nigel H. Croft, and Alka Jarvis write in an article forQPmagazine:

ISO 9001:1994 included changes to significantly improve the clause on control of design and development,
and to provide several other clarifications. The 1994 series also slightly modified the role of ISO 9002 and
The ISO 9001:2008 revision can be thought of as an amendment to clarify issues that had been raised during
the application of ISO 9001:2000. It included several changes to the text but no additional requirements.

Organizations certified to the ISO 9001:2008 standard will have a three-year period to transition to ISO
9001:2015. When the transition period ends in September 2018, ISO 9001:2008 certificates will no longer be
valid. Organizations looking to start their transition to the 2015 revision canpurchase a copy of ISO



What is Quality Management System (QMS)?

For more than two decades quality and quality management systems have been leading buzzwords
in the business world. Numerous consultants have built their careers around these topics, and quality issues in
business have been responsible for the development of new organizations and even industries, for instance,
the American Society for Quality and Six Sigma consulting. The notion of quality in business focuses on the
savings and additional revenue that organizations can realize if they eliminate errors throughout their
operations and produce products and services at the optimal level of quality desired by their customers. Errors
can take almost any formfor example, producing the wrong number of parts, sending bank statements to
customers who have already closed their accounts or sending an incorrect bill to a client. All of these errors
are very common, and the costs incurred seem minimal. But over time when mistakes are repeated the costs
add up to a significant amount, so eliminating errors can result in significant increases to the bottom line of a


According to the American Society for Quality, quality can be defined in the following ways:

Based on customers perceptions of a product/services design and how well the design matches the
original specifications.

The ability of a product/service to satisfy stated or implied needs.

Achieved by conforming to established requirements within an organization.

What Is a Quality Management System?

A quality management system is a management technique used to communicate to employees what is

required to produce the desired quality of products and services and to influence employee actions to
complete tasks according to the quality specifications.

What Purpose Does a Quality Management System Serve?

Establishes a vision for the employees.

Sets standards for employees.

Builds motivation within the company.

Sets goals for employees.

Helps fight the resistance to change within organizations.

Helps direct the corporate culture.

Why Is Quality Important?

Business success may simply be the extent to which your organization can produce a higher-quality
product or service than your competitors are able to do at a competitive price. When quality is the key to a
companys success, quality management systems allow organizations to keep up with and meet current
quality levels, meet the consumers requirement for quality, retain employees through competitive
compensation programs, and keep up with the latest technology.

Total Quality Management (TQM)

TQM is a management approach in which quality is emphasized in every aspect of the business and
organization. Its goals are aimed at long-term development of quality products and services. TQM breaks
down every process or activity and emphasizes that each contributes or detracts from the quality and
productivity of the organization as a whole.

Managements role in TQM is to develop a quality strategy that is flexible enough to be adapted to
every department, aligned with the organizational business objectives, and based on customer and
stakeholder needs. Once the strategy is defined, it must be the motivating force to be deployed and
communicated for it to be effective at all levels of the organization.

Some degree of employee empowerment is also encompassed in the TQM strategy and usually
involves both departmental and cross-functional teams to develop strategies to solve quality problems and
make suggestions for improvement.

Continuous Quality Improvement (CQI)

Continuous quality improvement came into existence in manufacturing as a different approach to

quality and quality systems. It does not focus as much on creating a corporate quality culture, but more on the
process of quality improvement by the deployment of teams or groups who are rewarded when goals and
quality levels are reached. CQI allows individuals involved in the day-to-day operations to change and improve
processes and work flows as they see fit.

CQI implementation attempts to develop a quality system that is never satisfied; it strives for constant
innovation to improve work processes and systems by reducing time-consuming, low value-added activities.
The time and resource savings can now be devoted to planning and coordination.

CQI has been adapted in several different industries. For example, in health care and other service
sectors, it has taken on the acronym FOCUS-PDCA work:

Find a process to improve.

Organize to improve a process.
Clarify what is known.
Understand variation.
Select a process improvement.
Then move through the process improvement plan:

Plancreate a time line, including all resources, activities, dates, and personnel training.
Doimplement the plan and collect data.
Checkanalyze the results of the plan.
Actact on what was learned and determine the next steps.

The FOCUS-PDCA acronym is an easy system for management to communicate to teams, and it helps
them stay organized and on track with the end result in mind. The system has proven to be very successful for
the CQI team approach.