ISO 9000

ISO 9000 is a series of standards, developed and published by the International Organization
for Standardization (ISO). It defines, establishes and maintains an effective quality assurance
(QA) system for manufacturing and service industries.

The ISO 9000 standard is the most widely known and has perhaps had the most impact of the
13,000 standards the ISO has published. It serves many different industries and organizations
as a guide to quality products, service and management.

The one standard in the ISO 9000 series of standards that an organization can earn a
certification in is the ISO 9001 individual standard. By earning that certification, an
organization shows it is compliant with its industry's ISO 9000 standards. To be certified, an
outside examiner must check the organization's practices.

As part of an assessment, staff members are interviewed to ensure they understand how
compliance works. The assessor examines the organization's paperwork for compliance and
files a detailed report that identifies any parts of the standard where the organization is not in
compliance. The organization then agrees to correct problems within a specific time. When
all problems are corrected, the organization can then be certified.

ISO 9000 Standards

ISO 9000 lays out in detail the fundamentals and vocabulary of quality management
systems.

The actionable portion of ISO 9000 is ISO 9001. Organizations that receive certification are
being recognized as meeting ISO 9001. Obtaining that certification is a process that takes
over a year and requires substantial documentation to demonstrate conformity with the
standards.

The ISO 9000 family contains these standards:

 ISO 9001:2015: Quality Management Systems—Requirements

 ISO 9000:2015: Quality Management Systems—Fundamentals and Vocabulary
(definitions)
 ISO 9004:2009: Quality Management Systems—Managing for the Sustained Success
of an Organization (continuous improvement)
 ISO 19011:2011: Guidelines for Auditing Management Systems
History of ISO 9000

ISO 9000 is perhaps the best-known and most widely adopted set of standards produced by
the International Organization for Standardization.

Established in 1947, ISO is an independent, non-governmental body that develops and

publishes technical, industrial, and commercial standards based on input from 170 member
nations. Its standards aim to establish management practices that produce safe, reliable, and
high-quality products and services at a globally acceptable level.

The organization has published more than 25,000 standards that it recommends. Most
notably, it publishes a set of environmental standards, ISO 14001, for companies and
organizations that want to adopt an effective environmental management system.

Other standards fall into many categories, including health and safety, energy management,
food safety, and information technology security

Importance of ISO 9000

ISO 9000 is significant in several ways, including the following:

 It establishes standards for how an organization's product or service will meet customer
and stakeholder needs within a set of regulatory requirements.

 It helps an organization build, maintain and continuously improve its QMS with the end
goal of providing the best service or product quality

 Companies that follow the guidelines are likely to reduce the cost of production because
the standards and controls put in place cut down on costly and time-consuming mistakes.
A focus on process also enables organizations to use personnel, resources and time most
efficiently.

 Following the standards can give organizations a competitive advantage because

compliance enhances an organization's reputation.

 Many industry-specific QMS standards are based on ISO 9000, such as ISO 13485,
which is used in the medical industry. ISO 9000 is often integrated with industry-specific
standards.
ISO 9000 Quality Management Guidelines
There are seven quality management principles included in ISO 9000:

1. Customer focus. Businesses must understand customer requirements and aim to exceed
customer expectations. Organizations should measure customer satisfaction with their
product or service as well. Surveys are one way to do this, monitoring customer
complaints is another.

2. Leadership. Organizational leaders should establish a vision for the direction of the
company and empower employees to reach that goal. Leaders should establish trusted
relationships with employees and recognize their contributions.

3. Engagement. Employees at every level should be involved.

4. Process. Organizations should manage resources as a process. They should use process
analysis tools to measure what the organization is capable of, identify links between
activities to streamline processes and look for ways to improve processes.

5. Continuous improvement. Companies should take a continual improvement approach

and empower people to make improvements, measure improvement consistently and
celebrate those improvements.

6. Evidence-based decision-making. Organizations should make decisions based on

sound data analysis, balanced with practical experience and qualitative evidence. This
involves using techniques like decision matrices to evaluate and rank options and
motivating, which helps a group narrow down a list of options.

7. Relationship management. Organizations should focus on fostering a mutually

beneficial relationship with partner organizations, including suppliers, service providers
and contractors. They should share resources, collaborate on development efforts and
recognize successes to achieve efficient supply chain management.
 ISO 4000

ISO 14000 is a series of international standards designed to help organizations operate with
sustainability, adhere to environmental regulations, and continuously improve processes. The
ISO 14000 standard contains ISO 14001:2015 which specifies the requirements for an
effective Environmental Management System (EMS)

Environmental Management System (EMS)

An Environmental Management System (EMS) is a set of processes created by companies to

help achieve environmental goals in a cost-effective manner. An EMS is also considered as
an organizational framework designed to meet regulatory standards.

History of ISO 14000

 The first environmental management system standard, BS 7750, was published in 1992 by
the BSI group.
 In 1996, the International Organization for Standardization (ISO) created the ISO 14000
family of standards.
 ISO 14001 underwent revision in 2004.
 The current revision of ISO 14001 was published in September 2015.
ISO 14000 Standards

The creation of ISO 14000 in 1996 can be traced back to BS 7750, or the specification for
environmental management systems, which was developed by the British Standards
Institution (BSI) in 1992. Over time, certifications from the Switzerland-based International
Organization for Standardization (ISO) became more recognized globally.

As the most widely adopted EMS certification, ISO 14000 is often integrated with similar
standards such as the quality management system (QMS) standard, ISO 9001.

ISO 14000 and ISO 9000 are related to each other in a way that both standards deal with
establishing, implementing, monitoring, and improving processes, especially for companies
involved in international trade. ISO 14001 specifically focuses on environmental
management, while ISO 9001 emphasizes on quality assurance programs for managing
businesses.

Importance of ISO 14000

ISO 14000 is important because it enables organizations to move beyond regulatory

compliance and take a proactive approach toward environmental management. Businesses
can create a massive impact when they actively take part in considering the environment—
which is arguably a root of all the world’s biggest problems.

When companies systematize and standardize their operations with an internationally-

accredited framework, not only can it help them implement sustainable business practices
that protect the environment, but they can also inevitably achieve conformance to
environmental regulations with ease.

ISO 14000 Environmental Management Guidelines

As recommended by the U.S. Environmental Protection Agency (EPA), listed below are
some basic elements of an EMS:

 Reviewing the organization’s environmental goals;

 Analyzing its environmental impacts and legal requirements;
 Setting environmental objectives and targets to reduce environmental impacts and
comply with legal requirements;
 Establishing programs to meet these objectives and targets;
 Monitoring and measuring progress in achieving the objectives;
 Ensuring employees’ environmental awareness and competence; and
 Reviewing progress of the EMS and making improvements.
Difference Between ISO 9000 and ISO 14000
ISO 9000 and ISO 14000 are both sets of standards created and published by the
International Organization for Standardization.

 ISO 9000 is devoted to quality management. It is designed to help companies and

other organizations ensure that the products and services they create and the
processes they use to create them meet a high standard of quality and integrity.
 ISO 14000 is a set of standards for companies and other organizations that want the
processes they use and the products they create to have a minimal adverse impact on
the environment.