ISO 9001:2015
ISO 9001 is
defined as 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 the ISO 9000 series and 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.
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:
v Organize
processes
v Improve
the efficiency of processes
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 a process-oriented
approach to 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 many topics, such as:
v Requirements
for a QMS, including documented information, planning and determining process
interactions
v Responsibilities
of management
v Management
of resources, including human resources and an organization’s work environment
v Product
realization, including the steps from design to delivery
v Measurement,
analysis, and improvement of the QMS through activities like internal audits and
corrective and preventive action
Changes
introduced in the 2015 ISO 9001 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:
v The
introduction of new terminology
v Restructuring
some of the information
v An
emphasis on risk-based thinking to enhance the application of the process
approach
v Improved
applicability for services
v Increased
leadership requirements
WHAT ARE THE BENEFITS OF ISO
9001?
ISO 9001 helps organizations ensure their
customers consistently receive high quality products and services, which in
turn brings 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:
v
Organize a QMS
v
Create satisfied customers, management,
and employees
v
Continually improve their processes
v
Save costs
In Nevada, the Clark County School District used ISO
9001 to 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 system’s
success: training, communication and respect, and efficiency.
WHAT
TOPICS DOES ISO 9001:2015 COVER?
ISO 9001 is based on the plan-do-check-act methodology and
provides a process-oriented
approach to 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 many topics, such as:
v Requirements
for a QMS, including documented information, planning and determining process
interactions
v Responsibilities
of management
v Management
of resources, including human resources and an organization’s work environment
v Product
realization, including the steps from design to delivery
v Measurement,
analysis, and improvement of the QMS through activities like internal audits and
corrective and preventive action
Changes introduced in the 2015 ISO 9001
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:
v The
introduction of new terminology
v Restructuring
some of the information
v An
emphasis on risk-based thinking to enhance the application of the process
approach
v Improved
applicability for services
v Increased
leadership requirements
WHAT ARE THE BENEFITS OF ISO 9001?
ISO 9001 helps
organizations ensure their customers consistently receive high quality products
and services, which in turn brings 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:
v
Organize a QMS
v
Create satisfied
customers, management, and employees
v
Continually
improve their processes
v
Save costs
In Nevada,
the Clark County
School District used ISO 9001 to 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
system’s success: training, communication and respect, and efficiency.
ISO 9001 is the
only standard in the ISO 9000 series to which organizations can certify.
Achieving ISO 9001:2015 certification means that an organization has demonstrated
the following:
v
Follows the
guidelines of the ISO 9001 standard
v
Fulfills its own
requirements
v
Meets customer
requirements and statutory and regulatory requirements
v
Maintains
documentation
Certification
to the ISO 9001 standard can enhance an organization’s 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 registrar’s audit confirming the organization
meets those requirements.
Organizations
should consider the following as they begin preparing for an ISO 9001 quality
management system certification:
v
Registrar’s
costs for ISO 9001 registration, surveillance, and recertification audits
v
Current level of
conformance with ISO 9001 requirements
v
Amount of
resources that the company will dedicate to this project for development and
implementation
v
Amount of
support that will be required from a consultant and the associated costs