ISO 9001 2015 Plain English Introduction

EXECUTIVE SUMMARY

ISO DIS 9001 2015 is a quality management standard. It defines
a set of quality management requirements. These requirements
can be found in the following seven sections:

  1. Context
  2. Leadership
  3. Planning
  4. Support
  5. Operations
  6. Evaluation
  7. Improvement

DIS stands for draft international standard. The DIS version is
not the final version. According to ISO, the final version of the
standard will be published in September of 2015
.

The purpose of this standard is to help organizations to meet
all customer needs and expectations and to comply with all
relevant regulatory and statutory requirements. According to
ISO 9001 2015, any organization can achieve these important
objectives if it establishes a quality management system (QMS)
and if it continually tries to improve the suitability, adequacy,
and effectiveness of this system.

A quality management system (QMS) is a set of interrelated or
interacting elements that organizations use to formulate quality
policies and quality objectives and to establish the processes
that are needed to ensure that these policies are followed
and these objectives are achieved.

SCOPE OF ISO DIS 9001 2015

ISO 9001 applies to all types of organizations. It doesnít matter
what size they are or what they do. It can help any organization
to achieve standards of quality that are recognized and
respected throughout the world.

Use ISO 9001 if you need to be able to prove that you can meet
customer requirements and enhance customer satisfaction.
Use it if:

  • You need to be able to show that your organization is
    consistently capable of providing products and services
    that meet customer requirements and comply with all
    relevant statutory and regulatory requirements.
  • You need to be able to demonstrate that your organization
    can enhance customer satisfaction because it is consistently
    capable of continually improving both its products and
    services and its practices and processes.
  • You need to be able to assess your organization's ability
    to consistently provide products and services that meet
    customer requirements and comply with all relevant
    statutory and regulatory requirements.

HOW TO USE ISO DIS 9001 2015

If you donít already have a quality management system (QMS), you
can use this ISO 9001 standard to establish one. And once youíve
established your organizationís QMS, you can use it to demonstrate
that your organization is capable of meeting customer requirements,
enhancing customer satisfaction, and continually improving both
its products and services and its practices and processes.

According to ISO 9001, your QMS must meet every requirement
if you wish to claim that it complies with this ISO standard. Every
requirement is both generic and mandatory and may only be
excluded if it cannot be applied. Furthermore, you may exclude
or ignore a requirement only if doing so does not compromise
your organization's ability or responsibility to ensure that its products and services are in compliance and only if you
can justify and explain why you cannot apply it. In short,
if a requirement can be applied it must be applied.

However, how you choose to meet ISO's requirements, and to
what extent, will depend on and be influenced by many factors.
It will depend on your organizationís context, its structure, its
objectives, its risks, its processes, its process interactions,
and its products and services; and will be influenced by the
competence of its personnel and the needs and expectations
of its customers and other interested parties. Consequently,
quality management systems can vary quite a bit.

ISO 9001 is designed to be used for certification purposes. Once
youíve established a QMS that meets ISO's requirements and deals
with your organizationís own risks and requirements, you can ask
a registrar (certification body) to audit your system. If you pass the
audit, your registrar will issue an official certificate that states that
your organization's QMS meets ISO's requirements.

While ISO 9001 is designed to be used for certification purposes,
you donít have to become certified. You can be in compliance
without being formally certified by an accredited certification body
(registrar). You can self-audit your QMS and then announce to the
world that it complies with the ISO 9001 standard (assuming that it
actually does). Of course, your compliance claim may have more
credibility in the marketplace if an independent certification body
agrees with your assessment.


MORE ISO 9001 2015 PAGES

Quality Management Principles

Outline of ISO 9001 2015 Standard

Overview of ISO 9001 2015 Standard

ISO 9001 2015 versus ISO 9001 2008

Plain English ISO 9001 2015 Definitions

ISO's Process Approach in Plain English

ISO 9001 2015 Translated into Plain English


MORE RESOURCES

ISO 9004 2009 QMS Library

ISO 19011 2011 Auditing Library

AS9100C 2009 Aerospace QMS Library

ISO 20000-1 Service Management Library

ISO 13485 2003 Medical Device QMS Library


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 Updated on November 24, 2014. First published on November 22, 2014.

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