03/06/2018 What is ISO 9001?

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What is ISO 9001?

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03/06/2018 What is ISO 9001?

“What is ISO 9001?” Are you looking for a simple

answer to this question?
Well, you’re not alone. This overview guide can help you learn why ISO 9001
creates benefits across your organization, help you discover what the ISO 9001
requirements are, and give the practical steps you need to take to get certified.

Your simple introduction to the basics of ISO 9001

ISO 9001 is the international standard for Quality Management Systems (QMS),
published by ISO (the International Organization for Standardization). The standard
was most recently updated in 2015, and is referred to as ISO 9001:2015. In order
to be released and updated, ISO 9001 had to be agreed upon by a majority of
member countries so that it would become an internationally recognized standard,
which means it is accepted by a majority of countries worldwide.

A survey of ISO 9001 certification at the end of 2012 shows that in spite of the
global recession the number of companies that have implemented an ISO 9001
quality management standard still shows a general positive trend worldwide.

Data taken from 2012 ISO Survey

In addition, there are other documents in the ISO 9000 family that support the ISO
9001 requirements: ISO 9000 defines the terms and principles behind ISO 9001,
and ISO 9004 provides guidance on making an ISO 9001 Quality Management
System more successful.

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What is a Quality Management System?

The Quality Management System, which is often referred to as a QMS, is a
collection of policies, processes, documented procedures and records. This
collection of documentation defines the set of internal rules that will govern how
your company creates and delivers your product or service to your customers. The
QMS must be tailored to the needs of your company and the product or service you
provide, but the ISO 9001 standard provides a set of guidelines to help make sure
that you do not miss any important elements that a QMS needs to be successful.

Getting to the heart of why ISO 9001 is important

As stated above, ISO 9001:2008 is an internationally recognized standard for
creating, implementing and maintaining a Quality Management System for any
company. It is intended to be used by organizations of any size or industry, and can
be used by any company. As an international standard, it is recognized as the basis
for any company to create a system to ensure customer satisfaction and
improvement, and as such, many companies demand this as the minimum
requirement for an organization to be a supplier.

Because you are auditing your processes, as well as having a certification body
audit them, your customers themselves do not need to audit your company. It is
because of this that ISO 9001 has become a necessity for many companies to
compete in the market.

In addition, your customers will be reassured that you have established a Quality
Management System based on the seven quality management principles of ISO
9001. To learn more about the quality management principles behind the ISO 9001
standard, take a look at this article: Seven Quality Management Principles behind
ISO9001 requirements.

In fact, ISO 9001 is such a basic and influential standard that it is used as the basis
when industry groups want to add specific industry requirements, thus creating
their own industry standard; this includes AS9100 for the aerospace industry, ISO
13485 for the medical devices industry and ISO/TS 16949 for the automotive
industry.

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What does ISO 9001 actually look like?

The ISO 9001 structure is split into eight sections. The first three are introductory,
with the last five containing the requirements for the Quality Management System.
Here is what the five main sections are about:

Section 4: Quality Management System – This section talks about general QMS
requirements, as well as the documentation requirements of the standard. It
includes the requirements for the Quality Manual, Control of Documents and
Control of Records, all of which are required documents in the QMS.

Section 5: Management Responsibility – The management responsibility

requirements cover the need for top management to be instrumental in the
implementation and maintenance of the QMS. Along with planning for the QMS,
there is a need for top management to be involved in the ongoing review of the
system to ensure customer satisfaction and improvement.

Section 6: Resource Management – The section on management of resources is

short, but covers the necessity to control all resources, including human resources,
buildings and infrastructure and the working environment.

Section 7: Product Realization – The product requirements deal with all aspects
of the planning and creation of the product or service. This section includes
requirements on planning, product requirements review, design, purchasing,
creating the product or service and controlling the equipment used to monitor and
measure the product or service. ISO 9001 allows for requirements in the section to
be excluded if they are not applicable to the company (such as a company that
does not design products or services).

Section 8: Measurement, Analysis and Improvement – This last section includes

the requirements needed to make sure that you can monitor whether your QMS is
functioning well. It includes assessing customer satisfaction, internal audits,
monitoring products and processes, dealing with non-conforming product and
corrective and preventive actions.

These sections are based on a Plan-Do-Check-Act cycle, which uses these

elements to implement change within the processes of the organization in order to
drive and maintain improvements within the processes.

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For more on how this works within the ISO 9001 standard, this blog article gives a
more detailed explanation: Plan-Do-Check-Act in the ISO 9001 Standard.

Why is ISO 9001 a good idea for your organization?

The benefits of ISO 9001 cannot be overstated; companies large and small have
used this standard to great effect, discovering and securing tremendous cost and
efficiency savings. Here are just a few of these benefits:

Improve your image and credibility – When customer see that you are certified
by a recognized certification body, they will understand that you have implemented
a system that is focused on meeting customer requirements and improvement. This
improves their trust that you will deliver what you have promised.

Improve customer satisfaction – One of the key principles of the ISO 9001 QMS
is the focus on improving customer satisfaction by identifying and meeting customer
requirements and needs. By improving satisfaction, you improve repeat customer
business.

Fully integrated processes – By using the process approach of ISO 9001, you
not only look at the individual processes in your organization, but also at the
interactions of those processes. By doing this, you can more easily find areas for
improvement and resource savings within your organization.

Use evidence-based decision making – Ensuring that you are making decisions
based on good evidence is a key to the success of an ISO 9001 QMS. By ensuring
that your decisions are based on good evidence, you can better target resources
to the best effect to correct problems and improve your organizational efficiency
and effectiveness.

Create a culture of continual improvement – With continual improvement as the

main output of the QMS, you can attain ever-increasing gains in savings of time,
money and other resources. By making this the culture of your company, you can
focus your workforce on improving the processes they are directly responsible for.

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Engage your people – Who better than the people working within a process to
help find the best solutions for improving that process? By focusing your workforce
on not only managing, but also improving the processes, they will be more engaged
in the outcome of the organization.

What are the practical steps to becoming ISO 9001

certified?
What is ISO 9001 certification? There are two types of certification: certification of a
company’s Quality Management System against the ISO 9001 requirements, and
certification of individuals to be able to audit against the ISO 9001 requirements.
This section discussed the steps for a company to implement an ISO 9001 Quality
Management System and have it certified.

ISO 9001 certification for your company involves implementing a QMS based on the
ISO 9001 requirements, then hiring a recognized certification body to audit and
approve your QMS as meeting the requirements of the ISO 9001 standard.

Starting with management support and identifying the customer requirements for
the QMS, you will need to start with defining your quality policy, quality objectives
and quality manual, which together define the overall scope and implementation of
the Quality Management System. Along with these, you will need to create the
mandatory and additional processes and procedures necessary for your
organization to properly create and deliver your product or service. There are six
mandatory documents that need to be included, and others to be added as the
company finds them necessary. For a good explanation on this, take a look at this
white paper on Mandatory Documentation Required by ISO 9001:2008.

This creation of documents can be done internally by your company, or you can get
help through hiring a consultant or purchasing standard documentation. To see
samples of documentation, visit this free ISO 9001 downloads page.

Once all of the processes and procedures are in place, you will need to operate the
QMS for a period of time. By doing this, you will be able to collect the records
necessary to go to the next steps: to audit and review your system and get
certified.

Mandatory steps to finish implementation and get

your company certified
After finishing all your documentation and implementing it, your organization also
needs to perform these steps to ensure a successful certification:

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Internal audit –The internal audit is in place for you to check your QMS processes.
The goal is to ensure that records are in place to confirm compliance of the
processes and to find problems and weaknesses that would otherwise stay hidden.

Management review –A formal review by your management to evaluate the

relevant facts about the management system processes in order to make
appropriate decisions and assign resources.

Corrective actions – Following the internal audit and management review, you
need to correct the root cause of any identified problems anddocument how they
were resolved.

The company certification process is divided into two stages:

Stage One (documentation review) – The auditors from your chosen certification
body will check to ensure your documentation meets the requirements of ISO 9001.

Stage Two (main audit) – Here, the certification body auditors will check whether
your actual activities are compliant with both ISO 9001 and your own
documentation by reviewing documents, records and company practices.

What ISO 9001 training and certification is available if

you’re an individual?
Training in the concepts of ISO 9001 is available, and there are a range of course
options for individuals to choose from. Only the first of these can lead to
certification for the individual to be able to audit for a certification body, but the
others are very useful for those who will be using these skills within their own
company:

ISO 9001 Lead Auditor Course – This is a four- to five-day training course
focused on understanding the ISO 9001 QMS standard and being able to use it for
auditing management systems against these requirements. The course includes a
test at the end to verify knowledge and competence, and it is only with an
accredited course that an individual can become approved to audit for a
certification body.

ISO 9001 Internal Auditor Course – This is commonly a two- or three-day course
that is based on the lead auditor course above, but does not include the test for
competence, so this is most useful for someone beginning to do internal audits
within a company.

ISO 9001 Awareness and Implementation Course – Several courses are offered
that provide knowledge of ISO 9001 and how to implement it. These can be one- or

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two-day courses, and can even include online e-learning sessions as a method of
teaching the material. These courses are good for those who need an overview on
the ISO 9001 standard, or those who will be involved in the implementation within a
company, and many are more economical than investing in the lead auditor course
for those involved at this level.

TABLE
There are aOF CONTENTS
number of accredited training organizations around the world where
you can gain individual qualifications in ISO 9001.

Introduction
To learn more about ISO 9001 implementation, please visit our ISO 9001
Learning Center. You’ll find a host of helpful resources, including free ISO
What is QMS?
9001 downloads.

Importance of ISO 9001

Structure of ISO 9001

Have any question about any step?
Benefits of ISO 9001
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