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ISO 9001: 2015

What You Need To Know!


A GUIDE TO THE KEY POINTS FOR YOUR BUSINESS

TABLE OF CONTENTS
1. WHY CHANGE

2. WHAT ARE THE KEY CHANGES

3. IMPLICATIONS TO BUSINESS

4. WHAT DO YOU NEED TO DO

5. HOW CG BUSINESS CONSULTANCY CAN


HELP

CHAPTER ONE

ISO 9001 Why is it


changing?

Introduction
The ISO 9000 Series of quality standards is by far the best selling
and most extensively used management system worldwide.

Like all ISO standards ISO 9001 is required to be considered for


revision every five years; if approved by vote, the three year
revision process starts.

The main reason for the change is to keep the ISO 9001 standard
relevant, ensure it can be translated accurately, reflect changes
in organisational environments and ensure that it continues to
deliver confidence in an organisations ability to provide product
or service in line with customer requirements.

What are the Changes?


The current focus on effective process management is to be maintained

but greater emphasis will be placed on producing desired outputs and


providing confidence in product within an increasingly dynamic
environment.

It will also make it easier to amalgamate the ISO 9001 standards with other
standards.
The term "product" will be replaced by "goods and services
The word improvement" will include corrective action, innovation
and "continual Improvement"

What are the Changes?


Preventive Action is replaced with risk-based thinking. The emphasis
now being placed on business and QMS objectives and the planning to
achieve them. Risk identification is part of the planning process and
actions to avoid risks will ensure that there are better chances of achieving
objectives.

There will be requirements for documented information, with no


specific references to quality manual, documented procedures or to
quality records.
Senior management will be made more accountable for the results of
their ISO 9001 system.
"Purchasing" and "outsourcing" will be incorporated within "external
provision of goods and services"

System Driven by Context

The new standard places greater emphasis on:


Understanding the organisations context
Identifying relevant stakeholders (interested parties) and those of
their requirements that are relevant

Understanding their customers requirements


Clearly defining the scope of their QMS and its fit within the
organisations activities.
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Risk Based Thinking


Having clear objectives .

Objectives

Risks

Risks

Risks
Risks

Risks
Risks

Planning

understanding the risks and how to avoid them

Agility
Companies need to be flexible and agile to
survive in an environment where
organisations often have more than one qualified
supplier
few organisations can afford to keep inventory
demand is seldom steady and predictable
mistakes can be costly

Agility
The QMS must support the organisation in this
environment
Controls must facilitate agility without
compromising quality

ISO 9001:2015 is about understanding


the risks to achieving objectives
the controls that are required to minimise these
risks
the strategies to provide the required flexibility and
agility while maintaining controls

What are the Implications


to your business?
The manual and documentation, including procedures
and records may need revising

Risk-based Thinking processes will need to be


implemented

What are the Implications


to your business?
Changes in external provision of goods and services
may have implications for procurement and
outsourcing activities and therefore implications on
suppliers

Transition audits (during the three year period


following publication) will be required to changeover
to the new ISO 9001:2015 Standard (these will be
specific surveillance or re-assessment audits).

INSERT IMAGES

a quality management
system is the obvious
route to take

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What do you need to do?


Transition to ISO 9001:2015 will be required
for all companies currently holding
certification to ISO 9001:2008

Transition will be allowed over the three year


period after publication.

Still in draft, however Working Draft and


Committee Draft versions has been issued
within ISO TC 176.

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Where CG Business
Consultancy Comes In
CG Business Consultants are fully trained in the requirements of the new ISO 9001:2015
changes and are here to assist companies through seamless transition from ISO
9001:2008 to ISO 9001:2015.
We have assisted in over 200 companies in successful certification to ISO 9001:2008
over the past few years and are ready to do it again ! By getting you through the
transition process with the minimum amount of fuss. Our experience in interpreting

standards to your needs and auditing to ensure you will successfully transition to ISO
2015 will been proven again and again.
We hold a 100% success rate for ISO certification.
Try us, you wont be disappointed
Hear what your clients have to say

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CG BUSINESS CONSULTING HAVE A 100%


CERTIFICATION SUCCESS RATE
CONTACT US NOW FOR A
Guaranteed certification from the experts

FREE CONSULTATION
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