ISO 9001: 2015

What You Need To Know!

A GUIDE TO THE KEY POINTS FOR YOUR BUSINESS

1

TABLE OF CONTENTS

1. WHY CHANGE 3

2. WHAT ARE THE KEY CHANGES 5

3. IMPLICATIONS TO BUSINESS 6

4. WHAT DO YOU NEED TO DO 8

5. HOW CG BUSINESS CONSULTANCY CAN

HELP 9

2

CHAPTER ONE

ISO 9001 – Why is it

changing?

3

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.

4

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"

5

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"

5

System Driven by Context

6

The new standard places greater emphasis on:

•Understanding the organisation’s 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 organisation’s activities.

Risk Based Thinking

Having clear objectives ……….

7

Objectives

Risks

Risks

Risks

Risks

Risks

Planning

… understanding the risks and how to avoid them

Risks

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

8

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

8

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

9

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).

9

INSERT IMAGES

““a quality management system is the obvious route to take”

10

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.

11

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 won’t be disappointed

Hear what your clients have to say

12

CG BUSINESS CONSULTING HAVE A 100% CERTIFICATION SUCCESS RATE

CONTACT US NOW FOR A

Guaranteed certification from the experts

FREE CONSULTATION

13