ISO 9001:2015

Consequence for

Organisation

FOOD QUALIITY MANAGEMENT

Presented by

Francesca Cipriani

Rakhee Rachel Rajan

TABLE OF CONTENTS

1 Introduction

2 ISO 9000 Family

3 Changes

4 Organisation

5 Structure

6 Differences

7 New Principles

8 Benefits

9 Timeline

10 Conclusion

INTRODUCTION •The increase in global competition forces organizations to

produce high quality products and to thrive for

improvement and the most common approach to this is

ISO 9001.

•Other popular quality management approaches used by

organizations - Lean management, Six Sigma, TQM, etc.

•The quality management standard has been

implemented by more than one million organizations in

163 countries since its introduction in 1987.

•A revised version of ISO 9001 will be introduced by

September 2015.

(Manders, p:1, 2015)

ISO 9000 FAMILY

• ISO has published more than 19 500 International

Standards. ISO 9001 is for quality management.

• Quality refers to all those features of a product/service

which are required by the customer. Quality management means what the organization does to

ensure that its products or services satisfy the

customer's quality requirements and comply with any

regulations applicable to those products or services.

• ISO 9000 family has five different related parts.

• ISO 9000,9001,9002,9003,9004

(Manders, p:14, 2015)

ISO 9000 FAMILY • ISO 9000 : ISO 9004- Guidelines for performance

improvements

•ISO 9001,9002,9003 are categories in which

companies can apply for certification

ISO 9000- Quality Management and Quality Assurance

Standards, guidelines for selection and use

ISO 9001- Quality Systems-Model for Quality Assurance

Design/Development, Production, Installation and

Services

ISO 9002- Quality Systems-Model for Quality Assurance

in Production and Installation

ISO 9003- Quality Systems-Model for Quality Assurance

in Final Inspection and Test

ISO 9004- Quality Management and Quality System

Elements Guidelines.

ISO 9001:2015 Revision Overview accessed on 17.06.2015

ISO 9001:2015…Why?

Why ISO 9001 being revised?

1. ISO standards are revised for suitability and

effectiveness every 5-7 years. The last revision was in

updated in 2008.

2. Compatible with other management systems

3. Developments in knowledge and technologies

4. Increasing diversity of ISO 9001 users

ISO 9001:2015 What has changed?

• Main Changes: - the adoption of the High Level Structure (HLS) Process Approach Risk-Based Thinking Documented Information

ISO 9001:2015 Revision Overview accessed on 17.06.2015

ISO 9001:2015 What has changed:

Process Approach - The approach to processes is what allows the

organization to plan its processes and their interactions.

- The Plan-Do-Check-Act (PDCA) ensures that processes

are properly fed and managed and which are identified

opportunities for improvement

The Process Approach is a Management Strategy

- Managers use this Approach to manage and control the

processes, the interactions between these processes,

and the inputs and outputs that tie these processes

together.

www.bsigroup.com/IS09001Revision accessed on 11.06.2015

ISO 9001:2015 Risk-Based Thinking

- Risk Based Thinking

It allows the organization to determine the factors which

may render ineffective processes and Quality Management

System, and to take necessary checks to ensure that this

does not happen.

Risk-based approach, make the organization proactively

prevent or reduce undesirable effects and promote

continuous improvement.

www.bsigroup.com/IS09001Revision accessed on 11.06.2015

ISO 9001:2015 Risk-Based Thinking

• Using the Risk Based Thinking to ISO 9001: 2015:

- improves the likelihood of achieving the stated

objectives.

- improves customer confidence and satisfaction

- customers can be confident that they will receive the

product or service expected.

-assures consistency of quality of goods or services

ISO 9001:2015 Documented

Information

- Use of the term "documented information" instead of

"documents“ and "recordings".

- May be a flow diagram, a dvd or a checklist, without

any distinction

- Determine by themselves what information is important

to document manage and control.

-The preparation of the documentation system is not an

activity separate from each process but, within each

process!

www.bsigroup.com/IS09001Revision accessed on 11.06.2015

ISO 9001:2015 Structure

1 Scope

2 Normative References

3 Terms and Definitions

4 Context of the Organisation

5 Leadership

6 Planning for the QMS

7 Support

8 Operation

9 Performance Evaluation

10 Improvement

ISO 9001:2015 Differences:

ISO 9001:2015 ISO 9001:2008

1 Scope

2 Nominative References

3 Terms and Definitions

4 Quality Management System

5 Management ResponsIbility

6 Resource Management

7 Product Realisation

8 Measurement, analysis and

improvement

ISO 9001:2015 Revision Overview

New Principles of 9001:2015 1. Costumer Focus satisfy the customer requirements

and customer expectations.

2. Leadership create and maintain the internal

environment

3. Engagement of People people competent to

achieve the objectives of the organization.

4. Process Approach Understand the results of the

system and its processes to optimize performance.

New Principles of 9001:2015 5. Improvment in organizational efficiency and

effectiveness

6. Evidence-based Decision Making on the analysis

and evaluation of data

7. Relationship Management manages relationships

with its interested parties to optimize its performance.

(supplier)

ISO 9001:2015 Revision Overview accessed on 17.06.2015

What the Organizations have to do to

preparate for ISO 9001:2015?

- Know about the main changes

- Educate yourself and your organization

- Identify the gaps between your current system and the

new requirements

- Plan implementation of the new requirements.

- Stays informed at the revision procedees

-Take full advantage at the revision of ISO 9001

ISO 9001:2015 What benefits are

expected?

- Tool for the control of all the risks of an

organization

- Tool for monitoring the efficiency of choices

organization.

ISO 9001:2015 Effects on Oganisations

- This will vary from organisation to organisation in

terms of how much change will be needed.

- Three-year transition period for certified organisations

which will start when the standard is published.

- The standard writers and certification bodies are

already encouraging organisations to make a start.

ISO 9001:2015: Preparing for the Change | Quality Digest accessed on

17.06.2015

ISO 9001:2015 Timeline

June 2013 CD

(Committee Draft)

May 2014 DIS

(Draft International

Standard)

July 2015 FDIS

(Final Draft International

Standard)

September 2015

Published International

Standard

2015 2014 2013

www.bsigroup.com/IS09001Revision

accessed on 11.06.2015

ISO 9001:2015 Certification

Transition Timeline

September 2015 start of 3 years transition period to

September 2018

• Certifications to ISO 9001:2008 will no longer be valid

after September 2018

2018 2017 2016 2015

September 2015

Published International Standard

ISO 9001:2015: Preparing for the

Change | Quality Digest accessed on

17.06.2015

ISO 9001:2015 Conclusion

• The new management systems can benefit from the application of the new standard, they will be much more: -"characterized" according to the specificities of each organization and its context -"adaptive" in function of the changing conditions of the external environment and internal organization.

• The revision helps ISO have more updated and advanced standards that is more reliable.

ISO 9001:2015 References

-Croft, N.H., 2013, ISO 9001:2015, from CD to DIS, DNV Webinar - Selection and use of the ISO 9000 family of standards» accessed at Web www.iso.org -Quality Management principle accessed at Web www.iso.org accessed on 10.06.2015

-ISO 9001:2015 DIS Changes, Requirements and Implementation.

-ISO 9001:2015: Preparing for the Change | Quality Digest accessed on 17.06.2015

-ISO 9001:2015 Revision Overview accessed on 17.06.2015

-www.bsigroup.com/IS09001Revision accessed on 17.06.2015