ISO 9001:2008 vs ISO 9001:2015

Prepare to change
Eng. Ahmed El Tuwaisy
Contents

1. Disclaimer
2. History
3. Objective of ISO 9001:2015
4. Timescale
5. What’s New?
a) HLS- High Level Structure
b) ISO DIS 9001:2015 compared to ISO 9001:2008
c) Risk Based Thinking
6. Transition Timeline

2 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

Disclaimer

 The presentation contains information related to the revision up to and

including July 2014

 Further changes may occur

 Firms may wish to consider these changes and plan accordingly.

3 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

History

Why revision for ISO 9001:2008

 In November 2011 the International Organization for Standardization

(ISO) voted to proceed with the revision process for ISO 9001

 In June 2013 the revision process had reached the stage where a
Committee Draft (CD) had been prepared for feedback from the
national mirror committees of those working on the revision.

 On May 2014 ISO/DIS 9001:2014 Draft International Standard was

set to vote.

4 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

Objectives of ISO 9001:2015

The world changes:

 Increased prominence of services
 Globalization
 More complex supply chain
 Increased interested parties’ expectations
 Information availability
 Integrate with other management systems

5 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

 ISO 9001 Current Timescale to Publication

2013 2014 2015

June 2013 CD
(Committee Draft)

May 2014 DIS

(Draft International
Standard)

July 2015 FDIS

(Final Draft International
Standard)

September 2015
Published
International Standard

6 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

 What’s New?

7 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

What’s New?

High Level Structure - Annex SL

 For all Management Standards, mandated by ISO’s Technical
Management Board (TMB)

 Common Structure, identical core text and common terms and core
definitions for use in all Management System Standards

 Purpose, enhance the consistency and alignment of different

management system standards

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 High Level Structure-
HLS

9 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

High Level Structure- Continued

1. Scope 7. Support
2. Normative references • Resources
3. Terms and definitions • Competence
4. Context of the organization • Awareness
• Understanding the organization and its • Communication
context • Documented information
• Needs and requirements 8. Operation
• Scope • Operational planning and control
• Management System 9. Performance evaluation
5. Leadership • Monitoring, measurement, analysis &
• General evaluation
• Management commitment • Internal audit
• Policy • Management review
• Roles, responsibility and authority 10. Improvement
6. Planning • Non conformity and corrective action
• Actions to address risks & • Continual Improvement
opportunities
• Objectives and plans to achieve them

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 High Level Structure- Continued

4. Context of Organization – addresses needs and expectations of interested parties,

scope of QMS

5. Leadership – addresses management commitment, policy, roles, responsibility &

authority

6. Planning – includes risks, opportunities, objectives and plans to achieve them, the
planning of changes

7. Support – includes resources, competence, awareness, communication, documented

information

8. Operation – includes planning & control, determine market needs, interaction

w/customers, planning process, control of external provisions of services, production
release of products/services, non-conforming products/services

9. Performance Evaluation – includes monitoring, measurement, analysis & evaluation,

internal audit, management review

10. Improvement – addresses non-conformity & corrective action, improvement

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Structure PDCA- Continued

4. Context of the organization

5. Leadership
Plan 6. Planning

7. Support
Do 8. Operation

9. Performance Evaluation
Check
10. Improvement
Act

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 Overview: Innovation DIS compared
to ISO 9001:2008

13 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

Process-based QMS & links to the Standard clauses

10 Continual Improvement
4.1, 4.2, 4.3
Establish context,
define relevant interested
parties & scope of QMS

*
5 Leadership

Customers & Customer

other relevant 4.4 QMS –General Satisfaction
interested parties & Process Approach

9 Performance
6 Planning
evaluation
*
Products &
Requirements Inputs 8 Operations Outputs Services

7 Support processes

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Schematic representation of a single process within QMS

Interaction with other processes

Act—

Interaction with other processes

incorporate Plan the process
improvements as (Extent of planning
necessary depends on RISK)

INPUTS Do—Carry out the OUTPUTS

process

Check -
monitor / measure
process performance

15 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

Overview- Introduction

ISO 9001:2008 ISO 9001:2015 (DIS version)

Products Products and Services
Documentation and Records Documented information
Work Environment Environment for the operation of processes
Purchased product Externally provided products and services
Supplier External Provider
 No Exclusions Clause
 Preventive Action vs Risk
 Process Approach- Explicit requirement of the Process Approach
 Documented Information vs Documents/Records
 Clients vs Interested Parties
 No ….
 Quality Manual
 Mandatory Procedures
 Management Representative

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO 9001:2015 Innovation compared to ISO 9001:2008

Chapter 1 to 4

-
1. Scope
-
2. Normative references
-
3. Terms and definitions
Widening the view from „client“ to
4. Context of the organization „interested parties“ Detailed definition of
process approach
-Demand to determine the processes inclusive Input
and Output
-Demand to determine the responsibilities and
authorities of these processes (process responsible
person)
-Demand to determine risks

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 5 (1/3)
5. Leadership Detailed definition of Responsibility of the top management.
Top management must ensure that
-quality policy is understood
-the QM-System is integrated into the business processes
-the importance of quality management and conforming the QM-
System requirements
-the QM-System achieves its intended results
-top management engages, directs and supports persons to
contribute to the effectiveness of the QM-System
-top management promotes continual improvement
-top management supports relevant management roles to
demonstrate their leadership

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 5 (2/3)
5. Leadership Customer focus
Top management not only must communicate – as actual – the
relevance of customer, statutory and regulatory requirements.
Additional top management must ensure that
-customer, statutory and regulatory requirements are
determined and met
-risks that can affect conformity of products and services are
determined and addressed
-Focus on enhancing customer satisfaction is maintained

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 5 (3/3)
5. Leadership Quality policy
Additionally the quality policy now must
-provide a framework for reviewing quality objectives
-be understood and applied
-be available to relevant interested parties

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 6 (1/3)
6. Planning for the Actions to address risks
quality management Addressable Risks must be determined to
system -ensure that the management system achieve its intended
results
-prevent/reduce undesired effects
-achieve continual improvement

It must be planned
-actions to address these risks
-how to integrate these actions into the QM-System processes
-how to evaluate the effectiveness of these actions

NOTE: Some of those requirements had been integrated in ISO

9001:2008, chapter 8.5.3 (preventive action)

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 6 (2/3)
6. Planning for the Quality objectives
quality management Additionally to the requirements of ISO 9001:2008 quality
system objectives must
-take into account applicable requirements
-be communicated
-be updated as appropriate

Concerning the actions to achieve these objectives the

organization shall determine
-what will be done
-required resources
-responsibilities (who)
-when the action is completed
-how the results will be evaluated

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 6 (3/3)
6. Planning for the Planning of changes
quality management Changes must be done in a planned and systematic
system manner.
The organization must take into account
-the objective or the change and its purpose
-potential consequences (risks)
-the integrity of the QM-System
-the availability of resources
-the allocation of responsibilities and authorities

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 7 (1/4)
7. Support Resources The organization shall take into account
-the capabilities of and constraints on existing internal
resources
-what is needed from external providers

Organizational knowledge
-The organization shall determine the relevant
knowledge for operation of its processes and to achieve
the conformity of goods and services
-In case of changes the organization must consider the
existing knowledge and determine how to get necessary
additional knowledge

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 7 (2/4)
7. Support Awareness
Persons who are working under the organization‘s
control shall be aware of
-quality policy
-relevant quality objectives
-their influence to the effectiveness of the QM-system
-the benefit of improved quality performance
-consequences of non-conformities concerning the
requirements of the QM-System

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 7 (3/4)
7. Support Communication
The organization must determine relevant internal and
external communications.
It must determine
- what has to be communicated
-when it has to be communicated
-to whom it has to be communicated
-how it has to be communicated

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 7 (4/4)
7. Support Creating and updating of documented information
When creating/updating documented information the
organization shall ensure appropriate:
-identification and description (e.g. a title, date, author or
reference number)
-format (e.g. language, software version, graphics) and
media (e.g. paper, electronic)

For document control the organization must address

-distribution, access, retrieval and use

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (1/10)
8. Operation 8.1 Operational planning and control
The organization shall
-determine the resources needed to achieve conformity
to product and service requirements
-control planned changes and review the consequences
of unintended changes and act to mitigate any adverse
effect as necessary

8.2 Determination of requirements for products and

services
The organization shall have processes for
communication to the client in relation to
-handling of customer property
-requirements for contingency actions, when relevant

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (2/10)
8. Operation The organization shall have a process to determine the
requirements for the products and services to be offered
to potential customers. (chapter 8.2.2)
The organization shall review requirements not stated by
the customer, but necessary for the customers specific or
intended use, when known and applicable. (chapter
8.2.3)
When the customer doesn‘t provide documented
requirements, the customer requirements shall be
confirmed by the organization before acceptance.
(chapter 8.2.3)

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (3/10)
8. Operation 8.3 Design and development of products and
services
If there are no detailed requirements for products and
services defined by customer or other interested parties
in such a way that they are adequate for production or
service provision, the organization shall have a design
and development process. (chapter 8.3.1)
In determining the stages and controls for design and
development the organization shall consider
-the nature, duration and complexity of the design and
development activities
-the need for involvement of customer and user groups in
the design and development process

(chapter 8.3.2)

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (4/10)
8. Operation Design and development inputs:
The organization shall determine:
-standards and code of practice that the organization has
committed to implement
-internal and external resource needs for the design and
development
-the potential consequences of failure due to the nature
of the products and services

8.4 Control of externally provided products and

services
The organization shall have criteria for the evaluation,
selection, monitoring of performance and re-evaluation of
external providers. (chapter 8.4.1)

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (5/10)
8. Operation In determining the type and extent of controls concerning
external provision of processes, products and services,
the organization shall consider
-the potential impact of the external provision related to
ability to meet customer, statutory and regulatory
requirements

(chapter 8.4.2)

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (6/10)
8. Operation The organization shall communicate the requirements to
the external provider concerning
-products, services and/or processes which will be
provided
-Control and monitoring of the external provider‘s
performance
-verification activities which are intended to be performed
at the providers production site

(chapter 8.4.3)

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (7/10)
8. Operation 8.5 Production and service provision
Post-delivery activities (chapter 8.5.5)
To determine the extend of post-delivery activities the
organization shall consider:
-risks associated with products and services
-nature, use and intended lifetime of products and
services
-customer feedback
-statutory and regulatory requirements

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (8/10)
8. Operation Control of changes (chapter 8.5.6)
The organization shall review and control unplanned
changes which are relevant for production and service
provision.
The organization shall retain documented information
concerning results of the review, the authorizing persons
and necessary actions.

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (9/10)
8. Operation 8.6 Release of products and services
Release of products and services to the customer shall
not be done before planned arrangements for verification
have been done satisfactorily. Exception: Otherwise
approved by relevant authority and, as applicable, by the
customer.

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 8 (10/10)
8. Operation 8.7 Control of nonconforming process outputs,
products and services
As applicable, the organization shall handle
nonconforming process outputs, products and services in
one or more of the following ways:
-correction
-segregation, containment, return or suspension of
provision of products and services
-informing the customer

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 9 (1/2)
9. Performance 9.2 Internal audit
evaluation The organization shall
-ensure that the results of the audits are reported to the
relevant management

(chapter 9.2.2)

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 9 (2/2)
9. Performance 9.3 Management review The review shall be planned
evaluation and carried out considering
-information of quality performance including trends and
indicators for:

- monitoring and measurement results

- issues concerning external providers and other
relevant interested parties
- adequacy of resources required for maintaining an
effective quality management system
-the effectiveness of actions to address risks

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 10 (1/2)
10. Improvement 10.1 General
The organization shall determine and select opportunities
for improvement and implement necessary actions to
meet customer requirements and enhance customer
satisfaction.
This shall include, as appropriate:
-improving processes to prevent nonconformities
-improving quality management system results

10.2 Nonconformity and corrective action

In case of nonconformities the organization shall
-make changes to the quality management system, if
necessary

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Overview: Innovation DIS compared to ISO 9001:2008

Chapter of DIS ISO Innovation compared to ISO 9001:2008

9001:2015 chapter 10 (2/2)
10. Improvement 10.3 Continual improvement
Concerning the QM-System the organization shall
continually improve
-suitability
-adequacy
-effectiveness

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 Risk Based Thinking

42 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

What’s Risk ?

 Risk: effect of uncertainty on an expected result

Note 1: An effect is a deviation from the expected — positive or negative

Note 2: Uncertainty is the state, even partial, of deficiency of information (3.50)

related to, understanding or knowledge (3.53) of, an event, its consequence, or
likelihood.

Note 3: Risk is often characterized by reference to potential “events” (as

defined in ISO Guide 73:209,3.5.1.3) and “consequences” (as defined in ISO
Guide 73:2009, 3.6.1.3), or a combination of these.

Note 4 : Risk is often expressed in terms of a combination of the consequences

of an event (including changes in circumstances) and the associated
“likelihood” (as defined in ISO Guide 73:2009, 3.6.1.1) of occurrence

43 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

Risk Based Thinking- Why?

 Successful companies intuitively take a risk-based approach

because it brings benefits

 To improve customer confidence and satisfaction

 To assure consistency of quality of goods and services

 To establish a proactive culture of prevention and improvement

44 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

 Where is risk addressed in ISO 9001:2015?

ISO 9001:2015 uses risk-based thinking to achieve this in the following way:
 Clause 4 (Context) the organization is required to determine the risks which may affect this.

 Clause 5 (Leadership) top management are required to commit to ensuring Clause 4 is

followed.

 Clause 6 (Planning) the organization is required to take action to identify risks and
opportunities.

 Clause 8 (Operation) the organization is required to implement processes to address risks

and opportunities.

 In Clause 9 (Performance evaluation) the organization is required to monitor, measure,

analyse and evaluate the risks and opportunities.

 In Clause 10 (Improvement) the organization is required to improve by responding to

changes in risk.

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 Risk Based Thinking- How?

 Identify what YOUR risks and opportunities are – it depends on

context

 Analyse and prioritize your risks and opportunities

 Plan actions to address the risks

 Implement the plan – take action

 Check the effectiveness of the actions – does it work?

 Learn from experience – continual improvement

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 Risk Based Thinking- Summary

RISK-BASED THINKING IS……

not new
something you do already
continuous
ensures greater knowledge and preparedness
increases the probability of reaching objectives
reduces the probability of poor results
makes prevention a habit

 Useful document
 ISO 31000:2009 Risk Management – Principles and guidelines

47 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

ISO 9001:2015 Certification Transition Timeline

2015 2016 2017 2018

September 2015
Published International
Standard

September 2015 start of 3 years transition period

to September 2018
• Certifications to ISO 9001:2008 will no longer be
valid after September 2018

48 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

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49 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS

50 02.12.2014 ISO 9001:2008 vs. ISO 9001:2015 DIS