Differences Between ISO 90012015 and ISO 90012008

Differences between ISO 9001:2015 and ISO 9001:2008
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Important differences between ISO 9001:2015
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improving business processes. We have a number of
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Luc Marivoet is one of our quality experts. We interviewed Luc A NEW

about the publication of the new ISO 9001:2015 standard and CHALLENGE?
the main differences between ISO 9001:2015 and ISO Are you looking for a new
9001:2008. challenge and do you
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Luc, can you tell us a little bit about yourself? and how your personality
Luc: I’m Luc Marivoet, Senior Engineering Consultant. I’ve been working at matches with Pauwels
Pauwels Consulting since January 2013 and I have twenty-five years’ Consulting.
experience of applying quality management systems.
How does it work?
After my studies as a technical engineer, I worked successively as a Quality
Test Engineer, Quality Control Manager, Quality Auditor and Quality
Manager in various sectors.
At the moment, I am working as an ISO Quality Manager for the service

Signalling Projects at Infrabel, the organisation that manages the Belgian rail
https://www.pauwelsconsulting.com/blog/iso-9001-2015/[08-Nov-16 8:44:35 AM]

network’s infrastructure. I am responsible for setting up, implementing,

monitoring and maintaining the ISO 9001 certified quality management
system.
What is ISO 9001 again?
Luc: ISO 9001 is the world’s most popular and most commonly used
standard for quality management systems.
A standard is not a law, but an agreement or best practice that an

organisation can apply voluntarily. A standard reflects a good level of
professionalism. A quality management system is a tool with which an
organisation can determine how it can meet the requirements of its
customers and the other interested parties that are involved in its activities.
What are the benefits of ISO 9001?
Luc: An ISO 9001 quality management system:
shows that you provide products and services of consistent quality;
shows that you provide products and services that meet the customer’s
requirements, comply with the law and legislation, and meet the
organisation’s own requirements;
can help you streamline your business processes and continuously

improve them.
There are two additional benefits:
ISO 9001 helps you increase customer satisfaction;
ISO 9001 is positive for your image: you show that you comply with
internationally recognised quality standards. This is often a requirement
for customers and suppliers to do business with you.
What does the ISO 9001 standard specify?
The most recent ISO 9001:2015 standard is constructed around seven quality
management principles:
1. customer focus;
2. leadership;
3. engagement of people;
4. process approach;
5. improvement;
6. evidence-based decision making;
7. relationship management.
ISO 9001:2015 describes for each part which requirements your products,

services and organisation have to meet in order to enjoy the above benefits.
Who determines, checks and manages ISO 9001?
ISO 9001 is managed by the International Organisation for Standardisation

(ISO) in Geneva, Switzerland. ISO is an independent membership
organisation and the world’s largest developer of voluntary international
standards. ISO 9001:2015 was developed by the ISO / TC 176 / SC 2 –
Quality Systems Technical Committee.
However, ISO does not provide certification or conformity assessment. This is

performed by accredited certification bodies. These are establishments that
evaluate an organisation’s management system and certify them with respect
to the published standards.
I understand that the previous version of ISO 9001 dates from 2008
and that there is now a new version?
That’s right. A new version of ISO 9001 appears about every seven years.
It was first issued in 1987: at that time, you had to describe in detail what your
business did. What applied in the 1994 version, was ‘say what you do and do
what you say’. In the 2000 version, you had to focus on proper processes in
order to continually improve and thereby increase your customer satisfaction.
There was nothing added in 2008, but it was more precise about the
interpretation of the standard. ISO 9001:2015 was published on 23
September 2015.
Do organisations have to move over from ISO 9001:2008 to ISO

9001:2015 immediately?
No. There is a transitional period of three years after the publication of each
new version of ISO 9001, during which organisations can adapt their quality
management to match the latest version. Organisations must therefore
implement the new ISO 9001:2015 standard before 23 September 2018 in
order to continue complying with ISO 9001.
What are the main differences between ISO 9001:2008 and ISO
9001:2015?
ISO 9001:2015 HAS TEN CLAUSES INSTEAD OF EIGHT
ISO 9001:2015 has ten clauses instead of eight. The following table shows
the relationship of the ISO 9001:2008 clauses to those in the new ISO
9001:2015.
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative reference 2. Normative reference

3. Terms and definitions 3. Terms and definitions
4. Quality management system 4. Context of the organisation
5. Management responsibility 5. Leadership
6. Planning
6. Resource management 7. Support
7. Product realisation 8. Operation
8. Measurement, analysis and 9. Performance evaluation

improvement
10. Improvement

The first three clauses in ISO 9001:2015 are largely the same as those in
ISO 9001:2008, but there are considerable differences between ISO
9001:2008 and ISO 9001:2015 from the fourth clause onwards. The last
seven clauses are now arranged according to the PDCA cycle (Plan, Do,
Check, Act). The following figure shows this.
Clauses 4, 5, 6 and 7 of ISO 9001:2015 come under PLAN, clause 8 comes

under DO, clause 9 comes under CHECK and clause 10 is covered by ACT.
With this new arrangement, the new ISO 9001:2015 strives to give additional
momentum to the continuous and systematic improvement of processes
within organisations.
ISO 9001:2015 HAS A HIGH LEVEL STRUCTURE (HLS)
As a result of the new arrangement in ten clauses, ISO 9001:2015 now has
the same unambiguous structure as all standardised management systems,
known as a ‘High Level Structure’ (HLS).
The core elements of ISO 9001, ISO 14001, ISO 22000, OHSAS 18001, etc.
are therefore all the same from now on. This has made the integration of

various management systems much simpler. If, for example, an organisation

wishes to implement ISO 14001 in addition to ISO 9001, the parts that cover
the same topic can easily be seen in the standards.
ISO 9001:2015 PUTS MORE FOCUS ON INPUT AND OUTPUT
There is more emphasis in ISO 9001:2015 on measuring and properly

assessing the input and output of processes. According to ISO 9001:2015,
you must closely monitor which articles, information and specifications are
involved in the production process. You must also clearly check whether
good articles come out of the production process.
RISK-BASED THINKING IS AT THE CORE OF ISO 9001:2015
Risk-based thinking has a very important place in ISO 9001:2015. You are
now strongly encouraged as an organisation to use risk analysis in order to
decide for yourself which challenges you see in the management of your
business processes.
Formal risk analysis, familiar to many organisations via FMEA or HACCP

techniques, is now standard for everyone. To emphasise their dominance,
the concept of ’risk’ occurs forty-eight times in ISO 9001:2015, compared
with only three times in ISO 9001:2008.

The addition of risk-based thinking has made the ‘preventive measures’ of

ISO 9001:2008 redundant. These preventive measures no longer appear in
ISO 9001:2015.
CONTEXT OF THE ORGANISATION IMPORTANT IN ISO 9001:2015
ISO 9001:2015 requires an organisation to construct its quality management

system from now on from the specific context within which it is active. This
means, among other things, that, as an organisation, you have to take into
account the needs and expectations of interested parties and that you
evaluate and deal with internal and external strategic questions. You have to
show that, as an organisation, you understand and respond to the
expectations of all the parties concerned.
ISO 9001:2015 AND THE ENGAGEMENT OF INTERESTED PARTIES
In ISO 9001:2008, customers were often named as being the only interested
party. This concept has been extended in ISO 9001:2015. Suppliers,
personnel, shareholders, legislative bodies, society, internal customers, etc.
are now included as interested parties, in addition to customers.
As an organisation, you have to be aware of the importance of these

interested parties’ (changing) requirements and standards, and anticipate
them in the features of your products and services.
This has always been part of the standard in another form, however.
Therefore, it is not expected that organisations will have to implement major
changes in this respect. You cannot make or deliver a good product without
knowing the requirements and expectations of customers and interested
parties in any case. This is the basis of a quality management system.
LEADERSHIP AND COMMITMENT IN ISO 9001:2015
ISO 9001:2015 also places more emphasis on leadership and management

commitment. It requires greater involvement by top managers and business
leaders in controlling the quality management system.
This way, ISO 9001:2015 is intended to encourage integration and

harmonisation with business processes and business strategies. The top
management now has to take more responsibility for the effectiveness of the
quality management system.
Because ISO 9001:2015 pays more attention to risk management, interested

parties and the context of the organisation, the quality management system
also fits in better with the needs of the top management.
The quality management system is now more than ever a means for being
strategically successful by addressing the needs of interested parties and by
managing opportunities and threats.
The ‘management representative’ of ISO 9001:2008 was a member of the

management committee who had the responsibility and authority for steering
the quality management system along the right lines. ISO 9001:2015 does
not mention this aspect any more. The idea behind the change is that quality
is a matter for everyone and for all levels within the organisation.
DOCUMENTED INFORMATION
ISO 9001:2015 no longer requires obligatory documented procedures or a

quality manual. This is noteworthy. This is now referred to as ‘documented
information’ in practically all clauses of ISO 9001:2015.
The definition states that it concerns ‘information that the organisation has to
control and maintain’. The information can be in any format and come from
various sources and media. Diverse forms of evidence or documentation are
therefore possible.
There is no longer any mention of ‘records’ neither, but of ‘retaining

documented information’.
DIFFERENT TERMINOLOGY IN ISO 9001:2008 AND ISO 9001:2015
The following table is a brief summary of a number of important changes to

the terminology compared with ISO 9001:2008.
ISO 9001:2008 ISO 9001:2015
Products Products and services
Documentation, quality manual, Documented information

documented procedures, records,
instructions
Work environment Environment for the operation of

processes
Monitoring and measuring Monitoring and measuring

equipment resources
Purchased product Externally provided products and

services
Supplier External provider

This is not an exhaustive list of the differences between ISO 9001:2008 and
ISO 9001:2015, but it does show the main points.
How can companies transition from ISO 9001:2008 to ISO

9001:2015?
Assuming that a company is already ISO 9001 certified, I recommend taking

the following steps in order to comply with ISO 9001:2015:

1. Baseline measurement
Perform a baseline measurement in your organisation. Make a complete

overview of the current status of your quality management system and your
organisation’s conduct of business.
2. Plan of approach
Draw up a plan based on the baseline measurement. Thanks to this plan, you
can take the time to make changes and to implement improvements step by
step.
3. Implementation
Implement the changes in accordance with the plan of approach. Incorporate

measurement points and milestones.
4. Auditing and process analysis
Measure whether the changes have had the desired effect. Measure the input
and output of the processes you consider to be important because they are
critical or risky, for example.
5. Certification
Have your organisation certified according to ISO 9001:2015.
6. Communication with interested parties
Show your interested parties not just the certificate, but also show them the
results with pride. Let them see how well your organisation manages its
processes and continuously improves them.
Is there anything else companies need to know before they get

going with ISO 9001 or the new version ISO 9001:2015?
The requirement for formal

procedures and a quality
manual have been scrapped in
ISO 9001:2015, as was stated
above. Only relevant
information has to be available
now.
Organisations that already have

an ISO 9001 quality
management system do not
have to discard their existing

procedures and documentation,

of course. A good system
remains a good system and you will still need a proper structure for your
crucial documentation.
If something is no longer obligatory, it doesn’t mean that you have to scrap it

right away, of course. It’s better to hang on to what you are happy with and
what helps your organisation to progress.
Thank you for this interesting conversation, Luc.
Questions or more information?

Do you have any questions about quality systems, ISO 9001, ISO 9001:2015
or the transition from ISO 9001:2008? Then contact us without obligation on
+32 9 324 70 80 or at contact@pauwelsconsulting.com. We will be pleased
to help you!
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23
REPLIES
abraham beckers
14/10/2015 at 9:16 am
Hi Luc,
Your article is extensive and complete and very clear. Thanks

a lot for the update about what to do next.
Q

Do you think ISO is become too prescriptive/technical in the
sense that SIPOC which we know from Six Sigma is more or
less a must?

I do agree that it makes life a lot easier when one can identify
the red line e.g. focus on the added value-
Reply
Pauwels Consulting
14/10/2015 at 7:06 pm
Hi Abraham,
I personally find that the ISO 9001: 2015 has become

more pragmatic and more in line with contemporary
business practices.
Unlike the ISO/TS 16949 (automotive) or ISO 9100

(space), the ISO 9001:2015 does not impose any process
management methodologies. But thinking in terms of
processes and systems, it is raised to a higher level in the
ISO 9001:2015. So process management methodologies
like SIPOC or Turtle Diagram are definitely the right tools
in defining and documenting processes.
Kind regards, Luc.
Reply
Sridhar
14/04/2016 at 8:52 am
Thanks for the quick reference between ISO9001:2008 and

ISO9001:2015
Reply
B john
25/04/2016 at 11:00 am
Very well clarified.Thanks
Reply

S.K Roy
18/05/2016 at 11:14 am
I learned a lot from this blog post. Thanks for sharing valuable
difference between ISO 9001:2015 and ISO 9001:2008 with
all the visitors.
Reply
L B Sharma
23/05/2016 at 3:09 am
Very nicely in simple language clarified.

Thanks a lot.

L B Sharma
Reply
Shanmuga
01/06/2016 at 10:12 am
Good article..Thanks and appreciate your genuine effort.

Regards

Shanmuga
Reply
Santosh Bhosale
16/06/2016 at 8:29 am
Hi

Good article.. But many of the questions about the transition
are unanswered.. E.g. we have talked of only SIPOC.. as a
tool for process based approach.
There are many other tools which one need to deploy like for
risk management tools like SWOT, FMEA, Fault tree
analysis, PESTEL analysis etc.. are must..

If the organisation is not measuring the critical processes,
deployment of Balanced score card as a tool is must..

For process improvement organisations need to deploy lean ,
six sigma, toc , methods, tools and techniques..

So ISO needs to be more prescriptive in the sense so that
the standard can be audit-able and add more value for the
organisations..
Reply

Luc Marivoet
16/06/2016 at 3:26 pm
Dear Santosh,
Thank you for your comment.
You are absolutely right. There are indeed more risk

management tools than the ones mentioned in the article.
I only mentioned ‘FMEA’, ‘HACCP’ or ‘SIPOC’ techniques
as general examples.
I also agree that the ISO 9001:2015 should be more

prescriptive. This would make audits a lot easier.
However, not all the processes of a quality management
system represent the same level of risk in terms of the
organization’s ability to meet its objectives.
And the effects of uncertainty are not the same for all
organizations. That is why the ISO 9001:2015 give no
requirements for formal risk management methods or
documented risk management processes.
Organizations can decide whether or not to develop a

more extensive risk management methodology than is
required by the ISO 9001:2015.
Kind regards, Luc Marivoet
Reply
VITTHAL JAGTAP
01/07/2016 at 6:50 pm
THANKS,
Good article..Thanks and appreciate your genuine effort.

Regards

VITTHAL JAGTAP

Reply
Reply
RR Iyer
08/07/2016 at 6:11 am
Even though 9001-2015 version says less document it is

same as before. Instead of saying documents like manual,

procedure, work instruction, the new version says

documented information.

Planning and risk based thinking are given more importance
rightly so
Reply
Luc Marivoet
09/07/2016 at 7:23 pm
Dear,
Thank you for your comment.
In my opinion it does not mean, the same documentation

as before. The ISO 9001:2015 requires you to maintain
documentation, but actually, these are limited and can be
in any format and can come from various sources and
media. Its flexibility means that you will be able to find a
way of using it that fits your organization without requiring
unnecessary paperwork.
But as I have already mentioned in the article,

organizations that already have an ISO 9001 quality
management system do not have to discard their existing
procedures and documentation, of course. A good system
remains a good system and you will still need a proper
structure for your crucial documentation.
Reply
RR Iyer
13/07/2016 at 8:46 am
Thank you very much for your reply.

It took quite some time (years) in developing
current system. Organisations will improve when
they add the additional requirement to the
existing system, for example when measurable
out put is introduces to the process
Reply
Faiza Aziz
23/07/2016 at 8:08 am
Very Very useful details

Reply
Sandy
26/08/2016 at 4:29 pm
Good morning:
May I get a clarification please? Is a Supplier Survey required

if the supplier is ISO and/or AS certified? Specifically, the
Industrial Specific Key Control section regarding FOD, ESD
and counterfeit part prevention?
Any information on this would be most appreciated.
Thank you!!!
Reply
Luc Marivoet
29/08/2016 at 11:42 am
Hello Sandy,
thank you for your reaction.
To come back to your question … That you must decide

by yourself.
I quote ISO 9001:2015 “The organization shall determine

and apply criteria for the evaluation, selection, monitoring
of performance, and re-evaluation of external providers,
based on their ability to provide processes or products
and services in accordance with requirements.” So, the
ISO 9001 standard sets the parameters, but it leaves the
details open for each individual organization to set their
criteria. Because you decide who, what and how a
supplier directly affects the conformance and the quality
of your products and services.
ISO 9001:2015 does not prescribe also why you should

evaluate and assess your suppliers, but there are several
common sense reasons why you should: a new product
or service, cost, compliance, financial stability, quality
history, on-time delivery, ESD and counterfeit part
prevention (your examples), etc. You as an organization
are going to determine what characteristics a supplier
needs to have, demonstrate, or maintain to become a
supplier for your company.
Important to know: If a supplier is ISO 9001 certified it

means that the supplier has established a systematic

approach to quality management to ensure that your
needs are clearly understood, agreed and fulfilled.
However an ISO 9001 certification is NOT a declaration
or statement of product or service conformity!
Reply
Priya M
29/08/2016 at 6:40 am
It was very helpful. Thank u so much
Reply
ghanshyam pandey
15/09/2016 at 1:38 pm
Dear Sir,
Thanks

Your understanding of QMS is fantastic and I am a novice. I
have an ISO 9001 certification in my company but need to
upgrade to AS 9100. Since the latter has IS 9001- 2008
enshrined within, do I have to now incorporate IS 9001-2015
in our new manual? Could you kindly guide me as to how I
can handle this transition smoothly.
With deep regards
Reply
Luc Marivoet
19/09/2016 at 5:51 am
Hello Ghanshyam,
Thank you for your reaction.
The AS 9100 includes ISO 9001 Quality Management

Systems requirements and specifies additional
requirements for the Quality Management Systems for
Aviation, Space and Defense Organizations. However,
currently the AS 9100 includes the ISO 9001:2008 Quality
Management Systems requirements.
It is expected that a revised version of AS 9100, based on

ISO 9001:2015, will be published at the end of this year.
Therefore, companies are urged to refrain from upgrading

their Quality Management System until after the AS 9100
revision is released. The ISO 9001:2015 have eliminate
some of the requirements of the current version of AS
9100. So if your company upgrade to ISO 9001:2015
before the AS 9100:2016 is released, your company’s
Quality Management System likely would not comply with
AS 9100’s requirements!
All organizations currently certified to AS 9100 will need to

transition to the new version of the standard by 14th
September 2018.
Reply
manuel costa
10/10/2016 at 9:24 pm
Very Good. I will put a link in my blog

https://producaoindustrialblog.wordpress.com/
Reply
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arrangement of clauses 4 through 10 according to PDCA cycle: […]
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Differences between ISO 9001:2015 and ISO 9001:2008

About us Expertise Solutions Careers Publications Contact Intranet English

Luc Marivoet is one of our quality experts. We interviewed Luc A NEW

Discover our job

At the moment, I am working as an ISO Quality Manager for the service

https://www.pauwelsconsulting.com/blog/iso-9001-2015/[08-Nov-16 8:44:35 AM]

network’s infrastructure. I am responsible for setting up, implementing,

What is ISO 9001 again?

A standard is not a law, but an agreement or best practice that an

What are the benefits of ISO 9001?

Luc: An ISO 9001 quality management system:

shows that you provide products and services of consistent quality;

can help you streamline your business processes and continuously

There are two additional benefits:

ISO 9001 helps you increase customer satisfaction;

What does the ISO 9001 standard specify?

6. evidence-based decision making;

https://www.pauwelsconsulting.com/blog/iso-9001-2015/[08-Nov-16 8:44:35 AM]

Who determines, checks and manages ISO 9001?

ISO 9001 is managed by the International Organisation for Standardisation

However, ISO does not provide certification or conformity assessment. This is

Do organisations have to move over from ISO 9001:2008 to ISO

ISO 9001:2008 ISO 9001:2015

2. Normative reference 2. Normative reference

https://www.pauwelsconsulting.com/blog/iso-9001-2015/[08-Nov-16 8:44:35 AM]

3. Terms and definitions 3. Terms and definitions

4. Quality management system 4. Context of the organisation

5. Management responsibility 5. Leadership

6. Resource management 7. Support

7. Product realisation 8. Operation

8. Measurement, analysis and 9. Performance evaluation

Clauses 4, 5, 6 and 7 of ISO 9001:2015 come under PLAN, clause 8 comes

ISO 9001:2015 HAS A HIGH LEVEL STRUCTURE (HLS)

https://www.pauwelsconsulting.com/blog/iso-9001-2015/[08-Nov-16 8:44:35 AM]

various management systems much simpler. If, for example, an organisation

ISO 9001:2015 PUTS MORE FOCUS ON INPUT AND OUTPUT

There is more emphasis in ISO 9001:2015 on measuring and properly

RISK-BASED THINKING IS AT THE CORE OF ISO 9001:2015

Formal risk analysis, familiar to many organisations via FMEA or HACCP

https://www.pauwelsconsulting.com/blog/iso-9001-2015/[08-Nov-16 8:44:35 AM]

The addition of risk-based thinking has made the ‘preventive measures’ of

CONTEXT OF THE ORGANISATION IMPORTANT IN ISO 9001:2015

ISO 9001:2015 requires an organisation to construct its quality management

ISO 9001:2015 AND THE ENGAGEMENT OF INTERESTED PARTIES

As an organisation, you have to be aware of the importance of these

LEADERSHIP AND COMMITMENT IN ISO 9001:2015

ISO 9001:2015 also places more emphasis on leadership and management

This way, ISO 9001:2015 is intended to encourage integration and

Because ISO 9001:2015 pays more attention to risk management, interested

The ‘management representative’ of ISO 9001:2008 was a member of the

https://www.pauwelsconsulting.com/blog/iso-9001-2015/[08-Nov-16 8:44:35 AM]

ISO 9001:2015 no longer requires obligatory documented procedures or a

There is no longer any mention of ‘records’ neither, but of ‘retaining

DIFFERENT TERMINOLOGY IN ISO 9001:2008 AND ISO 9001:2015

The following table is a brief summary of a number of important changes to

ISO 9001:2008 ISO 9001:2015

Products Products and services

Documentation, quality manual, Documented information

Work environment Environment for the operation of