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7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008

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Important differences between ISO 9001:2015 and ISO 9001:2008


About us
13/10/2015/57 Comments/in Blog, ISO QMS /by Pauwels Consulting

Pauwels Consulting assists companies in Belgium and abroad in setting up and monitoring quality systems and continuously improving business processes. We have a
number of experienced ISO 9001 consultants on board to achieve this.

Luc Marivoet is one of our quality experts. We interviewed Luc about the publication of the new ISO 9001:2015 standard and the main differences between ISO
9001:2015 and ISO 9001:2008.

Expertise

Solutions

Careers

Luc, can you tell us a little bit about yourself?

Luc: ImPublications
Luc Marivoet, Senior Engineering Consultant. Ive been working at Pauwels Consulting since January 2013 and I have twenty-five years experience of
applying quality management systems.

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 networks
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 worlds most popular and most commonly used standard for quality management systems.
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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
Intranet
in its activities.

What areEnglish
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 customers requirements, comply with the law and legislation, and meet the organisations 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.

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7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
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
worlds 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
organisations 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?

Thats 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. Leadership
5. Management responsibility
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.

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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.

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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.

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7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
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 procedures, records, Documented information
instructions
Environment for the operation of
Work environment
processes
Monitoring and measuring Monitoring and measuring
equipment resources
Externally provided products
Purchased product
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 organisations
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

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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 doesnt mean that you have to scrap it right away, of course. Its 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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57 replies

1. abraham beckers says:


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 says:
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
2. Sridhar says:
14/04/2016 at 8:52 am

Thanks for the quick reference between ISO9001:2008 and ISO9001:2015

Reply
3. B john says:
25/04/2016 at 11:00 am
https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 6/16
7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
Very well clarified.Thanks

Reply
4. S.K Roy says:
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
5. L B Sharma says:
23/05/2016 at 3:09 am

Very nicely in simple language clarified.


Thanks a lot.
L B Sharma

Reply
6. Shanmuga says:
01/06/2016 at 10:12 am

Good article..Thanks and appreciate your genuine effort.


Regards
Shanmuga

Reply
7. Santosh Bhosale says:
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 says:
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 organizations 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
8. VITTHAL JAGTAP says:
01/07/2016 at 6:50 pm

THANKS,

Good article..Thanks and appreciate your genuine effort.


Regards
VITTHAL JAGTAP
Reply

Reply
9. RR Iyer says:
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 says:
09/07/2016 at 7:23 pm

Dear,

Thank you for your comment.

https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 7/16
7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
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.

Kind regards, Luc Marivoet

Reply
RR Iyer says:
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
10. Faiza Aziz says:
23/07/2016 at 8:08 am

Very Very useful details

Reply
11. Sandy says:
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 says:
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!

Kind regards, Luc Marivoet

Reply
12. Priya M says:
29/08/2016 at 6:40 am

It was very helpful. Thank u so much

Reply
13. ghanshyam pandey says:
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 says:
19/09/2016 at 5:51 am

https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 8/16
7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
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 companys Quality Management System likely would not comply with AS 9100s requirements!

All organizations currently certified to AS 9100 will need to transition to the new version of the standard by 14th September 2018.

Kind regards, Luc Marivoet

Reply
14. manuel costa says:
10/10/2016 at 9:24 pm

Very Good. I will put a link in my blog


https://producaoindustrialblog.wordpress.com/

Reply
15. Mandar Chopade says:
04/11/2016 at 6:43 am

Very informative article.

Thanks Luc Marivoet

Reply
16. Kelly Sisson says:
13/12/2016 at 11:52 am

From studying myself standards and having done internships are different organizations, I have come to the conclusion that ISO is a must to comply with quality in
every aspect today. Without ISO implementation organizations can barely ensure quality for anybody.

Reply
Luc Marivoet says:
19/12/2016 at 10:47 am

Hi Kelly,

Thank you for your reaction.

You do not need to convince me, I am fully agreed with you. But the basic rule to implement an ISO Quality Management System into an organization
remains the same: you should not only implement it to meet the requirements of customers, but because the whole organization is convinced of the benefit
otherwise it makes no sense.

Kind regards, Luc Marivoet

Reply
17. James Anderson says:
16/12/2016 at 6:56 pm

I work for a finisher that services the automotive industry and with the upcoming changes to 16949 we are considering switching to ISO 9001-2015 for at least a
year to prepare for the IATF 16949-2016. It is difficult however to find online the differences between TS 16949 and ISO 9001-2015, your article was the most in
depth description of 2015 in comparison to previous versions that I have found thus far. Do you know of any significant difficulties we would have in transitioning
from TS 16959 to ISO 9001-2015? Also, for a company that is a Tier 2 to 3 automotive supplier but purely a finisher, would it be recommended to remain TS or
change to ISO?

Reply
Luc Marivoet says:
19/12/2016 at 10:48 am

Hi James,

Thank you for your reaction.

Previously, the technical requirements to implement a uniform Quality Management System in the automotive sector were defined in the ISO/TS 16949:2009
standard (jointly developed by the ISO and the International Automotive Task Force IATF).
However the ISO/TS 16949:2009 is now replaced by a new standard: IATF 16949:2016 (since October 2016).
The IATF 16949:2016 is no longer an international (ISO) standard or stand-alone standard for Quality Management Systems, but must be implemented as a
supplement to, and in conjunction with ISO 9001:2015. So you need to implement an ISO 9001 Quality Management System!
The IATF 16949:2016 will directly link to ISO 9001:2015, however the contents of ISO 9001 is not visible anymore in the text but it contains only the
additional requirements for a Quality Management System in the automotive sector.
Key changes are:
Risk-based thinking
Integration of customer-specific requirements
First and second party auditor competency
Product safety
Manufacturing feasibility
https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 9/16
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Warranty Management
Development of products with embedded software

Kind regards, Luc Marivoet

Reply
18. Arnob says:
29/12/2016 at 1:27 pm

Thank you for this information. I really appreciate the concept of this blog. Thanks for sharing.

Reply
19. Jayashantha Perera says:
17/01/2017 at 6:24 am

Thanks Luc ,for your very clear presentation of changes from 2008 to 2015 version ..Let me ask you a question ..i.e on HR aspects how about performance
appraisal of key categories of employees .I think it was included in 2008 version..but not in the new version

Reply
Luc Marivoet says:
17/01/2017 at 7:15 pm

Hi Jayashantha,

Thank you for your reaction.

There was or there is no specific reference to the words performance appraisal (of key categories of employees) in ISO 9001:2008 or ISO 9001:2015.

However, you need to determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the
quality management system and ensure that these persons are competent on the basis of appropriate education, training, or experience. And where
applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken, in accordance with 7.2 Competence of
the ISO 9001:2015.

This will be met in the recruitment process: by creation the job specifications that indicate clearly the skills and qualifications required for the job and
thereafter, the recruitment of a competent person. But once recruited, it is necessary to ensure that the person is actually demonstrating those skills. And if it
is necessary, actions are taken by providing education and/or training.

Kind regards, Luc Marivoet

Reply
20. wagih says:
18/01/2017 at 7:44 pm

Is it necessary to appoint a quality manager or should it be a team?

Reply
Luc Marivoet says:
19/01/2017 at 8:00 am

Dear Wagih,

Thank for your reaction.

First of all, there are no direct requirements for a Quality Manager or Quality Management Team in ISO 9001:2015.

However there are many required activities that fit well with the traditional role, e.g. managing the risks and opportunities for product quality, monitoring the
quality objectives and report this to Top management, verification of the products and services according to customer requirements, planning and execution
of internal audits, managing the nonconformities and validation of the corrective actions .

But to appoint a Quality Manager or a Quality Management Team depends on the size of the company. You cannot expect that a small company of 20 people
have a Quality Management Team. In contrast, big companies will have the advantage to work with a Quality Management Team, managed by the Quality
Manager.

Kind regards, Luc Marivoet

Reply
21. praveen kumar says:
02/02/2017 at 11:19 am

I learned a lot from this blog post. Thanks for sharing valuable difference between ISO 9001:2015 and ISO 9001:2008. Thanking you ISO 9001 Consultants delhi.

Reply
22. H.L.A.Wanigasekera says:
12/02/2017 at 5:44 pm

Hi Luc,
This article by you is very descriptive and easily understandable.Thanks for the good work.
Wanigasekera
SriLanka

Reply
23. HACKLY F. CHIKATHINA says:
13/02/2017 at 8:24 am

https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 10/16
7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
If the company have the certificate of ISO 9001:2008 and they receive the mail that the Auditors will come next month and that Audit will be conducted to ISO
9001:2015 but that company will not yet change the system for ISO 9001:2008 to ISO 9001:2015. How can the company reply that mail.

Reply
Luc Marivoet says:
14/02/2017 at 1:01 pm

Dear Hackly,

Thanks for your question.

This can be your answer: Our current ISO 9001:2008 certificate is valid until [see validity date on your certificate], so our quality management system can
only be audited in accordance with the requirements of ISO 9001:2008. There is no requirement to switch immediately to an ISO 9001:2015 quality
management system. We just need to take into account the transition period of 3 years (September 2018) or the expiry date of our current certificate.
So you are welcome to execute an audit, but you cannot identify deviations according to the ISO 9001:2015 standard, because that is in contradiction with the
standard of our current quality management system.

Kind regards, Luc Marivoet

Reply
24. S.Venkatesh says:
24/02/2017 at 7:47 am

Hi Luc,

Hope you are doing good.

Having following queries to clarify, kindly help me

1) Our company is already certified to ISO 9001:2008 by TUV India but the certificate expired on Dec 2016.

2) So do we actually need to switch to ISO 9001:2015 certification & implementing them now or can we wait untill Sep 2018.

3) Otherwise should we continue re-certification of ISO 9001:2008 currently.

Thanks in advance.

Regards
Venkatesh

Reply
Luc Marivoet says:
24/02/2017 at 10:57 am

Dear Venkatesh,

Thanks for your question.

The International Accreditation Organization (IAF) in cooperation with ISO/TC 176/SC 2/WG 23 prepared a guidance for the transition from ISO 9001:2008
to ISO 9001:2015. Here is a summary of the major points:

The IAF and the ISO Committee on Conformity Assessment (CASCO) have agreed to a 3 year transition period from the publication date of ISO
9001:2015.
The transition period will start in September 2015 (publication of ISO 9001:2015), so from this date the certification according to ISO 9001:2015 is already
possible.
The transition period will ends in September 2018, so from this date the certificates based on ISO 9001:2008 are no longer valid.
18 months after publication of the ISO 9001:2015, which is March 2017, it is not possible anymore to do certification according to ISO 9001:2008.
From March 2017 you can do only a certification based on ISO 9001: 2015.

As your certificate is already expired from December 2016, you can only start a new certification according to ISO 9001:2015.

Kind regards, Luc Marivoet

Reply
25. M.V. Krithivasan says:
27/02/2017 at 2:16 pm

ISO 9001:2015 Clause 8.1 Operational planning and control what is the appropriate title for this term provision of products and services for construction
industry that can be used in the Quality manual of a Building Contracting Company?

Reply
Luc Marivoet says:
03/03/2017 at 12:21 pm

Dear Krithivasan,

Thanks for your question.

Whether an output of the organization (company) is a product or a service depends on the preponderance of the characteristics involved, e.g. a building for
sale is a product whereas receiving an order and the delivery or handover of a building is part of a service.

So according to 8.1 of ISO 9001:2015, the organization shall plan, implement and control the processes needed to meet the requirements for the provision of
products (requirements for the building) and services (requirements for the order or handover of the building).

https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 11/16
7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
I hope this is an answer to your question.

Kind regards, Luc Marivoet

Reply
26. Jean Daniel says:
08/03/2017 at 5:25 pm

Hi Luc,

Thank you for this great information. Just need a clarification you mentioned of a transitional period of 3 years after the publication of each new version of ISO
9001 and that Organizations must therefore implement the new ISO 9001:2015 before 23 Sept 2018 in order to comply with ISO 9001.

A company has ISO 9001:2008 certificate which will expire on Sept 14, 2018. Does this mean that the company needs to transition to ISO 9001:2015 before Sept
23, 2018? Or can the company remain and renew its ISO 9001:2008 before it expires on Sept 2018?

If you could reply soonest, that will be much appreciated. Thank you.

Reply
Luc Marivoet says:
08/03/2017 at 9:22 pm

Dear Jean,

Thanks for your question.

If the ISO 9001:2008 certificate expire on September 14th 2018, it is impossible to renew it. They can only start a new certification according to ISO
9001:2015. See point d) and e) of the summary below.

The International Accreditation Organization (IAF) in cooperation with ISO/TC 176/SC 2/WG 23 prepared a guidance for the transition from ISO 9001:2008
to ISO 9001:2015. Here is a summary of the major points:

a) The IAF and the ISO Committee on Conformity Assessment (CASCO) have agreed to a 3 year transition period from the publication date of ISO
9001:2015.
b) The transition period will start in September 2015 (publication of ISO 9001:2015), so from this date the certification according to ISO 9001:2015 is
already possible.
c) The transition period will ends in September 2018, so from this date the certificates based on ISO 9001:2008 are no longer valid.
d) 18 months after publication of the ISO 9001:2015, which is March 2017, it is not possible anymore to do certification according to ISO 9001:2008.
e) From March 2017 you can do only a certification based on ISO 9001: 2015.

Kind regards, Luc Marivoet

Reply
27. Mitar says:
09/03/2017 at 2:38 pm

Thanks a lot!

Reply
28. Jonathan Eguren says:
16/03/2017 at 3:15 am

Theres no other way to explain this informacin, so simple.


Thanks Luc.

Reply
29. raj singh says:
22/03/2017 at 7:23 am

Dear Luc,

Pathetically ISO now has become more of a Marketing tool rather than a necessity for any Organization. This is a very sad situation for Standards or for the
Systems

http://gulfnews.com/xpress/news/xpress-expose-well-oiled-racket-involving-sale-of-iso-certificates-uncovered-1.1979048

Raj Singh

Reply
Luc Marivoet says:
23/03/2017 at 7:11 am

Dear Raj,

Thanks for your comment.

I do not fully agree with you. The new ISO 9001:2015 is really a powerful Management tool. Where previously there was quite often criticism that the ISO
9001 leads to many procedures and a lot of administration as means of securing, the ISO 9001:2015 has now evolved into a powerful tool that helps
management in establishing frameworks and helps in the strategy of the company. A good example is the context analysis: [1] an organization shall determine
external and internal issues that are relevant to its purpose and its strategic direction and [2] an analysis of the needs and expectations of their stakeholders.

But unfortunately you have fraudsters everywhere and every system is as strong as its weakest link. So check first if those certification bodies are accredited.
Accreditation is not compulsory, but it does provide independent confirmation of competence. In case they are, you can inform the national accreditation
body in your country of the fraud.

https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 12/16
7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
Kind regards, Luc Marivoet

Reply
30. Dieudonn says:
20/04/2017 at 7:04 pm

Very useful and clear! Thank U, Luc

Reply
31. Reuben says:
25/04/2017 at 2:56 pm

Hi Luc!

Enjoyed perusing your informative post. It is definitely a good primer. A small question to you.

What period of implementing ISO 9001:2015 standard would ideally be okay for a certification audit to that standard.

Thanks,
Reuben

Reply
Luc Marivoet says:
26/04/2017 at 7:11 am

Dear Reuben,

Thank you for your comment.

To come back to your question The period of implementing an ISO 9001:2015 quality management system for a certification audit depends on the current
state of affairs of your quality management system and the complexity of your organization. For example: do you have already a certified ISO 9001:2008
quality management system? Then it will take less time than when the quality management system has to be built from zero.

Therefore it is very important to execute first a gap analysis assessment in order to compare the current status of your quality management system to what
ISO 9001:2015 requires, and identifies the gaps between what is there already and what is not.

Pauwels Consulting can execute quickly and efficiently a gap analysis assessment in your organization. Based on the results of the gap analysis a realistic
planning and resources will be proposed for the implementation, verification and validation of your quality management system in accordance with the ISO
9001:2015 requirements. Important: a verification and validation period should not be overlooked, because your organization must comply with a three-
month period of proof before you can start with certification!

Would you like more information? Then do not hesitate to contact us, without obligation. Our ISO 9001 team at Pauwels Consulting will be pleased to help
you.

Kind regards, Luc Marivoet

Reply
Reuben says:
02/05/2017 at 2:24 pm

Thanks a lot Luc. I will reach you soon.

Reply
32. BALAJI THYAGARAJAN says:
08/05/2017 at 10:38 am

Sir,

Thank you for your Clear and informative article on how to transform Business Process / QMS from 2008 to 2015. It was very helpful.

Best regards

Balaji Thyagarajan

Reply
33. Jaganath Harihar says:
31/05/2017 at 12:34 pm

Hello Luc,

Great Article. It gives a clear insight into differences between ISO 9001-2008 and ISO 9001-2015. I had following queries:
1) The ISO Certification from Non-accredited bodies is much cheaper compared to certification from Accredited bodies. Is it only cost factor ? Your
reccommendation please.
2) UKAS, Australia AS- How different they are ?

Thanks,

Reply
Luc Marivoet says:
31/05/2017 at 8:10 pm

Dear Jaganath Harihar,

Thank you for your comment. To come back to your questions:

https://www.pauwelsconsulting.com/blog/iso-9001-2015/ 13/16
7/7/2017 Differences between ISO 9001:2015 and ISO 9001:2008
1) Is the price important? Of course, but price is not everything. You must consider also the following: How many / which companies in your sector they have
certified? ; What is their reputation? ; What is the experience of the auditors (sector experience, years of experience as auditor, language)?

Accreditation, on the other hand, is the formal recognition by an authoritative body of the competence to work to specified standards. It provides independent
confirmation of expertise (competence), impartiality, independence and improvement culture of certification bodies. I recommend cooperating with
accredited certification bodies.

2) UKAS (The United Kingdom Accreditation Service) is the national accreditation body for the UK. Its role is to assess organizations that are providing
testing, inspection, calibration and certification services (certification bodies) against internationally recognized standards. They are not a certification body.

Australia AS, on the other hand, is the Australian Bureau for Standardization. Their expertise and main responsibility is the development and adoption of
standards in Australia. They also facilitate Australian participation in international standards development. They are not an accreditation body or certification
body.

Kind regards, Luc Marivoet

Reply
34. Rama Chandra Rao Padi says:
31/05/2017 at 12:35 pm

Hi Luc Marivoet

Thank you for your Clear and informative article on how to transform ISO 9001:2008 to ISO 9001:2015. It was very helpful.

Thanks & Regards,


Rama Chandra Padi

Reply
35. Frat Kricekli says:
08/06/2017 at 11:08 am

Hi Luc Marivoet

Thank you for your Clear and informative article on how to transform ISO 9001:2008 to ISO 9001:2015. It was very helpful.
I have a simple question,in new standards clause 6.3,do we have to prepare procedure? Actually i did not understand what does the clause 6.3 mean.Would you be
kind of you giving small explanation about that clause?

Reply
Luc Marivoet says:
12/06/2017 at 11:06 am

Dear Firat,

Thank you for your comment. To come back to your question:

There is no any requirement to prepare a procedure. The intent of 6.3 is to determine the need for changes to your QMS in order to adapt to changes in your
business environment, as well as to ensure that any proposed changes are planned, introduced and implemented in a controlled manner.

The need for changes can be determined in different ways: from audit results, reviews of nonconformities, changing of process methods, using new ICT for a
service or process

The purpose of planning the change is to maintain the integrity of the QMS and the organizations ability to continue to provide conforming products and
services during the change. Therefore you should consider actions that could reduce the potential for negative impacts of the change, for example: plan
performance tests and validation before full implementation. The level of planning and action required will vary depending on the potential consequence(s)
of the change.

Kind regards, Luc Marivoet

Reply

Trackbacks & Pingbacks

1. Important differences between ISO 9001:2015 and ISO 9001:2008 | Produo Industrial says:
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2. Carnival of Quality Management Articles and Blogs December 2015 | The world is too small? or Is it? says:
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[] What are the main differences between ISO 9001:2008 and ISO 9001:2015? not only tabulates the 10 clauses of the revised standard in comparison to the
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