ISO 9001:2015

benefits of early transition

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Copyright 2016 Advisera Expert Solutions Ltd. All rights reserved.

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Table of Contents

Executive summary..................................................................................................................................................... 3
Introduction ................................................................................................................................................................ 3
What are the changes in ISO 9001:2015? .................................................................................................................. 4
Benefits of early transition ......................................................................................................................................... 5
Transition timing ......................................................................................................................................................... 6
The transition steps .................................................................................................................................................... 7
Conclusion .................................................................................................................................................................. 9
Sample documentation templates ............................................................................................................................. 9

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Executive summary
With the release of ISO 9001:2015, companies have been given three years to finish their transition to
the new standard. In any case, numerous organizations are transitioning early to drive expanded
business advantages and increase their upper hand.

Early transition provides organizations with tangible benefits for driving business improvements and
supply chain efficiency, as well as improved internal and external interested party engagement. The
revisions affect the scope, design, and maintenance of the management system; hence, it is crucial to
start planning early and develop a clear transition plan to ensure a smooth transition process.

Introduction
In case you didnt know already, ISO 9001 was revised in 2015 to reflect the current market and
expectations from customers. All organizations currently certified against ISO 9001:2008 will need to
transition to the new requirements by September 2018. This means that after the end of September
2018, a certificate based on ISO 9001:2008 will no longer be valid.

So, why change now if it can wait until 2018? Time is the most important factor. Most organizations
transition successfully; however, if you wait until near the deadline, there will be less time to correct
problems increasing the chances of not being certified on time. So, transition early, to reduce the risks
and costs to your business.

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What are the changes in ISO 9001:2015?
Although the new version brings some significant changes, the good news is that many of the
requirements we have become familiar with in previous versions of the ISO 9001 standard will remain
the same.

There are now seven principles instead of the eight in the 2008 revision, but the essence is the same.
The new version has 10 instead of the eight clauses in the old version, and instead of six mandatory
procedures, there are now six mandatory documents that dont have to be in the form of a procedure.
This can be little confusing at the beginning, but the intention was to provide more liberty in
documenting the Quality Management System. For more information, see: List of mandatory
documents required by ISO 9001:2015.

There are some new requirements, but the most significant are Context of the organization (Clause 4)
and Actions to address risks and opportunities (Clause 6.1). The idea behind these new requirements is
to make the QMS (Quality Management System) a part of everyday business activities, and vice versa.
Of course, some old requirements are history now: Quality Manual, management representative, and
preventive actions are no longer part of ISO 9001. Only time will tell which of these will survive now that
they are no longer a requirement. To learn more about changes in ISO 9001, attend this webinar: ISO
9001:2015 vs. ISO 9001:2008 The main changes.

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Benefits of early transition
If you dismiss the normal human feeling to oppose change, then there is no motivation to hold up
before executing the transition. The ISO committee has taken counsel from all segments of the business
community in numerous nations, and numerous experts have given input. The changes are all intended
to enhance your business, and its odds of survival, profitability, and development. Transitioning to the
new standard early can give various key advantages to an organization:

Better business performance The new structure of the standard is to guarantee the management
system is totally adjusted to the business procedures of the organization. Utilized as a business
management tool, this will enhance performance and drive real value, embedding healthy performance
processes into the organization earlier.

Your reputation Put quite simply, implement early and be the envy of your suppliers, customers,
and competitors! Early implementation also shows diligence and can only help in tenders, bids, and
existing business relationships, too.

Adopting risk-based thinking Introduction of risk and opportunity management into your
management system will shift your system from reactive to proactive, and will reinforce its use as a
governance tool, as well as a performance accelerator. This will ensure that your organization will be
able to identify risks and opportunities more effectively, thereby improving operational efficiency and
reducing duplication, saving both time and money.

More pragmatic approach Early transition to the new version of the standard means you can
benefit quickly from the less prescriptive requirements of the revised standard, i.e., reduced
documentation, saving time and resources.

Improved integration Some of the other standards, like ISO 27001 and ISO 14001, have also
adopted the new common structure, and other management system standards are sure to
follow. This will ensure that you can integrate more than one system into your organization
smoothly, without investing a lot of extra time and money.

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Transition timing
According to ISO, the transition period will last three years, meaning that you can become certified or
have surveillance audits according to the old version until September 23, 2018. Some of the biggest
certification bodies announced that they will stop issuing new certificates according to the old version
by September 2016.

If you became certified before September 23, 2015, you will have your surveillance audits according to
the 2008 revision, but your recertification audit will be conducted according to the 2015 revision.

If you get your certificate according to the 2008 revision after September 23, 2015, you will have to
transition to the new version by September 2018.

2015 2016 2017 2018

New ISO 9001 is September 23rd, 2018, is the ultimate deadline

published on
for the transition; the organizations that dont meet
September 23rd,
the deadline will lose their certificates.
2015.

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The transition steps
Looking at all the benefits and the timing for the transition, you are probably asking yourself whether
you need to implement the whole standard all over again. That is far from the truth; the current QMS
simply needs to be updated to meet the new requirements of the standard.

1) Define context of the organization. This is a new requirement and requires special attention,
because it provides the basis for your new QMS (Quality Management System). For more information,
see: How to identify the context of the organization in ISO 9001:2015.

2) List all interested parties. Although it belongs to the same clause as Context of the organization, it is
something new and should be considered carefully. Having all interested parties and their expectations
identified will help the organization to adjust its strategic direction. To learn more about interested
parties, see: How to determine interested parties and their requirements according to ISO 9001:2015.

3) Review the scope of the QMS. The transition is a good time to consider the existing scope of your
QMS, since the credibility of your Quality Management System depends on it. For more information
about the scope, see: How to define the scope of the QMS according to ISO 9001:2015.

4) Demonstrate leadership. The requirements are almost the same as those for management
commitment in the previous version, and the new version puts even greater emphasis on the
leadership. Demonstrate leadership through taking accountability for the QMS, providing resources, and
establishing a Quality Policy and quality objectives. For more information, see: How to comply with new
leadership requirements in ISO 9001:2015.

5) Align QMS objectives with the companys strategy. Your QMS must be compatible with the strategic
direction of the company, and quality objectives must aim in the same direction as other activities in the
company. The plans for achieving the objectives must be created, and that is the requirement of the
new version.

6) Assess risks and opportunities. According to the new version, the risks and opportunities must be
addressed. They focus on the ability of the organization to achieve the intended results, but also on
other parts of the system such as context of the organization and compliance obligations. After the
assessment of risks and opportunities, there should also be some plans for addressing them. For more
information, see: How to address risks and opportunities in ISO 9001.

7) Control of documented information. This new term refers to both procedures and records. Besides
aligning your old procedures to the new clause numbers, the transition process should be used for
improving your existing documentation. The requirements for preventive actions do not exist anymore
(preventive actions basically became a part of the risk assessment process), so you can decide whether

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to delete that procedure or not. You can use this free ISO online tool for handling your documentation,
i.e., using it as a document management system (DMS).

8) Operational control. The new version requires better control of the processes, including operating
criteria and implementing controls of processes according to the criteria.

9) Review the design and development process. Design and development need to be defined in more
detail. You need to define responsibilities, controls, inputs, and outputs, and also how you will handle
the changes in the design and development process, meaning who will review the results of the
changes, who is authorized to make the changes, and what actions will be taken to prevent adverse
impacts.

10) Control of external providers. Purchasing in the current version is now called Control of externally
provided processes, products and services. You need to ensure that externally provided processes,
services, and products are compliant with your requirements. This means that you will need to
determine controls, their type and extent, and information to be provided to the supplier. Basically, you
need to undertake all activities necessary to ensure that your provider will deliver what you expect from
him. For more information, see: How to control outsourced processes using ISO 9001.

11) Performance evaluation. This means that you need to determine what needs to be monitored, how,
and how often. The purpose is to evaluate the performance and effectiveness of your Quality
Management System. If you are familiar with key performance indicators, this change will be easy on
you. To learn more about Key Performance Indicators, see: How to define Key Performance Indicators
for a QMS based on ISO 9001.

12) Measurement and reporting. The new version of the standard strongly emphasizes the importance
of measurement and reporting, especially regarding the above-mentioned performance evaluation, but
also the internal audit and the management review need to be aligned with the new version of the
standard. Although the techniques for conducting them remain the same, there are changes in the input
elements of the management review and requirements to be audited during the internal audit. For
more information, see: Analysis of measuring and monitoring requirements in ISO 9001:2015.

And, this is it it might seem like a lot, but probably within the one-year period this wont take more
than a couple of hours per month to achieve. This is especially true because these changes really do
make sense they will not only bring your QMS closer to the needs of your business, but you will also
have a system in place to show the usefulness of your quality management.

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Conclusion
The new ISO 9001 is here to stay, and other management system standards will follow the same path
if they havent already gone through the revision. Adopting the new standards early also sends a clear
message to existing and prospective customers it shows you are taking a leading, innovative, and
proactive approach to quality management through new management systems. By embedding healthy
performance processes into the organization earlier, you will enhance your reputation overall.

It is better to start working on the transition sooner rather than later to gain early benefits of the new
standard and improve business performance.

Sample documentation templates

Here you can download a free preview of the ISO 9001 Transition Toolkit in this free preview, you will
be able to see the Table of Contents of each template, as well as a few sections from each document.

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