EXECUTIVE SUMMARY

CLAUSE 4 - CONTEXT OF
THE ORGANIZATION

CLAUSE 5 - LEADERSHIP

CLAUSE 6 - PLANNING
93% of organizations agree that QMS have
been a significant driver of their success
CLAUSE 7 - RESOURCES

CLAUSE 8 - OPERATIONS

CLAUSE 9 - PERFORMANCE
EVALUATION

CLAUSE 10 - IMPROVEMENTS

GETTING STARTED

HOW CAN YOU PREPARE FOR ISO

9001:2015?
ENHANCE YOUR TRANSITION WITH THIS READINESS CHECKLIST

BE THE BENCHMARK
ENHANCE YOUR TRANSITION WITH THIS READINESS CHECKLIST
2

Feedback from customers that have completed their ISO

“THE 9001:2015 transition audit with SGS indicates that, for many,
they were much closer to meeting the requirements of the
TRANSITION new standard than they had initially thought. As a result of this
MAY BE MORE feedback, we have developed a Readiness Checklist to outline
the changes contained in ISO 9001:2015. The checklist has
STRAIGHT been designed to help you understand what is required and to
highlight the areas where your business activities may already
FORWARD comply. Working through the Readiness Checklist will provide you
with valuable insight and guidance on how you can begin your
THAN YOU transition. It is important to note, however, that the Readiness
THINK” Checklist cannot count as evidence for your transition audit, as our
auditors will have to confirm compliance with the standard during
Deborah Cox, D&D Rail Ltd your transition audit visit. – Deborah Cox, D&D Rail Ltd
Read the full case study at www.sgs.com/DandDRail
ENHANCE YOUR TRANSITION WITH THIS READINESS
CHECKLIST 3

HOW DOES THE CHECKLIST WORK?

READY
This indicates that you feel you are ready to demonstrate this, and you should look to
transition during your next visit from SGS.

NEARLY READY
This indicates that, with guidance or support on this matter, you would be able to demonstrate
this. We would recommend looking to transition during your next SGS visit.

WORK TO DO
This option means that you will need further preparation for your audit, or perhaps even
training with the SGS Academy.
You can find the relevant next steps at the end of the checklist, where you should have a much
better idea on how close you are to transitioning.
CLAUSE 4 – CONTEXT OF THE ORGANIZATION
The ‘context’ of the organization (sometimes called its business or organizational environment) refers to the
combination of internal and external factors and conditions that can have an effect on your organization’s
approach to its products, services and investments.

4. CONTEXT OF THE ORGANIZATION

Have you considered READY NEARLY READY WORK TO DO

The external and internal context issues?

Products and services of your organization?

Boundaries and/or limits on the applicability of

your QMS?

Identifying, monitoring and reviewing the relevant

internal and external issues of your organization to
establish whether the impact of any changes to
them will affect your QMS?

Identifying the ‘interested parties’ that are

relevant to your QMS?

Identifying what requirements these interested

parties themselves have, which are relevant to your
organization’s QMS?

Continually monitoring and reviewing these

interested parties?

Adopting a process approach when developing,

implementing and improving the effectiveness of
your QMS?

Establishing the scope of your QMS?

CLAUSE 5 – LEADERSHIP
Your top management is now required to demonstrate a greater direct involvement in your organization’s QMS.
The removal of the need for a specific ‘Management Representative’ is partly an attempt to ensure that ‘ownership’
of your organization’s QMS is not simply focused on an individual person. Although the
requirements in relation to your organization’s Quality Policy are broadly the same as the previous version, there are some
new elements that now require that your organization’s quality policy is appropriate to both its purpose
and its ‘context’.

5. LEADERSHIP AND WORKER PARTICIPATION

Questions READY NEARLY READY WORK TO DO

Is top management involved in the QMS

preparation and continued review?

Do they ensure that the Quality Policy is

communicated within your organization and to
relevant parties?

Are responsibilities and authorities assigned and

communicated by top management?

Are these understood within your organization? Can

top management demonstrate that they

Have taken responsibility for emphasising the

importance of conforming to the requirements W
of your QMS?

Ensure that the QMS is achieving its intended

results?

Drive continual improvement within your

organization?

Promote the use of risk based thinking and

customer focus?
CLAUSE 6 – PLANNING
Your organization is now required to consider both its context and interested parties when planning and implementing
the QMS. You are required to identify those risks and opportunities that have the potential to impact (positively or
negatively) the operation and performance of your QMS. Although risks and opportunities have to be determined and
addressed, there is no requirement for a formal, documented risk management process and you are free to choose the
assessment and evaluation mechanism you consider most appropriate.

6. PLANNING
Questions READY NEARLY READY WORK TO DO

Have you established measurable quality

objectives at relevant functions and levels?

Are they consistent with your organization’s

quality policy?

Are they established for relevant processes and

are they relevant to the enhancement of
customer satisfaction?

Is your organization’s QMS maintained

when any changes to it are planned and
implemented?

When carrying out the changes, is

consideration taken into account of why
the change is being made and any potential
consequence of those changes?

Have you identified that there are resources

necessary to carry out the changes?
CLAUSE 7 – SUPPORT
You now need to consider both internal and external resource requirements and capabilities to be able to meet
customer, and statutory and regulatory requirements. Greater emphasis on monitoring and measuring
‘resources’ rather than simply equipment is now required.

7. SUPPORT
Questions READY NEARLY READY WORK TO DO

Have you determined and provided the

resources needed for the establishment,
implementation, maintenance and continual
improvement of the EnMS and energy
performance?

Have you determined and maintained the

knowledge obtained by your organization to
ensure that your organization can control your
energy performance and EnMS?

There is now an additional requirement for you to address the consequences of non-conformities, which is a recognition that not all its
processes and/or activities will represent the same level of risk in terms of your organization’s ability to meet its objectives.

Questions

Have you retained documented information to

demonstrate that all personnel under your
control are competent?

Are all personnel under your control aware both of

your organization’s quality objectives as well as the
consequences of nonconformance with your QMS
requirements?

Questions

What needs to be communicated?

When it needs communicating? How

will it be communicated?

Who will receive such communications?

KEY NOTES
The terms documented procedure and record have both been replaced by the term documented information. You will need to deter- mine the
level of documented information necessary to control your EnMS. Control of access to documented information is now a specific requirement
and can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and
change the documented information.
CLAUSE 8 – OPERATIONS
You are now required to manage SEUs and implement action plans. It allows energy management (SEU) and energy
performance improvement (action plans) to be linked to your organization’s business processes (competency,
training, communication, operational controls, etc.).

8. OPERATIONS
Can you READY NEARLY READY WORK TO DO

Demonstrate that you have specific processes in

place for establishing the requirements for the
products and services you intend to offer to
customers?

Substantiate any claims you make in respect to the

products and services you offer?

Show a designed process where requirements for

your products and services have not been
established or defined, to the extent that enables
product/service provision to take place?
You are now required to include ‘information derived from previous similar designs’ as design inputs, as well as the potential consequences
of failure due to the nature of your products and services, and any standard(s) or code(s) of practice that you are committed to implement.
Questions

Have you taken a risk-based approach when

determining the type and extent of controls to
apply to your external providers of processes,
products and service?

Do you communicate to your external providers any

‘competence’ requirements which will
apply to their personnel?

For identification and traceability, the emphasis is now on ‘process outputs’ rather than products and are a result of any activities which are
ready for delivery to your customer or to your internal customers.

Questions

Can you identify, verify, protect and safeguard

property belonging to any customer and/or
external providers used by your organization?

Do you retain documented information on the

release of products and services, verifying that they
have met customer requirements and
are traceable to the person(s) authorising the
release?

KEY NOTES
Process outputs that do not conform to their requirements must be identified and controlled. You will have to retain documented
information describing the nonconformity, the actions taken, any concessions obtained and identify the authority who decided the course of
action taken.
CLAUSE 9 – PERFORMANCE EVALUATION
You will find requirements have been better defined in respect to when monitoring and measuring shall be
performed and when the results shall be analysed and evaluated.

9. PERFORMANCE EVALUATION
Question READY NEARLY READY WORK TO DO

Can you demonstrate that you have sought out

information relating to how customers view your
organization, as well as your products and services?

There is no fundamental change in the approach to internal audits. However, you are now required to report the ‘results of audits’
to the relevant management within your organization.

KEY NOTES
The key requirements of the Management Review process remain as before but additional requirements relating to changes in exter- nal and
internal issues relevant to your QMS, external provider and relevant interested party issues, and the effectiveness of actions taken to address
any risks and/or opportunities have been included as inputs.
CLAUSE 10 – IMPROVEMENTS
This is a new section that emphasizes the general need to improve processes, products and services, as well as
QMS results, in order to meet customer requirements and enhance customer satisfaction.

10. IMPROVEMENTS
Question READY NEARLY READY WORK TO DO

Can you demonstrate that you are actively

looking for opportunities to improve the
performance of your EnMS?

There is now an additional requirement for you to address the consequences of non-conformities, which is a recognition that not all its
processes and/or activities will represent the same level of risk in terms of your organization’s ability to meet its objectives.

Can you identify whether any non-conformity could

also exist elsewhere within your facilities,
equipment, systems and processes or whether they
could potentially happen elsewhere?

Can you demonstrate that you are continually

improving the adequacy, suitability and
effectiveness of your EnMS?
GETTING STARTED
Hopefully this ISO 9001:2015 Readiness Checklist has helped you to understand more about the changes of the new
standard, and what is required from you to achieve a successful transition. Below is an indication of what your results
indicate in terms of your next step.

IF THE MAJORITY (OR ALL YOUR IF MAJORITY OF YOUR IF MAJORITY OF YOUR

ANSWERS ARE READY (WITH ANSWERS ARE NEARLY READY, ANSWERS WORK TO DO, WITH
NEARLY READY MAKING UP THE WITH A MIX OF READY AND THE MINORITY SHOWING
MINORITY): WORK TO DO MAKING UP THE EITHER READY OR NEARLY
MINORITY: READY:

Congratulations! You are ready to book In this instance, your organization It seems there are still some areas
your transition audit with SGS. This would benefit from a gap analysis to of the new standard that you are not
can be done by emailing help identify the areas that need to quite up-to-date with yet, but this can be
[email protected] be addressed and to provide practical resolved in a variety of ways.
ways in which this can be achieved. To do • SGS Academy – SGS Academy hosts a
this, please contact your SGS Auditor or variety of transition training courses.
local office directly. Aimed at organizations already certified
to the previous version of ISO 9001, the
transition courses last for one day and
offer a time-efficient way of
understanding the recent changes.
• SGS Product Expert Consultation –
Another way to increase your
knowledge of the new standard is
to schedule a
consultation with one of our product
experts over the phone.
• Gap Analysis Audit – A gap analysis is a
great method of identifying areas that
need attention and understanding the
ways in which they can be addressed.

RESOURCE MATERIAL TO HELP SUPPORT YOUR TRANSITION

The decision to book your transition audit should be a simple one, however aspects surrounding the publication of a new
standard can seem daunting. SGS is committed to make the transition as easy as possible for our customers, and provide
continuously updated information and resources on our website.

CONTACT SGS
For an optimal transition towards ISO 9001:2015 contact:

sustainable-development@ www.sgs.com/iso9001- www.sgs.com/facebook www.sgs.com/twitter www.sgs.com/linkedin

sgs.com 2015transition
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