C7 ISO9001 Awareness v3 15 03 16 Master

ISO 9001:2015 Awareness and Transition Planning
Welcome! Name ………………………………………………………
Course Trainer ………………………………… Course Dates ……………………………………………
This Course Workbook is your resource to take away with you. You will find in it:
• copies
i off the
h presentational
i l material
i l used
d in
i the
h training;
i i
• detailed notes under each slide, which you can build on with your own words; and
• practical work for you to complete during the course.
We hope you enjoy the course
ISO 9001:2015 states that ‘An effective QMS should deliver:

• products and services that consistently meet customer and applicable statutory and
regulatory requirements;
• opportunities to enhance customer satisfaction;
• a mechanism to address risks and opportunities associated with the context and objectives of
the organisation; and
• the ability to demonstrate conformity to specified QMS requirements.’
There is an opportunity to use the changes to embed the QMS into the strategic direction of the
organisation. Understanding how to interpret and apply the revised requirements is essential if
this is to be achieved.
1
Your trainer will brief you on fire safety procedures, including whether there are any fire
alarm tests or drills planned for on the day(s) that the course is running.
To avoid disturbing others in the group, we would appreciate it if you would switch phones
or pagers to silent or vibrate mode during the training sessions.
The trainer will arrange for the training room to be locked or supervised during breaks
however, please do not leave valuables in the training room unattended.
2
ISO 9001:2015 is based on the High Level Structure published in Annex SL Appendix 2. The
aim of this module is to provide an understanding of the changes and how to transition a
management system from the old to the revised standard.
Specific Learning objectives describe the knowledge and skills that trainees should possess by
the end of the course.
course
Upon completion of this course, delegates should have the knowledge and skills to:
• Explain the new and revised quality-related terms and definitions
• Explain the changes in the revised ISO 9001:2015.
• Plan the transition of a management system.
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Course materials:
• Course Workbook
• Loan copy of ISO 9001:2015 (please return this at the end of the course)
• Exercise and case study material – your trainer will provide this material when needed
3
ISO 9001:2015 is based on a set of seven ‘Quality Principles’ which are explained in ISO
9000:2015. The principles are reflected throughout the requirements standard.
Group activity 1 – Quality Principles
Purpose:
To update awareness of the quality principles that underpin ISO 9001:2015
Method:
Identify each of the listed principles with its associated rationale in the table overleaf.
Identify in the third column the ISO 9001:2015 clauses supported by each principle.
Duration:
10 minutes with 5 minutes for trainer feedback and review
Quality Principles:
• Customer focus
• Process approach
• Engagement of people
• Leadership
• Improvement
• Evidence-based decision making
• Relationship management
What do we need to do to transition?
Nothing. The principles are the basics upon which ISO 9001:2015 is based. Although
they have changed there is no substantive difference
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Principle Rationale ISO 9001 clause
To manage an organisation
T i ti effectively
ff ti l and d efficiently,
ffi i tl it is
i important
i t t
to involve all people at all levels and to respect them as individuals.
Recognition, empowerment and enhancement of skills and
knowledge facilitate the engagement of people in achieving the
objectives of the organisation.
Decision-making can be a complex process, and it always involves

some uncertainty. It often involves multiple types and sources of
inputs,
p , as well as their interpretation,
p , which can be subjective.
j It is
important to understand cause and effect relationships and
potential unintended consequences. Facts, evidence and data
analysis lead to greater objectivity and confidence in decisions
made.
Sustained success is achieved when an organisation attracts and

retains the confidence of customers and other interested parties on
whom it depends. Every aspect of customer interaction provides an
opportunity to create more value for the customer.
customer Understanding
current and future needs of customers and other interested parties
contributes to sustained success of an organisation.
Creation of unity of purpose, direction and engagement enable an

organisation to align its strategies, policies, processes and resources
to achieve its objectives.
IInterested
t t d parties
ti i fl
influence th performance
the f off an organisation.
i ti
Sustained success is more likely to be achieved when an
organisation manages relationships with its interested parties to
optimise their impact on its performance.
The quality management system is composed of interrelated

processes. Understanding how results are produced by this system,
including all its processes, resources, controls and interactions,
allows the organisation
g to optimise
p its p
performance.
Improvement is essential for an organisation to maintain current

levels of performance, to react to changes in its internal and
external conditions and to create new opportunities.
5
The introduction to the standard contains some useful information on:

• benefits of adopting the standard:
• verbal forms used in the standard – “shall”, “should”, “may”, “can”;
• quality management principles;
• p
process approach;
pp ;
• PDCA cycle;
• risk-based thinking; and
• relationship with other standards.
The scope (section 1) of the standard makes clear that it is intended to be applicable to
any organisation and that compliance with its requirements is intended to deliver:
• products and services that consistently meet requirements; and
• enhancing customer satisfaction.
The normative references section (2) references ISO 9000:2015, Quality

management systems – fundamentals and vocabulary.
Section 3 - Terms and Definitions references ISO 9000:2015 which houses the
terms.
Sections 4-10 set out the requirements.
Annex A provides clarifications on the new structure, terminology and concepts.
Annex B summarises other international standards that cover aspects of quality

management and quality management systems.
The standard also contains a bibliography.
6
In summary the key changes to ISO 9001 are:

• there is a move from products and services to business processes which in theory
means that the standard is clearly relevant to all organisations;
• Requirements of the standard that are not applicable may be excluded from scope
provided there is a written justification in the scope.
• the concept of building quality on a foundation of understanding the context of the
organisation, i.e. its customers, suppliers, operating environment, the issues it faces
g
and its obligations is not new. It is new to ISO 9001,, at least explicitly;
p y;
• there is greater emphasis on leadership from top management;
• there is a new requirement to manage risks associated with threats and opportunities.
Effectively this replaces the old requirement for preventive action. Risk-based thinking
has always been implicit – it is now explicit;
• the requirements for documented procedures are removed – the focus is now on
performance;
• process thinking again is not new and was a key concept of the 2008 standard. In
the new standard however the message is much clearer and there are clear references
to business processes;
• there is a new requirement that addresses organisational knowledge – what
knowledge is needed and how it is to be obtained;
• the terms ‘records’, ‘documents’ and ‘procedures’ are deleted and replaced by the all
encompassing term ‘documented information’. Some organisations may still have a
need for documented procedures but, provided there is evidence that output
consistently meets requirements, such documents may not be available;
• outsourcing of processes and purchasing are combined into a single set of requirements
under the heading ‘Control of externally provided processes, products and
services’
The revised standard also includes two Annexes. Annex A provides clarification on the
new structure, terminology and concepts embedded in ISO 9001:2008; it provides a good
insight into the use of the new standard. Annex B provides a summary of other
International Standards on quality management.
7
The high level structure of ISO 9001:2015 is exactly the same as the common
structure for management system standards contained in Annex SL Appendix 2; the
difference is in the detail.
Overall the new standard is a more intuitive layout than the previous version. In the
2008 version,, exclusions were limited to section 7,, Product realisation. The new
standard says that all requirements should be addressed if they are applicable.
Justification of any exclusion must be documented in the scope of the QMS.
Section 5.1 includes an additional sub-section, 5.1.2, which states the requirements
for customer focus.
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8
ISO 9001:2015 uses Annex SL Appendix 2 text in Sections 7, 8, 9 and 10 although there
are additions to the core text, particularly in sections 7 and 8. Section 7 for example goes
into much greater detail in specifying the requirements for resources (7.1).
Section 8 (Operations) of the standard addresses many of the requirements that were
grouped
g p under the heading g ‘Product realisation’ in the 2008 version.
Section 9 follows to standard text from Annex SL Appendix 2 although there are
additional requirements under 9.1 and there is an additional requirement for monitoring
of customer satisfaction.
Section 10 Improvement includes requirements for selection of improvement

opportunities; nonconformity control; corrective actions; and continual improvement.
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9
10
Group activity 2: Terminology and definitions
Purpose: to provide a feel for the standard and understand ISO 9001:2015
terminology and definition changes.
Method: using the training copy of ISO 9001:2015 provided, work in groups to identify
how the terms listed below have changed. Identify in the table overleaf which term
matches each definition.
Duration: 10 minutes with 5 minutes feedback and discussion
Products - becomes - …………………………………………………………………………………
Exclusions - becomes - ………………………………………………………………………………
Management representative - becomes-

becomes ……………………………………………………
Procedures, records, etc. - becomes - …………………………………………………………
Work environment - becomes - …………………………………………………………………
Monitoring and measuring equipment - becomes - ……………………………………
P
Purchased
h d product
d t - becomes
b - …………………………………………………………………
Supplier - becomes - ……………………………………………………………………………………
11
Group activity 3: Terms and Definitions
Purpose: to familiarise attendees with key terms used in ISO 9001:2015.
Method: match the listed terms with the definitions in the table below.
Duration: 10 minutes plus 5 minutes for review
Match the following terms to the definitions in the table below:

• Risk
• Outsource
• Improvement
• Performance
• Service
• Context of the organisation
• Documented information
• Interested party
• Monitoring
• Knowledge
Term Definition
information required to be controlled and maintained by an organisation and

the medium on which it is contained
measurable
bl result
lt
business environment combination of internal and external factors and

conditions that can have an effect on an organisation's approach to its
products, services and investments and interested parties
activity to enhance performance
available collection of information being a justified belief and having a high

certainty to be true
determining the status of a system, a process or an activity
effect of uncertainty
make an arrangement where an external organisation performs part of an

organisation’s function or process
output of an organisation with at least one activity necessarily performed

between the organisation and its customer
person or organisation that can affect, be affected by, or perceive itself to be

affected by a decision or activity.
12
Terminology
What is needed to transition?
There is no need for change the terminology used by the organisation, although some of
the new terms such as ‘risk’, ‘context of the organisation’ and ‘knowledge’ may need to
be adopted as processes may need to be developed to demonstrate compliance with
requirements in which the terms are used. Certification auditors will need to interpret
the terms used by an organisation in the context of
ISO 9001.
Consider:
At the next review of your QMS, harmonise any documentation with the new terms used
in ISO 9001:2015.
What will I/my organisation need to do to transition to ISO 9001:2015?
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How can we demonstrate to the Certification Auditor that we comply?
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13
Clause 4 of Annex SL refers to the context of the organisation and consists of 4 requirements:
4.1 Understanding the organisation and its context

4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the <discipline> management system
44
4.4 <discipline> management system
Most organisations will already understand the contextual information required to satisfy 4.1
and 4.2 because it is basic good business. The standard does not require that this contextual
information be documented; the auditor cannot therefore expect to see it in written form.
The intent of 4.1 is to provide a high-level understanding of the issues that affect the way that
the organisation manages its environmental responsibilities. Issues may be related to:
• Environmental conditions that can affect the organisation’s purpose or be affected by its
environmental aspects;
• External circumstances that affect the organisation, for example legal requirements or local
planning requirements; or
• Internal characteristics, for instance: products/services; culture; or strategic aims.
Both ISO 9001:2015 and ISO 14001:2015 go beyond core text:

• ISO 14001:2015
14001 2015 clarifies
l ifi that
th t issues
i i l d environmental
include i t l conditions
diti th t could
that ld affect
ff t the
th
organisation or be affected by it.
• ISO 9001:2015 goes beyond the core text to require that information concerning these
external and internal issues is monitored and reviewed, i.e. the organisation should have a
mechanism to update itself on this information.
14
Group activity 4 – Issues and Interested parties
In-house courses – Identify issues and interested parties relevant to the QMS
Open courses only: Consider a sushi bar – identify the potential internal and external issues
(4.1) and identify the potential interested parties and their potential requirements that are
relevant to the quality management system (4.2):
Internal Issues External Issues
Interested Party Need/Expectation
15
There is a clear link in the new standard between the contextual information required by
sections 4.1 and 4.2 to the planning of actions to address risks and opportunities (6.1).
Risks and opportunities should reflect issues and interested parties.
There is also a requirement in 8.1 to implement the planned actions. Information on the
effectiveness of the implemented actions needs to be fed into management review for
consideration.
The requirements for management review (9.3) include a consideration of changes in

external and internal issues and the effect of actions taken to address risks and
opportunities.
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Transition Implications - Issues and Interested parties

There should be no need for any significant change. Most organisations will understand
the external and internal issues that they face and will also know who are relevant
interested parties. There is no requirement in the standard to document this
information although there is a requirement for changes to issues to be monitored and
reviewed at management review – which means that changes will be documented.
Consider:
Although there is no specific requirement to document this information it may be worth
building it into the QMS, possibly as an addendum to the scope of the QMS or maybe in
the Quality Manual (if there is to be one in the future).

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The requirement for setting the scope of the QMS goes much further than the old standard.
It requires the contextual information from 4.1. and 4.2 to be taken into account as well as
the products and services that the organisation provides.
The scope must be documented and must include a justification of any of the
requirements of the standard that are excluded from the QMS (there is no restriction on
which
hi h clauses
l may be
b excluded,
l d d unlike
lik the
th 2008 version
i off the
th standard
t d d which
hi h allowed
ll d
exclusions only from section 7, Product realisation).
The scope must also state the products and services covered by the QMS.
Clause 4.4, Quality management system and its processes, is similar to the requirement in
ISO 9001:2008, the main exception being that it requires that risks and opportunities (clause
6.1 of the standard)) are taken into account.
Group activity 4: Scope and QMS processes
Purpose: to gain an understanding of the requirements of 4.3. and 4.4 of

ISO 9001:2015.
Method:
Open Course: using the training copy of ISO 9001:2015 provided, review the information in
the case study document concerning scope of the QMS and its processes. Use the table
overleaf to record your views on compliance or otherwise.
In-house variation: review the scope of your QMS against ISO 9001:2015 requirements.
Duration: 20 minutes with 10 minutes feedback and discussion
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Organisation …………………………………………………………
Scope of the QMS Compliant Concerns/further evidence
External and internal issues
Yes No
considered?
Requirements of interested parties
Yes No
considered?
Products and services considered? Yes No
Justification for any requirements that
Yes No
are not applicable?
Products and services stated?
Yes No
Other issues? Yes No
QMS and its processes Compliant Concerns/further evidence
QMS implemented? Yes No
Processes determined?
Yes No
Process inputs and outputs
Yes No
determined?
Sequence and interaction determined? Yes No
Control criteria and methods
Yes No
determined?
Resource needs determined? Yes No
Responsibilities and authorities
Yes No
assigned?
Risks and opportunities addressed? Yes No
Implement changes needed to ensure
that processes achieve their intended Yes No
results
Process and QMS improvement
Yes No
Yes No
addressed?
19
Transition Implications - Scope of the QMS and QMS Processes

The scope of your management system will almost certainly need to be revised to
take into account the external and internal issues and the needs of the relevant
interested parties. The scope will also need to include the products and/or services
that you provide. The scope statement will also need to include a justification for any
element of the standard that is not applicable to your organisation. In practice this will
most likely apply to the requirements in section 7 and 8.
The requirements for QMS processes (4.4) should not need too much change as the
requirements are very similar to the old standard, with one notable exception – the
risks and opportunities determined (see the notes on section 6.1). In practice the
risks will almost certainly have been considered already – they will probably have been
addressed through provision of: training; work instructions; automation; templates;
forms; etc).
Consider:
g the scope
Reviewing p of yyour Q
QMS to ensure that it contains the required
q information.
Reviewing identified risks to ensure that they have been addressed in process design.
What will I/my organisation need to do to transition to

ISO 9001:2015?
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This section of the standard addresses leadership issues and includes all the elements of
Annex SL, virtually unchanged except to add the word ‘quality’ in various places.
There is much more focus on leadership rather than management. What does
ISO 9001:2015 mean by ‘leadership’ mean? How does it differ from ‘top management’?
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A big difference in the new standard is that the standard requires top management to
demonstrate leadership and commitment and lists the areas where this leadership
and commitment must be evident.
From the system implementation perspective there is an opportunity here to make the
QMS more relevant to strategic direction. There is a requirement for quality policy and
quality objectives to be compatible with the context and the strategic direction of the
organisation. There is also a requirement for top management to be accountable for the
effectiveness of the QMS. They can of course delegate responsibility but not
accountability.
How does your top management (you don’t need to show them this!):
• take accountability for the QMS?
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• see quality and the QMS as a strategic issue?
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• promote risk-based thinking?
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• promote improvement?
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• Ensure that the QMS achieves its intended results?
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The requirements for customer focus are similar to those in the 2008 version of the
standard, the key difference being the addition of a requirement to address risks and
opportunities that can affect conformity of products and services (yet another link to
risks, demonstrating that the concept of risk-based thinking runs right through the
standard).
There is also a requirement to ensure that, in addition to customer requirements, the

organisation must determine any applicable statutory and regulatory requirements and
make sure that they are understood and consistently met. This requirement was
addressed in the 2008 version although under a different heading.
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The requirements for quality policy (5.2) are similar to the requirements in the 2008
standard with one important difference: the policy must not only be appropriate, it must
also reflect the context of the organisation and must support its strategic direction.
The auditor will therefore expect to see clear links in the form of commitment to
addressing any issues and the needs and expectations of interested parties.
The policy must also contain a commitments to satisfy applicable requirements (e.g.
customer, regulatory, etc.) and to continual improvement of the QMS.
That there is no longer a requirement to ‘… appoint a specific management

representative …’; in ISO 9001:2015 there is only a responsibility to assign responsibility
and authority for ensuring that the QMS conforms to the standard and for reporting on
performance of the QMS.
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Transition Implications - Leadership
Hopefully very little if top management already provide strong leadership and
commitment to the QMS. The revised standard is much stronger than the old standard
in this area. Auditors will receive training on how to audit top management against the
revised requirements so you can expect your top management to be interviewed more
effectively than was perhaps the case previously.
Consider:
Making your top management team aware of the revised requirements and of their
leading role in respect of the QMS, customer focus and policy.
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The requirement to address risks and opportunities is a major change from

ISO 9001:2008. There is no requirement for a formal risk assessment or for risks and
opportunities to be documented.
Risk is defined as ‘the effect of uncertainty on an expected result’. An effect is a

deviation from the expected and may be positive or negative.
The requirement is that the risks and opportunities associated with organisational
context and with interested parties need to be addressed to:
• give assurance that the quality management system can achieve its intended
result(s);
• prevent, or reduce, undesired effects; and
• achieve continual improvement.
improvement
Actions to address the risks and opportunities need to be planned and should be
proportionate to the potential impact on the conformity of products/services. What
are the implications of ‘proportionality’ from the perspective of the organisation?
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Also note that the revised requirements for management review require the
effectiveness of these actions to be considered at management review i.e. the analysis
needs to be an input to management review.
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The requirements for setting quality objectives are enhanced in ISO 9001:2015 .
Objectives must be set at relevant functions, levels and processes which is similar to the
requirement in ISO 9001:2008. The new standard specifically requires objectives to be:
• consistent with quality policy;
• measurable;
• cognisant of applicable requirements;
• relevant to conformity of products and services and the enhancement of customer
satisfaction;
• monitored
• communicated; and
• updated as appropriate.
ISO 9001:2015 is also much more specific about determining:

• what will be done;
• what resources will be required;
• who will be responsible;
• when it will be completed;
• how the results will be evaluated, i.e. how effective was implementation.
Quality objectives must be documented although there is no specific requirement for

documented information on the planning to achieve quality objectives.
How does your organisation plan to implement the defined quality objectives? How can
you demonstrate it?
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ISO 9001:2015 has an additional requirement over and above the standard Annex SL
requirements; when changes to the QMS are required the standard requires them to be
carried out in a planned manner. This requirement was in the 2008 version of ISO 9001
but is enhanced in the 2015 standard, requiring that the organisation considers:
• purpose and d potential
t ti l consequences (of
( f the
th changes):
h )
• the integrity of the QMS (whilst undergoing change);
• the availability of resources (to effect the change); and
• the allocation or reallocation of responsibilities and authorities.
Maintaining the integrity of the QMS whilst implementing change has been carried
forward from the previous version. The need to ensure the availability of resources to
i l
implement t change
h and
d to
t maintain
i t i clarity
l it off responsibilities
ibiliti and
d authorities
th iti throughout
th h t
the change are essential if the integrity of the QMS is to be maintained.
The enhanced requirements mean that there is more clarity for the auditor (and for the
organisation).
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28
Transition Implications - Planning

It depends to what extent risks and opportunities associated with issues, interested
parties and processes are understood. Many of the actions that were previously called
‘preventive actions’ are actions to address risks and opportunities so most organisations
will have such actions. There is no specific requirement to document the risks and
opportunities themselves and there is no requirement for formal risk assessment.
Quality objectives need to be relevant to conformity of products and to enhancement of

customer
t satisfaction.
ti f ti If you have
h an objective
bj ti along
l th lines
the li off ‘Maintain
‘M i t i ISO 9001
certification’ it’s not really a quality objective and you may be challenged.
Consider:
The simplest solution may be to refocus your mechanism for capturing preventive
actions to capture the actions to address risks and opportunities.
If yyour organisation
g does not have a risk assessment p process then yyou mayy need to
think about how you go about identifying risks and opportunities. It may be beneficial
to document the key risks associated with issues and interested parties.
Reviewing your quality objectives against the new requirements and making sure that
you have assigned responsibilities and timescales for implementation. Results might be
evaluated at management review.

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29
This section covers 5 main areas as indicated on the slide. There are some new and
some changed requirements.
This area includes a number of new requirements, enhancements and changes.
Section 7.1
7 1 concerns resources
resources, which may include:
• People (7.1.2);
• Infrastructure (7.1.3);
• Environment for the operation of processes (7.1.4);
• Monitoring and measuring resources (7.1.5); and
• Organisational knowledge (7.1.6).
The general requirement (7.1.1) is that the organisation must determine and provide
resources for the QMS in whatever state of development it is in at any point in time. In
doing this the organisation is required to consider capabilities of, and constraints on,
internal resources and what needs to be obtained from external providers.
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30
The infrastructure requirement is similar to the previous version of ISO 9001 and may
include:
• Buildings and utilities;
• Equipment;
• Transport; and
• IT and communications capability;
In respect of the environment for the operation of processes the standard (7.1.4) makes
clear that the environment may be a combination of social, psychological and physical
factors, which will differ from organisation to organisation. In the past this is an area of
the standard hat hasn’t attracted much auditor attention. That may change with the
enhanced requirement.
What kind of issues may be taken into account for each of these factors:
Physical environment?:
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Social environment?:
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Psychological environment?:
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31
The requirement to determine the resources needed to monitor and measure resources
(7.1.5) replaces the ‘Control of monitoring and measuring equipment’ requirement of ISO
9001:2008 and applies to any resource, so could involve the determination of:
• People employed to carry out checks for example: QC Inspectors, proof readers,
supervisors checking work done by their team. The attributes or senses required to
test or examine may also need to be evaluated,
evaluated for instance: eyesight,
eyesight hearing or taste.
taste
• The equipment that people need to check things, for example: sound meters,
microscopes, test kits etc.
• The environment in which checking is carried out, for example: lighting levels,
background noise levels, etc.
• Documents that are needed to monitor and measure, for example: spreadsheets,
software, etc.
The requirement
Th i i now much
is h more likely
lik l to be
b applicable
li bl as it
i now covers more than
h just
j
equipment that needs to be calibrated. Almost every organisation carries out some form
of monitoring and measuring on its products or services.
Where measurement traceability is necessary, the standard (7.1.5.2) has similar

requirements to those in ISO 9001:2008, including:
• calibration against measurement standards;
• identification; and
• protection from adjustment, damage and deterioration.
• checking the validity of previous measurements in the event that measuring equipment
becomes unfit for purpose.
This sub-clause may well not be applicable; if not it would need to be justified in the scope
of the QMS.
32
Open courses: What factors would need to be taken into account when determining the
suitability of the following monitoring and measuring resources?
1. The use of a spreadsheet based template to calculate heat profiles in a

nuclear waste repository.
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2. The use of a sound meter to measure noise levels at a construction site boundary.
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3. An inspector in a fabrics dying company responsible for comparing and sentencing

colour
l samples.
l
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4. A supervisor in a 5-star hotel with responsibility for checking that rooms are correctly
made up after cleaning.
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5. Use of a GO/NOGO gauge to check an aero engine component.

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6. Use of a buffer solution to check a pH measuring instrument.

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In-house courses: Identify any monitoring and measuring resources that are required
for the organisations products or services.
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33
This is not part of the standard text in Annex SL Appendix 2 core text and is a new
requirement unique to ISO 9001:2015.
Knowledge is essential to any organisation, both in the acquisition of it and the subsequent
maintenance of it.
Knowledge may be gained from:

• External sources, for example: government websites; standards; industry working
groups; conferences; training courses; etc.
• Internal sources such as: project reviews; deficiency analysis, nonconformity trending;
etc.
Knowledge includes intellectual property and how it is managed.

managed
The organisation also need to look at what additional information it may need due to
changing needs and trends (another link to contextual and planning sections here).
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34
Transition Implications - Resources (7.1)

In respect of people and infrastructure, little will need to change. The environment for
the operation of processes (7.1.4) may need to be looked at because of the introduction
of social and psychological factors. Monitoring and measuring resources will certainly
need to be looked at closely because of the introduction of the requirement to control
resources. Evidence of fitness for purpose is specifically required.
Organisation knowledge (7.1.6) is a new requirement so will need some attention in any
organisation There is no requirement for documented information on organisational
organisation.
knowledge so it may just require thinking about what knowledge is needed and being
able to demonstrate through performance measurement that it is being applied.
Consider:
Identifying and documenting monitoring and measuring resources that you apply to
products or services.
Thinking about what knowledge is needed to achieve required outcomes from processes
and be able to demonstrate that the knowledge is applied.

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35
The competence (7.2) requirements in ISO 9001:2015 are broadly similar to those in the
previous version, the main difference being that it applies to any person doing work
under the control of the organisation, i.e. it goes beyond employees and could include
for example: embedded contractors; or contractors working under the organisation’s
supervision.
Awareness (7.3) – this applies to anyone doing work under the control of the
organisation so could include: employees; embedded contractors; or people working on
site to the organisation’s procedures. Everyone working under the control of the
organisation must be aware of:
• the quality policy;
• relevant quality objectives;
• their contribution to the QMS; and
• the implications of not conforming with requirements.
Communications (7.4) covers both internal and external communications and addresses:
• what needs to be communicated;
• when communications are needed;
• with whom to communicate; and
• how communications will be executed.
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36
The term ‘documented information’ covers: records; procedures; any information that is
documented in any format – hard copy documents; photographs; electronically stored
information, etc.
Overall the specific requirements are broadly similar to those in the previous version,
g there are some additional or more explicit
although p requirements,
q , for example:
p
• integrity and confidentiality are now explicit requirements; in the previous version they
were implicit at best.
• format is directly in the requirements rather than in a note.
The standard makes clear in a note the extent of documented information can differ
between organisations due to:
• size and business environment;
• complexity of processes; and
• competence of persons.
There is a specific requirement for documented information retained as evidence of

conformity (i.e. what were records in ISO 9001:2008) to be protected from unintended
alterations. Interestingly it does not mention deliberate alterations.
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37
Transition Implications - Support (7.1 – 7.5)

In respect of competence, awareness and communications there should be little to

change if you comply with the 2008 requirements, with one exception – the standard
extends the awareness requirements to ‘… persons doing work under the organisation’s
control …’. Your arrangements for competence and awareness may need to be
expanded to cover contractors or agency staff who work under direct supervision of the
organisation.
IIn respectt off documented

d t d information
i f ti th
there will
ill probably
b bl be
b little
littl change.
h C t l still
Control till
needs to be applied to all documents (including records) that need it. Many
organisations will want to hang on to their documented procedures and manuals
although there is now no specific requirement for them. There is a requirement for
documented information to support the operation of processes (see 4.4).
Consider:
Ensuringg that yyou have a mechanism to make contractors or others working g under yyour
control aware of policy, relevant quality objectives, their contribution to the effectiveness
of the QMS and the implications of not conforming with QMS requirements.
Whether you really need to retain those procedures for control of document and
records. Can you demonstrate the application of control without the procedure is the
question to ask. If you have a ‘Quality Manual’ or equivalent a summary of the controls
applied might be incorporated.
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38
Many of the requirements from Section 7 (Product realisation) of ISO 9001:2015 are
located in this section of ISO 9001:2015. Many of the requirements are also
substantially unchanged.
Don’t look in this section for the requirements on measuring and monitoring equipment.
In the new standard this information is located in Section 7, Support.
In the old standard the requirements for release of products and for nonconformity
control were under the heading of Monitoring and measurement. In the revised
standard both of these topics are covered under Section 8, Operation.
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39
Operational planning and control is largely unchanged, although there is a clear link back to
the planning section (6.1) and a requirement for processes to implement the actions
determined under that requirement.
Requirements for products and services, section 8.2, (i.e. the old customer related
processes) is largely unchanged in terms of specific requirements although there are some
enhancements, in particular a requirement (8.2.2 b) to ensure the organisation can meet
claims for products and services offered.
There is a specific requirement for a review before committing to supply products and
services to a customer. Documented information of the results of the review is specifically
required and there is also a requirement for any relevant documented information to be
amended where requirements for products and services change.
The requirements for design and development now explicitly apply to services as well as
products. The requirement in 8.3.1 is for ‘… a design and development process that is
appropriate to ensure the subsequent provision of products and services’. In other words
it is now much more unlikely that design and development can be excluded from a QMS.
Organisations that are service oriented or which provide services in support of their
products will need to consider the implications. Existing processes will no need to
retrospectively subject to design and development control but new service processes or
changes to existing processes will need to meet the requirements.
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40
The design and development requirements (8.3) are generally similar to the
requirements in the old standard although the new standard does include more detail:
• 8.3.1, General, simply requires an appropriate design and development process;
• 8.3.2,
8 3 2 Design and development planning,
planning goes into more detail on what needs to
be considered when determining controls but does not require documented
information of the planning;
• 8.3.3, Design and development inputs, is similar to the old requirement although
it does include a new requirement to consider the potential consequences of failure
due to the nature of the products and services. Documented information on inputs is
required;
• 8.3.4, Design and development controls, requires definition of the results to be
achieved and also brings together under this one heading the old requirements for
design review, verification and validation;
• 8.3.5, Design and development outputs, is similar to the requirement in the old
standard;
• 8.3.6, Design and development changes, requires review and control of changes
and requires documented information on the changes.
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41
8.4, Control of externally provided products and services, addresses all forms of external
provision, whether it is by purchasing from a supplier, through an arrangement with an
associate company, through the outsourcing of processes and functions of the
organisation or by any other means. The organisation is still required to assess the
impact to determine the type and extent of controls appropriate to each external provider
and all external provision of products and services.
Many of the requirements remain unchanged from the auditor’s perspective. The key
change is in terminology what were ‘suppliers’ are now ‘external providers’. Outsourcing
of processes or functions now falls under this heading. There is an explicit requirement
to ensure that externally provided processes remain under the control of the QMS.
Clause 8.5, Production and service provision, will be familiar to QMS auditors. It contains
g sub-sections:
the following
• 8.5.1 - Production and service provision;
• 8.5.2 - Identification and traceability;
• 8.5.3 - Property belonging to customers or external providers;
• 8.5.4 - Preservation;
• 8.5.5 - Post-delivery activities
• 8.5.6 - Control of changes
The main diffe

differences
ences from
f om the old standard
standa d that aauditors
dito s sho
should
ld note a
are:
e
• the requirement for validation of processes is now rolled up into 8.5.1, Production and
service provision;
• The old requirement to look after customer property is extended to property owned by
external providers (suppliers);
• There is a new requirement to review and control changes for production or service
provision.
42
Release of products and services (8.6) requires planned arrangements, at appropriate

stages, to verify that product and service requirements have been met. The
requirement is essentially the same as the requirement in the old standard for
monitoring and measurement of product. Specifically the requirement is for:
• evidence of conformity; and
• traceable authorisation for release.
The requirements for Control of nonconforming outputs (8.7), are more explicit than
was previously the case. The requirement specifies how nonconforming outputs,
products or services may be dealt with:
• correction;
• segregation;
• informing the customer; and
• obtaining authorisation for: use “as
as is
is”;; acceptance under concession; or re
re-
provision.
As is to be expected, there is a requirements for documented information on

product/service nonconformities, including:
• description of the nonconformity;
• the actions taken;
• anyy concessions;; and
• the authority for deciding action to be taken.
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43
Transition Implications - Operation (8)

There should be very little to change if you comply with the 2008 standard. Some areas
that may need to be looked at are:
• the requirement to conduct a review before committing to supply products and services.
Not a new requirement but more clear on what is required.
• the potential need to apply design and development controls to service design.
• the control of outsourced processes. This was a requirement in the old standard
although it was not explicitly linked to procurement of externally provided products or
services (8
(8.4),
4) which it now is.
is
• release of products and services (8.6) has been enhanced.
• control of nonconforming outputs (8.7) goes further than the old standard.
The standard is also more explicit on the requirements for control of nonconforming output
(8.7).
Consider:
Reviewing your arrangements for review of requirements prior to committing to supply.
The standards does require documented information on the review, as applicable.
Whether design and development control is relevant to your services.
Making sure that you have appropriate control over outsourced processes.
Checking that you have clear approval mechanisms in place for release of product or
service.
Reviewing your arrangements for nonconformity control.
If you have procedures for issues such as design and development, purchasing, etc. And
you wish to retain them you might consider aligning terminology with the new
requirements.
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44
The core text of Annex Appendix 2 is used in the general clause (9.1.1) under the
heading Monitoring, measurement , analysis and evaluation (9.1). This simply requires
the organisation to:
• determine what needs to be measured;
• the methods to be employed;
• when the measuring will happen; and
• when the results will be analysed and evaluated
evaluated.
Customer satisfaction (9.1.2) – there is no substantive change.
Analysis and evaluation (9.1.3) – there is no substantive change from the old
standard although an additional requirement to analyse if planning has been
implemented effectively (yet another link to planning!).
Internal audit (9.2) – no substantive change other than the removal of a need for a
documented procedure.
Management review (9.3) – remains broadly similar to the previous version although
there is no longer an explicit requirement to review quality policy and quality objectives.
The effectiveness of actions taken to address risks and opportunities is included under
management review (effectively this replaces the requirement to review preventive
actions). This does give the auditor something more to think about because it ‘squares
squares
the circle’ of the PDCA cycle.
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45
Transition Implications - Performance evaluation (9)
The requirements for monitoring, measurement, analysis and evaluation (9.1) are
enhanced, particularly in respect of analysis and evaluation.
There is no requirement for a documented procedure for internal audits (9.2), only
documented information to provide evidence of audit.
The requirements for management review (9.3)

(9 3) are largely unchanged although there is
now a requirement under management review for the effectiveness of actions to address
risks and opportunities to be considered. This replaces the old ‘preventive action’.
Consider:
Reviewing the analysis of data to ensure that you cover all the required issues listed in
9.1.3.
Whether
h h you stillll need d that
h procedured f internall audit.
for d Would
ld it affect
ff your ability
b l to
carry out internal audits if it was removed?
Review the standard agenda for management review to make sure that it reflects the
requirements.
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46
Clause 10.1, General, requires the determination and selection of opportunities for
improvement. The use of ‘selection’ means that improvement opportunities can be
chosen on the basis of a number of factors, for example:
• payback;
• cost/benefit;
• priority;
• resource to implement (e.g. funding, skills, equipment); or
• achievability.
Improvements might be aimed at: products and/or services; the effectiveness of the
QMS; or at removing undesired effects.
A note to this section provides examples of improvement which include:

• corrections (somewhat dubiously);
• corrective actions;
• continual improvement;
• innovation;
• breakthrough change; and
• reorganisation.
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Clause 10.2, Nonconformity and corrective action, largely follows the Annex SL text.
The key changes in ISO 9001:2015 in this area are:
• the old ‘preventive action’ is removed from the standard, effectively replaced by the
risk-based thinking embodied throughout the standard;
• the requirements for a documented procedure is removed – there is a requirement to
maintain
i i documented
d d information
i f i as evidence
id off nonconformity
f i management and d
results of corrective actions; and
• the requirement to update risks and opportunities determined during planning, if
necessary – again another link back to planning.
Clause 10.3, Continual improvement goes beyond Annex SL text in requiring the
consideration of the results of analysis and evaluation and the outputs of management
review. There is no mention of using gppolicyy and objectives,
j , as was the case in the 2008
version.
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48
Transition Implications – Improvement (10)
The old requirement for preventive actions is gone, replaced by the actions to address
risks and opportunities.
The corrective action requirements are substantively unchanged.
Continual improvement requirements are enhanced.
Consider:
Ditch the procedure for preventive actions and consider whether you need the
procedure for corrective actions. If you have only a single procedure covering these two
issues, think about either removing it altogether or taking out the preventive action.
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49
Transition Action Plan

Using the Transition Implications pages you completed earlier record any actions that
you need to take in the table below:
Area Action Priority Who

(H,M,L)
Organisation to
achieve transition
Resources to achieve
transition
Training of staff
Communication
Extant Quality Manual
Issues and interested
parties (4.1/4.2)
i (4 1/4 2)
Scope of the QMS (4.3)
QMS processes (4.4)
Leadership (5.1)
Customer focus (5.1)
Quality Policy (5 2)
Quality Policy (5.2)
Risks and
opportunities (6.1)
Quality objectives (6.2)
Q y j ( )
50

(H,M,L)
Planning of changes
(6.3)
Resources (7.1.1, 7.1.2,
7.1.3, 7.1.4)
Monitoring and
measuring resources
(7.1.5)
Organisational
knowledge (7.1.6)
Competence and
Awareness (7.2, 7.3)
Communications (7.4)
Documented
information (7.5)
Operational planning
and control (8.1)
Requirements for
products and services
(8.2)
Design and
development (8.3)
Control of externally
provided processes,
products and services
(8.4)
Production and service
provision (8 5)
provision (8.5)
51

(H,M,L)
Release of products
and services (8.6)
Control of
nonconforming
product (8.7)
Monitoring,
measurement, analysis
and evaluation (9.1)
Internal audit (9.2)
Management review
(9.3)
Selection of
opportunities for
improvement (10.1)
Nonconformity and
corrective action (10.2)
Continual
improvement (10.3)
Other action areas:
52
Think about what you have learned during the training. What are the key learning
points?
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Date Version Author Changes

15/03/16 3 DJE This Change record added.
Slide 1 – note in red removed
Slide 4 – pronciples slide removed from the page and a brief
i t d ti to
introduction t quality
lit principles
i i l added
dd d
Page 5 – extra column added to the table to allow for ISO
9001 clauses to be identified.
Slide 8 split into two with slide 8 covering requirements 4-6
and slide 9 covering requirements 7-10
Group activity 3, Terms and definitions, expanded to include
additional terms
Page16 merged with page 15
Slide 16 – text enhanced to cover management review
Page 17 notes enhanced
Slide 40 notes enhanced to further explain the application of
design and development controls to services. Slide 41 added
to capture overflow text from slide 40.
54

C7 ISO9001 Awareness v3 15 03 16 Master

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ISO 9001:2015 Awareness and Transition Planning

Welcome! Name ………………………………………………………

Course Trainer ………………………………… Course Dates ……………………………………………

We hope you enjoy the course

ISO 9001:2015 states that ‘An effective QMS should deliver:

Group activity 1 – Quality Principles

What do we need to do to transition?

Principle Rationale ISO 9001 clause

Decision-making can be a complex process, and it always involves

Sustained success is achieved when an organisation attracts and

Creation of unity of purpose, direction and engagement enable an

The quality management system is composed of interrelated

Improvement is essential for an organisation to maintain current

The introduction to the standard contains some useful information on:

The normative references section (2) references ISO 9000:2015, Quality

Sections 4-10 set out the requirements.

Annex A provides clarifications on the new structure, terminology and concepts.

Annex B summarises other international standards that cover aspects of quality

The standard also contains a bibliography.

In summary the key changes to ISO 9001 are:

Section 10 Improvement includes requirements for selection of improvement

Group activity 2: Terminology and definitions

Duration: 10 minutes with 5 minutes feedback and discussion

Products - becomes - …………………………………………………………………………………

Exclusions - becomes - ………………………………………………………………………………

Management representative - becomes-

Procedures, records, etc. - becomes - …………………………………………………………

Work environment - becomes - …………………………………………………………………

Monitoring and measuring equipment - becomes - ……………………………………

Supplier - becomes - ……………………………………………………………………………………

Group activity 3: Terms and Definitions

Purpose: to familiarise attendees with key terms used in ISO 9001:2015.

Duration: 10 minutes plus 5 minutes for review

Match the following terms to the definitions in the table below:

information required to be controlled and maintained by an organisation and

business environment combination of internal and external factors and

activity to enhance performance

available collection of information being a justified belief and having a high

determining the status of a system, a process or an activity

make an arrangement where an external organisation performs part of an

output of an organisation with at least one activity necessarily performed

person or organisation that can affect, be affected by, or perceive itself to be

What is needed to transition?

What will I/my organisation need to do to transition to ISO 9001:2015?

How can we demonstrate to the Certification Auditor that we comply?

4.1 Understanding the organisation and its context

Both ISO 9001:2015 and ISO 14001:2015 go beyond core text:

Group activity 4 – Issues and Interested parties

The requirements for management review (9.3) include a consideration of changes in

Transition Implications - Issues and Interested parties

What will I/my organisation need to do to transition to ISO 9001:2015?

How can we demonstrate to the Certification Auditor that we comply?

Group activity 4: Scope and QMS processes

Purpose: to gain an understanding of the requirements of 4.3. and 4.4 of

Duration: 20 minutes with 10 minutes feedback and discussion

Scope of the QMS Compliant Concerns/further evidence

QMS and its processes Compliant Concerns/further evidence

Resource needs determined? Yes No

Transition Implications - Scope of the QMS and QMS Processes

What will I/my organisation need to do to transition to

There is also a requirement to ensure that, in addition to customer requirements, the

That there is no longer a requirement to ‘… appoint a specific management

Transition Implications - Leadership

What is needed to transition?