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Summary of changes between

ISO 9001:2008 and ISO 9001:2015 (CD)
INITIAL GUIDANCE
SUBJECT TO CHANGE IN FINAL DRAFT

More Information: Michael Ord

Email: Michael.ord@qualsys.co.uk
Direct Line: +44 (0)114 282 3425
Mobile: +44 (0)7720 678 141
Qualsys Ltd is registered in England, number 3022323

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1.0 Introduction and Aims

This working document supplements the recent ISO 9001 Webinar by Qualsys and provides an initial
summary of the upcoming changes between ISO 9001: 2008 and ISO 9001: 2015k.
It is particularly interesting for Quality professionals who want to be informed of the discussions
around the new standards and stay ahead of the curve.
Please note: the new ISO 9001 standard is still in the draft stages, and is subject to change. We
would strongly advise you carry out further investigations to supplement your readings here.

Free Resources

Webinar Video ISO 9001: 2015 Changes Presented by Colin Partington, an Quality
Management expert with many years experience. (30 mins)

ISO 9001: 2015 Changes Matrix Check Sheet for quick comparison

ISO 9001 Free Self-Check List Available on the Qualsys Website

We will be covering the changes over the next 12 months on Qualsys GRC Blog

About Qualsys
EQMS, the fully integrated Governance, Risk and Compliance (GRC) solution used by organisations
around the world to meet ISO 9001 obligations.

About CPA
If you think training is expensive, try ignorance."
Colin's past achievements include working for one of the UK's leading 3rd party certification
organisations. He currently conducts ISO 9001 certification audits for various certification bodies and
has extensive experience working at home and abroad.
His team of expert associates are available to provide a comprehensive, cost effective service for
organisations of all types and sizes.

Qualsys Ltd and Colin Partington Associates. Informal guidance provided in good faith, with no warranties or guarantees.
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2.0 Summary of changes between ISO 9001:2008 & ISO 9001:2015 (CD)
Proposed 3 year transition period for organisations to adopt the new standard expected to be
published late 2015.
The shape, structure and feel of the document has changed it is being issued under the common
document format, with common text and terminology used across various management system
standards.

Product has now become goods and services.

Removal of exclusions
Intended to be more easily applied to service industries

2.1 New clauses

4.1

Understanding the organisation and its context

4.2

Understanding the needs and expectations of interested parties

4.4.2

Process approach is now a clause, not just a principle

2.2 Other changes

Continual improvement has become just improvement.

Preventive action clause removed risk and preventive action integrated into rest of
standard under the title of risks and opportunities.

Documents and records are now referred to as documented information.

Purchasing and outsourcing control of external provision of goods and services risk
based approach to the amount of control applied.

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Scope
Unchanged apart from Note 1 b) realisation processes becomes operational processes

1.2

Removed 1.1

Normative References
ISO 9000:2005 becomes ISO 9000:2015

Terms and Definitions

Reference to product = service removed
A list of common definitions included

Context of the organisation

4.1

Understanding the organisation and its context new clause

This is a new requirement in which the organisation is required to demonstrate that it
understands what influences there are on it with regard to both internal and external issues
and may affect its strategic direction e.g. where it sits in the marketplace and what effect
changes may have on its future.

4.2

Determining the scope of the quality management system

This is now a stated requirement of the standard and requires the organisation to
determine the boundaries and applicability of the QMS. It also makes reference to 4.1 (the
context of the organisation).
There is also a requirement to state the scope in terms of the goods and services delivered
and the sites of the organisation to be included.
There is a requirement to document and justify any exclusions from the standard limited
to clauses 7.1.4 to 8. Exclusions cannot be justified by a decision to arrange for an external
provider to perform a function or process.

4.4

Quality management system

4.4.1

General - Still a requirement establish, implement, etc a QMS

4.4.2

Process approach now a stated requirement but the content is largely the same as
previous clause 4.1 apart from a requirement to determine the risks to conformity if
processes are ineffective.

Leadership

5.1

Leadership and commitment

This is a new clause title but it contains much of what is currently in section 5.

5.1.1

This relates to commitment to the QMS (currently 5.1) - There is a requirement for top
management to demonstrate leadership and commitment with respect to the QMS e.g.
ensuring the policy and objectives are compatible with the strategic direction, the policy is
understood and followed, the QMS is integrated into the organisations business processes,
etc.

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5.1.2

This relates to commitment to customers (currently 5.2) there are additional

requirements based on the need to identify and address any risks to conformity of goods
and services to customers.

5.2

Quality policy
Largely unchanged from current version (currently 5.3) but does have some additional
requirements about its availability to interested parties and being available as documented
information.

5.3

Organisational roles, responsibilities and authorities

Small changes to existing requirements (currently 5.5), no longer requires a specific position
of a management representative.

Planning
Whilst this is a familiar title, it is mostly a new section which relates to the establishment of
the QMS.

6.1

Actions to address risks and opportunities

The general requirement here is that the QMS must be able to achieve its intended
outcomes and consistently satisfy customers by integrating the QMS into the business and
by identifying and managing risks and opportunities.

6.2

Quality objectives and planning to achieve them

This is the existing requirement for quality objectives (currently 5.4.1) but has additional
requirements for them to be measurable and be relevant to conformity of goods and
services and customer satisfaction. There is additional information regarding the planning of
objectives.

6.3

Planning of changes
This is mostly what was in 5.4.2 and relates to the need to manage changes to the QMS and
to ensure that risks and opportunities are considered when changes are made.

Support
This is a new title but it contains mostly what is currently in section 6 (resource
management) plus some additional requirements.

7.1

Resources

7.1.1

General
A basic requirement to determine and provide sufficient resources to establish and
maintain a QMS. It also calls for consideration of which resources will be provided internally
as opposed to those which will be sourced externally.

7.1.2

Infrastructure
Virtually unchanged from present 6.3 but brings in customer satisfaction. The examples are
now in a note rather than in the main text.

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7.1.3

Process environment
This is also largely unchanged from the current 6.4 but again brings in customer satisfaction.

7.1.4

Monitoring and measuring devices

Whilst the clause title is the same as the current 7.6, the requirements of this clause have
been considerably reduced. Specific industry requirements will most likely dictate the amount of
control applied.
7.1.5

Knowledge
This is a new requirement.

7.2

Competence

This is currently addressed under clause 6.2 and is mostly unchanged it has been spread
out across a number of clause headings.
7.3

Awareness
This was previously addressed under clause 6.2.2

7.4

Communication
This was previously included in clause 5.5.3 and related to internal communication. It now
includes external communication too and has been expanded.

7.5

Documented information

7.5.1

General
Whereas the current version of ISO 9001 has 2 clauses relating to the control of documents
and records, the proposed changes include changing the title to documented information
which includes both documents and records.

7.5.2

Creating and updating

This is a new clause, though the intent to do these actions has always been there.

7.5.3

Control of documented information

These requirements are virtually the same as are currently in clauses 4.2.3 & 4.2.4 of ISO
9001:2008.

Operation

8.1

Operational planning and control

This is the equivalent of the current clause 7.1 and is largely unchanged though there are a
few small additions and clarifications.

8.2

Determination of market needs and interactions with customers

This is the equivalent of the current clause 7.2

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8.2.1

General
A broad statement regarding the need to implement a process for these activities.

8.2.2

Determination of requirements related to the goods and services

This is almost identical to the current clause 7.2.1

8.2.3

Review of requirements related to the goods and services

Once again, this is almost identical to the existing requirements in clause 7.2.2

8.2.4

This is almost identical to clause 7.2.3 but has a few small additions.

8.3

Operational planning process

This is very similar to the existing clause 7.1 but also contains additional elements to be
considered as part of the planning process.

8.4

Control of external provision of goods and services

This requirement includes what is currently included in the purchasing clause (7.4) and it
also any outsourced processes (addressed in clause 4.1).

8.4.1

A simple statement that externally provided goods and services must conform to specified
requirements.

8.4.2

Type and extent of control of external provision

There is a general statement regarding the type and amount of controls to be applied
should be dependent on the risks involved and their potential impacts. Similarly, as required
currently by clause 7.4.1, the organisation must establish and apply methods for evaluating,
selecting and re-evaluating external providers. Records of these activities are to be
maintained.

8.4.3

Documented information for external providers

This clause is based on what is currently in clause 7.4.2 but there also a few additions. This
clause now refers to handling customer property (currently clause 7.5.4) and also the need
to monitor the performance of external providers and to keep documented information.

8.5

Development of goods and services

The whole of this section (8.5.1 to 8.5.3) is new in comparison with the current version of
ISO 9001. It largely takes over from the current design and development clause (7.3) but is
considerably different in its content.

8.6

Production of goods and provision of services

8.6.1

Control of production of goods and provision of services

This clause is the equivalent of clauses 7.5.1 and 7.5.2 of the current version of ISO 9001. It
is not identical but contains very similar information plus a few additions.

8.6.2

Identification and traceability

This is almost identical to the current requirement (currently clause 7.5.3).

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8.6.3

Property belonging to customers or external providers

This is again almost identical to the existing clause on the subject (customer property,
currently clause 7.5.4).

8.6.4

Preservation of goods and services

Very similar to the existing clause (7.5.5) but with a little more emphasis on process outputs
in relation to provision of services rather than products.

8.6.5

Post-delivery activities
This is mostly a new requirement, though there was previously mention in clause 7.2.
This clause provides more detail of the requirement.

8.6.6

Control of changes
This is a new clause title but there are links into the existing clauses 4.2.3 (controlling
changes to documents) and clause 5.4.2 (controlling changes to the QMS. This clause has
brought these 2 elements together under 1 heading.

8.7

Release of goods and services

Whilst this is a new title, the requirements are very similar to the existing clause 82.4
(monitoring and measurement of product).

8.8

Nonconforming goods and services

Almost the same as the existing clause 8.3 (control of nonconforming product) but slightly
re-worded. An extra statement has been added to remind us that customer satisfaction
must be achieved. Some of the detail has been taken out of the clause and put into a note.
There is also a requirement to maintain documented information regarding the nature of
nonconformities discovered and the actions taken.

Performance evaluation

9.1.1

Monitoring, measurement, analysis and evaluation

The content of this clause is largely what is currently in clause 8.2 monitoring and
measurement but it has been further developed.
It requires the organisation to take into account the risks and opportunities to determine
what they will monitor and measure in order to:

Demonstrate conformity of goods and services

Evaluate the performance of processes
Ensure the conformity and effectiveness of the QMS
Evaluate customer satisfaction
Evaluate the performance of external providers

In doing the above, the organisation must determine the methods to be used, when the
activities will be performed, when the results will be analysed and determine the performance
indicators.
Overall, this clause has pulled together the monitoring and measuring activities, added to them
and requires the organisation to consider what they expect to achieve and how closely they
have met those expectations. More specific details are included below.
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9.1.2

Customer satisfaction
This is largely unchanged in its requirements though it has been clarified and re-worded.

9.1.3

Analysis and evaluation of data

This is very similar to the existing clause 8.4 (though more clearly explained) in requiring the
organisation to analyse the data obtained through the monitoring and measuring activities
described in previous clauses to:

Determine the suitability, adequacy and effectiveness of the QMS

Assure that goods and services meet customer requirements
Ensure that the processes are in control and effective
Identify improvements

The results are to be fed into management review.

9.2

Internal audit
Very similar in requirements to the existing clause 8.2.2 but it has been re-worded and
additional elements introduced such as the need to take into consideration the quality
objectives and related risks when programming audits.

9.3

Management review
The basic requirement to conduct management reviews of the QMS is much the same as in
the existing clause 5.6 but it now requires the organisation to take into account the
business strategic direction and changing business environment.
What are currently labelled as inputs, are now considerations and whilst similar to the
existing inputs, they are more clearly defined and rely heavily on utilising the data
generated form monitoring and measuring activities as defined in earlier clauses.
The outputs from management review are largely unchanged.

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Improvement

10.1

Nonconformity and corrective action

These 2 previously separate clauses have now been put together and whilst worded
differently, the intentions are the same.

10.2

Improvement
Similar to the existing clause 8.5.1 but the word continual has been dropped and the
sources of information used to drive improvement have changed.

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3.0 Annex A Quality Management Principles

The existing 8 quality management principles upon which ISO 9001 is founded are not currently in
ISO 9001, but are in ISO 9000. There are now only 7 principles, they have been re-worded and
included as a statement and also the rationale behind the principle. They are:
1.
2.
3.
4.
5.
6.
7.

Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence based decision making
Relationship management

4.0 Other Comments

It would be nice to think that by putting Leadership in the standard, it will cause senior management
to take the role more seriously but sadly, I doubt it. We have had a management principle called
'leadership' for the last 14 years and whilst this has not been an auditable requirement, I see little
evidence of top management taking much heed of it.
Interestingly, I have posed a question at a 'Quality Forum'; asking for people's opinions of how they
see auditors having to change their styles in order to properly audit the new requirements (assuming
they make it through to the published IS). My concerns are that a subject such as leadership is a 'soft'
skill and difficult to audit - much will come down to opinion and as we know, people often don't like
it when auditors express their opinions.
As for risk, I am not sure how organisations will deal with it. They all exercise risk assessments in
their day-to-day running of a business but once again, it will be hard to provide 'objective evidence'
of an organisation's assessment of risk unless it is documented somewhere.
Which brings me onto my main concern, the lack of requirements for documented systems. How will
a stage 1 audit be undertaken when there is no requirement for a quality manual or procedures? Will
it all be based on what the management rep tells us?
Hope this helps.
Regards

Colin Partington

Michael Ord

EQMS Certified Partner

Business Development / Account Manager

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