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NOTE 3 Ensuring control over Note 3 Reinforces the In theory no change to what
outsourced processes does not Clients responsibility should have been checked
absolve the organization of the for control over before.
responsibility of conformity to outsourced processes Control should still be
all customer, statutory and and expands on the demonstrated within the
regulatory requirements. The type of control that organisation.
type and extent of control to be may be applied.
applied to the outsourced
process can be influenced by
factors such as
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NOTE 1 Where the term NOTE 1 Where the term Note 1 Additional text This gives more freedom for
“documented procedure“ “documented procedure“ has been added to how requirements are
appears within this International appears within this International clarify a requirement documented.
Standard, this means that the Standard, this means that the or requirements may
procedure is established, procedure is established, be covered in a single In theory one procedure
documented, implemented and documented, implemented and document or many can cover many clauses or
maintained. maintained. A single document documents one requirement can be
may address the requirements spread over many
for one or more procedures. A documents. Where the
requirement for a documented organisation has spread
procedure may be covered by coverage over several
more than one document. documents or combined
into one the organisation
will need to be able to show
how it has done this.
4.2.3 Control of documents 4.2.3 Control of documents
f) to ensure that documents of f) to ensure that documents of Clarification that the Gives the freedom to
external origin are identified external origin determined by external documents exclude some external
and their distribution controlled, the organization to be needing control are documents where they do
and necessary for the planning and those needed for use not have any impact.
operation of the quality in the QMS
management system are
identified and their distribution
controlled, and
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b) provide training or take other b) where applicable, provide ‘Where applicable’ Confirms the allowance for
actions to satisfy these needs, training or take other actions to added and training alternative methods than
achieve the necessary should now ‘achieve training to establish
competence, the necessary competence.
competence’ as
opposed to satisfy
these needs.
6.3 Infrastructure 6.3 Infrastructure
c) supporting services (such as c) supporting services (such as Now includes IT should have previously
transport or communication). transport, communication or information systems been audited in
information systems). infrastructure. This just
confirms it.
6.4 Work environment 6.4 Work environment
NOTE The term "work New note added to No impact, just clarification.
environment" relates to clarify what is meant
conditions under which work is by the term ‘work
performed including physical, environment’
environmental and other factors
(such as noise, temperature,
humidity, lighting, or weather).
7 Product realization
7 Product realization
7.1 Planning of product 7.1 Planning of product
realization
realization
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d) any additional requirements d) any additional requirements The word ‘determined’ No impact.
determined by the organization. considered necessary by the has been changed to
organization. ‘considered necessary’
. NOTE Post delivery activities New note added to Post delivery was already
include, for example, actions explain what ‘post included in clause a), this
under warranty provisions, delivery activities’ just clarifies what is meant.
contractual obligations such as might mean. Such as This may impact on some
maintenance services, and warranty provisions. companies where not all
supplementary services such as post delivery activities were
recycling or final disposal. considered.
7.3 Design and development 7.3 Design and development
7.3.1 Design and development 7.3.1 Design and development
planning planning
NOTE Design and development New note added to This just gives more
review, verification and clarify that design freedom to recording
validation have distinct review, verification and design information.
purposes. They may be validation have distinct
conducted and recorded purposes but that they
separately or in any may be carried out in
combination as suitable for the any suitable manner or
product and the organization. combination.
7.3.2 Design and development 7.3.2 Design and development
inputs inputs
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These inputs shall be reviewed The inputs shall be reviewed for ‘These’ inputs changed No impact
for adequacy. Requirements adequacy. Requirements shall to ‘the’ inputs
shall be complete, unambiguous be complete, unambiguous and
and not in conflict with each not in conflict with each other.
other.
7.3.3 Design and development 7.3.3 Design and development
outputs outputs
The outputs of design and The outputs of design and ‘Provided in a form No impact
development shall be provided development shall be in a form that enables’ has been
in a form that enables suitable for verification against changed to ‘in a form
verification against the design the design and development suitable for’.
and development input and input and shall be approved
shall be approved prior to prior to release.
release.
NOTE Information for production New note added Preservation should be
and service provision can concerning the checked as design element
include details for the inclusion of for manuals.
preservation of product. preservation of product
7.5 Production and service 7.5 Production and service
provision provision
7.5.1 Control of production and 7.5.1 Control of production and
service provision service provision
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d) the availability and use of d) the availability and use of ‘Measuring devices’ No impact
monitoring and measuring monitoring and measuring has been changed to
devices, equipment, ‘measuring equipment’
to expand the scope of
coverage as a device is
a type of equipment.
f) the implementation of f) the implementation of ‘Release’ has been No impact
release, delivery and post- product release, delivery and changed to ‘product
delivery activities. post-delivery activities. release’
7.5.2 Validation of processes for 7.5.2 Validation of processes for
production and service production and service
provision provision
The organization shall validate The organization shall validate Sentences have been No impact
any processes for production any processes for production combined. ‘This
and service provision where the and service provision where the includes any processes
resulting output cannot be resulting output cannot be where’ modified to
verified by subsequent verified by subsequent ‘and as a consequence’
monitoring or measurement. monitoring or measurement
This includes any processes and, as a consequence,
where deficiencies become deficiencies become apparent
apparent only after the product only after the product is in use
is in use or the service has been or the service has been
delivered. delivered.
7.5.3 Identification and 7.5.3 Identification and
traceability traceability
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The organization shall identify The organization shall identify Clarification that Should have no impact but
the product status with respect the product status with respect inspection and test will need confirming
to monitoring and measurement to monitoring and measurement status must be
requirements. requirements throughout identified ‘throughout
product realization. product realization’
Where traceability is a Where traceability is a Rewording of records No impact
requirement, the organization requirement, the organization requirement under
shall control and record the shall control the unique traceability.
unique identification of the identification of the product and
product (see 4.2.4). maintain records (see 4.2.4).
7.5.4 Customer property 7.5.4 Customer property
NOTE Customer property can NOTE Customer property can The words ‘and Personal data will need
include intellectual property. include intellectual property and personal data’ has checking as part of
personal data. been added to the note Customer Property.
about intellectual
property
7.5.5 Preservation of product 7.5.5 Preservation of product
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The organization shall preserve The organization shall preserve Rewording to clarify The ‘As Applicable’ may
the conformity of product the product during internal the reasons for mean some records are
during internal processing and processing and delivery to the preservation. required to say why any
delivery to the intended intended destination in order to ‘This’ has changed to methods of preservation
destination. maintain conformity to ‘As applicable’ have been excluded or how
This preservation shall include requirements. methods are ‘applicable’.
identification, handling, As applicable, preservation shall
packaging, storage and include identification, handling,
protection. packaging, storage and
Preservation shall also apply to protection.
the constituent parts of a Preservation shall also apply to
product. the constituent parts of a
product.
7.6 Control of monitoring and 7.6 Control of monitoring and ‘Measuring devices’ No impact
measuring devices measuring equipment changed to ‘measuring
equipment’
The organization shall The organization shall ‘Measuring devices’ No impact
determine the monitoring and determine the monitoring and changed to ‘measuring
measurement to be undertaken measurement to be undertaken equipment’ and the
and the monitoring and and the monitoring and reference to 7.2.1 has
measuring devices needed to measuring equipment needed been removed
provide evidence of conformity to provide evidence of
of product to determined conformity of product to
requirements (see 7.2.1). determined requirements.
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The responsibilities and Records of the audits and their The records No impact.
requirements for planning and results shall be maintained (see requirements has been
conducting audits, and for 4.2.4). given a separate
reporting results and paragraph.
maintaining records (see 4.2.4)
shall be defined in a
documented procedure.
The management responsible The management responsible ‘Actions’ changed to Records for solving
for the area being audited shall for the area being audited shall make it clear that both problems found at audit will
ensure that actions are taken ensure that any necessary Correction and now need to show both
without undue delay to corrections and corrective Corrective Action are Correction and Corrective
eliminate detected actions are taken without undue required. Action
nonconformities and their delay to eliminate detected
causes. nonconformities and their
causes.
NOTE See ISO 19011 for New note No impact guidance only.
guidance.
8.2.3 Monitoring and 8.2.3 Monitoring and
measurement of measurement of processes
processes
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The organization shall apply The organization shall apply ‘To ensure conformity Changed to make sure all
suitable methods for monitoring suitable methods for monitoring of the product.’ has processes are considered
and, where applicable, and, where applicable, been removed. not just processes for
measurement of the quality measurement of the quality product.
management system processes. management system processes.
These methods shall These methods shall
demonstrate the ability of the demonstrate the ability of the
processes to achieve planned processes to achieve planned
results. When planned results results. When planned results
are not achieved, correction and are not achieved, correction and
corrective action shall be taken, corrective action shall be taken,
as appropriate, to ensure as appropriate.
conformity of the product.
NOTE When determining New Note added to No impact note only.
suitable methods, it is advisable explain that
that the organization consider consideration of the
the type and extent of type of monitoring and
monitoring or measurement measuring of
appropriate to each of its processes should
processes in relation to their relate to the extent to
impact on the conformity to which they affect
product requirements and on quality and the QMS
the effectiveness of the quality
management system.
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The organization shall deal with Where applicable, the The phrase ‘where Where one of the
nonconforming product by one organization shall deal with applicable’ has been prescribed methods has not
or more of the following ways: nonconforming product by one added. been followed reasons why
or more of the following ways: it was ‘Not Applicable’ will
need to be recorded. Other
actions will still need to
have been taken.
When nonconforming product is d) by taking action appropriate Paragraph 4 has been No impact
detected after delivery or use to the effects, or potential change to d) but
has started, the organization effects, of the nonconformity effectively no change.
shall take action appropriate to when nonconforming product is
the effects, or potential effects, detected after delivery or use
of the nonconformity. has started.
8.4 Analysis of data 8.4 Analysis of data
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The analysis of data shall The analysis of data shall b) conformity to No impact.
provide information relating to provide information relating to product requirements
b) conformity to product b) conformity to product is now pointed to the
requirements (see 7.2.1), requirements (see 8.2.4), Clause 8.2.4
c) characteristics and trends of c) characteristics and trends of monitoring and
processes and products processes and products, measurement of
including opportunities for including opportunities for product rather than
preventive action, and preventive action (see 8.2.3 and 7.2.1.
d) suppliers. 8.2.4), and c) A reference to the
d) suppliers (see 7.4). monitoring and
measuring clauses has
been added.
d) A reference to the
Purchasing clause has
been added.
8.5.2 Corrective action 8.5.2 Corrective action
The organization shall take The organization shall take ‘cause’ becomes Implies that corrective
action to eliminate the cause of action to eliminate the causes ‘causes’ actions should look for
nonconformities in order to of nonconformities in order to causes not just one cause.
prevent recurrence. prevent recurrence. If proper analysis is done
this will not have any
impact.
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f) reviewing corrective action f) reviewing the effectiveness of The words ‘the Review of actions should
taken. the corrective action taken. effectiveness’ have look at their effectiveness
been added to
emphasise the purpose
of the review.
8.5.3 Preventive action 8.5.3 Preventive action
e) reviewing preventive action e) reviewing the effectiveness The words ‘the Review of actions should
taken. of the preventive action taken effectiveness’ have look at their effectiveness
been added to
emphasise the purpose
of the review.
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