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Page 1 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 - Client Transition Checklist
How to use this document: It is not mandatory to use this document. It is a guide to give you an indication of your readiness for audit
against ISO 9001:2015. It may be useful to use this as an indication of how close to compliance you are and to give you confidence when
applying for the standard upgrade. Our auditors will not ask for this as evidence of compliance as they will be using their own audit
procedures. Please be aware that this does not guarantee that you will be recommended for certification to ISO 9001:2015 and you will also
need to obtain a copy of the published standard as the clauses are not covered in their entirety by this document.
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
4 Context of the organization
4.1 Understanding the organization
and its context
The organization shall determine
external andinternal issues that are
relevant to its purpose and its strategic
direction and that affect its abilityto
achieve the intendedresult(s) ofits
qualitymanagement system. The
organizationshall monitor andreview
the informationabout these external
and internal issues
Yes
4.2 Understanding the needs and
expectations of interested parties
Due to their impact or potential impact
on the organizations abilityto
consistentlyprovide products and
services that meet customer and
applicable statutoryandregulatory
requirements, the organizationshall
determine:
The interested partiesthat are relevant
to the qualitymanagement system
The requirements of these interested
parties that are relevant to the quality
management system;the organization
shallmonitor and reviewthe
informationabout these interested
parties and their relevant requirements
Yes
4.3 Determining the scope of the
quality management system
The organization shall determine the
boundaries andapplicabilityof the
qualitymanagement systemto
establishits scope
Yes
4.4 Quality management system
The organization shall establish,
implement, maintainandcontinually
improve a qualitymanagement system,
includingthe processes neededand
their interactions
Yes
For support regarding your transition, please contact us:
General enquiries: 0161 865 3699
To book a transition training course: 01296 678484
To book a transitiontraining courses:01296678484
Page 2 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
5 Leadership
5.1 Leadership and commitment
5.1.1 General
Top management shall demonstrate
leadershipandcommitment with
respect to the qualitymanagement
systemby:
Taking accountabilityof the
effectivenessof the QMS
Ensuring that the qualitypolicyand
objectives are establishedfor the QMS
and are compatible withthe context
and strategic direction oforganization
Ensuring the integrationof the QMS
requirements intothe organization’s
business processes
Promotingthe use of the process
approachandrisk based thinking
Ensuring that the resources needed for
the QMS are available
Communicating the importance of
effective qualitymanagement andof
conformingto the QMS requirements
Ensuring that the QMS achieves its
intendedresults
Engaging, directing and supporting
persons to contribute to the
effectivenessof the QMS
Promotingcontinual improvement
Supporting other relevant
management roles to demonstrate
their leadershipas it applies to their
areas of responsibility
5.1.2 Customer Focus
Top management shall demonstrate
leadershipandcommitment with
respect to customer focus byensuring:
a) Customer and applicable
statutoryandregulatory
requirements are
determined, understoodand
consistentlymet
b) The risks and opportunities
that can effect conformityof
products andservices and
the abilityto enhance
customer satisfaction are
determinedandaddressed
c) The focus onenhancing
customer satisfaction is
maintained
Yes
5.2 – Policy
5.2.1 Developing the Quality Policy
Top management shall establish,
review andmaintaina qualitypolicy
that:
Is appropriate to the purpose and
context of the organization.
Yes
Page 3 of 8 www.alcumusgroup.com Issue001 Sept 15
Provides a framework for setting and
reviewing qualityobjectives
Includesa commitment to satisfy
applicable requirements
It shouldcommunicatedand
understood andbe available to
relevant interestedparties as
appropriate
5.2.2 Communicating the Quality
Policy
The qualitypolicyshall:
a) Be available and be
maintained as documented
information
b) Be communicated,
understood andapplied
within the organisation
c) Be available to relevant
interestedparties, as
appropriate
5.3 Organizational roles,
responsibilities and authorities
Top management shall ensure that the
responsibilitiesandauthorities for
relevant roles are assigned,
communicatedandunderstood within
the organization
No
6 Planning
6.1 Actions to address risk and
opportunities
When planning for the QMS the
organizationshall consider the issues
referredto 4.1 and the requirements
referredto in4.2 anddetermine the
risks andopportunities that needto be
addressedto:
a)give assurance that the QMS can
achieve the intendedresults
b) enhance desirable effects
c) prevent or reduce, undesired
effects
d) achieve improvement
Yes
6.1.2 The organizationshall plan:
a) actions to address these risks and
opportunities
b) how to:
1) Integrate andimplement the
actions into its QMS
2) Evaluate the effectiveness of
these actions
Yes
6.2 Quality objectives and planning to
achieve them
6.2.1 The organisation shall establish
qualityobjectives at relevant functions,
levels and processesneeded for the
QMS
Yes
Page 4 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
6.2.2 When planning actions to achieve
qualityobjectives the organizationshall
determine:
What willbe done, what resourceswill
be required, whowillbe responsible,
when will it be completed, howwill the
results be evaluated
Yes
6.3 Planning of changes
When the organisationdeterminesthe
need for changes to the QMS, the
changes shall be carried out ina
planned manner:
The purpose of the change and any
potential consequences, the integrity
of the QMS, the availabilityof
resources, the allocationor re-
allocationof responsibilities and
authorities
No
7 Support
7.1 Resources
The organization shall determine and
provide the resourcesneededfor the
establishment, implementation,
maintenance andcontinual
improvement of the quality
management system
No
7.2 Competence
The organisation shall:
Determine the necessarycompetence
of persons doingwork under its control
that affects the performance and
effectivenessof the QMS
Ensure that these persons are
competent onthe basis of appropriate
education, trainingor experience
Where applicable take actions to
acquire the necessarycompetence and
evaluate the effectiveness of the
actions taken
Retainappropriate documented
informationas evidence ofcompetence
7. 3 Awareness
Persons doingwork under the
organization’s control shallbe aware
of:
The qualitypolicyand relevant quality
objectives
Their contributionto the effectiveness
of the QMS, includingthe benefits of
improvedperformance
The implications of not conforming
with the QMS requirements
Yes
Page 5 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
7.4 Communication
The organization shall determine
internal andexternal communications
relevant to the QMS
What it will communicate?
When to communicate?
With whomto communicate?
How to communicate?
Yes
7.5 Documented information
7.5.1 General
The organizations QMS shall include:
Documentedinformationrequired by
this international standard and
determinedbythe organizationas
being necessaryfor the effectiveness of
the QMS
7.5.2 Creating and updating
When creating and updating
documentedinformationthe
organizationshall ensure appropriate:
Identificationanddescription (e.g. a
title, date, author, or reference
number);
format (e.g. language, software
version, graphics) andmedia (e.g.
paper, electronic);
review andapprovalfor suitabilityand
adequacy.
No
7.5.3 Control of documented
information
Documentedinformationrequired by
the QMS and bythis International
Standardshall be controlledto ensure:
it is available andsuitable for use,
where andwhenit is needed it is
adequatelyprotected
No
7.5.3.2
For control ofdocumentedinformation
the organizationshall address the
following activities where applicable:
Distribution, access, retrieval and use
Storage and preservation
Control of changes
Retentionanddisposition
Documentedinformationof external
originshall be identifiedas appropriate
and controlled
Page 6 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
8 Operation
8.1 Operational planning and control
The organization shall plan, implement
and control the processes neededto
meet requirements for the provision
of products andservices, and to
implement the actions determinedin
6.0 by:
Determining requirements for the
products andservices
Establishing criteriafor the processes
and for the acceptance of products and
services
Determining the resources needed to
achieve conformityto product and
service requirements
Implementingcontrol of the processes
in accordance withthe criteria
Determining andkeeping documented
informationto the extent necessaryto
have confidence that the processes
have been carried out as planned and
to demonstrate conformityof products
and services to requirements
The organisation shall control planned
changes andreviewthe consequences
of unintendedchanges takingactionto
mitigate anyadverse effects as
necessary
The organisation shall ensure that
outsourced processes are controlled in
accordance with8.4
Yes
8.2 Requirements for products and
services
8.2.1 Customer communication
Communication withcustomers shall
include:
Providing information relating to
products andservices
Handlingenquiries, contracts or orders
includingchanges
Obtaining customer feedback,
includingcustomer complaints
The handling or controllingcustomer
property
Establishing specific requirements for
contingencyactions when relevant
No
Page 7 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
8.2.2 Determining requirements
related to products or services No
8.2.3 Review of requirements related
to products and services
No
8.2.4 Changes to requirements for
products and services No
No
8.3 Designand development No
8.3.1 General
The organisation shall establish,
implement andmaintaina designand
development process that is
appropriate to ensure the subsequent
provisionof products andservices
No
8.3.2 Design and development
planning
No
8.3.3 Design and development inputs No
8.3.4 Design and development
controls
No
8.3.5 Design and development outputs No
8.3.6 Design and development
changes
No
8.4 Control of externally provided
services
No
8.5 Production and service provision No
8.6 Release of products and services No
8.7 Control of nonconforming process
outputs
No
9 Performance evaluation
9.1 Monitoring, measurement,
analysis and evaluation
9.1.1 General
The organization shall determine:
what needs to be monitoredand
measured, the methods ofmonitoring
measurement, analysisandevaluation
as applicable to ensure validresults
when monitoring andmeasuring will be
performed and whenresults from
monitoringandmeasurement shallbe
analysedandevaluated
The organisation shall evaluate the
qualityperformance andeffectiveness
of the QMS
No
9.1.2 Customer Satisfaction No
9.1.3 Analysis and evaluation No
9.2 Internal Audit
9.2.1
The organization shall conduct internal
audits at planned intervalsto provide
information onwhether the QMS
conforms to the organisations own
requirements for its QMS andto this
international standardandis
effectivelyimplementedand
maintained
New clause
but not really
any new
requirements
Page 8 of 8 www.alcumusgroup.com Issue001 Sept 15
ISO 9001:2015 Clause New
requirement
Complies
(Yes/No)
Evidence
9.3 Management Review
Top management shall review the
organization's QMS, at planned
intervals, to ensure its continuing
suitability, adequacyandeffectiveness
New clause
but not really
any new
requirements
10 Improvement
10.1 General
10.2 Nonconformity and corrective
action
When a nonconformityoccurs,
includingthose arising from
complaints, the organizationshall react
to the nonconformity
New clause
but not really
any new
requirements
10.3 Continual improvement
The organization shall continually
improve the suitability, adequacyand
effectivenessof the QMS
New clause
but not really
any new
requirements

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Iso 9001-client-transition-checklist (1)

  • 1. Page 1 of 8 www.alcumusgroup.com Issue001 Sept 15 ISO 9001:2015 - Client Transition Checklist How to use this document: It is not mandatory to use this document. It is a guide to give you an indication of your readiness for audit against ISO 9001:2015. It may be useful to use this as an indication of how close to compliance you are and to give you confidence when applying for the standard upgrade. Our auditors will not ask for this as evidence of compliance as they will be using their own audit procedures. Please be aware that this does not guarantee that you will be recommended for certification to ISO 9001:2015 and you will also need to obtain a copy of the published standard as the clauses are not covered in their entirety by this document. ISO 9001:2015 Clause New requirement Complies (Yes/No) Evidence 4 Context of the organization 4.1 Understanding the organization and its context The organization shall determine external andinternal issues that are relevant to its purpose and its strategic direction and that affect its abilityto achieve the intendedresult(s) ofits qualitymanagement system. The organizationshall monitor andreview the informationabout these external and internal issues Yes 4.2 Understanding the needs and expectations of interested parties Due to their impact or potential impact on the organizations abilityto consistentlyprovide products and services that meet customer and applicable statutoryandregulatory requirements, the organizationshall determine: The interested partiesthat are relevant to the qualitymanagement system The requirements of these interested parties that are relevant to the quality management system;the organization shallmonitor and reviewthe informationabout these interested parties and their relevant requirements Yes 4.3 Determining the scope of the quality management system The organization shall determine the boundaries andapplicabilityof the qualitymanagement systemto establishits scope Yes 4.4 Quality management system The organization shall establish, implement, maintainandcontinually improve a qualitymanagement system, includingthe processes neededand their interactions Yes For support regarding your transition, please contact us: General enquiries: 0161 865 3699 To book a transition training course: 01296 678484 To book a transitiontraining courses:01296678484
  • 2. Page 2 of 8 www.alcumusgroup.com Issue001 Sept 15 ISO 9001:2015 Clause New requirement Complies (Yes/No) Evidence 5 Leadership 5.1 Leadership and commitment 5.1.1 General Top management shall demonstrate leadershipandcommitment with respect to the qualitymanagement systemby: Taking accountabilityof the effectivenessof the QMS Ensuring that the qualitypolicyand objectives are establishedfor the QMS and are compatible withthe context and strategic direction oforganization Ensuring the integrationof the QMS requirements intothe organization’s business processes Promotingthe use of the process approachandrisk based thinking Ensuring that the resources needed for the QMS are available Communicating the importance of effective qualitymanagement andof conformingto the QMS requirements Ensuring that the QMS achieves its intendedresults Engaging, directing and supporting persons to contribute to the effectivenessof the QMS Promotingcontinual improvement Supporting other relevant management roles to demonstrate their leadershipas it applies to their areas of responsibility 5.1.2 Customer Focus Top management shall demonstrate leadershipandcommitment with respect to customer focus byensuring: a) Customer and applicable statutoryandregulatory requirements are determined, understoodand consistentlymet b) The risks and opportunities that can effect conformityof products andservices and the abilityto enhance customer satisfaction are determinedandaddressed c) The focus onenhancing customer satisfaction is maintained Yes 5.2 – Policy 5.2.1 Developing the Quality Policy Top management shall establish, review andmaintaina qualitypolicy that: Is appropriate to the purpose and context of the organization. Yes
  • 3. Page 3 of 8 www.alcumusgroup.com Issue001 Sept 15 Provides a framework for setting and reviewing qualityobjectives Includesa commitment to satisfy applicable requirements It shouldcommunicatedand understood andbe available to relevant interestedparties as appropriate 5.2.2 Communicating the Quality Policy The qualitypolicyshall: a) Be available and be maintained as documented information b) Be communicated, understood andapplied within the organisation c) Be available to relevant interestedparties, as appropriate 5.3 Organizational roles, responsibilities and authorities Top management shall ensure that the responsibilitiesandauthorities for relevant roles are assigned, communicatedandunderstood within the organization No 6 Planning 6.1 Actions to address risk and opportunities When planning for the QMS the organizationshall consider the issues referredto 4.1 and the requirements referredto in4.2 anddetermine the risks andopportunities that needto be addressedto: a)give assurance that the QMS can achieve the intendedresults b) enhance desirable effects c) prevent or reduce, undesired effects d) achieve improvement Yes 6.1.2 The organizationshall plan: a) actions to address these risks and opportunities b) how to: 1) Integrate andimplement the actions into its QMS 2) Evaluate the effectiveness of these actions Yes 6.2 Quality objectives and planning to achieve them 6.2.1 The organisation shall establish qualityobjectives at relevant functions, levels and processesneeded for the QMS Yes
  • 4. Page 4 of 8 www.alcumusgroup.com Issue001 Sept 15 ISO 9001:2015 Clause New requirement Complies (Yes/No) Evidence 6.2.2 When planning actions to achieve qualityobjectives the organizationshall determine: What willbe done, what resourceswill be required, whowillbe responsible, when will it be completed, howwill the results be evaluated Yes 6.3 Planning of changes When the organisationdeterminesthe need for changes to the QMS, the changes shall be carried out ina planned manner: The purpose of the change and any potential consequences, the integrity of the QMS, the availabilityof resources, the allocationor re- allocationof responsibilities and authorities No 7 Support 7.1 Resources The organization shall determine and provide the resourcesneededfor the establishment, implementation, maintenance andcontinual improvement of the quality management system No 7.2 Competence The organisation shall: Determine the necessarycompetence of persons doingwork under its control that affects the performance and effectivenessof the QMS Ensure that these persons are competent onthe basis of appropriate education, trainingor experience Where applicable take actions to acquire the necessarycompetence and evaluate the effectiveness of the actions taken Retainappropriate documented informationas evidence ofcompetence 7. 3 Awareness Persons doingwork under the organization’s control shallbe aware of: The qualitypolicyand relevant quality objectives Their contributionto the effectiveness of the QMS, includingthe benefits of improvedperformance The implications of not conforming with the QMS requirements Yes
  • 5. Page 5 of 8 www.alcumusgroup.com Issue001 Sept 15 ISO 9001:2015 Clause New requirement Complies (Yes/No) Evidence 7.4 Communication The organization shall determine internal andexternal communications relevant to the QMS What it will communicate? When to communicate? With whomto communicate? How to communicate? Yes 7.5 Documented information 7.5.1 General The organizations QMS shall include: Documentedinformationrequired by this international standard and determinedbythe organizationas being necessaryfor the effectiveness of the QMS 7.5.2 Creating and updating When creating and updating documentedinformationthe organizationshall ensure appropriate: Identificationanddescription (e.g. a title, date, author, or reference number); format (e.g. language, software version, graphics) andmedia (e.g. paper, electronic); review andapprovalfor suitabilityand adequacy. No 7.5.3 Control of documented information Documentedinformationrequired by the QMS and bythis International Standardshall be controlledto ensure: it is available andsuitable for use, where andwhenit is needed it is adequatelyprotected No 7.5.3.2 For control ofdocumentedinformation the organizationshall address the following activities where applicable: Distribution, access, retrieval and use Storage and preservation Control of changes Retentionanddisposition Documentedinformationof external originshall be identifiedas appropriate and controlled
  • 6. Page 6 of 8 www.alcumusgroup.com Issue001 Sept 15 ISO 9001:2015 Clause New requirement Complies (Yes/No) Evidence 8 Operation 8.1 Operational planning and control The organization shall plan, implement and control the processes neededto meet requirements for the provision of products andservices, and to implement the actions determinedin 6.0 by: Determining requirements for the products andservices Establishing criteriafor the processes and for the acceptance of products and services Determining the resources needed to achieve conformityto product and service requirements Implementingcontrol of the processes in accordance withthe criteria Determining andkeeping documented informationto the extent necessaryto have confidence that the processes have been carried out as planned and to demonstrate conformityof products and services to requirements The organisation shall control planned changes andreviewthe consequences of unintendedchanges takingactionto mitigate anyadverse effects as necessary The organisation shall ensure that outsourced processes are controlled in accordance with8.4 Yes 8.2 Requirements for products and services 8.2.1 Customer communication Communication withcustomers shall include: Providing information relating to products andservices Handlingenquiries, contracts or orders includingchanges Obtaining customer feedback, includingcustomer complaints The handling or controllingcustomer property Establishing specific requirements for contingencyactions when relevant No
  • 7. Page 7 of 8 www.alcumusgroup.com Issue001 Sept 15 ISO 9001:2015 Clause New requirement Complies (Yes/No) Evidence 8.2.2 Determining requirements related to products or services No 8.2.3 Review of requirements related to products and services No 8.2.4 Changes to requirements for products and services No No 8.3 Designand development No 8.3.1 General The organisation shall establish, implement andmaintaina designand development process that is appropriate to ensure the subsequent provisionof products andservices No 8.3.2 Design and development planning No 8.3.3 Design and development inputs No 8.3.4 Design and development controls No 8.3.5 Design and development outputs No 8.3.6 Design and development changes No 8.4 Control of externally provided services No 8.5 Production and service provision No 8.6 Release of products and services No 8.7 Control of nonconforming process outputs No 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General The organization shall determine: what needs to be monitoredand measured, the methods ofmonitoring measurement, analysisandevaluation as applicable to ensure validresults when monitoring andmeasuring will be performed and whenresults from monitoringandmeasurement shallbe analysedandevaluated The organisation shall evaluate the qualityperformance andeffectiveness of the QMS No 9.1.2 Customer Satisfaction No 9.1.3 Analysis and evaluation No 9.2 Internal Audit 9.2.1 The organization shall conduct internal audits at planned intervalsto provide information onwhether the QMS conforms to the organisations own requirements for its QMS andto this international standardandis effectivelyimplementedand maintained New clause but not really any new requirements
  • 8. Page 8 of 8 www.alcumusgroup.com Issue001 Sept 15 ISO 9001:2015 Clause New requirement Complies (Yes/No) Evidence 9.3 Management Review Top management shall review the organization's QMS, at planned intervals, to ensure its continuing suitability, adequacyandeffectiveness New clause but not really any new requirements 10 Improvement 10.1 General 10.2 Nonconformity and corrective action When a nonconformityoccurs, includingthose arising from complaints, the organizationshall react to the nonconformity New clause but not really any new requirements 10.3 Continual improvement The organization shall continually improve the suitability, adequacyand effectivenessof the QMS New clause but not really any new requirements