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Page 1
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
4.3q2 When determining this scope, the How have:
organization shall consider: The external and internal issues;
a) the external and internal issues referred The requirements of relevant
to in 4.1; interested parties and;
b) the requirements of relevant The products and services of the
interested parties referred to in 4.2; organization been considered when
c) the products and services of determining the scope of the
the organization. organization?
4.3q3 Where a requirement of this International How has the application of the
Standard within the determined scope can be International Standard within the scope
applied, then it shall be applied by the been determined, and how has it been
organization. applied by the organization?
4.3q4 If any requirement(s) of this International How have any requirements of the
Standard cannot be applied, this shall not affect International Standard been determined
the organization’s ability or responsibility to as not applicable? Show me how
ensure conformity of products and services. conformity of products and services are
not affected by this.
4.3q5 The scope shall be available and be maintained Where is the scope available? Where is Scope required as documented information.
as documented information stating the: it maintained as documented
- products and services covered by information? Does it state what
the quality management system; products and services are covered by
- justification for any instance the QMS?
where a requirement of this Does it justify how instances of
International Standard cannot be requirements of the QMS cannot
applied. be applied?
4.4 Quality management system and its processes
4.4q1 The organization shall establish, implement, How has the QMS been established?
maintain and continually improve a quality Show me how this is implemented. How
management system, including the processes is it maintained and continually
needed and their interactions, in accordance improved? How have the processes
with the requirements of this International been determined and how do they
Standard. interact?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
4.4q2 The organization shall determine the How have the processes been
processes needed for the quality determined for the QMS?
management system and their application What are the inputs and outputs for
throughout the organization and shall those processes?
determine: What is the sequence and interaction of
a) the inputs required and the outputs the processes?
expected from these processes; What are the criteria, methods,
b) the sequence and interaction of measurement and related
these processes; performance indicators needed to
c) the criteria, methods, including operate and control those processes?
measurements and related performance What resources are needed and how
indicators needed to ensure the effective are these made available?
operation, and control of these processes; How are responsibilities and
d) the resources needed and ensure authorities assigned for those
their availability; processes?
e) the assignment of the responsibilities How are risks and opportunities
and authorities for these processes; considered and what plans are made to
f) the risks and opportunities in accordance implement actions to address them?
with the requirements of 6.1, and plan and What methods are used to monitor,
implement the appropriate actions to address measure and evaluate processes
them; and, if needed, what changes are
g) the methods for monitoring, measuring, as made to achieve intended results?
appropriate, and evaluation of processes and, How are opportunities to improve
if needed, the changes to processes to ensure the processes and the QMS
that they achieve intended results; determined?
h) opportunities for improvement of the
4.4q3 The organization shall maintain documented What documented information exists Documented information to support the operation
information to the extent necessary to support to support the operation of processes? of processes.
the operation of processes and retain How is this documented information
documented information to the extent retained? How is confidence that the
necessary to have confidence that the processes are being carried out as
processes are being carried out as planned. planned determined?
5 Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment for the quality management system
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
5.1.1q Top management shall demonstrate Show me how top management
1 leadership and commitment with respect to demonstrates leadership and
the quality management system by: commitment
a) taking accountability of the effectiveness of w.r.t. the QMS by taking
the quality management system; accountability of the effectiveness of
b) ensuring that the quality policy and quality the QMS.
objectives are established for the quality How is the quality policy and objectives
management system and are compatible with established for the QMS and how are
the strategic direction and the context of the they compatible with the strategic
organization; direction and the organizational
c) ensuring that the quality policy is context?
communicated, understood and applied within How is the quality policy communicated
the organization; within the organization? Show me how
d) ensuring the integration of the quality this is understood and applied.
management system requirements into How are the requirements of the
the organization’s business processes; QMS integrated into the business
e) promoting awareness of the process processes? How do you promote
approach; awareness of the process approach?
f) ensuring that the resources needed for How do you ensure that resources
the quality management system are needed for the QMS area available?
available; How do you communicate the
g) communicating the importance of importance of effective quality
effective quality management and of management?
conforming to the quality management How do you communicate the
system requirements; importance of conforming to the QMS
h) ensuring that the quality management requirements? How do you ensure that
system achieves its intended results; the QMS achieves its intended results?
i) engaging, directing and supporting How do you engage, direct and support
persons to contribute to the effectiveness of people to contribute to the effectiveness
the quality management system; of the QMS?
j) promoting continual improvement; How do you promote
k) supporting other relevant management continual improvement?
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean
those activities that are core to the purposes of the organization’s existence; whether the organization
is public, private, for profit or not for profit.
5.2.2
5.2.2q The quality policy shall: Where is the quality policy available as Quality Policy as document information
1 a) be available as documented information; documented information?
b) be communicated, understood and How is it communicated?
applied within the organization; Show me how it is understood and
c) be available to relevant interested applied within the organization.
parties, as appropriate. How have you made it available to
relevant interested parties?
7 Support
7.1 Resources
7.1.1 General
7.1.1q The organization shall determine and provide Demonstrate how resources are
1 the resources needed for the establishment, determined for the establishment,
implementation, maintenance and continual implementation, maintenance and
improvement of the quality management continual improvement of the QMS.
system. The organization shall consider: Show me how the capabilities
a) the capabilities of, and constraints on, and constraints on internal
existing internal resources; resources are considered.
b) what needs to be obtained from Show me how needs from
external providers. external providers are
considered.
7.1.2 People
7.1.2q To ensure that the organization can How do you provide persons
1 consistently meet customer and applicable necessary to consistently meet
statutory and regulatory requirements, the customer, applicable statutory and
organization shall provide the persons regulatory requirements for the QMS
necessary for the effective operation of the including the necessary processes?
quality management system, including the
processes needed.
7.1.3 Infrastructure
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
7.1.3q The organization shall determine, provide and How do you determine, provide and
1 maintain the infrastructure for the operation of maintain the infrastructure for the
its processes to achieve conformity of operation of processes to achieve
products and services. products and service conformity?
NOTE 1 Any product realization change affecting customer requirements requires notification to,
and agreement from, the customer.
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
NOTE 1 Organizational knowledge can include information such as intellectual property and
lessons learned.
NOTE 2 To obtain the knowledge required, the organization can consider:
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented
knowledge and experience of topical experts within the organization);
b) external sources (e.g. standards, academia, conferences, gathering knowledge with
customers or providers).
7.2 Competence
7..2q1 The organization shall: Show me how: Documented information as evidence of competence
a) determine the necessary competence of You determine the necessary where appropriate.
person(s) doing work under its control that competence of people doing work
affects its quality performance; under your control that affects quality
b) ensure that these persons are competent on performance;
the basis of appropriate education, training, or How do you determine competence on
experience; the basis of appropriate education,
c) where applicable, take actions to acquire training or experience?
the necessary competence, and evaluate How do you take actions to acquire
the effectiveness of the actions taken; necessary competence where
d) retain appropriate documented information applicable and how do you evaluate the
as evidence of competence. effectiveness of those actions?
Show me documented information
where appropriate of competence.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the
re- assignment of currently employed persons; or the hiring or contracting of competent persons.
7.3 Awareness
7.3q1 Persons doing work under the How are people aware
organization’s control shall be aware of: of: The quality policy?
a) the quality policy; Relevant quality objectives?
b) relevant quality objectives; Their contribution to the effectiveness
c) their contribution to the effectiveness of the of the QMS?
The benefits of improved performance?
quality management system, including the The implications of not conforming with
benefits of improved quality performance; the QMS requirements?
d) the implications of not conforming with
the quality management system
requirements.
7.4 Communication
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
7.4q1 The organization shall determine the internal How do you determine internal and
and external communications relevant to the external communications relevant to
quality management system including: the QMS?
a) on what it will communicate; How do you
b) when to communicate; determine: What?
When?
c) with whom to communicate; With
d) how to communicate. Whom?
How?
7.5 Documented information
7.5.1 General
7.5.1q The organization’s quality management What documented information do Documented information required by this standard.
1 system shall include: you have as required by this Documented information necessary for the effectiveness
a) documented information required by standard? of the QMS.
this International Standard; What documented information do
b) documented information determined by the you have as being necessary for the
organization as being necessary for the effectiveness of your QMS?
effectiveness of the quality management
system.
NOTE The extent of documented information for a quality management system can differ from
one organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.
8 Operation
8.1 Operational planning and control
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
8.1q1 The organization shall plan, implement and How are processes needed to meet Documented information to show processes have been
control the processes, as outlined in 4.4, requirements for provision of products carried out as planned and can demonstrate conformity
needed to meet requirements for the provision and services planned, implemented of products and services.
of products and services and to implement the and controlled?
actions determined in 6.1, by: How are requirements for products
a) determining requirements for the product and services determined?
and services; How is criteria for processes and
b) establishing criteria for the processes and acceptance for products and
for the acceptance of products and services; services determined?
c) determining the resources needed to How are resources determined?
achieve conformity to product and service How is process control implemented?
requirements; Show me the documented information
d) implementing control of the that shows confidence in that the
processes in accordance with the processes have been carried out as
criteria; planned and can demonstrate
e) retaining documented information to the conformity of products and services.
extent necessary to have confidence that the
processes have been carried out as planned
and to demonstrate conformity of products
8.1q2 The output of this planning shall be suitable for How have you determined that the
the organization's operations. output from the planning process is
suitable for your operations?
8.1q3 The organization shall control planned How do you control planned changes?
changes and review the consequences of How do you review the consequences of
unintended changes, taking action to unintended changes? What action is
mitigate any adverse effects, as necessary. taken to mitigate any adverse effects?
8.1q4 The organization shall ensure that How do you control outsourced
outsourced processes are controlled in processes?
accordance with 8.4.
8.2 Determination of requirements for products and services
8.2.1 Customer communication
8.2.1q The organization shall establish the processes What are your processes for
1 for communicating with customers in relation communicating with customers? How
to: do you communicate information
a) information relating to products and services; relating to: Products;
b) enquiries, contracts or order handling, Services;
including changes; Enquiries;
c) obtaining customer views and Contracts;
perceptions, including customer Order
complaints; handling;
d) the handling or treatment of customer Customer views, perceptions
property, if applicable; and complaints;
e) specific requirements for contingency Handling or treatment of
actions, when relevant. customer property;
Specific requirements for
contingency actions?
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
8.2.2 Determination of requirements related to products and services
8.2.2q The organization shall establish, implement What is your process to determine the
1 and maintain a process to determine the requirements for products and services
requirements for the products and services to to be offered to potential customers?
be offered to potential customers. How do you establish, implement and
maintain this process?
8.2.2q The organization shall ensure that: How do you define product and
2 a) product and service requirements (including service requirements including
those considered necessary by the statutory and regulatory
organization), and applicable statutory and requirements?
regulatory requirements, are defined; How do you ensure that you have
b) it has the ability to meet the defined the ability to meet the defined
requirements and substantiate the claims for requirements and substantiate any
the products and services it offers. claims for your products and
services?
8.2.3 Review of requirements related to products and services
8.2.3q The organization shall review, as applicable: How do you review:
1 a) requirements specified by the customer, Customer requirements for delivery
including the requirements for delivery and and post-delivery?
post- delivery activities; Requirements necessary for
b) requirements not stated by the customer, but customers’ specified or intended use,
necessary for the customers' specified or where known; Additional statutory
intended use, when known; and regulatory requirements
c) additional statutory and regulatory applicable to products and services;
requirements applicable to the products and Any other contract or order requirements.
services;
d) contract or order requirements differing
from those previously expressed.
NOTE Requirements can also include those arising from relevant interested parties.
8.2.3q This review shall be conducted prior to the Show me that the review is conducted
2 organization’s commitment to supply products prior to your commitment to supply
and services to the customer and shall ensure products and services to your
contract or order requirements differing from customers. How do you resolve contract
those previously defined are resolved. or order requirements which differ from
those previously defined?
8.2.3q Where the customer does not provide a How do you confirm customer
3 documented statement of their requirements, requirements where the customer does
the customer requirements shall be confirmed not provide a documented statement?
by the organization before acceptance.
8.2.3q Documented information describing the Show me where you retain Documented information of reviews describing new
4 results of the review, including any new or documented information which or changed requirements to products and services.
changed requirements for the products and describes results of the review including
services, shall be retained. any new or changed requirements.
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
8.2.3q Where requirements for products and services Show me the documented Documented information of amended reviews and
5 are changed, the organization shall ensure that information containing changes to how relevant personnel are made aware of those
relevant documented information is amended products and services. How do you changes.
and that relevant personnel are made aware of ensure that relevant personnel are
the changed requirements. made aware of those changes?
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Q# ISO 9001:2015 Clause Audit Question Audit Evidence
8.5.1q Controlled conditions shall include, as Can you show me controlled conditions Documented information defining characteristics of
2 applicable: for: the products and services
a) the availability of documented information a) the availability of documented
that defines the characteristics of the products information defining the
and services; characteristics of the products and
b) the availability of documented information services;
that defines the activities to be performed and b) the availability of documented
the results to be achieved; information defining the activities to
c) monitoring and measurement activities at be performed and the results to be
appropriate stages to verify that criteria for achieved;
control of processes and process outputs, and c) monitoring and measurement
acceptance criteria for products and services, activities at appropriate stages to verify
have been met. that criteria for control of processes
d) the use, and control of suitable and process outputs, and acceptance
infrastructure and process environment; criteria for products and services, have
e) the availability and use of suitable been met.
monitoring and measuring resources; d) the use, and control of suitable
f) the competence and, where applicable, infrastructure and process
required qualification of persons; environment;
g) the validation, and periodic revalidation, of e) the availability and use of
the ability to achieve planned results of any suitable monitoring and measuring
process for production and service provision resources;
where the resulting output cannot be verified f) the competence and, where
by subsequent monitoring or measurement; applicable, required qualification of
h) the implementation of products and persons;
services release, delivery and post-delivery g) the validation, and periodic
activities. revalidation, of the ability to achieve
planned results of any process for
8.5.2 Identification and traceability
8.5.2q Where necessary to ensure conformity of What means do you use to identify
1 products and services, the organization shall process outputs to ensure conformity of
use suitable means to identify process outputs. products and services?
8.5.2q The organization shall identify the status of How do you identify the status of
2 process outputs with respect to monitoring and process outputs?
measurement requirements throughout
production and service provision.
8.5.2q Where traceability is a requirement, the How do you control the unique Documented information of traceability, where required.
3 organization shall control the unique identification of process outputs,
identification of the process outputs, and retain where applicable? What
any documented information necessary to documented information do you
maintain traceability. retain?
NOTE Process outputs are the results of any activities which are ready for delivery to the
organization’s customer or to an internal customer (e.g. receiver of the inputs to the next process);
they can include products, services, intermediate parts, components, etc.
8.5.3q When property of the customer or external What means do you use to report to the
2 provider is incorrectly used, lost, damaged customer or external provider if their
or otherwise found to be unsuitable for use, property is incorrectly used, lost,
the organization shall report this to the damaged or found to be unsuitable for
customer or external provider. use?
NOTE Customer property can include material, components, tools and equipment, customer
premises, intellectual property and personal data.
8.5.4 Preservation
8.5.4q The organization shall ensure preservation of How do you ensure preservation of
1 process outputs during production and service outputs
process during production and service
provision, to the extent necessary to maintain provision to maintain conformity to
conformity to requirements. product
requirements?
NOTE Preservation can include identification, handling, packaging, storage, transmission or
transportation, and protection.
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
10 Improvement
10.1 General
10.1q The organization shall determine and select How do you determine and select
1 opportunities for improvement and implement opportunities for improvement? What
necessary actions to meet customer necessary actions have you
requirements and enhance customer implemented so that you have met
satisfaction. customer requirements and enhanced
customer satisfaction?
10.1q This shall include, as appropriate: Show me how you have:
2 a) improving processes to Improved processes to
prevent nonconformities; prevent nonconformities;
b) improving products and services to meet Improved products and services to
known and predicted requirements; meet known and predicted
c) improving quality management system results. requirements; Improved QMS results.
Q# ISO 9001:2015 Clause Audit Question Audit Evidence
NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual
improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organization
(e.g. transformation).
Page 30
5.4.2 Quality management system planning 6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.3 Planning of changes
5.5 Responsibility, authority and communication 5 Leadership
5.5.1 Responsibility and authority 5.3 Organizational roles, responsibilities
and authorities
5.5.2 Management representative Title removed
5.3 Organizational roles, responsibilities
and authorities
5.5.3 Internal communication 7.4 Communication
5.6 Management review 9.3 Management review
5.6.1 General 9.3.1 Management review
5.6.2 Review input 9.3.1 Management review
5.6.3 Review output 9.3.2 Management review
6 Resource management 7.1 Resources
6.1 Provision of resources 7.1.1 General
7.1.2 People
6.2 Human resources Title removed
7.2 Competence
6.2.1 General 7.2 Competence
6.2.2 Competence, training and awareness 7.2 Competence
7.3 Awareness
6.3 Infrastructure 7.1.3 Infrastructure
6.4 Work environment 7.1.4 Environment for the operation of processes
7 Product realization 8 Operation
7.1 Planning of product realization 8.1 Operational planning and control
7.2 Customer-related processes 8.2 Determination of requirements for products
and services
7.2.1 Determination of requirements related to 8.2.2 Determination of requirements related to
the product products and services
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7.2.2 Review of requirements related to the product 8.2.3 Review of requirements related to the
products and services
7.2.3 Customer communication 8.2.1 Customer communication
7.3 Design and development 8.5 Production and service provision
7.3.1 Design and development planning 8.3 Design and development of products and
services
8.3.1 General
8.3.2 Design and development planning
7.3.2 Design and development inputs 8.3.3 Design and development Inputs
7.3.3 Design and development outputs 8.3.5 Design and development outputs
7.3.4 Design and development review 8.3.4 Design and development controls
7.3.5 Design and development verification 8.3.4 Design and development controls
7.3.6 Design and development validation 8.3.4 Design and development controls
7.3.7 Control of design and development changes 8.3.6 Design and development changes
7.4 Purchasing 8.4 Control of externally provided products
and services
7.4.1 Purchasing process 8.4.1 General
8.4.2 Type and extent of control of external provision
7.4.2 Purchasing information 8.4.3 Information for external providers
7.4.3 Verification of purchased product 8.6 Release of products and services
7.5 Production and service provision 8.5 Production and service provision
7.5.1 Control of production and service provision 8.5.1 Control of production and service provision
8.5.5 Post-delivery activities
7.5.2 Validation of processes for production and 8.5.1 Control of production and service provision
service provision
7.5.3 Identification and traceability 8.5.2 Identification and traceability
7.5.4 Customer property 8.5.3 Property belonging to customers or
external providers
7.5.5 Preservation of product 8.5.4 Preservation
7.6 Control of monitoring and measuring equipment 7.1.5 Monitoring and measuring resources
8.0 Measurement, analysis and improvement 9.1 Monitoring, measurement, analysis
and evaluation
8.1 General 9.1.1 General
4.4 Quality management system and its processes 4 Quality management system
4.1 General requirements
5 Leadership 5 Management responsibility
5.1 Leadership and commitment 5.1 Management commitment
5.1.1 Leadership and commitment for the 5.1 Management commitment
quality management system
5.1.2 Customer focus 5.2 Customer focus
5.2; 5.2.1 & 5.2.2 Quality policy 5.3 Quality policy
5.3 Organizational roles, responsibilities 5.5.1 Responsibility and authority
and authorities 5.5.2 Management representative
6 Planning for the quality management system 5.4.2 Quality management system planning
6.1 Actions to address risks and opportunities 5.4.2 Quality management system planning
8.5.3 Preventive action
6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives
6.3 Planning of changes 5.4.2 Quality management system planning