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4.0 Context of the organization

Clause Q Observation/
Clause Title Audit Question Guidance & Suggestions C NC NA
No No Comments
Sources of evidence could come from SWOT or PESTLE analysis results,
Has your organization business strategy plans; quality plans; information provided on your
determined external and organization’s website; annual reports; management meeting minutes;
internal issues relevant to its documented procedure; and lists of external and internal issues and
conditions.
Organizational purpose and its strategic
4.1 1 Records of meetings where context is routinely discussed and monitored.
Context direction that affect its Interviews with relevant top management in relation to the organization’s
ability to achieve the context and its strategic direction are also a good source of compliance
intended result(s) of its evidence, such as: individual strategy or tactical plan documents written to
quality management system? underpin the organization’s policies and provide a road map for achieving
future goals.
External issues, examples could include:
1. Reports relating to your organization's competitive environment, new
technologies, new markets, customer expectations, supplier intelligence,
economic conditions, political considerations, investment opportunities,
social factors;
2. Identification of factors relating to changing legislation and regulation;
3. Feedback relating to product/service performance and lessons learned;
Does your organization 4. Register of identified external risks and their treatment.
Internal issues, examples could include:
Organizational monitor and review
4.1 2 1. Organizational structure, identification of roles/responsibilities and
Context information about these governance arrangements;
external and internal issues? 2. Reports on how well the organization is performing, statements relating to
mission, vision and core values;
4. Feedback obtained from employees, e.g. survey results;
5. Information and processes for capturing and sharing knowledge and
lessons learned;
6. Organizational capability studies: load/capacity, resource requirements to
achieve demand;
7. Register of identified internal risks and their treatment.
Does your organization
Relevant determine the interested Examples of interested parties include: customers, partners, end users,
4.2 Interested 3 parties that are relevant to external providers, owners, shareholders, employees, trade unions,
Parties the quality management government agencies, regulatory authorities, and the local community.
system?
Relevant Does your organization Include those parties that add direct value to your organization, or who are
4.2 4
Interested determine the requirements affected by your organization’s the activities. Use of surveys, networking,
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of these interested parties face-to-face meetings, association membership, attending conferences,

Parties that are relevant to the lobbying, participation in benchmarking, etc., in order to gain stakeholder
quality management system? information and their requirements.
Does your organization
Records of meetings where interested parties and their requirements are
Relevant monitor and review
routinely discussed and monitored, e.g. as part of the structured management
4.2 Interested 5 information about these review process, or within each of the respective function of the organization
Parties interested parties and their (Purchase, HR, Engineering, Sales, and Finance etc.).
relevant requirements?
Does your organization Consideration of boundaries and applicability of the QMS includes:
determine the boundaries
Management
4.3
System Scope
6 and applicability of the 1. Range of products and services;
quality management system 2. Different sites and activities;
to establish its scope? 3. External provision of processes, products and services.
When determining this
Ensure that issues relating to organizational context and the needs of
scope, has your organization
Management interested parties encompassed in the scope. A lack of a documented process
4.3
System Scope
7 considered the external and will require more reliance on objective evidence from interviews with Top
internal issues referred to in management and the evaluation of external and internal issues (see 4.1).
4.1?
When determining this Ensure that issues relating to organizational context and the needs of
scope, has your organization interested parties encompassed in the scope. A lack of a documented process
Management
4.3
System Scope
8 considered the requirements will require more reliance on objective evidence from interviews with Top
of relevant interested parties management and the evaluation to the requirements of relevant interested
referred to in 4.2? parties (see 4.2).
When determining this
scope, has your organization
considered all relevant
Obtain evidence that clearly defines what your organization sells, produces,
Management products, services and work-
4.3 9 or provides services for. Link this to the relevant standards or ACOPs that
System Scope related activities, functions they are governed by.
and physical boundaries to
the quality management
system?
Has your organization
applied all the requirements
Management of ISO 9001:2015 if they are Describe the application of ISO 9001 within the scope was determined, and
4.3 10
System Scope applicable within the how has it been applied by your organization.
determined scope of the
quality management system?
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Does the scope state the

types of products and
services covered, and
provide justification for any Describe how the application of ISO 9001 within the scope was determined,
Management requirement of ISO and how any clause exclusions are justified. There must be alignment
4.3 11
System Scope 9001:2015 that your between the documented scope of the organization’s QMS and their agreed
organization determines is scope of certification.
not applicable to the scope
of its quality management
system?
Is the scope of your
organization’s quality
management system Verify objective evidence that the scope of documented and available to
Management
4.3
System Scope
12 available and maintained as interested parties. A statement from your organization that the scope will be
documented information and provided upon request may be accepted as objective evidence.
available to interested parties
and workers? (See 7.5.1a)
Has your organization
established, implemented,
maintained and continually
improved its quality ISO 9001 includes specific requirements necessary for the adoption of
Management processes when developing, implementing and improving your QMS. This
management system,
4.4 System 13 requires your organization to systematically define and manage its
Processes including the processes processes, and their interactions, in order to achieve the intended results in
needed and their accordance with both the policy and strategic direction of your organization.
interactions, in accordance
with the requirements of ISO
9001:2015?
Has your organization
determined the process
required for the quality A process is set of interrelated or interacting activities which transforms
inputs into outputs. A procedure is a specified way of fulfilling an activity
Management management system,
within a process. QMS processes should be defined to address: suppliers,
4.4 System 14 including their interactions, manufacturers, internal or external customer issues, resources, design,
Processes in accordance with operation, production, logistics, products, and services, customers and end-
requirements and their users.
application throughout the
organization?
Management Has your organization What are the expected inputs and outputs from each of the identified
4.4 15
System determined the inputs processes, together with assignment of responsibilities and authorities e.g.
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required and the outputs

Processes expected from these Process Owner, Process Champion, Lead Process User and Process User?
processes?
Has your organization Describe the identification of the processes needed for the QMS, including
Management their sequence and interaction, e.g. E.g. process framework, process model,
determined the sequence and
4.4 System 16 process groupings, process flow diagram, process mapping, value stream
Processes interaction of these mapping, Turtle diagrams, SIPOC (Supplier, Input, Process, Output, and
processes? Customer) charts and process cards.
Has your organization
determined and applied the
criteria and methods Describe how what are the criteria, methods, measurement and related
performance indicators needed to operate and control those processes?
Management (including monitoring,
Criteria and methods to ensure effective operation and control of the
4.4 System 17 measurements and related identified processes, e.g. process monitoring indicators, process performance
Processes performance indicators) indicators, target setting, data collection, performance trends, and internal or
needed to ensure the external audit results.
effective operation and
control of these processes?
Has your organization
Management
determined the resources Describe how resources are determined and how they are made available,
4.4 System 18
Processes needed for these processes this might during operational planning or management reviews.
and ensure their availability?
Has your organization Describe how are responsibilities and authorities assigned for those
Management processes. Information needed to ensure effective operation and control of
assigned responsibilities and
4.4 System 19 the processes, e.g. defined process requirements (shall), good practice
Processes authorities for these (should), defined roles, required competencies, associated training, and
processes? guidance.
Has your organization
Describe how risks and opportunities are considered and what plans are
Management addressed the risks and
made to implement actions to address them? Risks and opportunities relating
4.4 System 20 opportunities as determined to the process, resource needs, user training/competency, continual
Processes in accordance with the improvement initiatives, frequency of reviews, agenda, minutes, and actions.
requirements of 6.1?
Has your organization
evaluated these processes
Management
and implement any changes Describe the methods that are used to monitor, measure and evaluate
4.4 System 21
Processes needed to ensure that these processes and, if needed, what changes are made to achieve intended results?
processes achieve their
intended results?
Management Does your organization Describe how opportunities to improve the processes and the QMS are
22
System improve the processes and determined. Examples include risk and opportunity matrices, corrective
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action and non-conformance records. Describe the approach towards
the quality management
Processes improvement and action taken when process performance is not meeting
system? intended results.
To the extent necessary,
Management does your organization Documentation identified and retained by the organization to show that
4.4 System 23 maintain documented processes are carried it as planned, e.g. physical hard copy records,
Processes information to support the electronic media (data servers, hard drives, CDs).
operation of its processes?
To the extent necessary,
does your organization retain Documentation created and maintained that includes a description of
Management relevant interested parties (4.2), scope of the QMS including boundaries and
documented information to
4.4 System 24 applicability (4.3), description of the processes needed for the QMS, their
Processes have confidence that the sequence, interaction and application and assignment of responsibilities for
processes are being carried the processes.
out as planned?

5.0. Leadership

Clause Question Guidance & Observation/

Clause Title Audit Question C NC NA
No No Suggestions Comments
Leadership and Has top management taken accountability for the
5.1 25
commitment effectiveness of the QMS?
Have the policy and objectives for the QMS,
which are compatible with the strategic direction
5.2 Quality Policy 26
of the organization, been established and
communicated?
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Have the objectives been established at relevant

Organizational roles, departmental and individual levels with the
5.3 responsibilities and 27 business? Has the organization established and
authorities communicated the responsibilities and authorities
for the effective operation of the QMS?

6.0. Planning

Clause Question Guidance & N

Clause Title Audit Question Observation/Comments C NA
No No Suggestions C
Have the requirements for the QMS been
integrated into the business processes and
Actions to have management promoted awareness of
address risks
6.1
and
28 the process approach? Have the risks and
opportunities opportunities that need to be addressed to
give assurance that the QMS can achieve its
intended result(s) been established?
Quality Have the objectives been established at
objectives and
6.2
planning to
29 relevant departmental and individual levels
achieve them with the business
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Have customer requirements and applicable

Planning of statutory and regulatory requirements been
6.3 30
changes determined, met and communicated
throughout the organization?

7.0 Support

Clause Q/ Guidance &

Clause Title Audit Question Observation/Comments C NC NA
No No Suggestions
Is there a defined process for the determining the
7.1 Resources 31 need for changes to the QMS and managing their
implementation?
Has the organization determined and provided the
resources needed for the establishment,
7.1.1 General 32 implementation, maintenance and continual
improvement of the QMS (including people,
environmental and infrastructure requirements)?
Has the organization ensured that those persons
7..1.2 People 33
who can affect the performance of the QMS are
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competent on the basis of appropriate education,

training, or experience or taken action to ensure
that those persons can acquire the necessary
competence?
Has the documented information required by the
standard and necessary for the effective
7.1.3 Infrastructure 34
implementation and operation of the QMS been
established?
Environment for the
7.1.4 operation of 35
processes

If monitoring or measuring is used for evidence

of conformity of products and services to
Monitoring and
7.1.5
Measuring
36 specified requirements, has the organization
determined the resources needed to ensure valid
and reliable monitoring and measuring of results?

Has the organization determined the knowledge

Organizational necessary for the operation of its processes and
7.1.6 37
Knowledge achievement of conformity of products and
services and implemented a lesson learnt process?
7.2 Competence 38

7.3 Awareness 39

7.4 Communication 40
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8.0. Operation

Clause Q/ Guidance & Observation/

Clause Title Audit Question C NC NA
No No Suggestions Comments
Is there a defined process for the provision of products and
8.1 Operational planning and control 41
services that meet requirements defined by the customer?
When changes are planned are they carried out in a
8.2 Determination of requirements 42 controlled way and actions taken to mitigate any adverse
effects?
8.2.1 Customer communication 43 Are any outsourced processes managed and controlled?
Is there a defined process for reviewing and communicating
Determination of requirements with customers in relation to information relating to
8.2.2 44
related to products and services products and services, enquiries, contracts or order
handling?
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Review of requirements related to

8.2.3 Is this review conducted prior to the organization’s
8.2.4
products and services Changes to 45
requirements commitment to supply products and services?
If you design and develop products or services, are these
8.3 Design and Development 46 processes established and implemented in line with the
requirements of the standard?
Do you ensure that externally provided processes, products,
8.3.1 General 47
and services conform to specified requirements?
Do you have criteria for the evaluation, selection,
8.3.2 Design and development planning 48 monitoring of performance and re-evaluation of external
providers?
Is the provision of products and services carried out in
8.3.3 Design and development inputs 49
controlled conditions which include:
· The availability of documented information that defines
8.3.4 Design and development controls. 50
the characteristics of the products and services;
8.3.5 Design and development Outputs · The availability of documented information that defines
51
8.3.6 Design and development changes the activities to be performed and the results to be achieved?
· Monitoring and measurement activities at appropriate
Type and extent of control of stages to verify that criteria for control of processes and
8.4.2 52
external provision process outputs, and acceptance criteria for products and
services, have been met?
8.4.3 Information for external providers 53 · The people carrying out the tasks are competent?
Do you have effective methods of ensuring traceability
8.5.1 Control of production and Service 54
during the operation process?
Where property belonging to customers or external
8.5.2 Identification and traceability 55 providers is used in the provision of the product or service,
is this controlled effectively?
If there is a requirement for post-delivery activities
Property belonging to customers associated with the products and services such as warranty,
8.5.3 56
or external providers maintenance services, recycling or final disposal, are these
defined and managed?
Are any nonconforming process outputs managed so as to
8.5.4 Preservation 57
prevent their unintended use?

8.5.5 Post-delivery activities 58

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8.5.6 Control of changes 59

8.6 Release of products and services 60

Control of nonconforming
8.7 61
products

9. Performance evaluation

Claus Questio Guidance & Observation/

Clause Title Audit Question C NC NA
e No n No Suggestions Comments

Has the organization determined

Monitoring,
• What needs to be monitored and measured and
9.1.1 measurement 62
and analysis • The methods for monitoring, measurement, analysis and
evaluation, to ensure valid results?
Customer Has it established when the results from monitoring and
9.1.2 63
Satisfaction measurement shall be analyzed and evaluated?
Analysis and Have methods of monitoring customer perceptions of the
9.1.3 64
evaluation provision of products and services been established?
Are any nonconforming process outputs managed so as to
9..2 Internal Audits 65
prevent their unintended use?
9.3 Management 66 Has it determined the need or opportunities for
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improvements within the QMS and how these will be fed

Review into management reviews? Has an approach to perform
management reviews been established and implemented

10. Improvement

Clause Question Guidance & Observation

Clause Title Audit Question C NC NA
No No Suggestions /Comments
Has the organization determined and selected opportunities for
Improvement
10.1
General
67 improvement and implemented the necessary actions to meet
customer requirements and enhance customer satisfaction?
Nonconformity/ Have the organization appropriate processes for managing
10.2 68
Corrective Action nonconformities and the related corrective actions?
Has the organization decided on how it will address the
Continual
10.3
improvement
69 requirement to continually improve the suitability, adequacy, and
effectiveness of the QMS?