ISO 9001 2015 Checklist 8 Yada 9

ISO 9001:2015 and AS/NZS ISO 9001:2016 Checklist
Company:
Address:
Client No:
Check list completed by Date completed
What you need to do:

Please consider all questions in sections 4 to 10 and provide references to your appropriate system documented information in
the corresponding column.
Note: Documented information
Information required to be controlled and maintained by an organization and the medium on which it is contained.
Documented information can be in any format and media and from any source.
Documented information can refer to:
- The quality management system, including related processes ;
- Information created in order for the organization to operate (documentation);
- Evidence of results achieved (records).
The Structure of Your System

The structure of your management system to support the Quality Management should be unique to your organisation. Information
may be in paper or electronic form and procedures can be interpreted in whatever method best suits your organisations needs,
including flow charts, picture diagrams, video imaging, soft copy computer based procedures etc. The main consideration is that the
documented information can be understood and utilised by the appropriate personnel within your organisation, which in turn
provides the control and continual improvement that the Standard requires.
The size and scope of your organisation will be key factors in determining the systems structure. It is the responsibility of the auditor
to determine compliance with ISO9001:2015 and AS/NZS ISO 9001:2016, regardless of how you have put it together.
Scope of the Quality Management System
Firstly, describe what products and services are covered under your management system that your organization wishes to include in
the certification scope: (e.g., transports over dimensional loads by road; grows and exports fruit; manufactures safety boots; designs
and manufactures childrens playground equipment; etc.)
<<Type here>>
Extract from ISO9001

The organization shall apply all of the requirements of this international standard if they are applicable within the determined scope
of its quality management system.
The scope of the quality management system shall be available and be maintained as documented information. The scope shall state
the types of products and services covered, and provide justification for any requirement of this International Standard that the
organization determines is not applicable to the scope of its quality management system.
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect
the organizations ability or responsibility to ensure the conformity of its products and services and the enhancement of customer
satisfaction.
Issue 1 May 2016

Page 1 of 29
4. Context of the organisation
4.1 Understanding the organisation and its context
Reference in your Area of
Clause ISO 9001: 2015 Requirements verification
system concern?
4.1 Have you determined external and internal issues that are Yes/No
relevant to your purpose and your strategic direction and
that affect your ability to achieve the intended result(s) of
your quality management system?
How do you monitor and review information about these Yes/No
external and internal issues?
Additional Notes:
4.2 Understanding the needs and expectations of interested parties

system concern?
4.2 Given the effect or potential effect on your ability to consistently provide products and services that meet customer
and applicable statutory and regulatory requirements, have you determined:
a) The interested parties that are relevant to the quality Yes/No

management system?
b) The requirements of these interested parties that are Yes/No
relevant to the quality management system?
How do you monitor and review information about these Yes/No
interested parties and their relevant requirements?
Additional Notes:
4.3 Determining the scope of the quality management system

system concern?
4.3 Have you determined the boundaries and applicability of the Yes/No
quality management system to establish your scope?
When determining the scope of the quality management system how did you consider:
a) The external and internal issues referred to in 4.1? Yes/No
b) The requirements of relevant interested parties referred Yes/No

to in 4.2?
c) The products and services of the organization? Yes/No
Additional Notes:
4.4 Quality Management System and its processes

Reference in your Auditor Area of
Clause ISO 9001: 2015 Requirements
system verification concern?
4.4 Have you implemented and have the system in place to Yes/No
maintain and continually improve your quality management
system, including the processes needed and their
interactions, in accordance with the requirements of
ISO9001?
Issue 1 May 2016

Page 2 of 29
How have you determined the processes needed for the quality management system and their application
throughout your organization, including determining:
a) The inputs required and the outputs expected from these Yes/No
processes;
b) the sequence and interaction of these processes; Yes/No
c) applying the criteria and methods (including monitoring, Yes/No

measurements and related performance indicators) needed
to ensure the effective operation and control of these
processes;
d) the resources needed for these processes and ensure Yes/No
their availability;
e) assigning the responsibilities and authorities for these Yes/No
processes;
f) addressing the risks and opportunities as determined in Yes/No
accordance with the requirements;
g) evaluate these processes and implement any changes Yes/No
needed to ensure that these processes achieve their
intended results;
h) improve the processes and the quality management
system.
To the extent necessary, are you:
a) Maintaining documented information to support the Yes/No

operation of its processes;
b) retaining documented information to have confidence Yes/No
that the processes are being carried out as planned.
Additional Notes:
5. Leadership
5.1 Leadership and commitment
system concern?
How does Top management demonstrate leadership and commitment with respect to the quality management
system by:
a) Taking accountability for the effectiveness of the quality Yes/No

management system;
b) ensuring that the quality policy and quality objectives are Yes/No
5.1 established for the quality management system and are
compatible with the context and strategic direction of the
organization;
c) ensuring the integration of the quality management Yes/No

system requirements into the organizations business
processes;
d) promoting the use of the process approach and risk-based Yes/No
thinking;
Issue 1 May 2016

Page 3 of 29
e) ensuring that the resources needed for the quality Yes/No
management system are available;
f) communicating the importance of effective quality Yes/No
management and of conforming to the quality
management system requirements;
g) ensuring that the quality management system achieves its Yes/No
intended results;
h) engaging, directing and supporting persons to contribute Yes/No
to the effectiveness of the quality management system;
i) promoting improvement; Yes/No
j) supporting other relevant management roles to Yes/No

demonstrate their leadership as it applies to their areas of
responsibility.
Additional notes:
5.1.2 Customer focus

system concern?
Do top management demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) Customer and applicable statutory and regulatory Yes/No

requirements are determined, understood and consistently
met;
5.1.2
b) the risks and opportunities that can affect conformity of Yes/No
products and services and the ability to enhance customer
satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is Yes/No
maintained.
Additional notes:
5.2 Quality policy

system concern?
Do top management demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) Customer and applicable statutory and regulatory Yes/No

requirements are determined, understood and consistently
met;
b) the risks and opportunities that can affect conformity of
products and services and the ability to enhance customer
satisfaction are determined and addressed;
5.2
c) the focus on enhancing customer satisfaction is
maintained.
Have top management established, implemented and maintained a quality policy that:
a) Is appropriate to the purpose and context of the Yes/No

organization and supports its strategic direction;
b) provides a framework for setting quality objectives; Yes/No
Issue 1 May 2016

Page 4 of 29
c) includes a commitment to satisfy applicable requirements; Yes/No
d) includes a commitment to continual improvement of the Yes/No

quality management system.
Additional Notes:
5.3 Organisational roles, responsibilities and authorities

system concern?
Does top management ensure that the responsibilities and Yes/No
authorities for relevant roles are assigned, communicated
and understood within the organization?
Has top management assigned the responsibility and authority for:
a) Ensuring that the quality management system conforms Yes/No
to the requirements of ISO9001;
b) ensuring that the processes are delivering their intended
outputs;
5.3
c) reporting on the performance of the quality management Yes/No
system and on opportunities for improvement (see 10.1), in
particular to top management;
d) ensuring the promotion of customer focus throughout the Yes/No
organization;
e) ensuring that the integrity of the quality management Yes/No
system is maintained when changes to the quality
management system are planned and implemented.
Additional Notes:
6. Planning
6.1 Actions to address risks and opportunities
system concern?
When planning for the quality management system, have you considered the issues referred to in 4.1 and the
requirements referred to in 4.2 and determined the risks and opportunities that need to be addressed to:
a) Give assurance that the quality management system can
Yes/No
achieve its intended result(s)?
b) Enhance desirable effects? Yes/No
c) Prevent, or reduce, undesired effects? Yes/No
6.1 d) Achieve improvement? Yes/No
How is your organization planning actions to address these Yes/No

risks and opportunities?
How is your organization planning to integrate and Yes/No
implement the actions into your quality management
system processes (see 4.4)?
How is your organization planning to evaluate the Yes/No
effectiveness of these actions?
Issue 1 May 2016

Page 5 of 29
Are actions taken to address risks and opportunities Yes/No
proportionate to the potential impact on the conformity of
products and services?
Additional Notes:
6.2 Quality objectives and planning to achieve them

system concern?
Has your organization established quality objectives at Yes/No
relevant functions, levels and processes that are needed for
the quality management system?
Are the quality objectives:
a) Consistent with the quality policy? Yes/No
b) Measurable? Yes/No
c) Take into account applicable requirements? Yes/No
d) Relevant to conformity of products and services and to Yes/No

enhancement of customer satisfaction?
e) Monitored? Yes/No
f) Communicated? Yes/No
6.2
g) Updated as appropriate? Yes/No
Do you maintain documented information on the quality Yes/No

objectives?
When planning how to achieve your quality objectives, has your organization determined:
a) What will be done? Yes/No
b) What resources will be required? Yes/No
c) Who will be responsible? Yes/No
d) When it will be completed? Yes/No
e) How the results will be evaluated? Yes/No
Additional Notes:
6.3 Planning of changes

system concern?
ISO9001 notes When your organization determines the need for changes to the quality management system, will
the changes be carried out in a planned manner (see 4.4).
How will your organization consider:
6.3
a) The purpose of the changes and their potential Yes/No
consequences?
b) The integrity of the quality management system? Yes/No
Issue 1 May 2016

Page 6 of 29
c) The availability of resources? Yes/No
d) The allocation or reallocation of responsibilities and Yes/No

authorities?
Additional Notes:
7. Support
7.1 Resources

system concern?
Has your organization determined and provided the Yes/No
resources needed for the establishment, implementation,
maintenance and continual improvement of the quality
management system?
When determining and providing the resources, has your organisation considered:
a) The capabilities of, and constraints on, existing internal Yes/No

resources and
b) what needs to be obtained from external providers? Yes/No
Has your organization determined and provided the persons Yes/No

necessary for the effective implementation of your quality
management system and for the operation and control of
your processes?
Has your organization determined, provided and maintained Yes/No
the infrastructure necessary for the operation of its
processes and to achieve conformity of products and
services?
Does your organization determine, provide and maintain the Yes/No
environment necessary for the operation of its processes
and to achieve conformity of products and services?
7.1
How has your organization determined and provided the Yes/No
resources needed to ensure valid and reliable results when
monitoring or measuring is used to verify the conformity of
products and services to requirements?
Do you ensure that the resources provided:
a) Are suitable for the specific type of monitoring and Yes/No

measurement activities being undertaken;
b) are maintained to ensure their continuing fitness for their Yes/No

purpose.
What does your organization retain as appropriate Yes/No

documented information as evidence of fitness for purpose
of the monitoring and measurement resources?
When measurement traceability is a requirement, or is considered by your organization to be an essential part of

providing confidence in the validity of measurement results, is your measuring equipment:
a) Calibrated or verified, or both, at specified intervals, or Yes/No

prior to use, against measurement standards traceable to
international or national measurement standards; when no
Issue 1 May 2016
Page 7 of 29
such standards exist, the basis used for calibration or
verification shall be retained as documented information;
b) identified in order to determine their status;

Yes/No
c) safeguarded from adjustments, damage or deterioration Yes/No

that would invalidate the calibration status and subsequent
measurement results.
How will your organization determine if the validity of Yes/No

previous measurement results has been adversely affected
when measuring equipment is found to be unfit for its
intended purpose, and shall you take appropriate action as
necessary?
Has your organization determined the knowledge necessary Yes/No

for the operation of your processes and to achieve
conformity of products and services?
Is this knowledge maintained and be made available to the Yes/No

extent necessary?
When addressing changing needs and trends, has your Yes/No

organization considered its current knowledge and
determined how to acquire or access any necessary
additional knowledge and required updates?
Additional Notes:
7.2 Competence
system concern?
Has your organization:
a) Determined the necessary competence of person(s) doing Yes/No
work under your control that affects the performance and
effectiveness of the quality management system?
b) Ensured that these persons are competent on the basis of Yes/No

appropriate education, training, or experience?
7.2
c) Where applicable, taken actions to acquire the necessary Yes/No
competence, and evaluated the effectiveness of the actions
taken?
d) Retained appropriate documented information as Yes/No

evidence of competence?
Additional Notes:
7.3 Awareness
system concern?
7.3 How does the organization ensure that persons doing work under their control are aware of:
Issue 1 May 2016

Page 8 of 29
a) The quality policy; Yes/No
b) relevant quality objectives; Yes/No
c) their contribution to the effectiveness of the quality Yes/No

management system, including the benefits of improved
performance;
d) the implications of not conforming to the quality Yes/No

management system requirements.
Additional Notes:
7.4 Communication
system concern?
How have you determined the internal and external communications relevant to the quality management system,
including:
a) On what it will communicate? Yes/No
b) When to communicate? Yes/No

7.4
c) With whom to communicate? Yes/No
d) How to communicate? Yes/No
e) Who communicates? Yes/No
Additional Notes:
7.5 Documented information

system concern?
Does your organizations quality management system include:
a) Documented information required by ISO9001? Yes/No
b) Documented information determined by the organization Yes/No

as being necessary for the effectiveness of the quality
management system?
7.5 When creating and updating documented information, how does your organization ensure appropriate:
a) Identification and description (e.g. a title, date, author, or Yes/No

reference number)?
b) Format (e.g. language, software version, graphics) and Yes/No

media (e.g. paper, electronic)?
c) Review and approval for suitability and adequacy? Yes/No
Issue 1 May 2016

Page 9 of 29
How do you ensure documented information required by your quality management system and by ISO9001 is
controlled to ensure:
a) It is available and suitable for use, where and when it is Yes/No

needed?
b) It is adequately protected (e.g. from loss of Yes/No

confidentiality, improper use, or loss of integrity)?
For the control of documented information, how does your organization address the following activities, as
applicable:
a) Distribution, access, retrieval and use? Yes/No

b) Storage and preservation, including preservation of
Yes/No
legibility?
c) Control of changes (e.g. version control)? Yes/No
d) Retention and disposition? Yes/No
How do you ensure documented information of external Yes/No

origin is identified and controlled?
How is documented information retained as evidence of Yes/No
conformity protected from unintended alterations?
Additional Notes:
8. Operation
8.1 Operational planning and control

system concern?
Does your organization plan, implement and control the processes (see 4.4) needed to meet the requirements for
the provision of products and services, and to implement the actions determined in Clause 6, by:
a) determining the requirements for the products and Yes/No

services;
b) establishing criteria for: Yes/No
1) the processes;
2) the acceptance of products and services;

8.1
c) determining the resources needed to achieve conformity Yes/No
to the product and service requirements;
d) implementing control of the processes in accordance with Yes/No

the criteria;
e) determining and keeping documented information to the Yes/No

extent necessary:
1) to have confidence that the processes have been carried

out as planned;
Issue 1 May 2016

Page 10 of 29
2) to demonstrate the conformity of products and services
to their requirements.
Is the output of this planning suitable for yours Yes/No

organizations operations?
How does your organization control planned changes and Yes/No

review the consequences of unintended changes, including
taking action to mitigate any adverse effects, as necessary?
How does your organization ensure that outsourced Yes/No

processes are controlled (see 8.4)?
Additional Notes:
8.2 Requirements for products and services

8.2.2 Determining the requirements related to products and services
system concern?
Does your organizations communication with your customers include:
a) Providing information relating to products and services? Yes/No
b) Handling enquiries, contracts or orders, including Yes/No

changes?
c) Obtaining customer feedback relating to products and Yes/No

services, including customer complaints?
d) Handling or controlling customer property? Yes/No
8.2.2 e) Establishing specific requirements for contingency Yes/No

actions, when relevant?
When determining the requirements for the products and services to be offered to your customers, how does your
organization ensure that:
a) The requirements for the products and services are Yes/No

defined, including:
1) Any applicable statutory and regulatory requirements?
2) Those considered necessary by the organization?
b) The organization can meet the claims for the products Yes/No
and services it offers?
Additional Notes:
8.2.3 Review of requirements related to products and services

system concern?
Issue 1 May 2016

Page 11 of 29
How does your organization ensure that it has the ability to
Yes/No
meet the requirements for products and services to be
offered to customers?
Does your organization conduct reviews before committing to supply products and services to a customer, to
include:
a) Requirements specified by the customer, including the Yes/No

requirements for delivery and post-delivery activities?
b) Requirements not stated by the customer, but necessary Yes/No
for the specified or intended use, when known?
c) Requirements specified by the organization? Yes/No
d) Statutory and regulatory requirements applicable to the Yes/No

8.2.3 products and services?
e) Contract or order requirements differing from those Yes/No
previously expressed?
Does your organization ensure that contract or order Yes/No
requirements differing from those previously defined are
resolved?
What steps are taken by your organization to ensure the Yes/No
customers requirements are confirmed by your organization
before acceptance, when the customer does not provide a
documented statement of their requirements?
In what form does your organization retain documented Yes/No
information, as applicable:
a) On the results of the review?
b) On any new requirements for the products and services?
Additional Notes:
8.2.4 Changes to requirements for products and services

system concern?
How does your organization ensure that relevant
Yes/No
documented information is amended, and that relevant
8.2.4 persons are made aware of the changed requirements,
when the requirements for products and services are
changed?
Additional Notes:
8.3 Design and development of products and services

8.3.1 General
system concern?
How does your organization ensure that relevant Yes/No
documented information is amended, and that relevant
8.3.1 persons are made aware of the changed requirements,
when the requirements for products and services are
changed?
Additional Notes:
Issue 1 May 2016

Page 12 of 29
8.3.2 Design and development planning
system concern?
In determining the stages and controls for design and development, how has your organization considered:
a) The nature, duration and complexity of the design and Yes/No

development activities?
b) The required process stages, including applicable design Yes/No

and development reviews?
c) The required design and development verification and Yes/No

validation activities?
d) The responsibilities and authorities involved in the design Yes/No

and development process?
e) The internal and external resource needs for the design Yes/No
and development of products and services?
8.3.2
f) The need to control interfaces between persons involved Yes/No

in the design and development process?
g) The need for involvement of customers and users in the Yes/No

design and development process?
h) The requirements for subsequent provision of products Yes/No

and services?
i) The level of control expected for the design and Yes/No

development process by customers and other relevant
interested parties?
j) The documented information needed to demonstrate that Yes/No

design and development requirements have been met?
Additional Notes:
8.3.3 Design and development inputs

Clause ISO 9001: 2015 Requirements verfication
system concern?
Does your organisation determine the requirements Yes/No
essential for the specific types of products and services to be
designed and developed?
When determining the requirements essential for the specific types of products and services to be designed and
developed, how does you organization consider:
a) Functional and performance requirements; Yes/No

8.3.3
b) information derived from previous similar design and Yes/No
development activities;
c) statutory and regulatory requirements; Yes/No
d) standards or codes of practice that the organization has Yes/No

committed to implement;
Issue 1 May 2016

Page 13 of 29
e) potential consequences of failure due to the nature of the Yes/No
products and services.
How does your organisation ensure that inputs for design Yes/No
and development purposes are adequate, complete and
unambiguous?
How does your organisation ensure that conflicting design Yes/No
and development inputs are resolved?
How does your organization retain documented information Yes/No
on design and development inputs?
Additional Notes:
8.3.4 Design and development controls

system concern?
What controls has your organization applied to the design and development process to ensure that:
a) The results to be achieved are defined? Yes/No
b) Reviews are conducted to evaluate the ability of the Yes/No

results of design and development to meet requirements?
c) Verification activities are conducted to ensure that the Yes/No

design and development outputs meet the input
8.3.4 requirements?
d) Validation activities are conducted to ensure that the Yes/No

resulting products and services meet the requirements for
the specified application or intended use?
e) Any necessary actions are taken on problems determined Yes/No

during the reviews, or verification and validation activities?
f) Documented information of these activities is retained? Yes/No
Additional Notes:
8.3.5 Design and development outputs

system concern?
How does your organization ensure that design and development outputs:
a) Meet the input requirements? Yes/No
8.3.5 b) Are adequate for the subsequent processes for the Yes/No
provision of products and services?
c) Include or reference monitoring and measuring Yes/No

requirements, as appropriate and acceptance criteria?
Issue 1 May 2016

Page 14 of 29
d) Specify the characteristics of the products and services Yes/No
that are essential for their intended purpose and their safe
and proper provision?
What does your organization retain as documented Yes/No

information on design and development outputs?
Additional Notes:
8.3.6 Design and development changes

Clause ISO 9001: 2015 Requirements Verification
system concern?
How does your organization identify, review and control
changes made during, or subsequent to, the design and Yes/No
development of products and services, to the extent
necessary to ensure that there is no adverse impact on
conformity to requirements?
In what form does your organization retain documented information on:
a) Design and development changes? Yes/No
8.3.6 b) The results of reviews? Yes/No
c) The authorization of the changes? Yes/No
d) The actions taken to prevent adverse impacts? Yes/No
Additional Notes:
8.4 Control of externally provided processes, products and services

8.4.1 General
system concern?
How does your organization ensure that externally provided Yes/No

processes, products and services conform to requirements?
What does your organization do to determine the controls to be applied to externally provided processes, products
and services when:
a) Products and services from external providers are Yes/No

intended for incorporation into the organizations own
8.4.1
b) Products and services are provided directly to the Yes/No

customer(s) by external providers on behalf of the
organization?
c) A process, or part of a process, is provided by an external Yes/No

provider as a result of a decision by the organization?
Issue 1 May 2016

Page 15 of 29
In what ways does your organization determine and apply Yes/No
criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based
on their ability to provide processes or products and services
in accordance with requirements?
What does your organization retain as documented Yes/No

information of these activities and any necessary actions
arising from the evaluations?
Additional Notes:
8.4.2 Type and extent of control

Clause ISO 9001: 2015 Requirements VERIFICATION
system concern?
How does your organization ensure that externally provided
processes, products and services do not adversely affect the Yes/No
organizations ability to consistently deliver conforming
products and services to its customers?
How does your organization:
a) Ensure that externally provided processes remain within

Yes/No
the control of its quality management system?
b) Define both the controls that it intends to apply to an
external provider and those it intends to apply to the Yes/No
8.4.2 resulting output?
c) Take into consideration:
1) The potential impact of the externally provided processes, Yes/No
products and services on the organizations ability to
consistently meet customer and applicable statutory and
regulatory requirements?
2) The effectiveness of the controls applied by the external
provider?
d) Determine the verification, or other activities, necessary Yes/No

to ensure that the externally provided processes, products
and services meet requirements?
Additional Notes:
8.4.3 Information for external providers

system concern?
How does your organization ensure the adequacy of Yes/No

requirements prior to their communication to the external
provider?
How does your organization communicate to external providers its requirements for:
8.4.3
a) The processes, products and services to be provided? Yes/No
b) the approval of: Yes/No
1) Products and services?
2) Methods, processes and equipment?
Issue 1 May 2016

Page 16 of 29
3) The release of products and services?
c) Competence, including any required qualification of Yes/No

persons?
d) The external providers interactions with the Yes/No

organization?
e) Control and monitoring of the external providers Yes/No

performance to be applied by the organization?
f) Verification or validation activities that the organization, Yes/No

or its customer, intends to perform at the external
providers premises?
Additional Notes:
8.5 Production and service provision

8.5.1 Control of production and service provision
system concern?
How does your organization implement production and
Yes/No
service provision under controlled conditions?
Do your organisations controlled conditions include (as applicable)
a) the availability of documented information that defines:

1) The characteristics of the products to be produced, the Yes/No
services to be provided, or the activities to be performed;
2) the results to be achieved;
b) the availability and use of suitable monitoring and Yes/No

measuring resources;
c) the implementation of monitoring and measurement Yes/No
activities at appropriate stages to verify that criteria for
control of processes or outputs, and acceptance criteria for
8.5.1 products and services, have been met;
d) the use of suitable infrastructure and environment for the Yes/No
operation of processes;
e) the appointment of competent persons, including any Yes/No
required qualification;
f) the validation, and periodic revalidation, of the ability to Yes/No
achieve planned results of the processes for production and
service provision, where the resulting output cannot be
verified by subsequent monitoring or measurement;
g) the implementation of actions to prevent human error; Yes/No
h) the implementation of release, delivery and post-delivery Yes/No

activities;
Additional Notes:
Issue 1 May 2016

Page 17 of 29
8.5.2 Identification and traceability
system concern?
What are the suitable means your organization uses to Yes/No

identify outputs when it is necessary to ensure the
conformity of products and services?
How does your organization identify the status of outputs Yes/No

with respect to monitoring and measurement requirements
8.5.2
throughout production and service provision?
How does your organization control the unique Yes/No

identification of the outputs when traceability is a
requirement, and what documented information is retained
as necessary to enable traceability?
Additional Notes:
8.5.3 Property belonging to customers or external providers

system concern?
How does your organisation exercise care with property Yes/No

belonging to customers or external providers while it is
under your organizations control or being used by your
organization?
How does your organization identify, verify, protect and Yes/No

safeguard customers or external providers property
8.5.3 provided for use or incorporation into the products and
services?
When the property of a customer or external provider is Yes/No

lost, damaged or otherwise found to be unsuitable for use,
how does your organization report this to the customer or
external provider and what documented information is
retained on what has occurred?
Additional Notes:
8.5.4 Preservation
system concern?
How does your organization preserve the outputs during Yes/No

8.5.4 production and service provision, to the extent necessary to
ensure conformity to requirements?
Additional Notes:
Issue 1 May 2016

Page 18 of 29
8.5.5 Post-delivery activities
system concern?
How does your organization meet requirements for post- Yes/No
delivery activities associated with the products and services?
In determining the extent of post-delivery activities that are required, how has your organization considered:
a) Statutory and regulatory requirements? Yes/No
b) The potential undesired consequences associated with its Yes/No

8.5.5
c) The nature, use and intended lifetime of its products and Yes/No
services?
d) Customer requirements? Yes/No
e) Customer feedback? Yes/No
Additional Notes:
8.5.6 Control of changes

system concern?
What processes does your organization have in place to Yes/No
review and control changes for production or service
provision, to the extent necessary to ensure continuing
conformity with requirements?
8.5.6
What documented information is retained by your Yes/No
organization describing the results of the review of changes,
the person(s) authorizing the change, and any necessary
actions arising from the review?
Additional Notes:
8.6. Release of products and services

system concern?
How does your organization ensure that the release of Yes/No

products and services to the customer shall not proceed
until the planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant
authority and, as applicable, by the customer?
8.6
In what format does your organization retain documented Yes/No
information on the release of products and services?
Does the documented information retained include: Yes/No
Issue 1 May 2016

Page 19 of 29
a) Evidence of conformity with the acceptance criteria? Yes/No
b) Traceability to the person(s) authorizing the release? Yes/No
Additional Notes:
8.7. Control of non-conforming outputs

system concern?
How does your organization ensure that outputs that do not Yes/No
conform to your requirements are identified and controlled
to prevent their unintended use or delivery?
Does your organization take appropriate action based on the Yes/No

nature of the nonconformity and its effect on the conformity
of products and services?
Does this also apply to nonconforming products and services Yes/No

detected after delivery of products, during or after the
provision of services?
How does your organization deal with nonconforming Yes/No

outputs in one or more of the following ways:
a) Correction?
b) Segregation, containment, return or suspension of

provision of products and services?
8.7 c) Informing the customer?
d) Obtaining authorization for acceptance under concession?
Conformity to the requirements shall be verified when Yes/No

nonconforming outputs are corrected. What process does
your organization have in place to manage this?

information that:
a) Describes the nonconformity? Yes/No
b) Describes the actions taken? Yes/No
c) Describes any concessions obtained? Yes/No
d) Identifies the authority deciding the action in respect of Yes/No

the nonconformity?
Additional Notes:
Issue 1 May 2016

Page 20 of 29
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
system concern?
How does your organization determine:
a) What needs to be monitored and measured? Yes/No
b) The methods for monitoring, measurement, analysis and Yes/No

evaluation needed to ensure valid results?
c) When the monitoring and measuring shall be performed? Yes/No

9.1.1
d) When the results from monitoring and measurement shall Yes/No
be analysed and evaluated?
How does your organization evaluate the performance and Yes/No

the effectiveness of the quality management system?
In what form does your organization retain appropriate Yes/No

documented information as evidence of the results?
Additional Notes:
9.1.2 Customer satisfaction

system concern?
Does organization shall monitor customers perceptions of Yes/No

the degree to which their needs and expectations have been
fulfilled?
9.1.2
What methods have been determined for obtaining, Yes/No

monitoring and reviewing this information?
Additional Notes:
9.1.3 Analysis and evaluation

system concern?
How does your organization analyse and evaluate Yes/No

appropriate data and information arising from monitoring
and measurement?
9.1.3
How are the results of analysis used to evaluate:
a) Conformity of products and services? Yes/No
Issue 1 May 2016

Page 21 of 29
b) The degree of customer satisfaction? Yes/No
c) The performance and effectiveness of the quality Yes/No

management system?
d) If planning has been implemented effectively? Yes/No
e) The effectiveness of actions taken to address risks and Yes/No

opportunities?
f) The performance of external providers? Yes/No
g) The need for improvements to the quality management Yes/No

system?
Additional Notes:
9.2 Internal audit

9.2.1 General
system concern?
Does your organization conduct internal audits at planned intervals to provide information on whether the quality
management system:
a) Conforms to: Yes/No
9.2.1 1) The organizations own requirements for its quality

management system?
2) The requirements of this International Standard?
b) Is effectively implemented and maintained? Yes/No
Additional Notes:
9.2.2 Internal audit programme

system concern?
Does your organization:
a) Plan, establish, implement and maintain an audit Yes/No

programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which
shall take into consideration the importance of the
9.2.2 processes concerned, changes affecting the organization,
and the results of previous audits?
b) Define the audit criteria and scope for each audit? Yes/No
c) Select auditors and conduct audits to ensure objectivity Yes/No

and the impartiality of the audit process?
Issue 1 May 2016

Page 22 of 29
d) Ensure that the results of the audits are reported to Yes/No
relevant management?
e) Take appropriate correction and corrective actions Yes/No

without undue delay?
f) Retain documented information as evidence of the Yes/No

implementation of the audit programme and the audit
results?
Additional Notes:
9.3 Management review

9.3.1 General
system concern?
ISO9001 requires Top management shall review the Yes/No
organizations quality management system, at planned
9.3.1 intervals, to ensure its continuing suitability, adequacy,
effectiveness and alignment with the strategic direction of
the organization. What format does this review(s) take?
Additional Notes:
9.3.2 Management Review inputs

system concern?
Is your organizations management review planned and carried out taking into consideration:
a) The status of actions from previous management reviews? Yes/No
b) Changes in external and internal issues that are relevant Yes/No

to the quality management system?
c) Information on the performance and effectiveness of the Yes/No

quality management system, including trends in:
1) Customer satisfaction and feedback from relevant

interested parties?
9.3.2
2) The extent to which quality objectives have been met?
3) Process performance and conformity of products and

services?
4) Nonconformities and corrective actions?
5) Monitoring and measurement results?
6) Audit results?
7) The performance of external providers?
d) The adequacy of resources? Yes/No
Issue 1 May 2016

Page 23 of 29
e) The effectiveness of actions taken to address risks and Yes/No
opportunities?
f) Opportunities for improvement? Yes/No
Additional Notes:
9.3.3 Management Review outputs

system concern?
Do the outputs of the management review include decisions and actions related to:
a) Opportunities for improvement? Yes/No
b) Any need for changes to the quality management system? Yes/No

9.3.3
c) Resource needs? Yes/No

information as evidence of the results of management
reviews?
Additional Notes:
10. Improvement
10.1 General
system concern?
Your organization is required to determine and select opportunities for improvement and implement any necessary
actions to meet customer requirements and enhance customer satisfaction.
How does your system include the following:
a) Improving products and services to meet requirements as Yes/No

10.1 well as to address future needs and expectations?
b) Correcting, preventing or reducing undesired effects? Yes/No
c) Improving the performance and effectiveness of the Yes/No

quality management system?
Additional Notes:
10.2 Nonconformity and corrective action

system concern?
Issue 1 May 2016

Page 24 of 29
When a nonconformity occurs, including any arising from complaints, how does your organization:
a) React to the nonconformity and, as applicable: Yes/No
1) Take action to control and correct it?
2) Deal with the consequences?
b) Evaluate the need for action to eliminate the cause(s) of Yes/No

the nonconformity, in order that it does not recur or occur
elsewhere, by:
1) Reviewing and analysing the nonconformity?
2) Determining the causes of the nonconformity?
3) Determining if similar nonconformities exist, or could

potentially occur?
c) Implement any action needed? Yes/No

10.2
d) Review the effectiveness of any corrective action taken? Yes/No
e) Update risks and opportunities determined during Yes/No

planning, if necessary?
f) Make changes to the quality management system, if Yes/No

necessary?
Does your organization take corrective actions appropriate to Yes/No

the effects of the nonconformities encountered?

information evidence of:
a) The nature of the nonconformities and any subsequent

actions taken?
b) The results of any corrective action? Yes/No
Additional Notes:
10.3 Continual improvement

system concern?
How does your organization continually improve the Yes/No

suitability, adequacy and effectiveness of the quality
management system?
10.3
How does your organization consider the results of analysis Yes/No
and evaluation, and the outputs from management review,
to determine if there are needs or opportunities that shall
be addressed as part of continual improvement?
Additional Notes:
Issue 1 May 2016

Page 25 of 29
Exclusions from ISO9001
The International Standard makes no specific reference to 'exclusions' when determining the
applicability of its requirements to the organizations quality management system. However, it is
recognised that an organization might need to review the applicability of requirements due to the size
of the organization, the management model it adopts, the range of the organizations activities, and
the nature of the risks and opportunities it encounters.
The following table relates to the most common types of situations please add others if applicable.
Determine- is the client responsible for: Clause Yes/Yes
outsourced/No
Design/development of products? 8.5
Modifying product or service specifications? 8.5
Modifying the content of any type of product specification? 8.5
Using and/or controlling monitoring devices for product or processes? 7.1.5
Using and/or controlling testing equipment (hardware or software) that 7.1.5

determines product conformity?
Incorporation of customer goods, product or data into deliverables? 8.5.3

Complete the following with comments
Comment:
Describe any particular audit team requirements for:
Technical competence (SIC) and competency codes? at particular locations/ site

Do any sites have specific occupational health and safety (PPE) requirements?
Working days, hours, shifts, seasonal attendance etc.
Access (e.g. security, offshore, special permits, induction etc.)
Travel requirements
Is English Language understood by all on site? If not identify the language.
Issue 1 May 2016

Page 26 of 29
Appendix 1
Objective of this Guidance
This guidance is intended to step you through a review of your Quality Management System (QMS) in
order to determine:
A level of confidence that the application of your QMS is likely to yield benefits and
opportunities through assisting your organization to meet its quality policies and objectives.
A level of confidence with respect to whether your QMS system complies with ISO 9001.
Please evaluate your current system using this document and address the requirements of ISO9001 if
they have not been addressed already. Please keep in mind the structure of the standard should not
oblige organizations to change their systems documented information to match the structure of the
standards. Systems documented information is unique to each organization.
Introduction
This guidance and self-evaluation statement provides you with a logical and systematic model that you
may use to indicate whether your quality management system meets ISO 9001 requirements.
The approach taken reflects the best business practices as exemplified by the seven quality
management principles that have been identified as a framework towards improved performance of
an organization. They are aimed at helping organizations to achieve sustained success. While it is
important to understand and apply these principles in the development of a quality management
system it is equally important to understand that the principles do not contain auditable requirements.
The following seven quality management principles form the basis for the quality management system
standards within the ISO 9000 family:
Customer focus
Statement
The primary focus of quality management is to meet customer requirements and to strive to exceed
customer expectations.
Rationale
Sustained success is achieved when an organization attracts and retains the confidence of customers
and other interested parties on whom it depends. Every aspect of customer interaction provides an
opportunity to create more value for the customer. Understanding current and future needs of
customers and other interested parties contributes to sustained success of an organization.
Leadership
Statement
Leaders at all levels establish unity of purpose and direction and create conditions in which people are
engaged in achieving the quality objectives of the organization.
Rationale
Creation of unity of purpose, direction and engagement enable an organization to align its strategies,
policies, processes and resources to achieve its objectives.
Engagement of People
Statement
Issue 1 May 2016

Page 27 of 29
It is essential for the organization that all people are competent, empowered and engaged in delivering
value.
Competent, empowered and engaged people throughout the organization enhance its capability to
create value.
Rationale
To manage an organization effectively and efficiently, it is important to involve all people at all levels
and to respect them as individuals. Recognition, empowerment and enhancement of skills and
knowledge facilitate the engagement of people in achieving the objectives of the organization.
Process Approach
Statement
Consistent and predictable results are achieved more effectively and efficiently when activities are
understood and managed as interrelated processes that function as a coherent system.
Rationale
The quality management system is composed of interrelated processes. Understanding how results are
produced by this system, including all its processes, resources, controls and interactions, allows the
organization to optimize its performance.
Improvement
Improvement
Statement
Successful organizations have an ongoing focus on improvement.
Rationale
Improvement is essential for an organization to maintain current levels of performance, to react to
changes in its internal and external conditions and to create new opportunities.
Evidence-based Decision Making

Statement
Decisions based on the analysis and evaluation of data and information are more likely to produce
desired results.
Rationale
Decision-making can be a complex process, and it always involves some uncertainty. It often involves
multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is
important to understand cause and effect relationships and potential unintended consequences. Facts,
evidence and data analysis lead to greater objectivity and confidence in decisions made.
Relationship Management
Statement
For sustained success, organizations manage their relationships with interested parties, such as
suppliers.
Rationale
Interested parties influence the performance of an organization. Sustained success is more likely to be
achieved when an organization manages relationships with its interested parties to optimize their
impact on its performance. Relationship management with its supplier and partner network is often of
particular importance.
Issue 1 May 2016

Page 28 of 29
We strongly encourage you to study these principles and apply them throughout your organization.
We suggest that you consider the Standard ISO 9004 Quality Management Systems Guidelines for
Performance Improvement. You will also need to refer to ISO 9000 Quality Management Systems
Fundamentals and Vocabulary for meanings of the terms used in ISO 9001 and in this document. Also
refer to ISO official web-sites (www.iso.ch), (www.iso.org/tc176/ISO9001AuditingPracticesGroup) for
latest guideline documents and brochures.
Issue 1 May 2016

Page 29 of 29

ISO 9001 2015 Checklist 8 Yada 9

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

ISO 9001 2015 Checklist 8 Yada 9

Uploaded by

Copyright:

Available Formats

ISO 9001:2015 and AS/NZS ISO 9001:2016 Checklist

Check list completed by Date completed

What you need to do:

The Structure of Your System

Scope of the Quality Management System

Extract from ISO9001

Issue 1 May 2016

4.2 Understanding the needs and expectations of interested parties

a) The interested parties that are relevant to the quality Yes/No

4.3 Determining the scope of the quality management system

a) The external and internal issues referred to in 4.1? Yes/No

b) The requirements of relevant interested parties referred Yes/No

4.4 Quality Management System and its processes

Issue 1 May 2016

c) applying the criteria and methods (including monitoring, Yes/No

To the extent necessary, are you:

a) Maintaining documented information to support the Yes/No

a) Taking accountability for the effectiveness of the quality Yes/No

c) ensuring the integration of the quality management Yes/No

Issue 1 May 2016

i) promoting improvement; Yes/No

j) supporting other relevant management roles to Yes/No

5.1.2 Customer focus

a) Customer and applicable statutory and regulatory Yes/No

5.2 Quality policy

a) Customer and applicable statutory and regulatory Yes/No

a) Is appropriate to the purpose and context of the Yes/No

b) provides a framework for setting quality objectives; Yes/No

Issue 1 May 2016

d) includes a commitment to continual improvement of the Yes/No

5.3 Organisational roles, responsibilities and authorities

b) Enhance desirable effects? Yes/No

c) Prevent, or reduce, undesired effects? Yes/No

6.1 d) Achieve improvement? Yes/No

How is your organization planning actions to address these Yes/No

Issue 1 May 2016

6.2 Quality objectives and planning to achieve them

c) Take into account applicable requirements? Yes/No

d) Relevant to conformity of products and services and to Yes/No

Do you maintain documented information on the quality Yes/No

a) What will be done? Yes/No

b) What resources will be required? Yes/No

c) Who will be responsible? Yes/No

d) When it will be completed? Yes/No

e) How the results will be evaluated? Yes/No

6.3 Planning of changes

b) The integrity of the quality management system? Yes/No

Issue 1 May 2016

d) The allocation or reallocation of responsibilities and Yes/No

Reference in your Area of

a) The capabilities of, and constraints on, existing internal Yes/No

b) what needs to be obtained from external providers? Yes/No

Has your organization determined and provided the persons Yes/No

Do you ensure that the resources provided:

a) Are suitable for the specific type of monitoring and Yes/No

b) are maintained to ensure their continuing fitness for their Yes/No

What does your organization retain as appropriate Yes/No

When measurement traceability is a requirement, or is considered by your organization to be an essential part of

a) Calibrated or verified, or both, at specified intervals, or Yes/No

b) identified in order to determine their status;

c) safeguarded from adjustments, damage or deterioration Yes/No

How will your organization determine if the validity of Yes/No

Has your organization determined the knowledge necessary Yes/No

Is this knowledge maintained and be made available to the Yes/No