ISO 9001:2015 Clause 9.2 Internal Audit The purpose of an internal audit is to systematic and contained assess the effectiveness of any organization's quality management organisation and its overall operation Internal audit demonstrate the compliance with a planned arrangements', due east.g. the QMS and how its processes are implemented and maintained.

Bring together for costless

Internal Quality Management Organization Inspect Checklist (ISO 9001:2015)

Q# ISO 9001:2015 Clause Audit Question Audit Evidence

4 Context of the System

4.one Agreement the organisation and its context

4.1q1 The organisation shall determine external and

internal issues that are relevant to its purpose and

its strategic management and that affect its ability to

accomplish the intended result(s) of its quality

direction system.

How has the organization determined

external and internal problems relevant to its

purpose and strategic management?

How do these affect the power to achieve

the intended event of the QMS?

4.1q2 The organization shall monitor and review the

information almost these external and internal

issues.

How do y'all monitor and review data

about these internal and external issues?

Notation 1 Understanding the external context can be facilitated by considering bug arising from legal,

technological, competitive, market place, cultural, social, and economic environments, whether international,

national, regional or local.

NOTE 2 Agreement the internal context can be facilitated by because issues related to values, civilisation

noesis and performance of the arrangement.

four.2 Understanding the needs and expectations of interested parties

4.2q1 Due to their impact or potential impact on the

organisation'due south ability to consistently provide

products and services that run into customer and

applicable statutory and regulatory requirements,

the organisation shall determine:

a) the interested parties that are relevant to the

quality direction organization;

b) the requirements of these interested parties

that are relevant to the quality management

arrangement.

How have yous determined what interested

parties are relevant to the QMS?

How have yous determined what

requirements those parties take that are

relevant to the QMS?

How has bear on or potential impact been

determined?

4.2q2 The organization shall monitor and review the

data about these interested parties and their

relevant requirements.

How practice you lot monitor and review the

information about interested parties and

their relevant requirements?

4.3 Determining the telescopic of the quality management system

4.3q1 The arrangement shall determine the boundaries

and applicability of the quality direction system

to constitute its scope.

How have the boundaries and applicability

of the QMS been used to constitute the

scope of the organization?

4.3q2 When determining this scope, the system

shall consider:

a) the external and internal issues referred to in

4.1;

b) the requirements of relevant interested parties

referred to in 4.2;

c) the products and services of the organization.

How have:

The external and internal issues;

The requirements of relevant interested

parties and;

The products and services of the

organization been considered when

determining the scope of the organization?

four.3q3 Where a requirement of this International Standard

within the determined scope tin be applied, then information technology

shall be applied past the organization.

How has the application of the International

Standard within the scope been determined,

and how has information technology been applied by the

organisation?

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Q# ISO 9001:2015 Clause Audit Question Audit Show

iv.3q4 If whatsoever requirement(s) of this International Standard

cannot be applied, this shall not bear on the

organization'due south ability or responsibility to ensure

conformity of products and services.

How have any requirements of the

International Standard been determined every bit

not applicable? Show me how conformity of

products and services are not affected by

this.

4.3q5 The scope shall be available and be maintained as

documented information stating the:

- products and services covered past the

quality management system;

- justification for any instance where a

requirement of this International Standard

cannot exist applied.

Where is the telescopic available? Where is it

maintained every bit documented information?

Does it state what products and services

are covered by the QMS?

Does it justify how instances of

requirements of the QMS cannot be

applied?

Scope required as documented information.

4.iv Quality direction system and its processes

iv.4q1 The organization shall institute, implement,

maintain and continually improve a quality

management system, including the processes

needed and their interactions, in accordance with

the requirements of this International Standard.

How has the QMS been established? Show

me how this is implemented. How is information technology

maintained and continually improved? How

take the processes been determined and

how practise they interact?

4.4q2 The organization shall determine the processes

needed for the quality management system and

their application throughout the arrangement and

shall determine:

a) the inputs required and the outputs expected

from these processes;

b) the sequence and interaction of these

processes;

c) the criteria, methods, including measurements

and related operation indicators needed to

ensure the effective functioning, and command of these

processes;

d) the resource needed and ensure their

availability;

e) the consignment of the responsibilities and

government for these processes;

f) the risks and opportunities in accordance with the

requirements of 6.1, and plan and implement the

appropriate actions to address them;

g) the methods for monitoring, measuring, as

advisable, and evaluation of processes and, if

needed, the changes to processes to ensure that

they attain intended results;

h) opportunities for improvement of the processes

and the quality direction organisation.

How have the processes been determined

for the QMS?

What are the inputs and outputs for those

processes?

What is the sequence and interaction of the

processes?

What are the criteria, methods,

measurement and related functioning

indicators needed to operate and control

those processes?

What resources are needed and how are

these made available?

How are responsibilities and authorities

assigned for those processes?

How are risks and opportunities considered

and what plans are made to implement

actions to address them?

What methods are used to monitor,

measure and evaluate processes and, if

needed, what changes are made to achieve

intended results?

How are opportunities to ameliorate the

processes and the QMS determined?

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Q# ISO 9001:2015 Clause Inspect Question Inspect Prove

4.4q3 The organization shall maintain documented

information to the extent necessary to support the

performance of processes and retain documented

information to the extent necessary to have

confidence that the processes are beingness carried out

every bit planned.

What documented information exists to

support the functioning of processes? How is

this documented information retained? How

is conviction that the processes are being

carried out as planned determined?

Documented information to support the operation of

processes.

v Leadership

5.1 Leadership and delivery

5.1.1 Leadership and delivery for the quality management arrangement

5.one.1q1 Top management shall demonstrate leadership and

commitment with respect to the quality

management system by:

a) taking accountability of the effectiveness of the

quality management system;

b) ensuring that the quality policy and quality

objectives are established for the quality

management system and are compatible with the

strategic management and the context of the

arrangement;

c) ensuring that the quality policy is communicated,

understood and applied within the arrangement;

d) ensuring the integration of the quality

management arrangement requirements into the

organization'south business processes;

e) promoting sensation of the procedure approach;

f) ensuring that the resources needed for the

quality management system are bachelor;

chiliad) communicating the importance of effective

quality management and of conforming to the

quality management arrangement requirements;

h) ensuring that the quality management system

achieves its intended results;

i) engaging, directing and supporting persons to

contribute to the effectiveness of the quality

management system;

j) promoting continual improvement;

k) supporting other relevant management roles to

demonstrate their leadership as information technology applies to their

areas of responsibility.

Show me how superlative management

demonstrates leadership and delivery

w.r.t. the QMS by taking accountability of

the effectiveness of the QMS.

How is the quality policy and objectives

established for the QMS and how are they

compatible with the strategic direction and

the organizational context?

How is the quality policy communicated

within the organization? Bear witness me how this

is understood and applied.

How are the requirements of the QMS

integrated into the business concern processes?

How exercise you promote awareness of the

process approach?

How practice you ensure that resources needed

for the QMS area available?

How exercise y'all communicate the importance of

effective quality management?

How exercise you lot communicate the importance of

conforming to the QMS requirements?

How practise you ensure that the QMS achieves

its intended results?

How do yous engage, direct and support

people to contribute to the effectiveness of

the QMS?

How do yous promote continual

comeback?

How exercise you back up other relevant

management roles to demonstrate

leadership in their areas of responsibility?

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence

NOTE Reference to "concern" in this International Standard can exist interpreted broadly to mean those

activities that are core to the purposes of the organization's existence; whether the organisation is public,

private, for profit or not for profit.

5.i.2 Customer focus

five.1.2q1 Top management shall demonstrate leadership and

commitment with respect to customer focus by

ensuring that:

a) customer requirements and applicable statutory

and regulatory requirements are determined and

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;

c) the focus on consistently providing products and

services that meet customer and applicable

statutory and regulatory requirements is

maintained;

d) the focus on enhancing customer satisfaction is

maintained.

Show me how superlative direction

demonstrates leadership and commitment

w.r.t. customer focus ensuring requirements

and applicable statutory and regulatory

requirements are determined and met.

How are risks and opportunities that tin can

impact conformity of products and services

determined?

How is the power to enhance customer

satisfaction determined and addressed?

How is the focus on consistently providing

products and services that meet customer

and applicable statutory and regulatory

requirements maintained?

How is client satisfaction maintained?

v.2 Quality policy

v.2.1

five.ii.1q1 Top manhistoric periodment shall establish, review and maintain

a quality policy that:

a) isouthward appropriateast to the purpose and context of the

organization;

b) provides a framework for setting and reviewin1000

quality objectives;

c) includes a commitment to satisfy applicable

requirements;

d) includes a commitment to continua50 improvement

of the quality yardanagement system.

How does height management establish,

review and maintain a quality policy?

How is it determined to be appropriate to

the purpose and context of the

system?

Does information technology provide a framework for setting and

reviewing quality objectives?

Does it contain a commitment to satisfy

applicative requirements?

Does information technology include a commitment to continual

improvement of the QMS?

5.two.2

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Q# ISO 9001:2015 Clause Inspect Question Audit Evidence

5.two.2q1 The quality policy shall:

a) be available as documented information;

b) exist communicated, understood and practical

within the organization;

c) be availableast to relevant interested parties, every bit

appropriate.

Where is the quality policy available as

documented information?

How is information technology communicated?

Show me how information technology is understood and applied

within the organisation.

How accept you made information technology available to relevant

interested parties?

Quality Policy every bit document information

five.3 Organizational roles, responsibleness and authorities

5.3q1 Top management shall ensure that the

responsibilities and authorities for relevant roles

are assigned, communicated and understood

within the system.

How does top management ensure that

responsibilities and regime for relevant

roles are assigned, communicated and

understood within the organisation?

five.3q2 Top management shall assign the responsibility

and authority for:

a) ensuring that the quality direction system

conforms to the requirements of this International

Standard;

b) ensuring that the processes are delivering their

intended outputs;

c) reporting on the performance of the quality

direction system, on opportunities for

improvement and on the need for modify or

innovation, and especially for reporting to top

management;

d) ensuring the promotion of customer focus

throughout the organization;

e) ensuring that the integrity of the quality

management system is maintained when changes

to the quality management system are planned and

implemented.

How does top management assign the

responsibility and authority for:

Ensuring that the QMS conforms to the

International standard?

Ensuring processes are delivering their

intended outputs?

How is the performance of the QMS,

opportunities for improvement and the need

for alter or innovation reported to top

management?

How is client focus promoted inside the

arrangement?

How is the integrity of the QMS maintained

when changes to the QMS are planned and

implemented?

6 Planning for the quality direction system

6.i Deportment to address risks and opportunities

6.one.1

half-dozen.1.1q1 When planning for the quality direction system,

the system shall consider the issues referred

to in 4.1 and the requirements referred to in four.two

and determine the risks and opportunities that

need to be addressed to:

a) give balls that the quality management

system tin can achieve its intended result(s);

b) prevent, or reduce, undesired effects;

c) achieve continual comeback.

How are the internal and external issues

and interested parties considered when

planning for the QMS?

How are risks and opportunities determined

and addressed so that the QMS tin can::

a) accomplish its intended results;

b) Prevent or reduce undesired effects;

c) Achieve continual comeback?

six.1.2

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Q# ISO 9001:2015 Clause Inspect Question Audit Prove

vi.1.2q1 The organization shall programme:

a) actions to address these risks and opportunities;

b) how to:

ane) integrate and implement the deportment into its

quality management system processes (see four.iv);

2) evaluate the effectiveness of these actions.

How are actions planned to accost risks

and opportunities?

How are actions integrated and

implemented into the QMS processes?

How practice yous evaluate the effectiveness of

the deportment?

6.1.2q2 Actions taken to address risks and opportunities

shall be proportionate to the potential bear on on the

conformity of products and services.

How are actions taken to address risks and

opportunities determined as being

advisable to the potential impact on the

conformity of products and services?

6.ii.2.one Production design skills

6.2.2.1q

1

The organisation shall ensure that personnel with

production design responsibleness are competent to

achieve design requirements and are skilled in

applicative tools and techniques.

Applicable tools and techniques shall exist identified

by the organization.

How do y'all decide that personnel with

product design responsibility are competent

to accomplish design requirements? How do

you decide skills required in applicable

tools and techniques? How do you place

applicable tools and techniques?

Notation Options to address risks and opportunities tin include: fugitive take a chance, taking risk in society to pursue an

opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the chance, or retaining

run a risk by informed decision.

six.two Quality objectives and planning to attain them

6.2.one

6.two.1q1 The organization shall establish quality objectives

at relevant functions, levels and processes.

The quality objectives shall:

a) exist consistent with the quality policy,

b) be measurable;

c) take into business relationship applicable requirements;

d) be relevant to conformity of products and

services and the enhancement of customer

satisfaction;

eastward) be monitored;

f) be communicated;

g) be updated as appropriate.

The organization shall retain documented

information on the quality objectives.

Where are the quality objectives and are

these at all relevant functions, levels and

processes?

Are they consistent with the quality policy?

Are they measureable?

Practise they consider applicative requirements?

Are they relevant to the conformity of

products and services and exercise they raise

customer satisfaction?

Are they monitored? How? How oftentimes?

How are they communicated?

How are they updated?

Where is the documented information on

the quality objectives?

Documented data on quality objectives

half-dozen.ii.2

6.ii.2q1 When planning how to achieve its quality

objectives, the organization shall decide:

a) what will be done;

b) what resources will exist required;

c) who will be responsible;

d) when information technology will be completed;

east) how the results volition be evaluated.

How does the organization determine what

will be done, with what resource, when

completed and how volition results be evaluated

for quality objectives?

vi.3 Planning of changes

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Q# ISO 9001:2015 Clause Inspect Question Audit Evidence

6.3q1 Where the organization determines the need for

change to the quality management organization (meet

iv.4) the change shall exist carried out in a planned

and systematic manner.

The organization shall consider:

a) the purpose of the change and any of its

potential consequences;

b) the integrity of the quality management system;

c) the availability of resource;

d) the allotment or reallocation of responsibilities

and authorities.

How are changes to the QMS planned

systematically?

Demonstrate the purpose and potential

consequences of changes;

Demonstrate the integrity of the QMS;

Demonstrate how resource are fabricated

bachelor?

Demonstrate how responsibility and

authority is allocated or reallocated.

7 Back up

seven.1 Resources

7.1.1 General

7.1.1q1 The organization shall make up one's mind and provide the

resources needed for the establishment,

implementation, maintenance and continual

improvement of the quality management system.

The organisation shall consider:

a) the capabilities of, and constraints on, existing

internal resources;

b) what needs to be obtained from external

providers.

Demonstrate how resources are determined

for the establishment, implementation,

maintenance and continual comeback of

the QMS.

Bear witness me how the capabilities and

constraints on internal resources are

considered.

Show me how needs from external

providers are considered.

7.1.2 People

7.ane.2q1 To ensure that the organization can consistently

meet customer and applicable statutory and

regulatory requirements, the organization shall

provide the persons necessary for the effective

operation of the quality direction system,

including the processes needed.

How exercise you provide persons necessary to

consistently meet customer, applicable

statutory and regulatory requirements for

the QMS including the necessary

processes?

seven.1.3 Infrastructure

vii.1.3q1 The organization shall make up one's mind, provide and

maintain the infrastructure for the operation of its

processes to accomplish conformity of products and

services.

How practise y'all make up one's mind, provide and

maintain the infrastructure for the operation

of processes to achieve products and

service conformity?

NOTE 1 Whatsoever product realization change affecting customer requirements requires notification to, and

agreement from, the client.

vii.1.4 Environment for the operation of processes

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Q# ISO 9001:2015 Clause Audit Question Audit Show

7.1.4q1 The organization shall decide, provide and

maintain the environment necessary for the

functioning of its processes and to achieve

conformity of products and services.

How do you determine, provide and

maintain the environment for the operation

of processes to accomplish products and

service conformity?

Note Environs for the operation of processes tin include concrete, social, psychological, environmental

and other factors (such as temperature, humidity, ergonomics and cleanliness).

7.1.5 Monitoring and measuring resources

7.1.5q1 Where monitoring or measuring is used for

prove of conformity of products and services to

specified requirements the system shall

make up one's mind the resource needed to ensure valid

and reliable monitoring and measuring results.

How are the resources determined for

ensuring valid and reliable monitoring and

measuring results, where used?

7.i.5q2 The system shall ensure that the resources

provided:

a) are suitable for the specific blazon of monitoring

and measurement activities being undertaken;

b) are maintained to ensure their continued fitness

for their purpose.

How exercise you ensure that resources provided

are suitable for the specific monitoring and

measurement activities and are maintained

to ensure continued fitness for purpose?

7.1.5q3 The organisation shall retain appropriate

documented information as prove of fitness for

purpose of monitoring and measurement

resources.

Testify me the documented information

which is evidence of fitness for purpose of

monitoring and measurement resources.

Documented information of fitness for purpose of monitoring

& measurement resources.

7.i.5q4 Where measurement traceability is: a statutory or

regulatory requirement; a customer or relevant

interested party expectation; or considered by the

organization to be an essential part of providing

confidence in the validity of measurement results;

measuring instruments shall be:

-verified or calibrated at specified intervals or prior

to use confronting measurement standards traceable to

international or national measurement standards.

Where no such standards exist, the basis used for

calibration or verification shall exist retained equally

documented information;

-identified in society to determine their calibration

condition;

-safeguarded from adjustments, impairment or

deterioration that would invalidate the calibration

status and subsequent measurement results.

Where applicable, show me how

measurement instruments are:

Verified or calibrated at specified intervals

against national or international

measurement standards;

If there are no standards, prove me the

documented information which is used as

the basis used for calibration or verification.

Show me how measurement instruments

are identified to decide their calibration

status.

Evidence me how they are safeguarded from

adjustments.

Show me how they are safeguarded from

damage and deterioration.

Documented information for the basis of calibration or

verification where no standards exist.

seven.one.5q5 The arrangement shall determine if the validity of

previous measurement results has been adversely

affected when an instrument is found to be

lacking during its planned verification or

calibration, or during its utilize, and accept advisable

corrective action as necessary.

How do y'all determine the validity of

previous measurements if you lot find an

instrument to be defective during verification

or calibration?

What appropriate actions tin can you lot take?

7.i.6 Organizational knowledge

vii.one.6q1 The organization shall determine the knowledge

necessary for the functioning of its processes and to

reach conformity of products and services.

How do you determine necessary

knowledge for the operation of processes?

How practise you determine necessary

knowledge to accomplish conformity of

products and services?

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence

7.1.6q2 This noesis shall exist maintained, and made

bachelor to the extent necessary.

How do you maintain this knowledge and

how practice you brand it available to the extent

necessary?

seven.1.6q3 When addressing changing needs and trends, the

organization shall consider its current cognition

and decide how to larn or access the

necessary additional cognition.

How practise y'all consider current knowledge

and how do you larn additional

knowledge when addressing irresolute

needs and trends?

Notation 1 Organizational knowledge can include information such every bit 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 cognition

and experience of topical experts within the arrangement);

b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or

providers).

7.ii Competence

7..2q1 The organization shall:

a) determine the necessary competence of

person(s) doing work nether its command that affects

its quality functioning;

b) ensure that these persons are competent on the

basis of appropriate education, training, or

experience;

c) where applicable, have actions to learn the

necessary competence, and evaluate the

effectiveness of the actions taken;

d) retain appropriate documented information as

show of competence.

Show me how:

You make up one's mind the necessary competence

of people doing work under your command that

affects quality functioning;

How do you determine competence on the

basis of appropriate educational activity, training or

feel?

How exercise y'all take actions to acquire

necessary competence where applicable

and how do you lot evaluate the effectiveness

of those actions?

Bear witness me documented information where

appropriate of competence.

Documented information as prove of competence where

appropriate.

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 organization's

control shall be aware of:

a) the quality policy;

b) relevant quality objectives;

c) their contribution to the effectiveness of the

quality direction organisation, including the benefits

of improved quality performance;

d) the implications of non conforming with the

quality management system requirements.

How are people aware of:

The quality policy?

Relevant quality objectives?

Their contribution to the effectiveness of the

QMS?

The benefits of improved performance?

The implications of not conforming with the

QMS requirements?

7.four Communication

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Q# ISO 9001:2015 Clause Inspect Question Audit Evidence

7.4q1 The organization shall determine the internal and

external communications relevant to the quality

management organization including:

a) on what it will communicate;

b) when to communicate;

c) with whom to communicate;

d) how to communicate.

How practice you determine internal and external

communications relevant to the QMS?

How do you lot determine:

What?

When?

With Whom?

How?

7.5 Documented information

vii.5.1 General

7.v.1q1 The organization's quality management system

shall include:

a) documented information required past this

International Standard;

b) documented information determined by the

system as being necessary for the

effectiveness of the quality management organization.

What documented information do you lot

have as required past this standard?

What documented information do you

have as being necessary for the

effectiveness of your QMS?

Documented information required by this standard.

Documented information necessary for the effectiveness of

the QMS.

NOTE The extent of documented data for a quality direction system can differ from one

organisation to some other due to:

a) the size of system and its blazon of activities, processes, products and services;

b) the complexity of processes and their interactions;

c) the competence of persons.

7.5.ii Creating and updating

7.5.2q1 When creating and updating documented

information the system shall ensure

advisable:

a) identification and description (eastward.g. a title, date,

writer, or reference number);

b) format (e.g. linguistic communication, software version,

graphics) and media (e.g. newspaper, electronic);

c) review and approving for suitability and adequacy.

Testify me that your documented

information contains:

Identification;

Description;

In what media format?

Prove me how the documented information

is reviewed and approved for suitability and

adequacy.

Documented information (in various media) needs

identification, description.

Review / blessing process?

7.5.3 Command of documented information

7.5.3.one

vii.5.iii.1q

one

Documented information required by the quality

direction system and by this International

Standard shall exist controlled to ensure:

a) it is available and suitable for utilise, where and

when it is needed;

b) it is adequately protected (e.g. from loss of

confidentiality, improper use, or loss of integrity).

Show me how you control documented

information.

Show me how you brand it available and

suitable for utilize.

How exercise y'all protect your documented

information?

Command of documented information.

Suitability and availability for use.

How is it protected?

7.v.3.ii

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7.5.3.2q

1

For the control of documented information, the

organization shall address the following

activities, every bit applicative:

a) distribution, access, retrieval and employ;

b) storage and preservation, including preservation

of legibility;

c) control of changes (e.g. version command);

d) retention and disposition.

When decision-making documented information,

how do you address:

Distribution;

Admission;

Retrieval;

Use;

Storage and preservation;

Legibility;

Command of changes;

Memory and disposition.

Control of documented information.

Change control, distribution, access, retrieval, utilize, storage,

preservation, legibility, retention and disposition.

7.v.3.2q

ii

Documented data of external origin

determined past the organization to be necessary for

the planning and operation of the quality

management system shall exist identified equally

appropriate, and controlled.

How do yous place as advisable and

control documented data of

external origin which you lot accept determined

as necessary for the QMS

Command of external documented information.

Notation Access can imply a decision regarding the permission to view the documented information but, or the

permission and authority to view and change the documented data.

8 Operation

8.i Operational planning and control

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8.1q1 The arrangement shall plan, implement and control

the processes, as outlined in 4.4, needed to meet

requirements for the provision of products and

services and to implement the actions determined

in 6.1, by:

a) determining requirements for the product and

services;

b) establishing criteria for the processes and for the

acceptance of products and services;

c) determining the resources needed to achieve

conformity to product and service requirements;

d) implementing control of the processes in

accordance with the criteria;

east) retaining documented data to the extent

necessary to have confidence that the processes

take been carried out as planned and to

demonstrate conformity of products and services to

requirements.

How are processes needed to meet

requirements for provision of products and

services planned, implemented and

controlled?

How are requirements for products and

services determined?

How is criteria for processes and

acceptance for products and services

determined?

How are resources determined?

How is process control implemented?

Evidence me the documented information

that shows conviction in that the processes

have been carried out equally planned and can

demonstrate conformity of products and

services.

Documented information to show processes have been

carried out as planned and can demonstrate conformity of

products and services.

eight.1q2 The output of this planning shall be suitable for the

organisation's operations.

How take you determined that the output

from the planning process is suitable for

your operations?

viii.1q3 The organization shall control planned changes

and review the consequences of unintended

changes, taking action to mitigate any adverse

effects, as necessary.

How practice y'all control planned changes? How

do y'all review the consequences of

unintended changes? What action is taken

to mitigate whatever adverse effects?

8.1q4 The organization shall ensure that outsourced

processes are controlled in accordance with 8.4.

How practice y'all control outsourced processes?

viii.2 Determination of requirements for products and services

8.2.one Client communication

8.ii.1q1 The system shall plant the processes for

communicating with customers in relation to:

a) information relating to products and services;

b) enquiries, contracts or order handling, including

changes;

c) obtaining client views and perceptions,

including client complaints;

d) the treatment or treatment of customer property, if

applicative;

e) specific requirements for contingency actions,

when relevant.

What are your processes for communicating

with customers? How do you communicate

information relating to:

Products;

Services;

Enquiries;

Contracts;

Order treatment;

Customer views, perceptions and

complaints;

Handling or treatment of customer property;

Specific requirements for contingency

actions?

8.2.2 Decision of requirements related to products and services

Folio 12

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8.2.2q1 The organization shall found, implement and

maintain a process to determine the requirements

for the products and services to be offered to

potential customers.

What is your process to decide the

requirements for products and services to

be offered to potential customers? How do

you establish, implement and maintain this

process?

8.2.2q2 The organisation shall ensure that:

a) product and service requirements (including

those considered necessary past the organization),

and applicable statutory and regulatory

requirements, are defined;

b) it has the ability to meet the defined

requirements and substantiate the claims for the

products and services it offers.

How practice you ascertain product and service

requirements including statutory and

regulatory requirements?

How do you ensure that y'all have the ability

to encounter the defined requirements and

substantiate whatsoever claims for your products

and services?

8.two.iii Review of requirements related to products and services

eight.2.3q1 The organization shall review, as applicable:

a) requirements specified past the client,

including the requirements for delivery and post-

delivery activities;

b) requirements not stated by the customer, but

necessary for the customers' specified or intended

use, when known;

c) additional statutory and regulatory requirements

applicable to the products and services;

d) contract or order requirements differing from

those previously expressed.

How practice you lot review:

Client requirements for delivery and

mail service-commitment?

Requirements necessary for customers'

specified or intended utilize, where known;

Additional statutory and regulatory

requirements applicable to products and

services;

Any other contract or order requirements.

Notation Requirements can also include those arising from relevant interested parties.

8.2.3q2 This review shall be conducted prior to the

arrangement's commitment to supply products and

services to the customer and shall ensure contract

or social club requirements differing from those

previously defined are resolved.

Prove me that the review is conducted prior

to your commitment to supply products and

services to your customers. How practice you

resolve contract or lodge requirements

which differ from those previously defined?

8.2.3q3 Where the client does not provide a

documented statement of their requirements, the

customer requirements shall exist confirmed by the

organization before acceptance.

How do you confirm customer requirements

where the client does not provide a

documented argument?

eight.2.3q4 Documented information describing the results of

the review, including any new or inverse

requirements for the products and services, shall

exist retained.

Testify me where you lot retain documented

information which describes results of the

review including any new or inverse

requirements.

Documented information of reviews describing new or

changed requirements to products and services.

viii.2.3q5 Where requirements for products and services are

changed, the organization shall ensure that

relevant documented information is amended and

that relevant personnel are fabricated aware of the

changed requirements.

Bear witness me the documented information

containing changes to products and

services. How do you lot ensure that relevant

personnel are made aware of those

changes?

Documented information of amended reviews and how

relevant personnel are made enlightened of those changes.

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Q# ISO 9001:2015 Clause Audit Question Inspect Evidence

8.3 Design and evolution of products and services

8.3.1 Full general

8.three.1q1 Where the detailed requirements of the

organisation'southward products and services are non

already established or non defined by the customer

or by other interested parties, such that they are

adequate for subsequent product or service

provision, the organization shall establish,

implement and maintain a design and development

process.

How do you establish, implement and

maintain a design and development process

(where detailed requirements of your

products and services are not already

established or defined by the customer or

other parties).

NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for

production and services provision.

Notation 2 For services, pattern and development planning can address the whole service commitment procedure. The

organization can therefore choose to consider the requirements of clauses eight.3 and viii.5 together.

8.3.2 Pattern and development planning

Page 14

Q# ISO 9001:2015 Clause Audit Question Audit Bear witness

8.three.2q1 In determining the stages and controls for design

and evolution, the arrangement shall consider:

a) the nature, duration and complexity of the

design and development activities;

b) requirements that specify item process

stages, including applicable design and

evolution reviews;

c) the required design and development verification

and validation;

d) the responsibilities and regime involved in

the design and development process;

e) the need to control interfaces betwixt

individuals and parties involved in the design and

development process;

f) the need for involvement of customer and user

groups in the pattern and evolution process;

g) the necessary documented data to

ostend that design and development requirements

take been met.

When determining the stages and command

for design and development, evidence me how

yous consider:

The nature, elapsing and complexity of the

activities;

Requirements that specify particular

process stages including applicable

reviews;

Required verification and validation;

Responsibilities and authorities;

How interfaces are controlled between

individuals and parties;

The need for involvement of customer and

user groups.

Show me documented information that

confirms blueprint and evolution

requirements have been met.

Documented information that confirms blueprint & development

requirements have been met.

8.3.3 Pattern and development inputs

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Q# ISO 9001:2015 Clause Audit Question Audit Show

8.3.3q1 The organization shall make up one's mind:

a) requirements essential for the specific type of

products and services being designed and

adult, including, equally applicable, functional and

performance requirements;

b) applicable statutory and regulatory

requirements;

c) standards or codes of practice that the

system has committed to implement;

d) internal and external resource needs for the

design and development of products and services;

e) the potential consequences of failure due to the

nature of the products and services;

f) the level of control expected of the design and

development procedure by customers and other

relevant interested parties.

Can yous evidence me how you make up one's mind:

Requirements essential for the type of

products and services existence designed and

adult, including every bit applicative:

Functional & performance requirements;

Statutory and regulatory requirements;

Standards or codes of practise where there

is a commitment to implement;

Internal and external resources needed for

the design and development of products

and services;

Potential consequences of failure;

Level of control expected of the design and

evolution process past customers and

other relevant parties.

8.3.3q2 Inputs shall be acceptable for pattern and

evolution purposes, consummate, and

unambiguous. Conflicts among inputs shall be

resolved.

How practice you make up one's mind that inputs are

acceptable, complete and unambiguous for

design and development? How do you

resolve conflicts among inputs?

8.iii.iv Design and evolution controls

8.three.4q1 The controls applied to the design and

development process shall ensure that:

a) the results to be achieved past the blueprint and

evolution activities are clearly defined;

b) pattern and development reviews are conducted

as planned;

c) verification is conducted to ensure that the

design and development outputs accept met the

design and development input requirements;

d) validation is conducted to ensure that the

resulting products and services are capable of

coming together the requirements for the specified

application or intended use (when known).

How do controls that are practical to the

design and development process ensure:

Results achieved by design and

development activities are clearly defined?

Pattern and evolution reviews are

conducted as planned?

Outputs run into the input requirements past

verification/

Validation is conducted to ensure that the

resulting products and services are capable

of meeting the requirements for the

specified application or intended use (when

known)?

eight.three.5 Blueprint and development outputs

viii.3.5q1 The organization shall ensure that design and

development outputs:

a) meet the input requirements for design and

evolution;

b) are acceptable for the subsequent processes for

the provision of products and services;

c) include or reference monitoring and measuring

requirements, and acceptance criteria, as

applicable;

d) ensure products to be produced, or services to

be provided, are fit for intended purpose and their

safety and proper use.

How do you lot ensure that blueprint and

evolution outputs:

Meet the input requirements for design and

development?

Are adequate for the subsequent processes

for the provision of products and services?

Include or reference monitoring and

measuring requirements, and acceptance

criteria, equally applicable?

Ensure products to be produced, or services

to be provided, are fit for intended purpose

and their prophylactic and proper use?

Folio 16

Q# ISO 9001:2015 Clause Audit Question Audit Evidence

8.3.5q2 The organization shall retain the documented

information resulting from the design and

development process.

Bear witness me the documented information

which results from the design and

development procedure.

Documented data from the design and evolution

procedure.

eight.3.6 Blueprint and development changes

viii.3.6q1 The organization shall review, control and identify

changes fabricated to design inputs and design outputs

during the design and development of products

and services or subsequently, to the extent that

there is no agin impact on conformity to

requirements.

How do you review, control and identify

changes made to the blueprint inputs and

outputs during design and development of

products and services ensuring no bear upon

on conformity to requirements?

8.3.6q2 Documented information on design and

evolution changes shall be retained.

Show me the documented data for

design and development changes.

Documented information for blueprint and evolution

changes.

8.4 Control of externally provided products and services

8.4.i General

eight.4.1q1 The organisation shall ensure that externally

provided processes, products, and services

suit to specified requirements.

How practise you lot ensure externally provided

processes, products and services accommodate

to specified requirements?

8.iv.1q2 The organization shall apply the specified

requirements for the control of externally provided

products and services when:

a) products and services are provided past external

providers for incorporation into the organization's

own products and services;

b) products and services are provided directly to

the customer(s) by external providers on behalf of

the organization;

c) a process or office of a process is provided past an

external provider equally a result of a decision by the

organization to outsource a procedure or role.

Show me how yous employ specified

requirements for the control of externally

provided products and services when:

Products and services are provided by

external providers for incorporation into your

own products and services;

You provide products and services directly

to customers by external providers on your

behalf;

A process or part-procedure is provided past an

external provider every bit a result of a conclusion to

outsource a procedure or function.

8.iv.1q3 The organization shall constitute and apply 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 specified requirements.

Evidence me how you establish and apply

criteria for evaluation, option, monitoring

of performance and re-evaluation of

external providers. How do you assess their

ability to provide processes or products and

services in accordance with specified

requirements?

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Q# ISO 9001:2015 Clause Inspect Question Audit Show

8.iv.1q4 The organization shall retain appropriate

documented information of the results of the

evaluations, monitoring of the performance and re-

evaluations of the external providers.

What documented information do you

have of the results of evaluations,

monitoring of functioning and re-

evaluations of external providers?

Documented information of external providers' performance.

8.4.2 Type and extent of control of external provision

8.4.2q1 In determining the type and extent of controls to be

practical to the external provision of processes,

products and services, the organization shall accept

into consideration:

a) the potential impact of the externally provided

processes, products and services on the

organization's ability to consistently meet client

and applicable statutory and regulatory

requirements;

b) the perceived effectiveness of the controls

applied by the external provider.

How exercise you lot determine the controls practical

to the external provision of processes,

products and services and have into

consideration:

a) The potential impact of the externally

provided processes, products and services

on the ability to consistently meet customer

and applicable statutory and regulatory

requirements?

b) The perceived effectiveness of the

controls applied by the external provider?

8.4.2q2 The organization shall found and implement

verification or other activities necessary to ensure

the externally provided processes, products and

services do not adversely affect the organization'south

ability to consistently deliver conforming products

and services to its customers.

What verification or other activities do yous

accept to ensure externally provided

processes, products and services exercise not

adversely affect your ability to consistently

evangelize conforming products and services to

your customers?

8.4.2q3 Processes or functions of the system which

take been outsourced to an external provider

remain within the telescopic of the arrangement'south

quality management arrangement; appropriately, the

organization shall consider a) and b) in a higher place and

define both the controls it intends to apply to the

external provider and those it intends to apply to

the resulting process output.

When processes or functions accept been

outsourced to external providers, how do

you consider a) and b) in 8.iv.1 and how do

you ascertain the controls intended to exist

applied to the external provider and to the

resulting process output?

8.iv.3 Information for external providers

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Q# ISO 9001:2015 Clause Audit Question Audit Evidence

8.4.3q1 The organization shall communicate to external

providers applicable requirements for the post-obit:

a) the products and services to be provided or the

processes to exist performed on behalf of the

organization;

b) approving or release of products and services,

methods, processes or equipment;

c) competence of personnel, including necessary

qualification;

d) their interactions with the organization's quality

management arrangement;

e) the command and monitoring of the external

provider'due south performance to be applied by the

organization;

f) verification activities that the system, or its

customer, intends to perform at the external

provider'southward premises.

Show me how you communicate to external

providers, applicable requirements for:

Products and services to be provided or the

processes to be performed on behalf of the

arrangement;

Approval or release of products and

services, methods, processes or equipment;

Competence of personnel, including

necessary qualification;

Their interactions with the organization'southward

quality management arrangement;

The control and monitoring of the external

provider'south performance to exist applied by the

organization;

Verification activities that the organization,

or its customer, intends to perform at the

external provider's premises.

eight.4.3q2 The organization shall ensure the adequacy of

specified requirements prior to their communication

to the external provider.

Earlier yous communicate with external

providers, how do you ensure the capability

of specified requirements?

8.v Production and service provision

8.5.1 Control of production and service provision

8.5.1q1 The organization shall implement controlled

conditions for product and service provision,

including delivery and post-commitment activities.

What controlled conditions do you have for

production and service provision, including

delivery and mail-delivery activities?

Page 19

Q# ISO 9001:2015 Clause Inspect Question Audit Evidence

8.five.1q2 Controlled conditions shall include, equally applicable:

a) the availability of documented information that

defines the characteristics of the products and

services;

b) the availability of documented information that

defines the activities to be performed and the

results to be accomplished;

c) monitoring and measurement activities at

appropriate stages to verify that criteria for control

of processes and process outputs, and acceptance

criteria for products and services, have been met.

d) the utilise, and control of suitable infrastructure

and process environment;

eastward) the availability and utilize of suitable monitoring

and measuring resources;

f) the competence and, where applicable, required

qualification of persons;

one thousand) the validation, and periodic revalidation, of the

ability to accomplish planned results of whatever process for

production and service provision where the

resulting output cannot be verified by subsequent

monitoring or measurement;

h) the implementation of products and services

release, delivery and post-delivery activities.

Tin can you lot show me controlled conditions for:

a) the availability of documented information

defining the characteristics of the products

and services;

b) the availability of documented

information defining the activities to be

performed and the results to be accomplished;

c) monitoring and measurement activities at

appropriate stages to verify that criteria for

control of processes and procedure outputs,

and credence criteria for products and

services, have been met.

d) the use, and control of suitable

infrastructure and process environment;

eastward) the availability and employ of suitable

monitoring and measuring resources;

f) the competence and, where applicative,

required qualification of persons;

one thousand) the validation, and periodic revalidation,

of the ability to reach planned results of

any procedure for production and service

provision where the resulting output cannot

be verified by subsequent monitoring or

measurement;

h) the implementation of products and

services release, delivery and post-delivery

activities.

Documented information defining characteristics of the

products and services

eight.v.two Identification and traceability

viii.5.2q1 Where necessary to ensure conformity of products

and services, the organisation shall use suitable

means to place procedure outputs.

What means exercise y'all apply to place procedure

outputs to ensure conformity of products

and services?

8.5.2q2 The system shall place the status of process

outputs with respect to monitoring and

measurement requirements throughout production

and service provision.

How practise you identify the status of process

outputs?

8.5.2q3 Where traceability is a requirement, the

organization shall command the unique identification

of the procedure outputs, and retain whatsoever documented

information necessary to maintain traceability.

How do you control the unique identification

of process outputs, where applicable? What

documented data do you retain?

Documented information of traceability, where required.

Notation Process outputs are the results of any activities which are prepare for delivery to the organization'south

client or to an internal customer (east.grand. receiver of the inputs to the next procedure); they tin can include

products, services, intermediate parts, components, etc.

8.v.iii Property belonging to customers or external providers

Folio 20

Q# ISO 9001:2015 Clause Audit Question Audit Show

8.5.3q1 The organization shall exercise care with property

belonging to the client or external providers

while it is under the organization'due south command or existence

used by the organization. The organization shall

identify, verify, protect and safeguard the

client's or external provider's property provided

for utilise or incorporation into the products and

services.

What care exercise you provide for client or

external provider's belongings while under

your control?

How do you place, verify, protect and

safeguard that property which is provided

for apply or incorporation into your products

or services?

8.5.3q2 When property of the customer or external provider

is incorrectly used, lost, damaged or otherwise

found to be unsuitable for use, the organization

shall report this to the client or external

provider.

What means do yous apply to study to the

client or external provider if their

property is incorrectly used, lost, damaged

or found to be unsuitable for utilize?

Note Client holding tin can include material, components, tools and equipment, customer bounds,

intellectual holding and personal data.

viii.5.4 Preservation

8.5.4q1 The arrangement shall ensure preservation of

process outputs during product and service

provision, to the extent necessary to maintain

conformity to requirements.

How practice yous ensure preservation of process

outputs during production and service

provision to maintain conformity to production

requirements?

Annotation Preservation tin can include identification, handling, packaging, storage, transmission or transportation,

and protection.

viii.5.5 Post-delivery activities

8.v.5q1 As applicative, the arrangement shall meet

requirements for post-commitment activities associated

with the products and services.

How exercise you run into requirements for post-

delivery activities associated with products

and services?

eight.five.5q2 In determining the extent of mail-delivery activities

that are required, the organisation shall consider:

a) the risks associated with the products and

services;

b) the nature, use and intended lifetime of the

products and services;

c) customer feedback;

d) statutory and regulatory requirements.

How exercise you decide:

Risk;

Nature, use and intended lifetime;

Customer feedback;

Statutory and Regulatory requirements,

when determining the extent of post-commitment

activities required with products and

services?

Annotation Mail service-delivery activities tin can include actions under warranty provisions, contractual obligations such as

maintenance services, and supplementary services such as recycling or last disposal.

8.5.6 Control of changes

8.5.6q1 The organization shall review and control

unplanned changes essential for production or

service provision to the extent necessary to ensure

continuing conformity with specified requirements.

How do you review and control unplanned

changes to ensure continuing conformity

with specified requirements?

viii.5.6q2 The arrangement shall retain documented

information describing the results of the review of

changes, the personnel authorizing the change,

and whatever necessary actions.

What documented information can yous

evidence me which describes the results of

reviews of changes, the personnel

authorizing change and any necessary

actions?

Documented data describing results of review of

changes, personnel and actions.

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8.6 Release of products and services

8.6q1 The organisation shall implement the planned

arrangements at appropriate stages to verify that

product and service requirements have been met.

Testify of conformity with the credence criteria

shall be retained.

Prove me how planned organisation have

been implemented at appropriate stages to

verify production and service requirements

have been met. Show me what evidence

you lot retain.

viii.6q2 The release of products and services to the

client shall not proceed until the planned

arrangements for verification of conformity have

been satisfactorily completed, unless otherwise

canonical by a relevant authorisation and, as

applicative, by the customer. Documented

information shall provide traceability to the

person(s) authorizing release of products and

services for delivery to the client.

Show me how the release of products and

services is held until planned arrangements

for verification of conformity have been

satisfactorily completed, unless approved by

a relevant authorisation, or the customer if

applicable. Evidence me documented

information which shows traceability to the

person authorizing release of products and

services.

Documented information providing traceability, authorizing

release of products and services.

eight.7 Control of non-conforming process outputs, products and services

8.7q1 The organization shall ensure process outputs,

products and services that practice non conform to

requirements are identified and controlled to

prevent their unintended use or delivery.

How do you lot place and control process

outputs, products and services that do non

arrange to requirements and prevent their

unintended use or delivery?

8.7q2 The organisation shall have appropriate corrective

action based on the nature of the nonconformity

and its impact on the conformity of products and

services. This applies also to nonconforming

products and services detected after delivery of the

products or during the provision of the service.

What appropriate corrective deportment are

taken based on the nature of the

nonconformity and its impact on the

conformity of products and services? How

practise y'all apply this to nonconformity detected

later commitment?

viii.7q3 As applicable, the system shall deal with

nonconforming procedure outputs, products and

services in 1 or more of the following ways:

a) correction;

b) segregation, containment, return or suspension

of provision of products and services;

c) informing the client;

d) obtaining authorization for:

- use "as-is';

- release, continuation or re-provision of the

products and services;

- acceptance under concession.

How you bargain with nonconforming process

outputs, products and services in terms of:

Correction;

Segregation, containment, return or

break of provision of products and

services?

Informing the customer?

Obtaining authorization for use every bit-is?

Release, continuation or re-provision of the

products and service?

Credence nether concession?

viii.7q4 Where nonconforming process outputs, products

and services are corrected, conformity to the

requirements shall be verified.

How do yous verify conformance where

process outputs, products and services are

corrected following nonconformance?

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8.7q5 The organization shall retain documented

information of actions taken on nonconforming

process outputs, products and services, including

on any concessions obtained and on the person or

dominance that made the decision regarding dealing

with the nonconformity.

What documented data do you lot

keep following deportment taken to accost

nonconformities, including any concessions

obtained and on the person or potency that

made the decision regarding dealing with

the nonconformance.

Documented information for actions taken following

nonconformance, including concessions and say-so

granted.

9 Performance evaluation

9.one Monitoring, measurement, analysis and evaluation

ix.ane.1 General

ix.1.1q1 The organisation shall determine:

a) what needs to be monitored and measured;

b) the methods for monitoring, measurement,

analysis and evaluation, as applicable, to ensure

valid results;

c) when the monitoring and measuring shall exist

performed;

d) when the results from monitoring and

measurement shall be analysed and evaluated.

Bear witness me how you make up one's mind:

What needs to be monitored and

measured?

Methods for monitoring, measurement,

analysis and evaluation to ensure valid

results?

When to perform monitoring and

measuring?

When results shall be analysed and

evaluated?

9.one.1q2 The organization shall ensure that monitoring and

measurement activities are implemented in

accordance with the determined requirements and

shall retain appropriate documented information as

bear witness of the results.

What documented information tin y'all

bear witness me that monitoring and measurement

activities have been implemented in

accordance with determined requirements?

Documented information of monitoring and measurement

activities in accordance with determined requirements.

ix.1.1q3 The organization shall evaluate the quality

functioning and the effectiveness of the quality

management arrangement.

Prove me how you evaluate the quality

performance and the effectiveness of the

QMS.

9.one.2 Customer satisfaction

9.1.2q1 The arrangement shall monitor client

perceptions of the degree to which requirements

have been met.

How do yous monitor customer perception of

the degree to which requirements have

been met?

9.one.2q2 The organization shall obtain information relating to

customer views and opinions of the organization

and its products and services.

How do you obtain data relating to

client views and opinions of your

products and services?

9.one.2q3 The methods for obtaining and using this

information shall exist determined.

What methods for obtaining and using this

information exercise you have?

NOTE Information related to client views can include client satisfaction or opinion surveys, customer

data on delivered products or services quality, marketplace-share analysis, compliments, warranty claims and

dealer reports.

9.1.3 Assay and evaluation

9.1.3q1 The system shall analyse and evaluate

advisable data and information arising from

monitoring, measurement and other sources.

So me how y'all analyse and evaluate data

and information arising from monitoring,

measurement and other sources.

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9.1.3q2 The output of analysis and evaluation shall be used

to:

a) demonstrate conformity of products and services

to requirements;

b) assess and heighten customer satisfaction;

c) ensure conformity and effectiveness of the

quality direction system;

d) demonstrate that planning has been successfully

implemented;

due east) assess the performance of processes;

f) assess the performance of external provider(s);

k) determine the need or opportunities for

improvements within the quality management

system.

Show me how the output of analysis and

evaluation is used to:

Demonstrate conformity of products and

services to requirements?

Appraise and enhance customer satisfaction?

Ensure conformity and effectiveness of the

QMS?

Demonstrate that planning has been

successfully implemented?

Assess process performance?

Appraise performance of external providers?

Determine the need or opportunities for

improvements within the QMS?

9.1.3q3 The results of analysis and evaluation shall also be

used to provide inputs to management review.

Show me where the results of analysis and

evaluation are used to provide inputs to

direction review.

ix.2 Internal audit

ix.2.1

9.2.1q1 The organization shall conduct internal audits at

planned intervals to provide information on whether

the quality management system;

a) conforms to:

i) the organization's own requirements for

its quality management system;

two) the requirements of this International

Standard;

b) is finer implemented and maintained.

Are internal audits beingness conducted at

planned intervals? Practise they make up one's mind

whether the QMS conforms to the

requirements of ISO 9001 and to the other

requirements established by Organization?

(Review records to demonstrate

conformance)

Practice they determine whether the QMS is

finer implemented and maintained?

(Review records)

9.2.2

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Q# ISO 9001:2015 Clause Inspect Question Audit Evidence

9.ii.2q1 The organisation shall:

a) programme, establish, implement and maintain an audit

programme(s) including the frequency, methods,

responsibilities, planning requirements and

reporting, which shall take into consideration the

quality objectives, the importance of the processes

concerned, customer feedback, changes

impacting on the organization, and the results of

previous audits;

b) ascertain the inspect criteria and scope for each

audit;

c) select auditors and behave audits to ensure

objectivity and the impartiality of the audit process;

d) ensure that the results of the audits are reported

to relevant management;

e) accept necessary correction and cosmetic actions

without undue delay;

f) retain documented information as testify of the

implementation of the inspect programme and the

inspect results.

Can you show me audit programme(s) that

takes into consideration the quality

objectives, importance of the processes,

customer feedback, changes impacting the

organisation and the results of previous

audits?

Where are the audit criteria and telescopic for

each audit?

Tin you lot demonstrate that selection of

auditors and the conduct of audits are

objective and impartial and that auditors

don't audit their own piece of work?

How are audit results reported to relevant

management?

Can y'all demonstrate that necessary

correction and corrective actions are taken

without undue filibuster?

Can you show me documented

information of the inspect plan and

the audit results?

Documented information of the audit plan and results

Note See ISO 19011 for guidance.

9.iii Management Review

9.3.i

9.3.1q1 Top management shall review the organization's

quality management system, at planned intervals,

to ensure its continuing suitability, adequacy, and

effectiveness.

What is the frequency that elevation management

reviews the organization's QMS? How is

the QMS accounted suitable, adequate and

effective?

Page 25

Q# ISO 9001:2015 Clause Inspect Question Audit Prove

9.3.1q2 The management review shall be planned and

carried out taking into consideration:

a) the status of deportment from previous direction

reviews;

b) changes in external and internal problems that are

relevant to the quality management system

including its strategic direction;

c) information on the quality performance, including

trends and indicators for:

1) nonconformities and corrective deportment;

two) monitoring and measurement results;

iii) audit results;

4) customer satisfaction;

5) problems concerning external providers and other

relevant interested parties;

half-dozen) adequacy of resources required for maintaining

an effective quality management system;

seven) process performance and conformity of products

and services;

d) the effectiveness of actions taken to address

risks and opportunities (see clause 6.1);

e) new potential opportunities for continual

improvement.

What kinds of information are reviewed in

management reviews? These must include:

actions status of previous reviews;

changes to internal/external bug relevant

to the QMS;

problems that bear upon strategy;

KPIs for nonconformities and corrective

actions;

monitor and measurement of results;

audit results;

customer satisfaction;

issues concerning external providers;

issues apropos other relevant parties;

adequacy of resources and effectiveness of

QMS;

process functioning;

conformity of products and services;

actions taken to address risks and

opportunities and their effectiveness;

new potential opportunities for continual

improvement.

9.iii.two

9.3.2q1 The outputs of the direction review shall

include decisions and actions related to:

a) continual comeback opportunities;

b) any need for changes to the quality

management system, including resource needs.

Show me that management reviews include

decisions and deportment relating to:

Continual improvement opportunities;

The need for changes to the QMS including

resource needs.

9.iii.2q2 The arrangement shall retain documented

information as show of the results of

management reviews.

Bear witness me what documented information

you have every bit evidence of management

reviews.

Documented information of management reviews.

10 Improvement

10.one General

ten.1q1 The organization shall determine and select

opportunities for improvement and implement

necessary actions to encounter customer requirements

and enhance customer satisfaction.

How practise you determine and select

opportunities for improvement? What

necessary actions have you lot implemented

so that you have met customer

requirements and enhanced client

satisfaction?

ten.1q2 This shall include, as advisable:

a) improving processes to prevent nonconformities;

b) improving products and services to come across known

and predicted requirements;

c) improving quality management organization results.

Show me how y'all accept:

Improved processes to prevent

nonconformities;

Improved products and services to meet

known and predicted requirements;

Improved QMS results.

Notation Improvement tin can be effected reactively (e.g. cosmetic action), incrementally (e.g. continual

improvement), by footstep change (due east.yard. breakthrough), creatively (eastward.g. innovation) or by re-system (e.g.

transformation).

ten.2 Nonconformity and cosmetic action

Page 26

Q# ISO 9001:2015 Clause Audit Question Audit Evidence

10.2.1

10.2.1q1 When a nonconformity occurs, including those

arising from complaints, the organization shall:

a) react to the nonconformity, and as applicable:

1) take activity to control and correct it;

2) deal with the consequences;

b) evaluate the need for action to eliminate the

cause(s) of the nonconformity, in society that information technology does

not recur or occur elsewhere, by:

1) reviewing the nonconformity;

ii) determining the causes of the nonconformity;

3) determining if similar nonconformities be, or

could potentially occur;

c) implement any activeness needed;

d) review the effectiveness of whatsoever corrective action

taken;

e) brand changes to the quality management

arrangement, if necessary.

When nonconformities occur, show me how;

You react;

Take action to control and correct it;

Bargain with the consequences;

Evaluate the demand for activity to eliminate the

crusade so that it does not recur or occur

elsewhere past:

Reviewing the nonconformity;

Determining the cause of the nonconformity;

Determining if similar nonconformities be

or could potentially occur;

Deportment needed are implemented;

Review the effectiveness of corrective

actions taken, if whatever;

Brand necessary changes to the QMS.

10.two.1q2 Corrective actions shall be appropriate to the

effects of the nonconformities encountered.

Evidence me how correction actions were

appropriate to the effects of the

nonconformities encountered.

Notation 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.

NOTE ii Cosmetic activeness can reduce the likelihood of recurrence to an acceptable level.

ten.2.two

10.2.2q1 The arrangement shall retain documented

information as evidence of:

a) the nature of the nonconformities and any

subsequent actions taken;

b) the results of any corrective activeness.

What documented information tin you lot

bear witness me as evidence of:

The nature of the nonconformities and

subsequent actions taken;

The results of whatsoever corrective activity.

Documented information of the nature of nonconformities,

subsequent actions and results of cosmetic action.

x.three Continual improvement

10.3q1 The arrangement shall continually better the

suitability, adequacy, and effectiveness of the

quality management system.

Demonstrate that yous continually improve

the suitability, adequacy and effectiveness

of the QMS.

10.3q2 The organisation shall consider the outputs of

assay and evaluation, and the outputs from

direction review, to confirm if there are areas

of underperformance or opportunities that shall be

addressed equally part of continual improvement.

Demonstrate that outputs of assay and

evaluation and the outputs from

management review are considered to

confirm if there are areas of

underperformance or opportunities that shall

exist addressed as part of continual

improvement.

10.3q3 Where applicable, the organization shall select and

utilise applicable tools and methodologies for

investigation of the causes of underperformance

and for supporting continual improvement.

What applicable tools and methodologies

for investigation of the causes of

underperformance and to back up continual

improvement are selected?

Page 27

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