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AS/NZS ISO 9001:2008 Queensland

Pre-Audit Questionnaire & Audit Checklist Government
Department of
Prepared by Supplier QMS Certification Services - Queensland Government Chief Procurement Office
Public Works
General Questions
Business Name: Trading Name:
ACN: ABN:
Business Address:
List all business sites to be audited. Use separate sheet if necessary.
Postal Address:
E-Mail Address: Internet Address:
Telephone: Facsimile:
Contact Name: Position In No. of
(For Audit) Business: Staff:
Does the business hold any other second or third party certification or, are any second or third party audits programmed? Y  N 
If “Yes” please provide the name of the Certification Certification Audit Date/
body and the date when the last audit took place or Body: Planned Date:
when the audit is scheduled to take place.
Background To The Business:

State briefly the type of service or product the business supplies, including a brief outline of any specific technical expertise and/or technical processes, which
the company possesses.
Name of
Auditor/Evaluator: Date:
Issue Date: June 2010 AS/NZS ISO 9001:2008 Pre-Audit Questionnaire & Audit Checklist Page 1 of 34
Please complete the following questions which are based on AS/NZS ISO 9001:2008
0 Introduction
Comments
0.1 General Y
Has the system been developed around N
ISO 9001:2008?
Y
0.2 Process model
Has a process approach been adopted? N
0.3 Relationship with ISO 9004

Has the system been developed in
9004
conjunction with ISO 9004 or only
around ISO 9001? 9001
1 Scope
Have exclusions been claimed and if so Y
what are they? N
(see 4.2.2 below)
4 Quality Management System (QMS)

4.1 General requirements
Has the system been documented,
implemented, maintained and Y
continually improved in accordance N
with ISO 9001?
Has the organisation

a) Determined the processes needed
and their application?
b) determined the sequence and
interaction of these processes?
c) determined criteria/methods to
ensure effective operation and
control of these processes? Y
d) ensured availability of information
necessary to support the operation N
and monitoring of these processes?
e) monitored, measured where
applicable, and analysed these
processes?
f) implemented action necessary to
achieve planned results and
continual improvement?
4.1 General requirements (continued)
Y
Are these processes managed in N
accordance with the ISO 9001?
Y
Does the organisation ensure control
over processes that affects product N
conformity that are outsourced?
Y
Is the type and extent of these control
defined in the QMS? N
4.2 Documentation requirements.

4.2.1 General
Does the quality management system
documentation include:-
a) documented statements of quality
policy and quality objectives?
b) a quality manual? Y
c) documented procedures and records
required by ISO 9001: 2008? N
d) documents, including records,
determined to be necessary to
ensure effective planning, operation
& control of its processes?
Note 1 - Documented procedure” means the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more
procedures. A requirement for a document procedure may be covered by more than one document.
Note 2 - Documentation can differ from one organisation to another due to size of organisation and type of activities, complexity of processes and their interactions and the
competency of personnel.
Note 3 – Documentation can be in any form or type of medium
4.2.2 Quality Manual

Has a quality manual been established
and maintained that includes:-
a) scope of QMS including details and
justification of any exclusion? Y
b) the documented procedures N
established for the QMS or reference
to them?
c) a description of the interaction
between the processes of the QMS?
For the following questions please complete column(s) 2, 3, 4 & 5 as appropriate. Column 6 is for the auditors comments.
The shaded area below is an example. If a requirement of the standard has been implemented but not documented then please indicate this in column 3.
1. 2. 3. 4. 5. 6.
ISO 9001:2008 System element Documented Implemented QMS Have records Auditor comments
and but not reference been generated,
4.
implemented documented number where required
4.2.3
Has a documented procedure
been established to define Clause # of
Y
controls needed to:-
a) approve documents for
 Y procedure
XYZ
Y

N N N
adequacy prior to use?
5.1
Quality
Is top management committed to Y Y
the development and  Manual
clause #
Y

implementation of the QMS? N N N
Page ##
7.4.1
Y Y
Are the criteria for selection,
evaluation and re-evaluation
 Y

N N N
established?
4.2.3 Control of documents
Are documents required by the QMS Y

controlled? N

been established to define controls
Y Y Y
needed to:-
N N N
a) approve documents for adequacy
prior to use?
Y Y Y
b) review and update as necessary N N N

and re-approve?
Y Y Y
c) ensure changes and current
revision status of documents are N N N
identified?
1. 2. 3. 4. 5. 6.
and but not Reference been generated,
implemented documented Number where required
4.2.3 Control of documents (continued)
d) ensure relevant versions of Y Y

applicable documents are
N N
available at points of use?
Y Y
e) ensure documents remain legible N N
and readily identifiable?
f) ensure documents of external

origin determined by the Y Y Y
organisation to be necessary for
N N N
planning and operation of the
QMS are identified and their NA
distribution controlled?
g) prevent unintended use of

obsolete documents and to apply Y Y Y
suitable identification to them if N N N
retained for any purpose?
4.2.4 Control of records
Are records established to provide Y

evidence of conformity to
requirements and of the effective N
operation of the QMS controlled?
Y
Do records provide evidence of N
effective operation of the QMS?
Y
Do records remain legible, readily N
identifiable and retrievable?

been established that defines the
controls needed for the Y Y Y
identification, storage, protection,
retrieval, retention time and N N N
disposition of records?
1. 2. 3. 4. 5. 6.
5 Management Responsibility
5.1 Management commitment
Is top management committed to Y Y Y
the development and
implementation of the QMS? N N N
Does commitment include

continually improving its
effectiveness by:-
a) communicating to organisation
importance of meeting customer, Y Y Y
statutory & regulatory N N
requirements? N
b) establishing the quality policy?

(see 5.3 below)
c) ensuring quality objectives are
established?
(see 5.4.1 below)
d) conducting management reviews?
(see 5.6 below)
e) ensuring the availability of Y Y
resources?
(See 6 below) N N
5.2 Customer focus

Does top management ensure that
customer requirements are
determined, and are met with the
aim of achieving customer Y
satisfaction? N
(see 7.2.1 & 8.2.1 below)
5.3 Quality Policy

the quality policy:- Y Y
a) is appropriate to the purpose of
the organisation? N N
b) includes a commitment to Y Y
comply with requirements and
N N
continually improve the
effectiveness of the QMS?
1. 2. 3. 4. 5. 6.
5.3 Quality Policy (continued)
c) provides a framework for Y Y

establishing and reviewing N N
quality objectives?
d) is communicated and understood Y Y Y

at appropriate levels in the N N N
organisation?
Y Y Y
e) is reviewed for continuing N N N
suitability?
5.4 Planning
5.4.1 Quality Objectives

quality objectives are established Y Y Y
at relevant functions and levels N N N
within the organisation?
Does this include the objectives Y Y Y

needed to meet requirements for N N N
product?
Are the quality objectives Y Y Y

measurable and consistent with the N N N
quality policy?
5.4.2 QMS planning
Does top management ensure :-

a) the planning of the QMS is Y Y Y
carried out in order to meet
requirements in 4.1 above as N N N
well as the quality objectives?
b) the integrity of the QMS is

maintained when changes to the Y Y Y
system are planned and N N N
implemented?
1. 2. 3. 4. 5. 6.
5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority
Has top management ensured that

responsibility and authority are Y Y Y
defined and communicated within
the organisation? N N N
5.5.2 Management representative
Has top management appointed a

member of the organisation’s
management who, irrespective of
other responsibilities, has
responsibility and authority for:
Y Y
a) ensuring that processes needed
for the QMS are established, N N
implemented and maintained?
b) reporting to top management on Y Y Y

the performance of the quality
management system, including N N N
needs for improvement?
c) promoting awareness of Y Y Y
customer requirements N N N
throughout organisation?
Note - The responsibility of a management representative can include liaison with external parties on matters relating to the quality management systems.
5.5.3 Internal communication

appropriate communication
processes have been established Y Y Y
within the organisation and that N N N
communication takes place
regarding effectiveness of the QMS?
1. 2. 3. 4. 5. 6.
5.6 Management review

5.6.1 General
Does top management review the Y Y

QMS, at planned intervals, to
ensure its continuing suitability, N N
adequacy and effectiveness?
Does the review include assessing

opportunities for improvement and Y Y
the need for changes to the QMS,
including quality policy and quality N N
objectives?
Y Y Y
Are records of management
reviews maintained (see 4.2.4 N N N
above)?
5.6.2 Review input
Do inputs to management review

include information on:-
a) results of audits?
b) customer feedbacks?
c) process performance?
d) status of preventive and
corrective actions?
e) follow-up actions from previous Y Y Y
management reviews?
f) changes that could affect the N N N
QMS?
g) recommendations for
improvement?
5.6.3 Review output
Do management review outputs

include actions related to:
a) improvement of the QMS and its Y Y Y
processes?
b) improvement of product related N N N
to customer requirements?
c) resource needs?
1. 2. 3. 4. 5. 6.
6 Resource Management
6.1 Provision of resources
Has the organisation determined

and provided resources needed to:- Y Y
a) implement & maintain the QMS &
continually improve its N N
effectiveness?
b) to enhance customer satisfaction Y Y
by meeting customer N N
requirements?
6.2 Human resources

6.2.1 General
Are personnel performing work-
affecting conformity to product Y Y
requirements competent on the
basis of appropriate education, N N
training, skills and experience?
6.2.2 Competency, training and awareness
Does the organisation:

a) determine the necessary Y Y Y
competency needs for personnel
performing work affecting N N N
product requirements?
b) where applicable provide training Y Y Y

or take other actions to achieve N N N
the necessary competence?
Y Y Y
c) evaluate the effectiveness of the N N N
actions taken?
d) ensure personnel are aware of

the relevance & importance of Y Y Y
their activities & how they
contribute to achievement of N N N
quality objectives?
e) maintain appropriate records of Y Y Y

education, training, skills and
experience (see 4.2.4 above)? N N N
1. 2. 3. 4. 5. 6.
6.3 Infrastructure
Does the organisation determine,

provide and maintain the
infrastructure needed to achieve Y Y
conformity to product N N
requirements?
Does the infrastructure include as

Y Y
applicable:-
a) building, workspace and N N
associated utilities?
Y Y Y
b) process equipment (both
N N N
hardware and software)?
Y Y Y
c) supporting services (such as
transport & communication or N N N
information systems)?
6.4 Work Environment
Does the organisation determine

Y Y
and manage the work environment
to achieve conformity to product N N
requirements?
Note - The term “work environment” relates to those conditions under which work is performed including physical environment and other factors (such as noise, temperature,
humidity, lighting or weather.
1. 2. 3. 4. 5. 6.
7 Product Realisation
7.1 Planning of realisation process
Does the organisation plan and Y Y

develop the processes needed for N N
product realisation?
Is planning of product realisation

consistent with requirements of Y Y
other processes of the QMS? N N
(see 4.1 above)
In planning product realisation does

the organisation determine the
following, as applicable:-
Y Y
a) quality objectives and N N
requirements for the product?
b) the need to establish processes,

documents, and to provide Y Y
resources specific to the N N
product?
c) required verification, validation,

monitoring, measurement,
inspection and test activities Y Y
specific to the product and the N N
criteria for product acceptance?
d) records needed to provide

evidence that the realisation
processes and resulting product Y Y Y
meet requirements? N N N
(see 4.2.4 above)
Is the output of this planning in a Y Y Y

form suitable for the organisation’s N N N
method of operations?
Note 1 – A document specifying the processes of the QMS (including the product realisation processes) and the resources to be applied to a specific product, project or contract,
can be referred to as a quality plan.
Note 2 – The organisation may also apply the requirements given in 7.3 to the development of product realisation processes
1. 2. 3. 4. 5. 6.
7.2 Customer-related processes

7.2.1 Determination of requirements related to the product
Does the organisation determine:-
a) the requirements specified by

the customer, including Y Y Y
requirements for delivery and N N N
post delivery activities?
b) requirements not specified by

the customer but necessary for Y Y Y
specified or intended use, where N N N
known?
c) statutory and regulatory Y Y Y

requirements applicable to the N N N
product?
d) any additional requirements Y Y Y

considered necessary by the N N N
organisation?
Note - Post-delivery activities include, for example, actions under warranty provisions contractual obligations such as maintenance services, and supplementary services such as
recycling or final disposal.
7.2.2 Review of requirements related to the product
Does the organisation review the Y Y Y

requirements related to the N
N N
product?
Is this review conducted prior to

the organisation’s commitment to
supply a product to the customer
(e.g. submission of a tender, Y Y Y
acceptance of a contract or orders,
N N N
acceptance of changes to contracts
or orders)?
Does the review ensure that:-

Y Y Y
a) product requirements are N N N
defined?
1. 2. 3. 4. 5. 6.
7.2.2 Review of requirements related to the product (continued)
b) contract or order requirements Y Y Y

differing from those previously N N N
expressed are resolved?
c) the organisation has the ability Y Y Y

to meet the defined N N N
requirements?
Are records of the results of the Y Y Y

review and actions arising from the N N N
review maintained?
Where the customer provides no

documented statement of
requirement, are the customer Y Y Y
requirements confirmed by the N N N
organisation before acceptance?
Where product requirements are

changed, does the organisation Y Y Y
ensure that the relevant N N N
documentation is amended?
Does the organisation ensure that

the relevant personnel are made Y Y Y
aware of the changed N N N
requirements?
Note – In some situations, such as Internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or
advertising material.
7.2.3 Customer communication
and implement arrangements for
communication with customers
relating to:
a) product information?
b) enquiries, contracts or order Y Y Y
handling, including amendments?
c) customer feedback, including N N N
customer complaints?
1. 2. 3. 4. 5. 6.
7.3 Design and development

7.3.1 Design and development planning
Does the organisation plan and Y Y Y
control design and development of N N N
the product?
During design and development

planning does the organisation Y Y Y
determine: N N N
a) the design/development stages?
Y Y Y
b) review, verification & validation
that are appropriate to each N N N
design/development stage?
Y Y Y
c) responsibilities and authorities N N N
for design/development?
Does the organisation manage the

interfaces between different
groups involved in design and
Y Y Y
development to ensure effective
communication and clear N N N
assignment of responsibilities?
Is planning output updated, as Y Y Y

appropriate, as the design and N N N
development progresses?
Note - Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for
the product and the organisation.
7.3.2 Design and development inputs

Are inputs relating to product
requirements determined and Y Y Y
records maintained? N N N
(see 4.2.4 above)
Does this include: Y Y Y

a) functional and performance N N N
requirements?
1. 2. 3. 4. 5. 6.
7.3.2 Design and development inputs (continued)

Y Y Y
b) applicable statutory and N N N
regulatory requirements?
c) where applicable, information Y Y Y

derived from previous similar N N N
designs?
Y Y Y
d) other requirements essential for N N N
design and development?
Y Y Y
Are these inputs reviewed for N N N
adequacy?
Are these requirements complete, Y Y Y

unambiguous and not in conflict N N N
with each other?
7.3.3 Design and development outputs

Are the outputs of the design and
Y Y Y
development in a form suitable for
verification against the design & N N N
development inputs?
Y Y Y
Are outputs approved prior to N N N
release?
Do design & development outputs: Y Y Y
a) meet the input requirements for N N N
design and development?
b) provide appropriate information Y Y Y
for purchasing, production and N N N
service provision?
Y Y Y
c) contain or reference product N N N
acceptance criteria?
d) specify the characteristics of the Y Y Y

product that are essential to its N N N
safe and proper use?
Note - Information for production and service provision can be include details for the preservation of product
1. 2. 3. 4. 5. 6.
7.3.4 Design and development review
At suitable stages, are systematic

reviews of design and development
performed in accordance with
planned arrangements (see 7.3.1
above) to:
Y Y Y
a) evaluate the ability of the results
of design and development to N N N
meet requirements?
Y Y Y
b) identify problems and proposed N N N

necessary actions?
In such reviews, are

representatives of functions
Y Y Y
concerned with the design and
development stage(s) being N N N
reviewed included?
Y Y Y
Are the result of the reviews and
any necessary actions maintained? N N N
(see 4.2.4 above)
7.3.5 Design and development verification
Is verification performed in
accordance with planned
arrangements to ensure the design Y Y Y
and development outputs meet the
design and development inputs N N N
requirements?
Are records of the results of the Y Y Y

verification & any necessary
actions maintained? N N N
(see 4.2.4 above)
1. 2. 3. 4. 5. 6.
7.3.6 Design and development validation
Is design and development

validation performed in accordance
with planned arrangements (see
7.3.1 above) to ensure that
resulting product is capable of
Y Y Y
meeting the requirements for the
specified application or intended N N N
use, where known?
Y Y Y
Wherever practicable, is validation
completed prior to the delivery or N N N
implementation of the product?
Are records of the result of the Y Y Y

validation and any necessary
actions maintained? N N N
(see 4.2.4 above)
7.3.7 Control of design and development changes
Y Y Y
Are design and development
changes identified and records N N N
maintained?
Y Y Y
Are the changes reviewed, verified
and validated, as appropriate, and N N N
approved before implementation?
Does this review include evaluation Y Y Y

of the effect of the changes on
constituent parts and products N N N
already delivered?
Are records of the result of the Y Y Y

review of changes and any
necessary actions maintained? N N N
(see 4.2.4 above)
1. 2. 3. 4. 5. 6.
7.4 Purchasing
7.4.1 Purchase process
Y Y
purchased product conforms to N N
specified purchase requirements?
Is the type and extent of control

applied to the supplier and the
purchased product dependent upon
Y Y
the effect of the purchased
product on subsequent product N N
realisation or the final product?
Does the organisation evaluate and

select suppliers based on their
ability to supply product in Y Y Y
accordance with the organisation’s N N N
requirements?
Are the criteria for selection, Y Y Y

evaluation and re-evaluation N N N
established?
Are records of the result of

evaluations & any necessary actions Y Y Y
arising from the evaluation N N N
maintained? (see 4.2.4 above)
7.4.2 Purchasing information

Does purchasing information
describe the product to be
purchased, including where
appropriate:
a) requirements for approval or
qualification of product,
procedures, process and
equipment?
b) requirements for qualification of Y Y Y
personnel? N N N
c) QMS requirements?
Does organisation ensure adequacy Y Y Y

of specified purchase requirements N N N
prior to communicating to supplier?
1. 2. 3. 4. 5. 6.
7.4.3 Verification of purchased products
Does the organisation establish and

implement inspection and other
activities necessary for ensuring Y Y Y
purchased product meets specified N N N
purchase requirements?
Where the organisation or its

customer proposes to perform
verification activities at the
supplier’s premises, does the
organisation state the intended
Y Y Y
verification arrangements and
method of product release in the N N N
purchasing information?
7.5 Production and service provision

7.5.1 Control of production and service provision
Does the organisation plan and

carry out production and service
provision under controlled
conditions including as applicable:-
Y Y Y
a) the availability of information
that describes the characteristics N N N
of the product?
Y Y Y
b) the availability of work
instructions, as necessary? N N N
Y Y Y
c) the use of suitable equipment ? N N N
1. 2. 3. 4. 5. 6.
7.5.1 Control of production and service provision (continued)
Y Y Y
d) the availability and use of
monitoring and measuring N N N
equipment?
Y Y Y
e) the implementation of N N N
monitoring and measuring?
Y Y Y
f) the implementation of product
release, delivery and post- N N N
delivery activities?
7.5.2 Validation of processes for production and service provision (processes that cannot be verified by subsequent monitoring or measurement)
Does the organisation validate

processes for production and
service provision where the
resulting output cannot be verified
by subsequent monitoring or
measurement and as a
consequence deficiencies become
Y Y Y
apparent only after the product is
in use or the service has been N N N
delivered?
Y Y Y
Does validation demonstrate the
ability of these processes to N N N
achieve planned results?
1. 2. 3. 4. 5. 6.
7.5.2 Validation of processes for production and service provision (continued)
Does the organisation establish

arrangements for these processes
including, as applicable:-
a) defined criteria for review and
approval of the processes?
b) approval of equipment and
qualification of personnel?
c) use of specific methods and
procedures?
Y Y Y
d) requirements for records?
(see 4.2.4 above) N N N
e) revalidation?
7.5.3 Identification and traceability
Where appropriate, does the Y Y Y

organisation identify the product
N N N
by suitable means throughout
product realisation?
Does the organisation identify the

product status with respect to Y Y Y
monitoring and measurement
N N N
requirement throughout product
realisation?
Where traceability is a
requirement, does the organisation Y Y Y
control the unique identification of
the product and maintain records? N N N
(see 4.2.4 above)
Note – In some industry sectors, configuration management is a means by which identification and traceability are maintained.
1. 2. 3. 4. 5. 6.
7.5.4 Customer Property
Does the organisation exercise care Y Y Y

with customer property while it is
under the organisation’s control or N N N
being used by the organisation?
Does the organisation identify, Y Y Y

verify, protect and safeguard
customer property provided for use N N N
or incorporation into the product?
If customer property is lost,

damaged or otherwise found to be
unsuitable for use does the Y Y Y
organisation report this to the
customer and maintain records? N N N
(see 4.2.4 above)
Note - Customer property may include intellectual property and personal data
7.5.5 Preservation of product
Does the organisation preserve

product during internal processing
and final delivery to the intended Y Y Y
destination in order to maintain N N N
conformity to requirements?
Does this include as applicable:-

- identification
- handling
- packaging Y Y Y
- storage and N N N
- protection?
Y Y Y
Does preservation also apply to the N N N
constituent parts of a product?
1. 2. 3. 4. 5. 6.
7.6 Control of monitoring and measuring equipment

the monitoring & measurement to
be undertaken and the monitoring
& measuring equipment needed to Y Y Y
provide evidence of conformity of
the product to determined N N N
requirements?
Does the organisation establish

processes to ensure that monitoring
& measurement can be carried out
Y Y Y
& are carried out in a manner
consistent with the monitoring & N N N
measurement requirements?
Where necessary to ensure valid
results, is measuring equipment:-
a) calibrated/verified, or both, at
specified intervals, or prior to
use, against measurement
Y Y Y
standards traceable to
international or national N N N
measurement standards;
Y Y Y
where no such standards exist, is
the basis used for calibration or N N N
verification recorded?
b) adjusted or re-adjusted as
necessary?
c) identified in order to determine

its calibration status?
d) safeguarded from adjustments

that would invalidate the
measurement result?
Y Y Y
e) protected from damage and
deterioration during handling, N N N
maintenance and storage?
1. 2. 3. 4. 5. 6.
7.6 Control of monitoring and measuring equipment (continued)
Does the organisation assess the

validity of previous measuring Y Y Y
results when the equipment is
found not to conform to N N N
requirements?
Does the organisation take Y Y Y

appropriate action on equipment &
any product affected as referenced N N N
above?
Are records of the results of Y Y Y

calibration and verification
maintained? N N N
(see 4.2.4 above)
When used in the monitoring and

measurement of specified Y Y Y
requirements, is the ability of
N N N
computer software to satisfy the
intended application confirmed?
Y Y Y
Is this undertaken prior to initial N N N

use and reconfirmed as necessary?
Note - Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its
suitability for use.
1. 2. 3. 4. 5. 6.
8 Measurement, Analysis and Improvement

8.1 General
Does the organisation, plan and

implement the monitoring,
measurement analysis and
improvement processes needed to:-
Y Y Y
a) demonstrate conformity of to N N N
product?
Y Y Y
N N N
b) ensure conformity of the QMS?
Y Y Y
c) continually improve the N N N
effectiveness of the QMS?
Does this include the determination

Y Y Y
of the need for applicable
methods, including statistical N N N
techniques and extent of their use?
8.2 Monitoring and measurement

8.2.1 Customer Satisfaction
As one of the measurements of the

performance of the QMS, does the
organisation monitor information
on customer perception as to Y Y Y
whether the organisation has met
customer requirements? N N N
(see 5.2 above)
Y Y Y
Are the methods for obtaining and N N N
using this information determined?
Note - Monitoring customer perception can include obtaining input for sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion
surveys, lost business analysis, compliments, warranty claims and dealer reports.
1. 2. 3. 4. 5. 6.
8.2.2 Internal Audit
Does the organisation conduct

internal audits at planned intervals
to determine whether the QMS:-
a) conforms to the planned

arrangements (see 7.1 above), Y Y Y
to requirements of 9001:2008 &
to the requirements of the N N N
organisations QMS?
Y Y Y
b) has been effectively N N N

implemented and maintained?
Does the organisation plan the

audit program taking into
consideration the status and Y
Y Y
importance of the processes and
areas to be audited as well as N N N
results of previous audits?
Y Y Y
Are the audit criteria, scope, N N N
frequency and methods defined?
Do the selection of auditors and

Y Y Y
the conduct of audits ensure
objectivity and impartiality of the N N N
audit process?
Are auditors independent of area Y Y Y

being audited (e.g. do not audit N N N
their own work)?

been established to define the
responsibilities and requirements
for planning and conducting audits, Y Y
establishing records and reporting
results N N
1. 2. 3. 4. 5. 6.
8.2.2 Internal Audit (continued)

Y Y Y
Have records of the audits and
their results been maintained? N N N
(See 4.2.4 above)
Do management responsible for the

area being audited ensure that any
necessary corrections and
corrective actions are taken
Y Y Y
without undue delay to eliminate
detected nonconformities and their N N N
cause?
Do follow-up actions include the

verification of the actions taken Y Y Y
and the reporting of verification N N N
results? (see 8.5.2 below)
Note - See ISO 19011 for guidance
8.2.3 Monitoring and measurement of processes
Does the organisation apply

suitable methods for monitoring Y Y Y
and, where applicable,
measurement of the QMS N N N
processes?
Y Y Y
Do these methods demonstrate the
ability of the processes to achieve N N N
planned results?
When planned results are not Y Y Y

achieved, is correction &
corrective action taken as N N N
appropriate?
Note - When determining suitable methods, it is advisable that the organisation consider the type and extent of monitoring or measurement appropriate to each of its processes
in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.
1. 2. 3. 4. 5. 6.
8.2.4 Monitoring and measurement of product
Does the organisation monitor and Y Y Y

measure the characteristics of the
product to verify that product N N N
requirements have been met?
Is this carried out at appropriate Y Y Y

stages of the product realisation
process in accordance with planned N N N
arrangements? (see 7.1 above)
Y Y Y
Is the evidence of conformity with
the acceptance criteria N N N
maintained?
Do records indicate the person(s)

authorising release of product for Y Y Y
delivery to the customer? N N N
(see 4.2.4 above)
Does release of product and service

delivery to the customer not
proceed until planned
arrangements (see 7.1 above) have
been satisfactorily completed,
Y Y Y
unless otherwise approved by a
relevant authority and where N N N
applicable, by the customer?
8.3 Control of nonconforming product

product which does not conform to
product requirements is identified Y Y Y
and controlled to prevent N N N
unintended use or delivery?

been established to define the
controls and related responsibilities Y Y
and authorities for dealing with N N
nonconforming product?
1. 2. 3. 4. 5. 6.
8.3 Control of nonconforming product (continued)
Where applicable does the

organisation deal with
nonconforming product by one or
more of the following ways:-
Y Y Y
a) taking action to eliminate the N N N
detected nonconformity?
b) authorising its use, release or Y Y Y

acceptance under concession by
a relevant authority and, where N N N
applicable, by the customer?
Y Y Y
c) by taking action to preclude its
N N N
original intended use or
application?
d) by taking action appropriate to

the effects, or potential effects, Y Y Y
of the nonconformity when
nonconforming product is N N N
detected after delivery?
When nonconforming product is Y Y Y

corrected is it subject to re-
verification to demonstrate N N N
conformity to the requirements?
Are records of the nature of the

nonconformities and any
subsequent actions taken, including
Y Y Y
concessions obtained maintained?
(see 4.2.4 above) N N N
1. 2. 3. 4. 5. 6.
8.4 Analysis of data
Does the organisation determine,

collect and analyse appropriate
data to demonstrate the suitability
and effectiveness of the QMS and Y Y Y
to evaluate continual improvement N N N
of the effectiveness of the QMS?
Does this include data generated as

a result of monitoring and Y Y Y
measurement and other relevant N N N
sources?
Does the analysis of data provide

information relating to: Y Y Y
a) customer satisfaction? N N N
(see 8.2.4 above)
b) conformance to customer Y Y Y
requirements? N N N
(see 7.2.1 above)
c) characteristics and trends of

processes and products including
opportunities for preventive Y Y Y
action? N N N
(see 8.2.3& 8.2.4 above)
Y Y Y
N N N
d) suppliers? (see 7.4 above)
8.5 Improvement
8.5.1 Continual improvement
Does the organisation continually

improve the effectiveness of the
QMS through its use of the quality
policy, quality objectives, audit
Y Y Y
results, analysis of data, corrective
and preventive actions and N N N
management review?
1. 2. 3. 4. 5. 6.
8.5.2 Corrective Action
Does the organisation take action

Y Y Y
to eliminate the cause of
nonconformities in order to prevent N N N
recurrence?
Is the corrective action appropriate Y Y Y

to the effects of the N N N
nonconformities encountered?

been establishes and does it define
the requirements for:- Y Y Y
a) reviewing nonconformities N N N
(including customer complaints)?
Y Y Y
b) determining the causes of N N N
nonconformities?
c) evaluating the need for action to Y Y Y

ensure that nonconformities do N N N
not recur?
Y Y Y
d) determining and implementing N N N
the action needed?
Y Y Y
e) recording results of action taken? N N N
(see 4.2.4 above)
Y Y Y
f) reviewing the effectiveness of N N N
corrective action taken?
1. 2. 3. 4. 5. 6.
8.5.3 Preventive action
Does the organisation determine Y Y Y

action to eliminate the cause of
potential nonconformities in order N N N
to prevent their occurrence?
Y Y Y
Are the preventive actions taken
appropriate to the effects of the N N N
potential problems?

been established and does it define
requirements for:-
a) determining potential Y Y Y
nonconformities and their N N N
causes?
Y Y Y
b) evaluating the need for action to
prevent occurrence of N N N
nonconformities?
Y Y Y
c) determining and implementation N N N

action needed?
Y Y Y
d) recording results of action taken? N N N
(see 4.2.4 above)
Y Y Y
e) reviewing the effectiveness of N N N
preventive action taken?
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AS/NZS ISO 9001:2008 Queensland

Business Name: Trading Name:

E-Mail Address: Internet Address:

Background To The Business:

0.3 Relationship with ISO 9004

4 Quality Management System (QMS)

Has the organisation

4.2 Documentation requirements.

4.2.2 Quality Manual

4.2.3 Control of documents

Are documents required by the QMS Y

Has a documented procedure

b) review and update as necessary N N N

4.2.3 Control of documents (continued)

d) ensure relevant versions of Y Y

f) ensure documents of external

g) prevent unintended use of

4.2.4 Control of records

Are records established to provide Y

Has a documented procedure

Does commitment include

b) establishing the quality policy?

5.2 Customer focus

5.3 Quality Policy

5.3 Quality Policy (continued)

c) provides a framework for Y Y

d) is communicated and understood Y Y Y

Does top management ensure that

Does this include the objectives Y Y Y

Are the quality objectives Y Y Y

5.4.2 QMS planning

Does top management ensure :-

b) the integrity of the QMS is

5.5 Responsibility, authority and communication

Has top management ensured that

5.5.2 Management representative

Has top management appointed a

b) reporting to top management on Y Y Y

5.5.3 Internal communication

Does top management ensure that

5.6 Management review

Does top management review the Y Y

Does the review include assessing

5.6.2 Review input

Do inputs to management review

5.6.3 Review output

Do management review outputs

Has the organisation determined

6.2 Human resources

6.2.2 Competency, training and awareness

Does the organisation:

b) where applicable provide training Y Y Y

d) ensure personnel are aware of

e) maintain appropriate records of Y Y Y

Does the organisation determine,

Does the infrastructure include as

6.4 Work Environment

Does the organisation determine

Does the organisation plan and Y Y

Is planning of product realisation

In planning product realisation does