Quality Management Systems Guidelines
Appendix C - Quality Management System assessment checklist
This checklist has been designed to assist Government agencies and others in assessing a service
provider’s Quality Management System. It may also assist agencies, other customers and service
providers as a guide in developing their Quality Management Systems. The number references are to
clause numbers in the current AS/NZS ISO 9001, Quality management systems – Requirements.
Key to symbols to be used in check-boxes is:  = Yes  = No O = Not applicable
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QUALITY MANAGEMENT SYSTEM
4.2.2 Quality manual
Does the Quality Manual include:

a description of the scope of the Quality Management System, including details of, and
justifications for, any exclusions?

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documented procedures, as part of the Quality Management System, or reference to them?
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approve documents for adequacy prior to use?
a description of the interaction between the processes of the Quality Management System?
4.2.3 Control of documents
Is a documented procedure established to define the controls needed to:
review and update as necessary and re-approve documents?
ensure the changes to, and the current version status of, documents are identified?
ensure that applicable documents are available at point of use?
ensure that documents remain legible and readily identifiable?
ensure that documents of external origin are identified and their distribution controlled?
prevent unintended use of obsolete documents, and apply suitable identification to obsolete
documents where they are to be retained?
4.2.4 Control of records

Are procedures documented for the identification, storage, protection, retrieval, retention and
disposal of records needed to provide evidence of conformity of contract work and of the
effective operation of the Quality Management System?
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MANAGEMENT RESPONSIBILITY
5.1
Management commitment
Has senior management shown evidence of its commitment by:
5.2
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communicating to service provider personnel the importance of meeting customer,
statutory and regulatory requirements?
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establishing and implementing the quality policy?
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ensuring quality objectives are established?
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conducting management reviews?
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ensuring the availability of appropriate resources?
Customer focus
Are processes documented and implemented by senior management, covering processes for
determining and meeting customer requirements, and enhancing customer satisfaction?
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5.3
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Quality policy
Is documented quality policy appropriate for the product/services that the service provider wants
to provide to the customer?
Does quality policy include a commitment to comply with customer requirements and continually
improve the effectiveness of the Quality Management System?
Does quality policy provide a framework for establishing and reviewing quality objectives?
Are there procedures for communicating the quality policy, and for senior management to verify it
is understood?

Are there procedures for reviewing the quality policy for continuing suitability, and for senior
management to regularly verify its suitability?
5.4
Planning
5.4.1 Quality objectives

Are the quality objectives established and documented? Are the quality objectives measurable
and consistent with the quality policy and products/services provided, for relevant service
provider functions and levels?
 Are there procedures for reviewing the quality objectives for continuing suitability, and for senior
management to regularly verify this suitability?
5.4.2 Quality management system planning
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5.5
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5.6
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Does the planning process documented and implemented meet the quality management
requirements and quality objectives?
Are there procedures for reviewing the planning process implementation, and for senior
management to regularly verify process suitability and the achievement of objectives?
Have Quality Management Plan templates been included or are procedures documented to
ensure that required processes (where they are documented only in the Quality Management
Plans) will be consistently applied, where relevant?
Are there procedures for ensuring the integrity of the Quality Management System is maintained
when changes to the Quality Management System are planned and implemented, and for senior
management to regularly verify their implementation and suitability?
Responsibility, authority and communication
Are persons identified with their responsibilities and authorities defined and communicated within
the service provider organisation?
Are processes documented for the communication, and reviewing the definition and
communication procedure, for continuing suitability, and for senior management to regularly
verify this suitability?
Is the corporate management representative appointed with appropriate responsibilities and
authority (Clause 5.5.2)?
Management review
Has senior management planned, carried out and recorded regular reviews of the Quality
Management System and verified its suitability, adequacy and effectiveness?

Are the planned system reviews documented?
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RESOURCE MANAGEMENT
6.1
Provision of resources
Has the service provider developed and implemented a process, with documentation, to plan,
determine and provide the resources needed:
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Quality Management Systems Guidelines
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to implement the Quality Management System and continually improve its
effectiveness?
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to enhance customer satisfaction by better meeting customer requirements?
6.2
Human resources
Has the service provider documented and implemented procedures for processes to:
6.3
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6.4
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7.1
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determine the necessary competence of personnel performing work affecting
conformity to product and service quality requirements?
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provide personnel with the required skills and experience, and to provide training or
take other actions to address deficiencies in competence and evaluate the
effectiveness of the actions taken?

ensure personnel are aware of how their roles contribute to achieving quality
objectives?

maintain appropriate records of education, training, skills and experience?
Infrastructure (may be addressed in QMP)
Has the service provider documented and implemented a process to determine, provide and
maintain the infrastructure (facilities, equipment and services) needed to achieve product/service
requirements?
Work environment (may be addressed in QMP)
Has the service provider documented and implemented a process to determine, identify and
manage the work environment (including identifying/assessing risks) needed to achieve
product/service requirements?
PRODUCT REALISATION
Planning of product realisation
Has the service provider documented and implemented procedures for a process to plan product
realisation, including determining the following, as appropriate:

quality objectives and requirements for the product/service?
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the need to establish processes, documents and provide resources specific to the
product/service?
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required verification, validation, monitoring, measurement, inspection and test activities
specific to the product/service and the criteria for product/service acceptance?

records needed to provide evidence that the realisation processes and resulting
product/service meet requirements?
Does planning include the preparation of contract QMPs and associated documents,
including guidelines and procedures for determining contract-specific requirements in
accordance with Clause 7.2.1?
7.2
Customer-related processes
In the processes documented and implemented by the service provider:
 Does the service provider determine the customer’s requirements, including those
specified, those not specified but necessary for the customer’s intended use, and relevant
statutory and regulatory requirements? (Clause 7.2.1)
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Quality Management Systems Guidelines
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Is a review carried out and recorded, before submitting a tender, to check that the
customer’s tender documents adequately define the requirements for work under the
contract? (Clause 7.2.2)
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Is action taken to resolve any differences with requirements previously expressed or
otherwise expected? (Clause 7.2.2)

Does the review of tender documents include confirmation that the service provider has
the ability to meet the defined requirements confirmed? (Clause 7.2.2)

Does the service provider deal with changes to customer requirements and ensure that
documents are amended and personnel are made aware of the changes? (Clause 7.2.2)

Does the service provider deal with customer communications/feedback, including
customer complaints? (Clause 7.2.3)
7.3
Design and development (may be addressed in QMP/design plan)
7.3.1 Design and development planning
In the processes documented and implemented by the service provider:

Does the service provider provide for the determination of the design stages, including the
review, verification and validation that are appropriate to each design stage?

Is provision made for personnel/group responsibility and authority to be determined for the
design processes?
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Is provision made for the interfaces between different groups involved in the design
processes to be managed to ensure effective communication and clear assignment of
responsibility?
7.3.2 Design and development inputs
In the processes documented and implemented by the service provider:

Is provision made to determine and record design input requirements, including:

functional and performance requirements?
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applicable statutory and regulatory requirements?
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other essential requirements and, where applicable, information from previous similar
designs?
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Is provision made for the design inputs to be reviewed for adequacy, including consistency and
completeness?
7.3.3 Design and development outputs
In the processes documented and implemented by the service provider:

Does the service provider provide for the outputs of design and development to be in a form that
enables verification against the design inputs and approval prior to release?
Does the service provider ensure that in the design outputs:
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all design input requirements have been met?
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appropriate information is provided to enable the procurement of relevant materials and
products/services?
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relevant acceptance criteria for completed work are provided or referenced?
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characteristics essential for safe and proper use of products (during construction and
post-construction, as applicable) are specified?
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7.3.4 Design and development review
In the processes documented and implemented by the service provider, is provision made:

For systematic design reviews at suitable design stages by relevant personnel to evaluate
whether the design meets requirements and to identify any problems and propose any necessary
actions?

For records of the results of design reviews and any necessary actions to be maintained?
7.3.5 Design and development verification
In the processes documented and implemented by the service provider, is provision made:
 For the design to be verified at appropriate stages to confirm that the design outputs have met
the design input requirements?

For records of the results of design verification and any necessary actions to be maintained?
7.3.6 Design and development validation
In the processes documented and implemented by the service provider, is provision made:
 For the design to be validated (preferably before delivery/use) to show that the resulting
designed product will be capable of meeting the specified requirements?
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For records of the results of design validation and any necessary actions to be maintained?
7.3.7 Control of design and development changes
In the processes documented and implemented by the service provider, is provision made:
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For design changes to be identified, reviewed (including the consequences with other product
parts), verified and validated, as appropriate, and approved before being implemented?

For records of the results of the review of changes and any necessary actions to be maintained?
7.4
Purchasing
7.4.1 Purchasing process
In the processes documented and implemented by the service provider, is provision made:
 For providing effective control over planning for, placing orders for, and verifying purchased
products/services, and over the suppliers/service providers, to ensure that specified
requirements are met?
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For the service provider to evaluate and select its service providers on the basis of their ability to
meet specified requirements, including their past performance?
For the service provider to establish criteria for selection, evaluation and re-evaluation of its
service providers?

For records to be maintained of the results of the control and evaluation processes and any
necessary actions arising from the processes?
7.4.2 Purchasing information
In the processes documented and implemented by the service provider, is provision made:
 For the description of the product/service to be purchased, including where applicable:

requirements for approval of service, product, procedures, processes and equipment?
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requirements for qualifications of personnel?
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quality management system/plan/ITP requirements?
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verification arrangements, including at its service provider’s premises and the method
of product release?
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Quality Management Systems Guidelines
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For the service provider to ensure the adequacy of specified purchase requirements before being
communicated to its potential and actual service providers?
7.4.3 Verification of purchased product
In the processes documented and implemented by the service provider, is provision made:

For the service provider to ensure the purchased product/service meets the specified
requirements (including release/accept the product/service and the specification)?

For the service provider to plan, specify and implement surveillance and inspection of its service
providers’ operations/activities, to verify conformity with quality systems and with specified
product/service quality requirements?
7.5
Production and service provision
7.5.1 Control of production and service provision
In the processes documented and implemented by the service provider, is provision made:

To plan, document, implement and monitor the controlled conditions needed for each work
process, including:

information that describes the product/service characteristics?
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the availability of work instructions, as necessary?

the use of suitable equipment?
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the availability and use of monitoring and measuring equipment?
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the implementation of monitoring and measurement?
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the implementation of product release, delivery and post-delivery activities, as
applicable?
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methods for monitoring the effectiveness of new or changed processes (Clause 8.2.3)?
7.5.2 Validation of processes for production and service provision
In the processes documented and implemented by the service provider, is provision made:

To identify work processes for which the resulting output cannot be fully verified by subsequent
monitoring, inspection and testing?
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For work process descriptions, indicating the criteria for process review/approval, equipment
approval and operator qualifications, equipment controls, method for validating process outputs
and records to be kept, when appropriate?
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For performing process validation and keeping validation records, when appropriate?
7.5.3 Identification and traceability
In the processes documented and implemented by the service provider, is provision made:

For the service provider to progressively identify work output by subdividing work into lots or
discrete work areas and uniquely identifying each lot or work area?
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To identify samples and test results against the lot or work area to which they relate?
7.5.4 Customer property (may be addressed in QMP)
In the processes documented and implemented by the service provider, is provision made:
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To identify, verify, protect and safeguard the customer’s property provided for use or for
incorporation into the product?
To advise the customer of any loss or damage to, or unsuitability of, the property, to act to
correct this, and to keep appropriate records?
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Quality Management Systems Guidelines
7.5.5 Preservation of product (may be addressed in QMP)
In the processes documented and implemented by the service provider, is provision made:

For the service provider to preserve the product during internal processing and delivery to
maintain conformity to requirements. As applicable, preservation shall include identification,
handling, packaging, storage and protection?
7.6
Control of monitoring and measuring equipment (may be addressed in QMP)
In the processes documented and implemented by the service provider, is provision made for the
service provider to:

Determine the monitoring and measurement to be undertaken to provide evidence of conformity
of product/service to specified requirements?

Determine, provide and maintain the monitoring and measurement equipment required to
provide evidence of conformity of product/service to specified requirements?
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Implement the monitoring and measurement required?
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MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1
General
In the processes documented and implemented by the service provider, is provision made:

To plan, document and implement the monitoring, measurement (such as performance
statistics), analysis and improvement processes/methods, and their use frequency, needed to:

demonstrate conformity of the product/service requirements? (may be addressed in
QMP)

ensure conformity of and with the Quality Management System?

continually improve the effectiveness of the Quality Management System?
8.2
Monitoring and measurement
8.2.1 Customer satisfaction
In the processes documented and implemented by the service provider, is provision made:
 For the service provider to follow a determined method to monitor and measure performance as
the customer perceives it, and act to address any lack of performance and misconceptions?

For the determination and/or description of the method, including obtaining and using the
information required?
8.2.2 Internal audit
In the procedures documented and implemented by the service provider, is provision made:

For the service provider to conduct internal audits at planned intervals to determine whether the
Quality Management System conforms to the planned arrangements and specified requirements,
and that the Quality Management System is being effectively implemented and maintained?

For the audit program to take into consideration the status and importance of the processes and
work areas to be audited as well as the results of previous audits?
For audits to be conducted with objectivity and impartiality, by auditors who are not directly
responsible for or involved in the activity being audited?
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For the audit criteria, scope, frequency and methods to be defined?
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For the responsibilities and requirements to be defined for planning and conducting audits, and
for reporting results and maintaining records?
For audit results to be recorded and brought to the attention of the responsible personnel for
prompt action and follow-up?
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Quality Management Systems Guidelines
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For the management responsible for the area being audited to ensure that actions are taken
without undue delay to eliminate detected nonconformities and their causes?
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For the follow-up activities to include the verification of the actions taken and the reporting of the
verification results?
8.2.3 Monitoring and measurement of processes (may be addressed in QMP)

In the processes documented and implemented by the service provider, does the service
provider allow for monitoring, and where applicable, measuring the ability of quality management
processes to achieve planned results?
8.2.4 Monitoring and measurement of product (may be addressed in QMP)

In the processes documented and implemented by the service provider, does the service
provider allow for progressively (as planned) monitoring and measuring the characteristics of
products/services to ensure requirements have been met?
8.3
Control of nonconforming product
In the procedures documented and implemented by the service provider, is provision made:

For the controls and related responsibilities for ensuring that a product/service which does not
conform to product/service requirements is identified and controlled to prevent its unintended use
or delivery?

For the service provider to deal with a nonconforming product or service by one or more of the
following ways:

by taking action to eliminate the detected nonconformity?

by authorising its use, release or acceptance under a concession by a relevant
authority and, where applicable, by the customer?

by taking action to preclude its original intended use or application?

For reworked and repaired products and rectified services to be re-inspected, re-tested or
evaluated to demonstrate conformity with the requirements?

For records to be maintained of the nature of nonconformities and any subsequent actions taken,
including concessions obtained?
For the service provider to take action appropriate to the effects, or potential effects, of the
nonconformity when a nonconforming product/service is detected after delivery or use has
started?
Analysis of data

8.4

In the processes documented and implemented by the service provider, is provision made for the
service provider to determine, collect and analyse (including trends) appropriate data to
demonstrate the suitability and effectiveness, and for the improvement, of the Quality
Management System (including to suit Clause 8.2)?
8.5
Improvement
8.5.1 Continual improvement

In the procedures documented and implemented by the service provider, is provision made for
the service provider to continually improve the Quality Management System?
8.5.2 Corrective action
In the procedures documented and implemented by the service provider, is provision made:
 For the action the service provider will take to eliminate the causes of nonconformities in order to
prevent their recurrence, including requirements for:

reviewing nonconformities (including customer complaints)?
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Quality Management Systems Guidelines
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determining the causes of nonconformities?
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evaluating the action needed to ensure that nonconformities do not recur?

determining and implementing the action needed and appropriate to the effects of the
nonconformities encountered?

recording the results of the action taken?

reviewing the effectiveness of the corrective action taken?
8.5.3 Preventive action
In the procedures documented and implemented by the service provider, is provision made:

For the action the service provider will take to eliminate the causes of potential nonconformities
in order to prevent their occurrence, including requirements for:

determining potential nonconformities and their causes?

evaluating the action needed to prevent the occurrence of nonconformities?

determining and implementing the action needed?

recording the results of the action taken?

reviewing the effectiveness of the preventive action taken?
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